[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Oklahoma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,49,79,103,126,148,172,200,225,245,271,290,313,342,374,394,423,470,494,520,547,564,586,608,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100649992","feasibility-and-acceptability-of-empowered-relief-for-american-indians-with-pain-during-and-after-cancer-treatment-100649992",false,"NCT07742449","Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment","ejames3","Inclusion Criteria:\n\n* Identifies as American Indian\n* Has history of a cancer diagnosis\n* Is currently undergoing or has completed active cancer treatment\n* Experiences body pain most or every day\n* Pain duration at least 3 months\n* English fluency\n\nExclusion Criteria:\n\n* Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)\n* Life-threatening acute illness (e.g., infection, heart attack, injury)\n* No access to a computer, a smartphone, or a tablet","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.",[27,28,29,30,31],"Cancer","Pain","Pain Management","Chronic Pain","American Indian or Alaska Native",[27,33,28,30,34,35],"Cancer Survivor","Native American","American Indian","NOT_YET_RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-20","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2027-12",{"name":46,"class":47},"University of Oklahoma","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100600603","phase-2-trial-of-varenicline-with-nicotine-lozenges-and-a-smartphone-medication-adherence-intervention-for-smoking-cessation-100600603","NCT07099638","Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation","Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation","COMBOII","Inclusion Criteria:\n\n* Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents)\n* Reports daily smoking ≥5 cigarettes per day\n* Provides a breath CO sample ≥6ppm to verify current smoking\n* Willing to schedule a smoking cessation attempt within the next 1-2 weeks\n* Willing to abstain from smoking cannabis or other combustible products during the study\n* Willing to use varenicline and nicotine lozenges\n* Willing to participate in the study for ≈6 months\n* Able to demonstrate \\>6th grade literacy which is necessary to read intervention materials and complete study assessments\n\nExclusion Criteria:\n\n* Does not own a smartphone that is compatible with the study app\n* Using an FDA-approved smoking cessation medication within the past 30 days\n* Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days\n* History of seizures (varenicline contraindication)\n* History of allergic reaction to varenicline\n* Pregnant, planning to become pregnant, or currently breastfeeding\n* Unwilling or unable to use varenicline or nicotine lozenges for other reasons (e.g., severe dry mouth, past history of severe medication side effects)\n* Other medical reasons at the discretion of the prescribing physician (e.g., uncontrolled hypertension, recent myocardial infarction)\n* Weekly or more frequent use of combustible cannabis during the past 30 days with a score ≥2 on the Cannabis Use Disorder Identification Test-Short Form",true,{"count":59,"type":21},496,[61],"PHASE2","No published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings\u002Fwithdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.",[64],"Smoking Cessation",[64,66,67,68,69],"Varenicline","Nicotine Lozenges","Medication Adherence","Smartphone Intervention","RECRUITING","2026-08-17",{"date":73,"type":40},"2026-08-19",{"date":75,"type":40},"2026-07-21",{"date":77,"type":21},"2029-06-01",{"name":46,"class":47},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":48},"100566810","phase-2-head-and-neck-cancer-patients-with-oral-mucositis-treated-with-ketamine-oral-rinse-100566810","NCT06660017","Head and Neck Cancer Patients With Oral Mucositis Treated With Ketamine Oral Rinse","Ketamine Oral Rinse in the Management of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy","Inclusion Criteria:\n\n1. Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure.\n2. At least 18 years-of-age at the time of signature of the informed consent form (ICF).\n3. Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.\n5. The patients has received at least one radiation treatment for (HNSCC) the current disease.\n6. CTCAE v. 5.0 grade 2 or greater oral cavity or pharyngeal mucositis documented to have developed after initiation of radiotherapy.\n7. Males or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Male patients must also refrain from donating sperm during participation in the study.\n\nExclusion Criteria:\n\n1. Inability to sign an informed consent form.\n2. Any other malignancy diagnosed or treated within 10 years prior to enrollment.\n3. Any documented hypersensitivity to ketamine.\n4. Contraindication for ketamine use, including allergy.\n5. Patients with schizophrenia, acute psychosis, or any psychiatric disorder that could be dangerous if exacerbated.\n6. Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least \\\u003C\\\u003C6\\>\\> months after the last administration of study treatment.\n7. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.\n8. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n9. Patients with a prior or concurrent malignancy whole natural history or treatment does not have potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n10. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.","99 Years",{"count":88,"type":21},62,[61],"This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment.",[92],"Head and Neck Cancer",[92,94,95,96],"Ketamine","Oral Rinse","Radiation",{"date":37,"type":40},{"date":99,"type":21},"2026-09",{"date":101,"type":21},"2027-11",{"name":46,"class":47},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":125},"100327345","phase-1-reveal-biomarkers-of-engraftment-after-alternative-donor-hsct-100327345","NCT03541889","REVEAL Biomarkers of Engraftment After Alternative Donor HSCT","Multi-institutional Prospective Pilot Research of Imaging and Blood Biomarker EValuation of Engraftment After ALlogeneic Hematopoietic Stem Cell Transplantation","REVEAL","Inclusion Criteria:\n\nGeneral\n\n* Ability to undergo 18F FLT imaging without sedation\n* Patients \\> 4 years of age and less than 80 years of age at highest risk for graft failure: cord blood HSCT, haplo HSCT, or lack of engraftment by day 28.\n* Diagnosed with a condition for which hematopoietic stem cell transplant (HSCT) is standard of care and HSCT is planned (Arm A) or occurred (Arm B)\n* In morphologic remission prior to HSCT\n* Patient or guardian able to give informed consent\n* Investigational therapies within past 28 days or planned on protocol are pre-approved by the PI or Site PI\n* Karnofsky or Lansky performance status \\> 60%\n\nArm A\n\n* A1 Cord blood recipients: Absence of donor specific antibodies to cord HLA\n* Haplo-identical recipients: ≥ 5\u002F10 and \\\u003C 7\u002F8 allele mismatch donor\n* A2- myeloablative Haplo-identical transplant is planned\n* A3- reduced intensity Haplo-identical transplant is planned (non-myeloablative is excluded)\n* A1- myeloablative or reduced intensity transplant is planned (non-myeloablative is excluded)\n* Diagnosed with a condition for which hematopoietic stem cell transplant (HSCT) is standard of care and HSCT is planned\n* Total bilirubin \\\u003C 2.5 mg\u002FdL (unless documented Gilbert's syndrome) and transaminases (ALT and AST) \\\u003C 5 x the upper limit of normal\n* Creatinine clearance or GFR \\> 60 ml\u002Fmin\u002F1.73 m2. (performed pre-HSCT)\n* FEV1 \\> 80% pre or post-bronchiolator whichever is higher and DLCO Adj \\> 70% (performed pre-HSCT if age appropriate) and Sa02 \\> 94% on room air\n* Ejection fraction \\> 50% (performed pre-HSCT)\n\nArm B\n\n• Non-engraftment recipients of HCT with any donor source (related or unrelated): primary graft failure as defined by ANC not \\> 500 for 3 consecutive days and at least 20 days after HSCT.\n\nInclusion Criteria - Donors\n\n* 1-2 cords and \\>.4\u002F6 match to recipient for each (as per current National Marrow Donor guidelines), with a dose \\>2 x 10e6 CD34 cells\u002Fkg for each cord OR \\> 5\u002F10 and \\\u003C7\u002F8 allele mismatch related donor\n* Institutional guidelines met for donor suitability\n\nExclusion Criteria:\n\n* History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent\n* Clinically significant systemic illness with manifestations of significant organ dysfunction which, in the judgment of the PI, or Co-I, would render the patient unlikely to tolerate the protocol therapy or complete the study\n* Presence of active malignancy from an organ system other than hematopoietic\n* Pregnant or lactating females\n* Patients who are unable or unwilling to use effective form (s) of contraception during the course of the study\n* Prior history of fluorothymidine allergy or intolerance\n* Decline enrolment on CIBMTR research protocol","4 Years","80 Years",{"count":114,"type":21},50,[116],"PHASE1","The purpose of this study is to find new tests that could help determine if the newly infused bone marrow cells are growing well after bone marrow transplantation or if new bone marrow cells are needed. The Investigator will use FLT imaging, an investigational imaging test, and collect blood samples to investigate whether the cells are growing well.",[119],"Primary Graft Failure",{"date":37,"type":40},{"date":122,"type":40},"2020-10-21",{"date":101,"type":21},{"name":46,"class":47},4,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":48},"100456987","neuromodulation-of-inflammation-and-endothelial-function-100456987","NCT05230732","Neuromodulation of Inflammation and Endothelial Function","Neuromodulation of Inflammation and Endothelial Function to Treat Elderly Patients With Systolic Heart Failure","Inclusion Criteria:\n\nSystolic heart failure with EF \\\u003C or equal to 50%.\n\nExclusion Criteria:\n\n1. patients in overt congestive heart failure \u002F recent acute myocardial infarction (\\\u003C 4 weeks) or Unstable angina\n2. Active malignancy\n3. unilateral or bilateral vagotomy\n4. pregnant patients\n5. End stage liver disease\n6. history of recurrent vasovagal syncope, Sick sinus syndrome with no pacemaker, 2nd or 3rd degree AV block.\n7. Significant hypotension (Blood pressure \\\u003C 90 mm Hg) secondary to autonomic dysfunction","85 Years",{"count":135,"type":21},158,[24],"Heart failure with reduced ejection fraction (HFrEF) is a major cause of mortality in United States. Aging is a major risk factor for adverse outcomes associated with HFrEF, with majority of the patient's over the age of 50, continuing to experience symptoms, reduced exercise capacity and poor quality of life. We have previously demonstrated that low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) suppresses inflammation in patients with atrial fibrillation and diastolic dysfunction and improved endothelial dysfunction in patients with chronic heart failure. The overall objective of this proposal is to examine the effects of LLTS on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function. Our specific aims include: 1. To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2. To determine the effects of medium-term LLTS on sympathovagal\u002Fautonomic balance (assessed by heart rate variability) and systemic inflammation in patients with HFrEF and 3. To determine the effects of medium-term LLTS on endothelial function in patients with HFrEF. The proposed proof-of-concept human studies will provide the basis for the design of further human studies using LLTS among larger populations with HFrEF. In light of the increasing number of elderly patients who continue to experience HFrEF symptoms, recognized is a key point of interest in this funding mechanism, and the suboptimal success of the currently available treatment options to ameliorate the problems mentioned above, an alternative novel approach such as LLTS has the potential to impact clinical practice and improve health outcomes among the large number of patients. It is anticipated that these investigations will contribute to a broader understanding of the role of autonomic imbalance, inflammation and endothelial dysfunction in the pathogenesis of HFrEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of autonomic tone, inflammation and endothelial function affects one of the hallmarks of HFrEF will lead to the development of normal nonpharmacological and pharmacological approaches to treat this disease.",[139],"Systolic Heart Failure","2026-08-06",{"date":142,"type":40},"2026-08-11",{"date":144,"type":40},"2022-09-01",{"date":146,"type":21},"2027-02-27",{"name":46,"class":47},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":57,"sex":17,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100632989","efficacy-of-the-buzzy-system-on-pain-and-fear-reduction-in-elbow-fracture-pin-removal-100632989","NCT07520851","Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal","Inclusion Criteria:\n\n* between 3 to 10 years old\n* undergoes percutaneous pinning of an elbow fracture\n\nExclusion Criteria:\n\n* under age 3 or over age 10\n* unable to quantify or express their pain\n* Lack of parental consent\n* Absence of caregiver during procedure","3 Years","10 Years",{"count":157,"type":21},75,[24],"The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of elbow fracture pin.",[161],"Elbow Fractures",[163],"Pin Pulling","2026-07-28",{"date":166,"type":40},"2026-07-30",{"date":99,"type":21},{"date":169,"type":21},"2027-04",{"name":46,"class":47},2,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100612540","feasibility-of-a-multi-channel-intervention-to-promote-colorectal-cancer-screening-among-american-indians-in-oklahoma-100612540","NCT07254910","Feasibility of a Multi-Channel Intervention to Promote Colorectal Cancer Screening Among American Indians in Oklahoma","YVONNE","Inclusion Criteria:\n\n* Age 45-75 Live within IHS Clinton Service Unit catchment area Fluent in English and read at or above 6th grade level Self report as American Indian or have CDIB\n\nExclusion Criteria:\n\n* Self report up to date with CRC screening FIT within 1 year","45 Years","75 Years",{"count":182,"type":21},150,[24],"The Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS) Program addresses major regional CRC screening disparities among AI in Oklahoma. The investigators are engaged in a participatory and collaborative effort with Tribal Nations, Area Indian Health Boards, and Indian Health Service (IHS) healthcare facilities. The overall objective of this proposal is to leverage these relationships and examine the feasibility of co-developing and disseminating a v-TCHE as part of a multi-channel communication intervention. To achieve this objective, the investigators have partnered with IHS Clinton Service Unit, which serves members of the Cheyenne and Arapaho Tribes. The intervention will be disseminated across two channels: (1) Social Media (i.e., accessed via online study adverts) and (2) Clinic (i.e., direct messaging to patients via a study link in a SMS text). Across both channels, the investigators will examine reach of the intervention and its potential efficacy via a randomized controlled trial. Once participants click on the study link they will be randomized 1:1 to one of two intervention conditions: (1) watch a Narrative Testimonial Video of a real-life Tribal community health educator (control) or (2) an interaction with a v-TCHE. Participants will then complete a post-intervention survey, in which they can click to order a FIT kit afterwards.",[186,187],"CRC Screening","CRC (Colorectal Cancer)",[189,190,191,192,193],"colorectal screening","virtual clinician","multi-channel communication","tribal outreach","Tribal Nations",{"date":166,"type":40},{"date":196,"type":21},"2026-08-30",{"date":198,"type":21},"2026-09-30",{"name":46,"class":47},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":48},"100611241","promoting-active-living-among-people-with-metastatic-breast-cancer-100611241","NCT07238023","Promoting Active Living Among People With Metastatic Breast Cancer","Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer","Inclusion Criteria:\n\n* having been diagnosed with metastatic breast cancer\n* medical clearance from healthcare provider to participate in this study\n* life expectancy of at least 6 months as per the participant's healthcare provider\n* Eastern Cooperative Oncology Group performance status of or 0 or 1\n* being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available\n* adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report\n* adequate motor capacity to use a smartphone and web interface as indicated by self-report\n* willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes as needed\n* completed baseline survey\n\nExclusion Criteria:\n\n* contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider)\n* presence of bone metastases deemed unstable by the treating healthcare provider.\n* untreated brain metastases\n* history of dementia or other major neurocognitive disorder\n* received a diagnosed of Major Depressive Disorder within the previous 6 months\n* received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and\u002For complete the study\n* currently hospitalized\n* enrolled in hospice\n* inability to speak, read, and write in English at the 7th grade level",{"count":208,"type":21},38,[24],"Individuals with metastatic breast cancer are living longer but often face persistent fatigue, functional decline, and psychological distress. Physical activity is generally safe for this population and may alleviate symptom burden. Yet, limited interventions are tailored to the unique and needs and preferences of this population. This study aims to evaluate the acceptability and feasibility of a mindfulness- and acceptance-based physical activity program designed to support mental, social, and spiritual well-being among people with metastatic breast cancer. A single group, pretest-posttest trial (N=38) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.",[212],"Metastatic Invasive Breast Cancer",[214,215,216,217,218],"aerobic physical activity","muscle strengthening physical activity","mindfulness","acceptance","telehealth",{"date":166,"type":40},{"date":221,"type":40},"2026-02-27",{"date":223,"type":21},"2026-12",{"name":46,"class":47},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":233,"minAge":18,"maxAge":179,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":244,"locationsCount":48},"100610340","early-phase-1-the-hysterosalpingogram-hsg-experience-and-tubal-spasm-heat-study-100610340","NCT07226310","The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study","The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial","HEAT","Inclusion Criteria:\n\n1\\. Women ages 18-45 undergoing tubal assessment via HSG.\n\nExclusion Criteria:\n\n1. History of fibroids\n2. History of pelvic inflammatory disease (PID or STD including gonorrhea, chlamydia, or trichomonas)\n3. History of surgically diagnosed endometriosis or suspected endometriosis on ultrasound (indicated by visualization of likely endometrioma)\n4. History of ectopic pregnancy or 3 or more biochemical pregnancies\u002Fpregnancy of unknown location\n5. History of tubal or ovarian surgery\n6. History of known Mullerian anomaly\n7. History of pelvic surgery including appendectomy\n8. Allergy to iodine-based contrast media\n9. History of prior abnormal fallopian tubes on HSG\n10. History of ultrasound with hydrosalpinx (unilateral or bilateral)","FEMALE",{"count":235,"type":21},240,[237],"EARLY_PHASE1","The hysterosalpingogram (HSG) is the gold standard of assessing fallopian tube patency and involves the placement of a transcervical catheter to allow for instillation of radio-opaque dye into the uterine cavity and fallopian tubes which are then imaged with abdominal x-ray. A common side effect of the instillation of dye is the uterine cramping, which is both uncomfortable for the patient as well as can cause iatrogenic proximal occlusion of the fallopian tubes. Proximal tubal obstruction is often not representative of true tubal obstruction but is rather an artifact of the test. Prior studies measuring the perceived pain and cramping during HSG have been conducted which have shown reduced pain scores and decreased uterine cramping when warmed contrast dye is used. The researchers propose that the use of warmed contrast media during HSG will be correlated with decreased pain scores and fewer cases of proximal tubal occlusion in women with otherwise normal uterine anatomy.",[240],"Infertility",{"date":166,"type":40},{"date":99,"type":21},{"date":223,"type":21},{"name":46,"class":47},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":171},"100594066","smoking-cessation-program-for-lao-people-with-hiv-100594066","NCT07014605","Smoking Cessation Program for Lao People With HIV","Implementing Sustainable Mobile Health Technology to Optimize Smoking Cessation Program for Lao People With HIV","I-STOP","Inclusion Criteria:\n\n1. aged ≥18 years\n2. reachable within 30 days of the target assessment date by different methods (up to 4 phone calls on different days and times, 3 text messages for each platform \\[e.g., SMS, Telegram, or WhatsApp\\], 3 emails if applicable, and via direct contact at a prescheduled clinic appointment if applicable)\n3. consenting to be contacted after 6 months of enrollment and able to provide written informed consent to participate.\n\nExclusion Criteria:\n\n* None.",{"count":254,"type":21},1200,[24],"Tobacco use remains the leading modifiable risk factor for preventing cancer globally, particularly among people with HIV (PWH). In Laos, 61-80% of male PWH and 3-10% of female PWH smoke cigarettes. PWH who smoke in Laos have no reliable smoking cessation support. Thus, implementing sustainable and evidence-based smoking cessation interventions for PWH in Laos is needed. The investigators developed a scalable and affordable mHealth-based automated treatment program (MAP) to support Lao and Cambodian smokers to quit smoking. MAP involves interactive, tailored, personalized content (text messages, photos, and videos) delivered via a smartphone app. Along with effective cessation treatments, it is imperative to implement procedures to identify patients who smoke and to connect them to treatment. Our team pioneered the Ask-Advise-Connect (AAC, asking patients about smoking at every visit, briefly advising those who smoke to quit, and connecting them to treatment) approach, which showed great impact in our previous US studies. The purpose of this study is to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 6 most populous regions in Laos, using a hybrid type-2 pragmatic effectiveness-implementation study and a parallel cluster randomized trial design. Specifically, the investigators will compare an AAC approach paired with our previously developed MAP (AA-MAP) to an AAC approach paired with less resource-intensive printed self-help material (AA-SH). The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM), which expands the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to include more contextual factors relevant to program implementation. Aim 1 is to evaluate the reach and effectiveness of AA-MAP versus AA-SH. Reach is the proportion of PWH who smoke and are willing to make a quit attempt that enroll in treatment. Effectiveness is the proportion of enrolled participants who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. The investigators will also estimate the real-world impact (impact = reach × effectiveness) of each intervention. Aim 2 is to determine other implementation outcomes of AA-MAP and AA-SH. Aim 3 is to assess the resource use and costs of implementing AA-MAP and AA-SH. The project has the potential to transform HIV care and to reduce tobacco-related cancers and other morbidities.",[64,258],"HIV",[260,261,262,263,264],"smoking cessation","cancer control","implementation science","low- and middle-income countries","mobile health",{"date":166,"type":40},{"date":267,"type":21},"2026-08",{"date":269,"type":21},"2029-07-31",{"name":46,"class":47},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":57,"sex":17,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":289,"locationsCount":48},"100323760","outcomes-in-simulated-endoscopy-training-100323760","NCT03495141","Outcomes in Simulated Endoscopy Training","Simbionix GI Mentor Simulated Endoscopy Training","Inclusion Criteria:\n\n* Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center.\n\nExclusion Criteria:\n\n* Unwilling to consent.","22 Years","50 Years",{"count":114,"type":21},[24],"Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised\u002Fcoached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised\u002Fcoached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.",[284],"Impact of Supervision on Endoscopy Simulation Curriculum",{"date":166,"type":40},{"date":287,"type":40},"2018-03-06",{"date":223,"type":21},{"name":46,"class":47},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":233,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":48},"100649526","phase-2-evaluating-the-addition-of-ok-1-weekly-paclitaxel-in-patients-with-endometrial-cancer-100649526","NCT07737795","Evaluating the Addition of OK-1 Weekly Paclitaxel in Patients With Endometrial Cancer","A Single Arm Phase 2 Trial With a Safety Lead in Evaluating the Addition of OK-1 to Weekly Paclitaxel in Patients With Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* At least 18 years-of-age at the time of signature of the informed consent form (ICF).\n* Histologically documented carcinoma of the endometrium, including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed, or is refractory to curative therapy or established treatments.\n* Must have pre-treatment archival tissue.\n* Measurable disease by RECIST v1.1 is required for the phase 2 portion of the study. Patients with accessible disease are eligible for the safety lead in cohorts. Patients with biochemical recurrent disease only (ie Ca125 elevation or ctDNA elevation in absence of visible disease on CT scan are NOT eligible)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Adequate organ function, defined in study protocol.\n* Prior therapy: Patients must have received ≥1 platinum-based therapy in the recurrent\u002Fmetastatic setting and not more than 5 prior lines of therapies.\n\n  * Adjuvant therapy given for early stage, high risk endometrial cancer does NOT count as the line of qualifying platinum based chemotherapy unless disease recurrence is documented \\\u003C 12 months from completion. If \\>12 months has elapsed, patients should receive another line of platinum based chemotherapy.\n  * Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase \\[PARP\\] inhibitor, endocrine therapy or immune checkpoint inhibitor will be considered part of the preceding line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently)\n  * Hormonal therapy will not be counted as a separate line of therapy.\n  * Patients should have received an immune checkpoint inhibitor as part of a prior line of therapy unless contraindicated to participate in this trial.\n  * If the Patient has a tumor that is HER2 3+, trastuzumab deruxtecan should have been used unless ineligible.\n  * During the course of this clinical trial, if an antibody drug conjugate becomes available therapy for recurrent endometrial cancer, patients should be treated with that therapy unless ineligible\n* The patient must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.\n* QTcF \\\u003C 470 msec\n\nExclusion Criteria:\n\n* Patients who have received prior weekly paclitaxel for recurrent endometrial cancer.\n* Major surgical procedure within 28 days prior to registration, or anticipation of need for major surgical procedure during the study. Note: Placement of a vascular access device, thoracentesis, and\u002For paracentesis will not be considered major surgery.\n* Women who are pregnant or are unwilling to discontinue nursing.\n* Evidence of bleeding diathesis or clinically significant coagulopathy within the past 3 months. Patients are not excluded for past or current use of anticoagulation.\n* There is no prespecified washout from prior therapies.\n* Patients with adverse events related to prior therapies must have resolution to \\\u003C grade 1. Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. Note: Grade 2 neuropathy is neuropathy on one medication so patients may be eligible following discussions with the medical monitor.\n\nAdditional exceptions include immune-related AEs such as adrenal insufficiency, hypothyroidism (controlled), endocrine-related toxicities due to checkpoint inhibitor treatment (can be corrected through hormone replacement therapy) and Grade 2 laboratory abnormalities that meet the eligibility requirements.\n\n* Patients currently taking and unwilling\u002Funable to discontinue the use of drugs that are known to be strong\u002Fmoderate inhibitors or inducers of CYP3A4, CYP2C8, CYP2C19, and CYP2C9. (Refer to Appendix III)\n* Comorbid Conditions: No active infection requiring parental antibiotics except for urinary tract infection.\n* No evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula, gastrointestinal perforation, or GI obstruction requiring gastrostomy tube. NOTE: required interval since last bowel obstruction: 30-day minimum for incomplete obstruction, resolved with conservative means; 6 months for fistula. Patients with a history of a large bowel obstruction that has been successfully diverted and do not meet the criteria for small bowel obstruction are eligible.\n* Patients with risk factors for torsade de pointes (TdP) such as clinically significant heart failure (defined as a known ejection fraction \\\u003C 50%), uncorrected grade 2 or greater hypokalemia, family history of long QT syndrome )",{"count":298,"type":21},66,[61],"The purpose of this study is to evaluate whether treatment with the investigational drug OK-1 in combination with paclitaxel can reduce tumor burden in patients with advanced or recurrent endometrial cancer (A\u002FR-EC).",[302],"Endometrial Cancer",[304,305,306],"OK-1","A\u002FR-EC","ShetA2","2026-07-27",{"date":166,"type":40},{"date":267,"type":21},{"date":311,"type":21},"2029-08",{"name":46,"class":47},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":329,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":48},"100645458","testing-warning-labels-for-retail-cannabis-products-using-a-discrete-choice-experiment-100645458","NCT07701304","Testing Warning Labels for Retail Cannabis Products Using a Discrete Choice Experiment","Developing and Testing Warning Labels for Retail Cannabis Products","Eligibility for participation includes: 1) being 21 years of age or older, 2) being able to speak and understand English, 3) self-reported having consumed cannabis in the last 30 days (any mode, e.g., flower, vape, edible, etc.), and 4) residing in a U.S. state or jurisdiction where retail (i.e., non-medical) cannabis use is legal.","21 Years",{"count":322,"type":21},450,[24],"This discrete choice experiment (DCE) study aims to address gaps in cannabis packaging regulatory research by testing how variations in cannabis packaging and health warning design impact reactions to packaging and intentions about cannabis use. The goal of this work is to identify the most effective combination of health warning features to improve consumer awareness of cannabis health risks. Establishing criteria for cannabis products in the US is critical because inconsistent state guidelines have resulted in contradictory policies in legal retail states, arguably leading to increased hazardous use and failure to meet public health standards. The contributions of this study's outcomes are expected to be significant because they will benefit public health as cannabis becomes available in legal retail markets and regulatory and governmental agencies seek effective ways to communicate cannabis risks to the public.",[326,327,328],"Cannabis Use","Risk Perception","Decision Making",[330,331,332,333,334],"Cannabis warning labels","Discrete choice experiment","Risk perception","Cannabis use","Health communication","2026-07-24",{"date":307,"type":40},{"date":338,"type":40},"2026-05-19",{"date":340,"type":21},"2026-12-31",{"name":46,"class":47},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":351,"phases":4,"briefSummary":352,"conditions":353,"keywords":362,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":48},"100649344","analysis-of-breath-volatile-organic-compounds-using-mass-spectrometry-100649344","NCT07732686","Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry","Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)","Inclusion Criteria:\n\n* Age ≥ 18 at the time of consent. Male and female patients to be tested.\n* Capable of understanding written and\u002For spoken English language.\n* Able to provide informed consent.\n* Cancer of any type.\n* Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)\n\nExclusion Criteria:\n\n* Under the age of 18.\n* Anticipated inability to complete breath sampling procedure.\n* Unable to provide informed consent.\n* Pregnant women\n* Active respiratory infection symptoms\n* Recent use of antibiotics\n* Difficulty in performing coached exhalation\n* Individuals who are unable to follow the instructions\n* Cancer patients who are on active treatment for cancer or have received cancer treatment within one month",{"count":350,"type":21},2000,"OBSERVATIONAL","The purpose of this clinical trial is to evaluate whether volatile organic compound (VOC) signatures detected in the breath of patients with cancer can serve as a potential screening tool for the early detection of cancer.",[354,355,356,357,358,92,359,360,361],"Pancreas Cancer","Hepatocellular Carcinoma","Lung Cancer","Ovarian Cancer","Breast Cancer","Colon Cancer","Bladder Cancer","Other Cancer",[363,364,365],"VOC","PTR-MS","ML","2026-07-23",{"date":368,"type":40},"2026-07-29",{"date":370,"type":21},"2026-10",{"date":372,"type":21},"2029-10",{"name":46,"class":47},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":393,"locationsCount":48},"100634026","phase-2-disulfiram-in-rheumatoid-arthritis-100634026","NCT07534332","Disulfiram in Rheumatoid Arthritis","Therapeutic Targeting of Gasdermin D-Mediated Pyroptosis to Attenuate Joint Inflammation in Rheumatoid Arthritis","Inclusion Criteria:\n\nAge 18-75 years Body mass index (BMI) ≥25 kg\u002Fm² Diagnosis of rheumatoid arthritis (RA) according to ACR\u002FEULAR classification criteria Active disease defined as Clinical Disease Activity Index (CDAI) \\>10 Stable disease-modifying antirheumatic drug (DMARD) therapy for ≥3 months prior to enrollment Willingness to abstain from alcohol for the duration of the study Ability and willingness to comply with study procedures\n\n\\-\n\nExclusion Criteria:\n\nSignificant liver dysfunction (ALT or AST \\>2.5× upper limit of normal) Current or recent alcohol dependence (based on screening, e.g., AUDIT) Known hypersensitivity to disulfiram or other thiuram derivatives Pregnancy or breastfeeding Severe cardiovascular disease (e.g., myocardial infarction, arrhythmia, coronary occlusion) Severe psychiatric illness (e.g., psychosis, suicidal ideation) Neurologic disorders (e.g., epilepsy, peripheral neuropathy, cerebral damage) Chronic or acute renal disease (e.g., nephritis) Hepatic cirrhosis or hepatic insufficiency Use of contraindicated medications (e.g., metronidazole, phenytoin, paraldehyde, alcohol-containing preparations, warfarin) Other autoimmune diseases or active\u002Fchronic infections Diabetes mellitus or hypothyroidism Allergy to topical iodine Any condition that, in the opinion of the investigator, would pose undue risk or interfere with study participation",{"count":382,"type":21},20,[61],"Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent joint inflammation and systemic immune activation. Obesity is common among individuals with RA and is associated with increased disease activity, reduced treatment response, and worse functional outcomes. Inflammation in adipose tissue, driven in part by activation of the NLRP3 inflammasome and downstream gasdermin D (GSDMD)-mediated pathways, may contribute to systemic inflammation and RA disease severity.\n\nDisulfiram (DSF), an FDA-approved medication for alcohol use disorder, has recently been identified as an inhibitor of GSDMD-mediated inflammatory signaling and pyroptosis. Preclinical studies suggest that DSF reduces inflammasome activation, inflammatory cytokine release, and metabolic dysfunction.\n\nThis study is a 12-week, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the safety, tolerability, and preliminary efficacy of DSF in overweight and obese adults with active RA despite stable disease-modifying antirheumatic drug (DMARD) therapy. Participants will be randomized to receive either DSF (250 mg daily) or placebo.\n\nThe primary objective is to assess safety and tolerability. Secondary and exploratory objectives include evaluating the effects of DSF on systemic inflammation, RA disease activity, metabolic parameters, and adipose tissue inflammasome activation. Findings from this study will inform the feasibility and design of larger clinical trials targeting GSDMD-mediated inflammation in RA.",[386,387,388],"Rheumatoid Arthritis","Inflammation","Obesity",{"date":307,"type":40},{"date":99,"type":21},{"date":392,"type":21},"2028-04-30",{"name":46,"class":47},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":409,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":48},"100638177","reset-challenge-reducing-high-risk-drinking-for-cancer-prevention-100638177","NCT07591428","Reset Challenge: Reducing High-risk Drinking for Cancer Prevention","Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge","Inclusion Criteria:\n\n* Adults +18\n* Individuals who drink alcohol regularly\n* Further inclusion criteria will be determined via a Zoom screening with a member of the research staff.\n* Current Oklahoma Resident\n\nExclusion Criteria:\n\n\\- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.","120 Years",{"count":182,"type":21},[24],"This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.",[406,407,408],"Alcohol Drinking","Heavy Drinking","Binge Drinking",[410,411,412,413,414],"Daily drinking","Binge or Heavy Drinking","Dry January","Abstinence Challenge","30-day break","2026-06-24",{"date":417,"type":40},"2026-06-26",{"date":419,"type":40},"2026-06-10",{"date":421,"type":21},"2028-04",{"name":46,"class":47},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":431,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":48},"100642202","using-light-therapy-for-mild-cognitive-impairment-100642202","NCT07651787","Using Light Therapy for Mild Cognitive Impairment","Neurovascular and Mitochondrial Mechanisms of Transcranial Photobiomodulation in Vascular Mild Cognitive Impairment","LTMC","Inclusion Criteria:\n\n* Age: 55-95 years of age\n* Clinical Dementia Rating (CDR) equal to 0.5 and\u002For Montreal Cognitive Assessment (MoCA) \\\u003C26 and ≥19\n* Adequate hearing and visual acuity to participate in the examinations\n* English speaker\n* Presence of cerebrovascular pathology confirmed by structural brain imaging method\n\nExclusion Criteria:\n\n* Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer\n* Cerebrovascular accident other than TIA within 60 days prior to Visit 0\n* Diagnosis of amyloid angiopathy\n* Major psychiatric disease, including major depression not controlled on medications, alcohol or drug abuse\n* Neurodegenerative diseases, e.g: Parkinson's, any kind of dementia\n* Patients currently using commercial brain stimulation \u002F neuromodulation device as part of a research study\n* Patients currently take dietary supplements with an expected cerebrovascular benefit such as NAD- or NR-supplementum, L-citrullin, urolithin\n* Unstable medical condition, including uncontrolled diabetes, chronic heart issues, heart failure, chronic obstructive pulmonary disease, hypertension uncontrolled by medication (\\>160\u002F100 mmHg)\n* Any other medical condition or medication which, in the opinion of investigator, would render the patient too unstable to complete the study protocol\n* Severe sensory deficits interfering with the testing","55 Years","95 Years",{"count":434,"type":21},40,[24],"The goal of this clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in people with mild cognitive impairment (MCI). The main questions it aims to answer are:\n\n* Does tPBM enhance cognitive function and cerebral hemodynamic responses during memory and finger tapping tasks?\n* Does tPBM reduce oxidative stress, inflammation, and mitigate brain cell damage?\n* Is cognitive improvement linked to amyloid status, greater cerebral hemodynamic response, and lower levels of brain inflammation and oxidative stress? Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation.\n\nParticipants will:\n\n* Receive a 20-minute-long active tPBM or sham stimulation session once per day, 6 times per week, for 12 weeks.\n* Complete questionnaires and an iPad-based cognitive testing protocol.\n* Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG). Dynamic analysis of the vessels in the eye will also be performed based on eligibility. Transcranial Doppler (TCD) flowmetry is optionally performed.\n* Provide blood samples to test for biomarkers of inflammation, oxidative stress, and brain cell damage.",[438,439],"Mild Cognitive Impairment (MCI)","Amyloid Pathology",[441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463],"Cognition","Neurovascular Coupling Mechanism and Cognitive Function","Neurovascular Control","Brain Aging","Brain Activity","Mild Congitive Impairment (MCI)","Amyloid","Transcranial photobiomodulation","Near-infrared spectroscopy","Cerebral hemodynamics","Near-infrared light therapy","NIH Toolbox Cognition Battery","Electroencephalography","Amyloid-positive mild cognitive impairment","Amyloid-negative mild cognitive impairment","Extracellular vesicles","Neuroinflammation","Proinflammatory cytokines","Home-based neuromodulation","Non-invasive brain stimulation","Sham-controlled clinical trial","Randomized clinical trial","photobiomodulation therapy",{"date":465,"type":40},"2026-06-16",{"date":467,"type":40},"2025-10-01",{"date":340,"type":21},{"name":46,"class":47},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":48},"100609668","program-in-oncology-for-tribal-health-systems-100609668","NCT07217574","Program in Oncology for Tribal Health Systems.","Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO)","Inclusion Criteria:\n\n* Participants must be at least 18 years of age, within eight weeks of newly diagnosed cancer confirmed by pathology\u002Fimaging, navigated through the NANP at SCC and have verbal fluency in English.\n\nExclusion Criteria:\n\n* Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.",{"count":478,"type":21},187,[24],"This clinical trial aims to develop and implement more navigation assistance programs tailored specifically for Native American cancer patients, addressing the current lack of available support. The goal is to improve communication barriers within the healthcare system by fostering a collaborative approach between the Stephenson Cancer Center (SCC) and tribally operated healthcare systems (ITU). Through this partnership, the trial seeks to enhance patient outcomes by providing culturally sensitive, coordinated care.",[482],"Patient Outcomes",[484,485],"American Indian (AI)","American Native (AN)","2026-06-08",{"date":488,"type":40},"2026-06-11",{"date":490,"type":40},"2026-02-11",{"date":492,"type":21},"2031-03",{"name":46,"class":47},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":171},"100643840","early-phase-1-nebulized-aer101-in-pre-op-nsclc-100643840","NCT07631299","Nebulized AER101 in Pre-op NSCLC","Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)","AER101","Inclusion Criteria:\n\n* 18 years or older\n* Agree to sign consent and follow study requirements\n* Recently diagnosed with lung adenocarcinoma or squamous cell carcinoma\n* Primary patients prior to resection\n* Candidate for surgery (patients are qualified for inclusion if surgery or radiation treatment are agreed to)\n* Baseline PET\u002FCT imaging performed at Stephenson Cancer Center available and performed within previous 30 days\n\nExclusion Criteria:\n\n* Recurrent tumor(s)\n* Nodal or metastatic tumor (multiple lung tumors are acceptable)\n* Pregnant patients\n* Patients unable to provide informed consent\n* Prisoners","100 Years",{"count":504,"type":21},5,[237],"The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is the process cells use to break down sugar (glucose) into a smaller substance in the fluid part inside the cell. Many lung cancers begin in bronchi, bronchioles and alveoli cells surrounding the airways, which enables nebulization to deposit AER101 on lung tumors.\n\nParticipants in the study will self-administer AER101 via a hand-held personal nebulizer three times per day (dosing at least 4 hours apart) for 14 days prior to undergoing surgery for lung cancer.",[508,509],"Non-small Cell Lung Cancer Stage I","Non-small Cell Lung Cancer Stage II",[511,512],"Non-small Cell Lung Cancer","Nebulization","2026-06-03",{"date":486,"type":40},{"date":516,"type":21},"2026-06",{"date":518,"type":21},"2027-06",{"name":46,"class":47},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":544,"leadSponsor":546,"locationsCount":48},"100630744","fiber-mhealth-intervention-for-prediabetes-100630744","NCT07491653","Fiber mHealth Intervention for Prediabetes","Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study","GO-FAR","Inclusion Criteria:\n\n* Pre-diabetes based on HbA1c\n* Young adult, aged 18-39 years\n* Reside near Tulsa metro area\n* Ability to access\u002Fuse a compatible smartphone\n* Proficient in English\n\nExclusion Criteria:\n\n* Suspected eating disorder\n* Current glucagon-like peptide-1 receptor agonist use\n* Food allergies or intolerances\n* Currently pregnant or breastfeeding","39 Years",{"count":530,"type":21},80,[24],"This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber foods, and use of continuous glucose monitors.",[534],"Prediabetes",[536,537,538,539],"Diet","Young adults","Fiber","Diabetes","2026-05-28",{"date":542,"type":40},"2026-06-01",{"date":267,"type":21},{"date":545,"type":21},"2028-07-01",{"name":46,"class":47},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":563,"locationsCount":48},"100640705","acute-pharmacokinetics-of-create-wellness-gummies-in-healthy-adults-100640705","NCT07579455","Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults","Inclusion Criteria:\n\n* Adults between the ages of 18-45 yrs\n* Body mass index of \\\u003C35 kg\u002Fm2\n* Recreationally active \\[(≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire (IPAQ)\\]\n* Healthy and free from major diseases as determined from screening call and health history questionnaire.\n* Agrees to complete pre-assessment guidelines (8-hour fast from caloric foods and beverages, 24-hour abstention from vigorous physical activity, caffeine, alcohol, and tobacco).\n\nExclusion Criteria:\n\n* Chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer.\n* Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).\n* Currently using creatine monohydrate\n* Severely impaired hearing or speech or inability to speak English.",{"count":554,"type":21},16,[24],"The purpose of this study is to compare blood creatine levels following acute oral supplementation of Create Wellness creatine gummies to creatine monohydrate powder.",[558],"Creatine Absorption in Healthy Adults","2026-05-27",{"date":540,"type":40},{"date":516,"type":21},{"date":223,"type":21},{"name":46,"class":47},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":351,"phases":4,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":48},"100637601","the-role-of-dietary-fiber-in-mitigating-sarcopenia-risk-in-head-and-neck-cancer-100637601","NCT07622914","The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer","A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer","Inclusion Criteria:\n\n* ≥18 years of age\n* Newly diagnosed with squamous cell carcinoma of the: paranasal sinuses, nasal cavity, oral cavity, tongue, larynx, pharynx \\[i.e., nasopharynx, oropharynx, hypopharynx\\]\n* Meeting at least 60% of baseline energy needs\n* Willingness to provide data prior to treatment\n* Access to the internet\n* Access to a home freezer\n* Ability to do remote interview\n* Access to a phone\n* Willingness to avoid pre-, pro-, or synbiotics\n\nExclusion Criteria:\n\n* Previously diagnosed or positive screen for a GI-related condition or eating disorder\n* Able to complete bioelectrical impedance (stand unsupported, no pacemaker or limb amputation) and Timed Chair Stands\n* Currently pregnant, planning to become pregnant, or breastfeeding\n* Current or past 3-month antibiotic use",{"count":572,"type":21},59,"Emerging data suggest consumption of dietary fiber before and during cancer treatment may improve prognosis for patients with head and neck cancer, in part via increased production of short chain fatty acids, systemic anti-inflammatory effects, and decreased risk of sarcopenia. Foods rich in dietary fiber are often low in calories and protein, thus are not typically targeted in current treatment paradigms that focus on countering the catabolic state associated with sarcopenia. This project entails an observational, mixed methods study to: observe dietary fiber intake in patients with head and neck cancer from time of diagnosis for six months; elucidate the relationship between dietary fiber intake, short chain fatty acids, inflammatory markers, and sarcopenia; and explore the feasibility of and patient perceptions regarding promoting dietary fiber as part of their treatment approaches.",[575],"Head and Neck Cancers",[577,536,578,579],"Head and neck cancer","Sarcopenia","Dietary fiber",{"date":513,"type":40},{"date":582,"type":40},"2025-10-31",{"date":584,"type":21},"2027-06-30",{"name":46,"class":47},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":593,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":607,"locationsCount":48},"100493994","the-effects-of-a-novel-non-ischemic-and-pain-free-exercise-intervention-in-peripheral-artery-disease-100493994","NCT05712395","The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease","NICE","Inclusion Criteria:\n\n1. history of claudication assessed by the Walking Impairment Questionnaire,\n2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,\n3. an ABI \\\u003C= 0.90 at rest or \\> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.\n4. age \\>= 40 years.\n\nExclusion Criteria:\n\n1. absence of PAD (ABI \\> 0.90 at rest and ankle systolic blood pressure \\\u003C 20% decrease after exercise,\n2. inability to obtain an ABI measure due to non-compressible vessels (ABI \\> 1.40),\n3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,\n4. rest pain due to PAD (Fontaine stage III)\n5. tissue loss due to PAD (Fontaine stage IV)\n6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,\n7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,\n8. exercise tolerance limited by any disease process other than PAD,\n9. active cancer,\n10. kidney failure defined as stage 5 chronic kidney disease,\n11. a calf skin fold measurement \\> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,\n12. pulse arterial oxygen saturation of the index finger \\\u003C 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and\n13. failure to complete the baseline run-in phase within three weeks.","40 Years",{"count":595,"type":21},100,[24],"This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).",[599,600],"Claudication","Peripheral Artery Disease","2026-05-26",{"date":603,"type":40},"2026-05-29",{"date":605,"type":40},"2024-09-09",{"date":269,"type":21},{"name":46,"class":47},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":621,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":631,"leadSponsor":633,"locationsCount":48},"100630984","early-phase-1-topical-methylene-blue-photodynamic-therapy-mb-pdt-for-burn-wound-infection-100630984","NCT07494773","Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection","Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study","Inclusion\n\n* Age ≥18\n* Partial- or full-thickness burn with partial-thickness component\n* Expected ≥7 days dressing changes\n* Able to consent\n\nExclusion\n\n* Pregnancy or lactation\n\n  o Pregnancy status will be determined by review of the medical record and, when clinically indicated per institutional policy, standard-of-care pregnancy testing. No additional pregnancy testing will be performed solely for research purposes.\n* Current use of SSRIs, SNRIs, MAO inhibitors, and other serotonergic agents\n* Inability to tolerate wound exposure\n* Inability to consent\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency",{"count":114,"type":21},[237],"Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria.\n\nThis randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.",[619,620],"Burns","Wound Infection",[622,623,624,625,626,627],"Photodynamic Therapy","Methylene Blue","Burn Wound Infection","Antimicrobial Photodynamic Therapy","Reactive Oxygen Species","Burn Wound Bacterial Burden","2026-05-14",{"date":338,"type":40},{"date":516,"type":21},{"date":632,"type":21},"2028-05-31",{"name":46,"class":47},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":642,"briefSummary":643,"conditions":644,"keywords":647,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":654,"leadSponsor":655,"locationsCount":171},"100619383","impact-of-chia-seeds-on-human-breast-milk-composition-100619383","NCT07343908","Impact of Chia Seeds on Human Breast Milk Composition","An RCT: Impact of Chia Seeds on Human Breast Milk Composition","Inclusion Criteria:\n\n* pre-pregnancy BMI \\>25 kg\u002Fm²\n* Maternal age 18 - 45 years at time of delivery\n* Singleton pregnancy\n* Vaginal delivery\n* Intention to breast feed for at least three months\n* No prescription medications that may interfere with gut microbiome\n* Not taking antibiotics for ≥ 1 week prior to each visit\n* No chia seed supplements during pregnancy\n\nExclusion Criteria:\n\n* Inability to understand English\n* Preterm or post-term birth (gestational age \\\u003C37 or \\>42 weeks)\n* Congenital or other defect or medical condition that would affect the mother's ability to produce milk or the infant's growth or ability to breastfeed\n* Infant eating more than 12 ounces of any liquid other than breast milk in the two weeks prior to each study visit\n* Taking Antibiotics (all), Proton pump inhibitors\u002FH2 blockers, Metformin, NSAIDs, Statins, SSRIs and tricyclic antidepressants",{"count":530,"type":21},[24],"The investigators' over-arching hypothesis is that mechanical and compositional properties of chia seeds supplemented during lactation diminish obesity-induced intestinal inflammation and barrier dysfunction. The investigators hypothesize these changes will result in: 1) reduced maternal systemic inflammation (serum CRP and IL-6) and increased gut microbial diversity and richness, 2) reduced HM fat and inflammatory markers, metrics the research team have demonstrated differ in tandem with maternal metabolic health and 3) improved infant growth\u002Fbody composition. To test these hypotheses, investigators will evaluate chia seed supplementation during lactation in a 6wk multi-site pilot RCT (Aim 1) and through translational studies using human enteroids (Aim 2).",[645,646],"Obesity and Overweight","Breastfeeding, Exclusive",[645,646,648,649,650],"Breastmilk","Body Composition","Infant Growth",{"date":652,"type":40},"2026-05-15",{"date":267,"type":21},{"date":44,"type":21},{"name":46,"class":47},""]