[{"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:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,50,98,122,151,179,199,222,245,273,296,323,346,369,394,417,439,460,483,510,539,564,588,611,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100638177","reset-challenge-reducing-high-risk-drinking-for-cancer-prevention-100638177",false,"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.","ALL","18 Years","120 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30],"Alcohol Drinking","Heavy Drinking","Binge Drinking",[32,33,34,35,36],"Daily drinking","Binge or Heavy Drinking","Dry January","Abstinence Challenge","30-day break","RECRUITING","2026-06-24",{"date":40,"type":41},"2026-06-26","ACTUAL",{"date":43,"type":41},"2026-06-10",{"date":45,"type":22},"2028-04",{"name":47,"class":48},"University of Oklahoma","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":49},"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":61,"type":22},40,[25],"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.",[65,66],"Mild Cognitive Impairment (MCI)","Amyloid Pathology",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"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":92,"type":41},"2026-06-16",{"date":94,"type":41},"2025-10-01",{"date":96,"type":22},"2026-12-31",{"name":47,"class":48},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":49},"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":106,"type":22},187,[25],"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.",[110],"Patient Outcomes",[112,113],"American Indian (AI)","American Native (AN)","2026-06-08",{"date":116,"type":41},"2026-06-11",{"date":118,"type":41},"2026-02-11",{"date":120,"type":22},"2031-03",{"name":47,"class":48},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"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":132,"type":22},5,[134],"EARLY_PHASE1","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.",[137,138],"Non-small Cell Lung Cancer Stage I","Non-small Cell Lung Cancer Stage II",[140,141],"Non-small Cell Lung Cancer","Nebulization","NOT_YET_RECRUITING","2026-06-03",{"date":114,"type":41},{"date":146,"type":22},"2026-06",{"date":148,"type":22},"2027-06",{"name":47,"class":48},2,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":49},"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":161,"type":22},80,[25],"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.",[165],"Prediabetes",[167,168,169,170],"Diet","Young adults","Fiber","Diabetes","2026-05-28",{"date":173,"type":41},"2026-06-01",{"date":175,"type":22},"2026-08",{"date":177,"type":22},"2028-07-01",{"name":47,"class":48},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":196,"leadSponsor":198,"locationsCount":49},"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.",true,"45 Years",{"count":188,"type":22},16,[25],"The purpose of this study is to compare blood creatine levels following acute oral supplementation of Create Wellness creatine gummies to creatine monohydrate powder.",[192],"Creatine Absorption in Healthy Adults","2026-05-27",{"date":171,"type":41},{"date":146,"type":22},{"date":197,"type":22},"2026-12",{"name":47,"class":48},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":49},"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":207,"type":22},59,"OBSERVATIONAL","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.",[211],"Head and Neck Cancers",[213,167,214,215],"Head and neck cancer","Sarcopenia","Dietary fiber",{"date":143,"type":41},{"date":218,"type":41},"2025-10-31",{"date":220,"type":22},"2027-06-30",{"name":47,"class":48},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":49},"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":231,"type":22},100,[25],"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).",[235,236],"Claudication","Peripheral Artery Disease","2026-05-26",{"date":239,"type":41},"2026-05-29",{"date":241,"type":41},"2024-09-09",{"date":243,"type":22},"2029-07-31",{"name":47,"class":48},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":49},"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":253,"type":22},50,[134],"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.",[257,258],"Burns","Wound Infection",[260,261,262,263,264,265],"Photodynamic Therapy","Methylene Blue","Burn Wound Infection","Antimicrobial Photodynamic Therapy","Reactive Oxygen Species","Burn Wound Bacterial Burden","2026-05-14",{"date":268,"type":41},"2026-05-19",{"date":146,"type":22},{"date":271,"type":22},"2028-05-31",{"name":47,"class":48},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":150},"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":161,"type":22},[25],"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).",[284,285],"Obesity and Overweight","Breastfeeding, Exclusive",[284,285,287,288,289],"Breastmilk","Body Composition","Infant Growth",{"date":291,"type":41},"2026-05-15",{"date":175,"type":22},{"date":294,"type":22},"2027-12",{"name":47,"class":48},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":320,"leadSponsor":322,"locationsCount":49},"100640046","empowered-relief-for-cancer-survivors-with-chronic-pain-100640046","NCT07578376","Empowered Relief® for Cancer Survivors With Chronic Pain","Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain","Inclusion Criteria:\n\nHistory of cancer diagnosis, completion of active cancer treatment, cancer free at the time of enrollment, experience of body pain most or every day, pain duration at least 3 months, and English fluency.\n\nExclusion Criteria:\n\nSignificant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the zoom-based ER class). Life-threatening acute illness (e.g., infection, heart attack, injury), and no access to a computer, a smartphone or a tablet.",{"count":304,"type":22},215,[25],"This randomized controlled study to examine the efficacy of ER class in cancer survivors with chronic pain. Eligible participants will be randomly assigned to a ER class or a waitlist control condition. We will recruit 250 participants with a goal of having 200 completers (20% attrition). Participants in the control condition will be invited to attend ER class after the 3-month observation period.",[308,309],"Chronic Pain Due to Cancer","Pain Catastrophizing",[311,312,313,314,315,316],"Empowered Relief","Chronic Pain","Cancer survivor","Survey Study","Monthly follow-ups","Zoom class","2026-05-11",{"date":266,"type":41},{"date":146,"type":22},{"date":321,"type":22},"2030-04-30",{"name":47,"class":48},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":185,"sex":17,"minAge":186,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":345,"locationsCount":4},"100632595","raising-awareness-of-colorectal-screening-in-american-indian-communities-100632595","NCT07515729","Raising Awareness of Colorectal Screening in American Indian Communities","An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy","AIC-DC","Inclusion Criteria:\n\n* Inclusion for patient interviews: American Indian Men and Women eligible for services at OKCIC and IHS facilities. American Indian Men and Women aged 45 to 75 years who are eligible for colorectal cancer screening.\n* Inclusion for the provider\u002Fstaff\u002Fleadership interviews: Adults (18 to 80 years old) who are employed by the participating clinic.\n* Inclusion for caregiver\u002Fcommunity member interviews: Adults aged 18 and over who are caregivers for patients eligible for CRC screening. Community members who are aged 18 and over.\n\nExclusion Criteria:\n\n* Exclusion for patient interviews: Non-American Indian Men and Women and American Indian Men and Women that are not in the required age range for CRC screenings.\n* Exclusion for provider\u002Fstaff\u002Fleadership interviews: Employees less than 18 years old or people not employed by the participating clinics.\n* Exclusion for caregivers\u002Fcommunity members: People less than 18 years old, not a caregiver for a patient eligible for CRC screening. People less than 18 years old and not a member of the community where the participating clinics are located.","75 Years",{"count":333,"type":22},446,"This study focuses exclusively on American Indian individuals within their communities to enhance health equity and address a critical tribal health priority. American Indian populations experience some of the highest colorectal cancer (CRC) mortality rates in the nation. By conducting research within these communities, this study aims to improve early detection, prevention, and treatment strategies tailored to their specific needs. The findings will help develop targeted interventions to reduce CRC disparities and improve health outcomes for American Indian individuals.",[336],"Colorectal Cancer (CRC)",[112,338,339],"Implementation Science (IS)","Alaskan Native (AN)","2026-05-08",{"date":317,"type":41},{"date":146,"type":22},{"date":344,"type":22},"2030-06",{"name":47,"class":48},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":354,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":150},"100605470","cigar-legislation-and-regulation-in-tobacco-for-the-young-project-clarity-100605470","NCT07162935","Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY)","Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos","CLARITY","Inclusion Criteria:\n\n1. Ages 18 to 24\n2. Report past 30-day use of a cigarillo\n3. Ability to read English at least an 8th grade level\n4. No immediate plans to quit using tobacco\n5. At least 1 prior experience with a flavored tobacco product\n6. U.S. Citizen or permanent resident of the United States.\n\nExclusion Criteria:\n\n1. Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;\n2. Pregnant, planning to become pregnant, or currently breastfeeding;\n3. Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;\n4. Inability to abstain from nicotine\u002Ftobacco products for at least 12 hours\n5. Unwillingness to use the research cigarillos in the lab","24 Years",{"count":356,"type":22},300,[25],"This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients\u002Fadditives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.",[360,361],"Cigar Smoking","Tobacco Use","2026-05-07",{"date":317,"type":41},{"date":365,"type":41},"2026-02-23",{"date":367,"type":22},"2030-05-31",{"name":47,"class":48},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":379,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":49},"100579110","phase-2-empowering-cessation-acs-south-region-100579110","NCT06820034","Empowering Cessation ACS South Region","Empowering Smoking Cessation for People With High Levels of Stress and Low Social Support in Oklahoma and the ACS South Region","CHERC","Exclusion criteria:\n\n* Currently using other smoking cessation treatments.\n* Unable or unwilling to use Nicotine Replacement Therapy (NRT)\n* Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)\n\nInclusion criteria will be:\n\n1. ≥ 18 years old\n2. sexual and\u002For gender minority-identified (SGM) (see definition below)\n3. living in Oklahoma, Texas, or Arkansas (verified by address)\n4. a current cigarette smoker (see definition)\n5. willing to quit smoking within 30 days of enrollment (see definition)\n6. ability to read and speak English 'well' or 'very well'\n7. ≥ weekly internet access\n8. willing and able to participate in SGM-serving volunteer activities.\n9. own a smartphone\n\nSexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state).\" Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by \"Trans male\u002FTrans man;\" \"Trans female\u002FTrans woman;\" \"Gender queer\u002FGender non-conforming;\" \"Different identity (please state)\" or a binary identity (male or female) non-concordant with natal sex.\n\nCurrent cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes \"every day\" or \"some days\".\n\nHigh SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'. High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index.\n\nWillingness to quit smoking will be assessed with a single item: \"Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes\u002Fno)\". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the \"Preparation\" stage of change).",{"count":378,"type":22},400,[380,381],"PHASE2","PHASE3","Sexual and\u002For gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.",[384],"Smoking Cessation",[386],"smoking cessation","2026-05-05",{"date":317,"type":41},{"date":390,"type":41},"2025-08-14",{"date":392,"type":22},"2028-12-31",{"name":47,"class":48},{"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":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":414,"leadSponsor":416,"locationsCount":49},"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":403,"type":22},62,[380],"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.",[407],"Head and Neck Cancer",[407,409,410,411],"Ketamine","Oral Rinse","Radiation",{"date":340,"type":41},{"date":146,"type":22},{"date":415,"type":22},"2027-11",{"name":47,"class":48},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":49},"100585711","comparison-between-spectacles-and-contact-lenses-100585711","NCT06905912","Comparison Between Spectacles and Contact Lenses","Comparison Between FL41 Tinted Spectacles, Biomedics55 Premier Contact Lenses, and Altius Tinted Contact Lenses on Photophobia","Two hundred voluntary subjects will be recruited by researching those who have purchased FL-41 tinted spectacles from the Dean McGee Eye Institute Optical Department. If this does not recruit enough subjects then subject referrals will be solicited from the patient population of the Dean McGee Eye Institute and\u002For neurology clinics throughout the Oklahoma City metro area.\n\nSubjects must meet the following criteria in order to participate in this study:\n\n* Subjects must have worn FL-41 tinted spectacles for at least one month prior to participating in this study.\n* Subjects must have at least 20\u002F30 distance visual acuity in each eye while wearing the contact lenses. Altius lenses are currently available in spherical powers from plano to -6.00.\n* Subjects must demonstrate the ability to insert and remove contact lenses. Assistance from friends and family is acceptable.\n* Subjects must not have an infectious or progressive ocular disease.\n\nSubjects not meeting all of the above criteria will be excluded from participating in this study.\n\nEarly Termination:\n\nIf a subject feels their photophobia increases to an intolerable level, they can stop wearing that contact lens type and switch to the other the next day or terminate participation in the study. If this occurs, the data from those subjects will still be included in the study data analysis.\n\nIf a subject or physician feel that the health of their cornea is at risk, the subject will cease wearing all contact lenses and seek medical care from the Dean McGee Eye Institute.\n\n\\-",{"count":425,"type":22},200,[25],"Many people suffer from migraine headaches, some more so than others and a common trigger\u002Fcomplaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work\u002Fschool\u002Fsocial activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.",[429],"Photophobia",[429,431],"Light Sensitivity","2026-04-28",{"date":387,"type":41},{"date":435,"type":22},"2026-07-01",{"date":437,"type":22},"2027-12-31",{"name":47,"class":48},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":447,"minAge":18,"maxAge":186,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":49},"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":449,"type":22},240,[134],"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.",[453],"Infertility","2026-04-27",{"date":432,"type":41},{"date":457,"type":22},"2026-05",{"date":197,"type":22},{"name":47,"class":48},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":480,"leadSponsor":482,"locationsCount":49},"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* 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",{"count":469,"type":22},496,[380],"Although the prevalence of smoking has declined among U.S. adults, smoking remains the leading preventable cause of cancer incidence and mortality. Quitting smoking increases life expectancy, and quitting at an earlier age is associated with more years of life gained. Effective pharmacotherapies to aid cessation are available, and the combination of behavioral support with pharmacotherapy optimizes cessation outcomes. Varenicline is an effective, first-line smoking cessation treatment, and recent research has investigated combination pharmacotherapy to improve the modest quit rates observed with monotherapy. The findings of two meta-analyses have indicated that varenicline combined with the nicotine patch was more effective than varenicline alone for smoking cessation However, 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.",[384],[384,474,475,476,477],"Varenicline","Nicotine Lozenges","Medication Adherence","Smartphone Intervention",{"date":432,"type":41},{"date":457,"type":22},{"date":481,"type":22},"2029-06-01",{"name":47,"class":48},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":498,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":49},"100579207","phase-2-efficacy-of-a-smartphone-based-jitai-to-reduce-drinking-among-adults-experiencing-homelessness-100579207","NCT06821295","Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness","Efficacy of a Smartphone-Based Just-In-Time Adaptive Intervention to Reduce Drinking Among Adults Experiencing Homelessness","SmartT_A","Inclusion Criteria:\n\n* At least 18 years old\n* 8 or above on the AUDIT\n* Receiving shelter-based services\n* Consuming 1 or more standard drink of alcohol in the past week\n* Score of 4 or higher on the REALM-SF\n* Score under 8 on the 6CIT\n\nExclusion Criteria:\n\n* Under 18 years old\n* Not meeting other inclusion criteria",{"count":492,"type":22},600,[380,381],"Approximately 1 out of every 3 adults experiencing homelessness has a current alcohol use disorder (AUD). Alcohol use plays a central role in increased morbidity and mortality in this population, with some studies suggesting it plays a direct role in as many as 17% of deaths. Alcohol is also a leading cause of homelessness and contributes to its chronicity by inhibiting progress toward obtaining employment and a stable living environment. Shelter-based treatments are common, but compliance is often poor. There are many documented challenges to effectively implementing traditional evidence-based interventions in shelter settings. In the current project, we will conduct a randomized controlled trial. Adults currently experiencing homelessness who report hazardous alcohol use (N = 600) will be recruited from five shelters across the Dallas, TX and Oklahoma City, OK metropolitan areas. Individuals will attend screening and training visits, then complete one week of self-monitoring (via smartphone app) before being randomized to receive either standard shelter-based treatment (Usual Care; UC), or the Smart-T Alcohol intervention + UC. The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period will span eight-weeks (i.e., weeks 2-9), with follow-up assessments occurring at weeks 9, 13, and 26. All participants will complete brief daily smartphone-based surveys for 13 weeks. Aims of the project will be to assess the effects of the Smart-T Alcohol intervention on alcohol use and alcohol-related problems (Aim 1), intervention effects on key drinking risk indicators and their mediation of use outcomes (Aim 2), and identify specific subpopulations (e.g., women, racial\u002Fethnic minorities, younger adults; Exploratory Aim 3) for which the intervention is most effective. Findings will provide a rigorous evaluation of the efficacy of the Smart-T Alcohol intervention and guide future smartphone-based interventions for this population.",[496,497],"Alcohol Misuse","Homeless",[499,500,501,502],"Just In Time Adaptive Intervention","Mobile Health","homeless","ecological momentary assessment",{"date":504,"type":41},"2026-05-01",{"date":506,"type":41},"2025-03-05",{"date":508,"type":22},"2029-04-30",{"name":47,"class":48},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":49},"100571876","remote-physical-activity-programming-to-improve-outcomes-in-cancer-survivors-with-and-without-type-2-diabetes-100571876","NCT06725953","Remote Physical Activity Programming to Improve Outcomes in Cancer Survivors With and Without Type 2 Diabetes","Cerebrovascular, Cognitive, Pro-Inflammatory, and Cardiometabolic Outcomes in Cancer Survivors With and Without Type II Diabetes Reporting Chemo-Brain: Baseline Differences and Impact of Activity","CICI-PA","Inclusion Criteria:\n\n1. ≥18 years old\n2. ability to speak\u002Fread English\n3. ability to provide informed consent\n4. underwent treatment within the last three years for a non-central nervous system-related cancer with said treatment having included chemotherapy\n5. self-reported cognitive difficulties following cancer treatment\n6. For CS+T2D: current T2D diagnosis as classified by a fasted blood glucose of ≥126 mg\u002FdL, 2-hour oral glucose tolerance test of ≥200 mg\u002FdL, HbA1c level of ≥6.5%, or use of medications to treat hyperglycemia (e.g., Metformin) or For CS: no current T2D diagnosis as classified by a fasted blood glucose \\\u003C100 mg\u002FdL, 2-hour oral glucose tolerance test \\\u003C140 mg\u002FdL, or HbA1c level of \\\u003C5.7%. Presence\u002Fabsence of T2D to be confirmed preferentially via physician's documentation\n7. own smartphone and\u002For computer with internet access\n8. willing to participate in the 12-week remotely-delivered PA program\n\nExclusion Criteria:\n\n1. reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding \"Yes\" to any of the follow-up questions except \\[1\\] if the individual indicates that they have high blood pressure but subsequent responses indicate that they do not have problems keeping it under control and that their resting blood pressure is less than 160\u002F90 mmHg, and \\[2\\] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications)\n2. engaging in ≥75 min\u002Fweek of vigorous-intensity PA, ≥150 min\u002Fweek of moderate-intensity PA, or an equivalent combination of both over the last 3 months\n3. currently a prisoner, pregnant, or planning to become pregnant during study.",{"count":519,"type":22},38,[25],"The growing U.S. cancer survivor population is projected to hit 26M by 2040. Chemotherapy represents an effective cancer treatment but can diminish cancer survivors' quality of life-particularly cognitive function-through select pathophysiological processes. Research on chemotherapy-induced cognitive impairment (hereafter, 'chemo-brain') is therefore critical. Chemotherapy disrupts immune system function and antioxidant regulation, causing inflammatory molecule release and damaging the brain's blood vessels. The brain's vascular function and, possibly, its neurons, are subsequently impaired-likely contributing to chemo-brain. Type 2 diabetes (T2D), a common cancer survivor comorbidity, shares underlying pathophysiology with chemo-brain. T2D-related insulin resistance can precipitate repeated high blood sugar episodes which increase inflammatory molecule release. In individuals with T2D without cancer, negative relationships are observed between inflammatory molecule concentrations and the brain's vascular and\u002For cognitive function. Cancer survivors with T2D might thus have higher chemo-brain risk than those without T2D. Yet, more research must compare how the brain's vascular function, as well as cognitive, inflammatory, and cardiometabolic indices, differ between these groups. Physical activity (PA) counteracts chemo-brain's and T2D's pathophysiology, with higher PA\u002Ffitness resulting in better vascular function of the brain, lower inflammatory molecule concentrations, and improved insulin sensitivity. We are therefore conducting a 30-participant quasi-experimental pilot study in cancer survivors with (cases) and without (controls) T2D. We will first investigate between-group differences in the brain's vascular function as well as cognitive, inflammatory, cardiometabolic, and epigenetic outcomes. We will then examine between-group changes in these outcomes and select psychosocial metrics during a 12-week technology-based PA program-potentially further elucidating involved mechanisms.",[523,524],"Cancer Survivorship","Chemotherapy Side Effects",[526,527,528,529,530,531,532],"Aerobic Physical Activity","Resistance Training","Wearable Devices","Smartphone Applications","Cancer Survivors","Chemo-Brain","Health Outcomes",{"date":504,"type":41},{"date":535,"type":41},"2025-03-10",{"date":537,"type":22},"2027-02",{"name":47,"class":48},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":49},"100567710","self-determination-theory-informed-occupational-therapy-program-to-increase-physical-activity-among-survivors-of-breast-cancer-100567710","NCT06671730","Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer","Digitally Mediated Occupational Therapy Program to Increase Physical Activity in Urban and Rural Breast Cancer Survivors Who Have Undergone Breast-conserving Surgery or Mastectomy","SDOTS","Inclusion Criteria:\n\n1. ≥18 years old.\n2. Ability to speak\u002Fread English.\n3. Ability to provide informed consent.\n4. Having ever received a histologically confirmed diagnosis of invasive breast carcinoma.\n5. Having undergone breast conserving surgery or mastectomy for BC in the last 12 months.\n6. Owning a smartphone and\u002For computer with internet access.\n7. Willing to participate in once-weekly telehealth-delivered OT sessions for eight weeks.\n\nExclusion Criteria:\n\n1. Currently undergoing chemotherapy or radiation as primary cancer treatment.\n2. Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months.\n3. Presence of distant metastasis.\n4. Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q+) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding \"Yes\" to any of the follow-up questions except \\[1\\] if the individual indicates that they have high blood pressure but subsequent responses indicate that both they do not have problems keeping it under control and that their resting blood pressure is less than 160\u002F90 mmHg, and \\[2\\] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications).\n5. Already engaging in ≥ 75 min\u002Fweek of vigorous-intensity PA, ≥ 150 min\u002Fweek of moderate-intensity PA, or an equivalent combination of both over the last 3 months.\n6. Being a prisoner, pregnant, or planning to become pregnant.\n7. Currently participating in another PA- or OT-based study, or seeking physical therapy or occupational therapy treatment.",{"count":519,"type":22},[25],"We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). The telehealth-based delivery of this OT program circumvents some barriers to OT access and participation (e.g., time burden; distance to OT clinic) among breast cancer survivors- particularly important for Oklahoma given that 33% of residents live in rural areas. Additionally, the focus of this program is to promote the preferred aerobic PA and MSE choices of each individual survivor to increase the likelihood of long-term PA engagement. In turn, participants will be more likely to experience the longer-term benefits associated with PA such as improved physical functioning, reduced anxiety, depressive, and pain symptoms, better sleep, and better cardiorespiratory fitness.",[551],"Breast Cancer Survivor",[526,553,554,555,556,528,557],"Muscle Strengthening Exercise","Patient Reported Outcomes","Feasibility","Acceptability","Telehealth",{"date":504,"type":41},{"date":560,"type":41},"2024-11-27",{"date":562,"type":22},"2026-05-31",{"name":47,"class":48},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":150},"100538900","phase-2-dyadic-financial-incentive-treatments-for-dual-smoker-couples-100538900","NCT06296849","Dyadic Financial Incentive Treatments for Dual Smoker Couples","Randomized Controlled Trial of Dyadic Financial Incentive Treatments for Dual Smoker Couples: Evaluation of Efficacy, Mechanisms, and Cost Effectiveness (1R01CA276594-01A1)","Inclusion Criteria:\n\n* 1\\) age of 18+; 2) smoking of 5+ cigarettes\u002Fday; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months.\n\nExclusion Criteria:\n\n* 1\\) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use.\n\nInclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll.",{"count":572,"type":22},900,[380],"Smokers partnered with other smokers (i.e., dual-smoker couples) represent \\~2\u002F3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.\n\nThe investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.",[576],"Smoking, Cigarette",[386,578,579,580],"dual-smoker couples","behavioral economics","financial incentives",{"date":582,"type":41},"2026-04-29",{"date":584,"type":41},"2024-01-18",{"date":586,"type":22},"2028-05",{"name":47,"class":48},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":185,"sex":17,"minAge":595,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":49},"100484386","phase-4-beta-adrenergic-modulation-of-drug-cue-reactivity-100484386","NCT05587361","Beta-Adrenergic Modulation of Drug Cue Reactivity","Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms","Inclusion Criteria:\n\n1. Generally healthy\n2. Age 21-60\n3. Right-handed using a three-item scale\n4. Daily smoker of ≥ 5 cigarettes\u002Fday delivering 0.5 mg nicotine (FTC)\n5. Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months\n6. Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and\u002For morning urinary cotinine \\>100 ng\u002Fml\n7. Must identity at least 4 different smoking locations used in a typical week\n8. Able to read and understand English\n\nExclusion Criteria:\n\n1. Inability to attend all required sessions\n2. Significant health problems that would preclude active participation\n3. Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)\n4. Current use of psychoactive medications\u002Fdrugs as indicated by self-report or urine screen\n5. Positive breath alcohol concentration\n6. Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)\n7. Problems with vision that cannot be corrected with contacts or glasses\n8. Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes)\n9. Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications\n10. Systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg (sitting or standing)\n11. Abnormal EKG\n12. Presence of severe anemia\n13. Presence of electrolyte imbalance that could impact blood pressure\n14. Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)","21 Years","60 Years",{"count":161,"type":22},[599],"PHASE4","This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.",[602,603,604],"Tobacco Use Disorder","Nicotine Dependence","Cigarette Smoking",{"date":432,"type":41},{"date":607,"type":41},"2024-11-26",{"date":609,"type":22},"2027-03-31",{"name":47,"class":48},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":49},"100453726","a-culturally-tailored-smartphone-application-for-african-american-smokers-100453726","NCT05188287","A Culturally Tailored Smartphone Application for African American Smokers","Identifying the Barriers and Facilitators of Participation in mHealth Research Among African Americans Using a Mixed-Methods Approach.","HC","Study Inclusion Criteria\n\n* Must be 18 years of age or older\n* Must identify as Black\u002FAfrican-American\n* Must smoke at least 5 cigarettes or cigarette equivalents per day (i.e., cigarettes, cigars, and cigarillos)\n* Must be willing to use NRT, a smartphone watch and app, and a smoking cessation counselor to help them quit smoking\n* Must be willing to quit smoking within the next 3 weeks\n* Must have a CO level of \\>6 ppm at app activation.\n* Are not currently active, defined as engaging in less than 150 minutes of moderate-intensity aerobic physical activity (e.g., brisk walking) or 75 minutes of vigorous-intensity aerobic physical activity (e.g., running or jogging) each week?\n\nStudy Exclusion Criteria\n\n* Does not give permission to administer screening survey\n* Does not understand or speak English\n* Is not a U.S. citizen or permanent U.S. resident\n* Does not use tobacco products\n* Does not want to provide SSN, residency status, or OUHSC employee status\n* Is not willing to abstain from smoking marijuana or cannabis during their quit attempt\n* Is not willing to upload a picture of their tobacco product\n* Is not ready to quit smoking as defined by scoring 4 or lower on the readiness to quit ladder\n* Has a medical condition that prevents the use of NRT without approval from a healthcare provider\n* Has had a serious allergic reaction or side effect from the use of NRT\n* Does not give permission to collect contact information\n* Must not be currently active, defined as engaging in less than 150 minutes of moderate-intensity aerobic physical activity (e.g., brisk walking) or 75 minutes of vigorous-intensity aerobic physical activity (e.g., running or jogging) each week.",{"count":620,"type":22},30,[25],"The overall objectives of this research proposal, are to (a) create a smartphone application for smoking cessation (i.e., HealthyCells), which will be achieved by integrating two pre-existing evidence-based smartphone interventions, (b) create culturally tailored treatment content (i.e., messages, images, and videos) for African American smokers, and (c) evaluate the feasibility of HealthyCells at addressing smoking and sedentary behavior among African Americans. A pilot sample of African American smokers (N = 15) will briefly use the HealthyCells app and provide critical feedback through semi-structured interviews to refine the smartphone intervention. Once the HealthyCells app is refined, African Americans (N = 30) who are interested in quitting smoking will use the app during a scheduled quit attempt. Starting on the scheduled quit date, HealthyCells will prompt participants to complete twice-daily remote smoking status assessments to earn rewards for abstinence. The app will deliver real-time messages telling participants to stand up and move around during prolonged bouts of sedentary behavior (i.e., ≥ 30 minutes of uninterrupted time spent in a sitting, reclining, or lying posture). Participants will also have on-demand access to culturally tailored information and strategies for remaining abstinent and reducing sedentary behavior within the HealthyCells app. The primary outcomes will be biochemically confirmed point prevalence smoking abstinence at 8 weeks post-quit date, and the difference in sedentary time 7 consecutive days before quitting compared with 7 consecutive days at 8-weeks post-quit, as measured by a research-grade accelerometer.",[384],{"date":504,"type":41},{"date":626,"type":41},"2025-02-03",{"date":628,"type":22},"2026-07-31",{"name":47,"class":48},{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":648,"leadSponsor":650,"locationsCount":49},"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":638,"type":22},20,[380],"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.",[642,643,644],"Rheumatoid Arthritis","Inflammation","Obesity","2026-04-24",{"date":432,"type":41},{"date":457,"type":22},{"date":649,"type":22},"2028-04-30",{"name":47,"class":48},""]