[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Nebraska\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":711},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,49,76,105,128,154,176,200,220,247,268,296,316,346,367,399,431,506,531,554,577,600,634,665,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100623233","development-of-a-real-time-controller-to-estimate-walking-performance-using-a-bilateral-ankle-exoskeleton-100623233",false,"NCT07393971","Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton","Controller Development to Enable Individualized Assistance in Robotic Ankle Exoskeletons","Inclusion Criteria:\n\n* able to walk independently on a treadmill for 10 minutes,\n* free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,\n* no current lower extremity pain or injury,\n* able to wear an exoskeleton and safety harness, can provide informed consent\n\nExclusion Criteria:\n\n* history of neurological disease that affected gait or balance,\n* current or recent lower extremity musculoskeletal injury or surgery,\n* chronic lower extremity pain during walking,\n* inability to participate in moderate-intensity exercise,\n* require an assistive device for walking,\n* any metabolic or systemic diseases that may be exacerbated by exercise",true,"ALL","19 Years","35 Years",{"count":22,"type":23},6,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.",[29],"Healthy Young Adults",[31,32,33,34,35],"robotic ankle exoskeleton","human-in-the-loop optimization","wearable robotics","musculoskeletal modeling","muscle activation analysis","NOT_YET_RECRUITING","2026-08-19",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":23},"2026-09-01",{"date":44,"type":23},"2028-12",{"name":46,"class":47},"University of Nebraska","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100458800","phase-2-trial-of-the-efficacy-and-safety-of-short-and-long-course-radiation-therapy-withwithout-bmx-001-100458800","NCT05254327","Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With\u002FWithout BMX-001","A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma","Inclusion Criteria:\n\n1. Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.\n2. AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.\n3. Adult, age \\> or equal to 18 years (for Nebraska, age of consent is ≥19 years old)\n4. ECOG Performance Status 0-2\n5. Hemoglobin ≥ 9.0 g\u002Fdl, ANC ≥ 1,500 \u002Fdl, platelets ≥ 100,000 \u002Fdl (The use of transfusion or other intervention to achieve Hgb \\> 9.0 g\u002Fdl is acceptable)\n6. Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal\n7. Adequate renal function defined as follows:\n\n1)Serum creatinine \\\u003C 1.5 mg\u002Fdl within 2 weeks prior to enrollment or 2)Creatinine clearance (CC) ≥ 50 ml\u002Fmin within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\]\u002F\\[(Serum Cr mg\u002Fdl) x (72)\\], CCr female = 0.85 x (CrCl male) 8. Signed, written informed consent prior to completing any study specific procedures 9. Negative pregnancy test for women of child-bearing potential at the time of screening 10. Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment 11. Chest\u002FAbdominal\u002FPelvic (CAP) CT\u002F pelvic MRI done within 8 weeks prior to randomization.\n\nExclusion Criteria:\n\n1. Breast-feeding or pregnant\n2. Active infection requiring IV antibiotics 7 days before enrollment\n3. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer\n4. Prior history of rectal adenocarcinoma (RAC)\n5. Prior history of pelvic radiotherapy for any other type of malignancy\n6. Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.\n7. Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be excluded unless they are on stable or decreasing corticosteroids dose at the time of randomization.\n\n   BMX-001 Specific Exclusion Criteria (Subjects meeting any of the following criteria are ineligible for study entry)\n8. Inadequately controlled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n9. Active or history of postural hypotension and autonomic dysfunction within the past year\n10. Known hypersensitivity to BMX-001\n11. Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment\n12. History or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment\n13. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment\n14. A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds (ms) (CTCAE grade 1) using the specific\u002Fusual choice by clinical center for correction factor.\n15. A history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome).\n\nNote: Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.","18 Years",{"count":58,"type":23},118,[60],"PHASE2","In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.",[63],"Rectal Cancer",[65],"Radiation","RECRUITING","2026-08-18",{"date":69,"type":40},"2026-08-20",{"date":71,"type":40},"2022-08-15",{"date":73,"type":23},"2029-06",{"name":46,"class":47},3,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100611183","phase-2-abipred--adt-vs-adt-in-psma-positive-conventionally-node-negative-prostate-cancer-100611183","NCT07237269","Abi\u002FPred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer","Abiraterone\u002FPrednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy","Inclusion Criteria:\n\n1. Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.\n2. Targetable PSMA-avid pelvic lymph node measuring \\\u003C1cm in short axis diameter.\n3. No prior definitive treatment or intervention received.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration.\n5. Age ≥ 30 years.\n6. Patient must be able to provide study-specific informed consent prior to study entry.\n7. Patient must be able to swallow medications.\n\nExclusion Criteria:\n\n1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).\n2. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.\n3. Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but are not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.\n4. Severe, active co-morbidity, defined as follows:\n\n   1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months prior to registration.\n   2. Congestive heart failure (NYHA functional capacity class II or greater).\n   3. Transmural myocardial infarction within the last 3 months prior to registration.\n   4. History of stroke or transient ischemic attack within 3 months prior to registration.\n   5. Currently uncontrolled diabetes mellitus.\n   6. Ongoing arrhythmias of Grade \\>2 \\[National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE), version 5.03\\]; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.\n   7. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month.\n   8. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.\n   9. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n   10. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.\n   11. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n   12. Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention definition that is being treated with contraindicated medications, including but not limited to Atazanavir, Saquinavir, Ritonavir, Indinavir, or Nelfinavir. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n   13. Uncontrolled seizures or seizures in the past 3 months. Patients can enroll if their seizures have been well-controlled for \\>3 months on antiseizure medications.\n   14. Gastrointestinal bleeding or any other hemorrhage\u002Fbleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration.\n   15. History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration.\n   16. Total bilirubin ≥1.5X upper limit of normal (ULN) \\[except for subjects with Gilbert's disease, in which case total bilirubin not to exceed 10X ULN\\], alanine (ALT) and aspartate (AST) aminotransferase \\>= 2.5X ULN.","MALE","30 Years",{"count":86,"type":23},140,[60],"The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \\\u003C1 cm in smallest diameter).\n\nThis study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy.\n\nA total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes.\n\nThe primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.\n\nExploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.",[90],"Prostate Cancer",[92,90,93,94,95,96,97],"PSMA-PET","Androgen Deprivation Therapy","Abiraterone","Radiation Therapy","Pelvic Lymphadenopathy","Hormone Therapy","2026-08-17",{"date":37,"type":40},{"date":101,"type":23},"2026-10-15",{"date":103,"type":23},"2033-04-03",{"name":46,"class":47},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100578457","evaluating-the-effects-of-an-electrical-stimulator-on-improving-the-walking-ability-of-children-with-cerebral-palsy-100578457","NCT06811545","Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy","Exploring the Effects of Multi-Joint Neuromuscular Electrical Stimulation on Training Gait of Children With Cerebral Palsy","CP","\\*Inclusion Criteria\\*\n\nCP Group:\n\n* Age 7-18\n* Diagnosis of spastic diplegic cerebral palsy (CP)\n* GMFCS level I-III (be able to walk with or without assistive devices)\n* MIGR \\\u003C 40% femoral head covering in acetabulum\n* Crouch, equinus, or jump gait\n* At least 0° passive dorsiflexion range of motion (ROM)\n* Sufficient visuoperceptual, cognitive, and communication skills\n* Seizure-free or well-controlled seizures\n* No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability\n* Ability to travel to the University of Nebraska at Omaha two times\n* Ability to communicate pain or discomfort\n* Ability to obtain child assent and obtain parent\u002Fguardian consent\n\nHealthy adults (control) group:\n\n* Adults aged 20 to 40\n* Adults with good physical health\n* Adults with the ability to follow verbal instructions\n* Adults with the ability to walk on a treadmill for 15 minutes\n* No orthopedic surgery on the lower limb within the past 3 months\n\n\\*Exclusion Criteria\\*\n\nCP Group:\n\n* Diagnosis of athetoid or ataxic cerebral palsy (CP)\n* Scoliosis with primary curve \\> 49%\n* Spinal fusions extending into the pelvis\n* Lower Extremity (LE) joint instability or dislocation\n* Severe tactile hypersensitivity\n* LE botulinum injections in the past 6 mo\n* Implanted medical device contraindicative of functional electrical stimulation (FES)\n* Pregnancy\n* Severe LE spasticity (Modified Ashworth Scale score of 4 or greater)\n* History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen)\n* History of cardiac disease (American Heart Association, AH,) screen)\n* Excessive LE joint pain during walking\n* Severely limited range of joint motion\u002F irreversible muscle contractures, i.e.\\> 10° knee flexion, \\>15° hip flexion contractures, or \\>5° plantarflexion contractures\n* LE surgery or significant injury within 1 yr.\n\nHealthy adults (control) group:\n\n* Adults with any chronic illnesses or medical conditions that could impact their health.\n* Adults with significant behavioral or emotional issues that could indicate developmental disorders or psychological conditions.\n* Adults with diagnosed developmental disorders (e.g., autism, ADHD, learning disabilities)\n* Adults with surgery on their lower limb within the past 3 months.","7 Years","40 Years",{"count":116,"type":23},65,[26],"The goal of this study is to see if gentle electrical stimulation can help children with cerebral palsy (CP) walk more easily. This stimulation, called neuromuscular electrical stimulation (NMES), sends small pulses to muscles to help them activate. Researchers will test different ways of using NMES to find out which method works best.\n\nParticipants will walk on a treadmill at a comfortable speed while NMES is applied to leg muscles. The study will compare different stimulation settings to see which one helps the most.",[120,121],"Cerebral Palsy Children","Healthy Adults",{"date":37,"type":40},{"date":124,"type":23},"2026-09",{"date":126,"type":23},"2029-07",{"name":46,"class":47},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":146,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100431492","improving-cognitive-function-in-older-adults-undergoing-stem-cell-transplant-100431492","NCT04898790","Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant","Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation","PROACTIVE","Arm 1:\n\nInclusion Criteria for Participants:\n\n* age 60 years and older\n* have a diagnosis of hematological malignancy\n* have received autologous or allogeneic HCT within the prior 3-6 months\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Participants' Care-Partner:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria\n\nArms 2 and 3:\n\nInclusion Criteria for Participants:\n\n* age 55 years and older\n* have a diagnosis of hematological malignancy\n* planned to receive an autologous or allogeneic HCT\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\n* Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n  * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n  * (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes):\n* history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma)\n* history of major stroke with obvious residual deficits\n* history of relapsing and remitting Multiple Sclerosis\n* active moderate to severe psychiatric symptoms due to primary psychiatric disorder\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form\n\nExclusion Criteria for Participants' Care-Partner:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\no Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n* other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria",{"count":137,"type":23},114,[26],"Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.\n\nThe study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners.\n\nThe second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.",[141,142,143,144,145],"Leukemia","Lymphoma","Multiple Myeloma","Myelodysplastic Syndromes (MDS)","Myeloproliferative Neoplasm",[147],"Hematopoietic cell transplantation",{"date":37,"type":40},{"date":150,"type":40},"2021-11-18",{"date":152,"type":23},"2027-07",{"name":46,"class":47},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":48},"100588348","validating-a-blood-test-for-the-detection-of-traumatic-brain-injury-in-children-100588348","NCT06940232","Validating a Blood Test for the Detection of Traumatic Brain Injury in Children","Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) as Acute Biomarkers for Prediction of Traumatic Brain Injury (TBI) in Children","Inclusion Criteria:\n\n* 0-17 years of age\n* Presentation of non-penetrating trauma\n* Blood draw within 24 hours of injury\n* For TBI group: head CT or MRI obtained\n\nExclusion Criteria:\n\n* Presentation to Children's Nebraska after 24 hours of injury\n* 18 years of age or older","17 Years",{"count":163,"type":23},330,"OBSERVATIONAL","The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.",[167],"Pediatric Traumatic Brain Injury","2026-08-11",{"date":170,"type":40},"2026-08-14",{"date":172,"type":40},"2025-05-14",{"date":174,"type":23},"2027-12",{"name":46,"class":47},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":24,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100560200","phase-1-carbon-monoxide-hyperbaric-oxygen-with-steroid-therapy-100560200","NCT06574048","Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy","Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning","CODex","Inclusion Criteria:\n\n* Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization\n* Age \\>18 years\n* Nebraska Medicine admission\n\nExclusion Criteria:\n\n* Mechanical ventilation\n* No hospital admission or admission to hospital Critical Care Medicine Service\n* Allergy to dexamethasone\n* Pre-Existing neurological condition confounding outcome determination",{"count":185,"type":23},20,[187,60],"PHASE1","Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.",[190,191,192,193],"Carbon Monoxide Poisoning","Carbon Monoxide Intoxication","Carbon Monoxide Encephalopathy","Carbon Monoxide-induced Parkinsonism",{"date":170,"type":40},{"date":196,"type":23},"2026-10",{"date":198,"type":23},"2028-01",{"name":46,"class":47},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":24,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":48},"100449658","study-using-prebiotics-to-improve-gut-microbiome-diversity-after-autologous-cellular-therapy-100449658","NCT05135351","Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy","A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy in Multiple Myeloma and Lymphoma: The PRIMAL Trial","Inclusion Criteria:\n\n1. Willing to provide informed consent\n2. Willing to comply with all study procedures and be available for the duration of the study\n3. Has pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma as determined on medical record review per standard of care transplant procedures (no tissue required for study)\n4. Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator\n5. Adult Individuals (male or female) at least 19 years of age\n6. Meeting indications and recommended for first autologous stem cell transplantation by investigator\n\nExclusion Criteria:\n\n1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease\n2. Previous intolerance to fiber supplementation\n3. Allergy or intolerance to potato starch or maltodextrin\n4. Subject unwilling to comply with stool sample collection\n5. Not suitable for study participation due to other reasons at the discretion of the investigators\n\nEligibility Criteria for CAR T-cell Therapy Cohort\n\nInclusion Criteria:\n\n1. Willing to provide informed consent\n2. Willing to comply with all study procedures and be available for the duration of the study\n3. Has pathologically confirmed lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy\n4. Adult Individuals (male or female) at least 19 years of age\n5. Meeting indications and recommended for CAR-T cell therapy by investigator\n\nExclusion Criteria:\n\n1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator\n2. Previous intolerance to fiber supplementation\n3. Allergy or intolerance to resistant starch or maltodextrin\n4. Subject unwilling to comply with stool sample collection\n5. Not suitable for study participation due to other reasons at the discretion of the investigators",{"count":208,"type":23},30,[26],"Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.",[143,142],"2026-07-23",{"date":214,"type":40},"2026-07-27",{"date":216,"type":40},"2022-05-13",{"date":218,"type":23},"2028-07",{"name":46,"class":47},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":24,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":48},"100617172","phase-2-enteral-nutrition-versus-standard-of-care-in-allogeneic-hematopoietic-stem-cell-transplantation-100617172","NCT07315165","Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation","A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Diagnosis of a hematological condition or serious blood disorder\n* Patient planned for an allogeneic hematopoietic stem cell transplant\n* Any conditioning regimen or graft source\n\nExclusion Criteria:\n\n* Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube.\n* Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.",{"count":228,"type":23},112,[60],"This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).",[232],"Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)",[234,235,236,237,238],"Enteral Nutrition","Acute GVHD","Stage 3-4, Stage 2-4 Gut GVHD","Nutritional Support","allo-HSCT","2026-07-22",{"date":241,"type":40},"2026-07-24",{"date":243,"type":23},"2026-07-03",{"date":245,"type":23},"2031-04",{"name":46,"class":47},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":24,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":48},"100423868","novel-dbs-stimulation-patterns-for-treatment-of-parkinsons-disease-100423868","NCT04799470","Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease","Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC\u002FMedtronic Collaborative Acute Feasibility Pilot","Inclusion Criteria:\n\n* Patients with idiopathic Parkinson's Disease who were recommended for STN DBS using standard clinical inclusion and exclusion criteria (e.g., presence of coagulopathy, dementia, untreated depression, pre-existing implanted stimulation system, prior intracranial surgery, history of alcohol or drug abuse)\n* Patients have been previously implanted with bilateral STN DBS and the Medtronic Percept PC implantable neural stimulator.\n* Patients are optimized for clinical stimulation and medication for at least 3 months post-surgery for the implantation of their DBS system.\n* Consent to study participation\n* Presence of a robust beta peak (detectable using the Percept BrainSense Survey feature; ≥ 0.7 µV\u002FrtHz), intra-operatively (assessed via Lead Confirm technology from Alpha Omega)\n* Good response to stimulation (30% improvement on UPDRS III compared to baseline OFF), at least 3 months post-surgery.\n\nExclusion Criteria:\n\n* Not currently implanted with the Medtronic Percept INS\n* Not willing to participate in the study\n* Unstable stimulation with need for frequent reprogramming or further adjustment\n* Significant stimulation-induced side effects\n* Need for unusual programming parameters such as very high (\\> 200 Hz) or low (\\\u003C 100) frequencies (due to cycle limitations)\n* The patient has an implanted cardiac device\n* The patients Medtronic Percept TM PC indicates elective-replacement-indicated (ERI) at the start of the study","80 Years",{"count":256,"type":23},10,[26],"This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with Parkinson's disease (PD) being treated with Deep Brain Stimulation (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patterns designed to better target excessive synchrony in a patient-tailored manner may result in more efficient and effective therapy with fewer side effects. Medtronic 3rd-generation sensing implantable neural stimulator, Percept PC, is FDA-approved for treating PD. The Percept PC device features BrainSense, the first and only available sensing technology for deep brain stimulation. BrainSense technology allows the device to capture and record brain signals (local field potentials, or LFP) using the brain-implanted DBS lead, while simultaneously delivering therapeutic stimulation. Investigators plan to enroll and complete investigations in 15 study subjects total, who have been previously implanted with the Medtronic Percept PC for the treatment of PD, and who are optimized for clinical stimulation and anti-Parkinsons medication. Investigations will be performed in UNMC Movement Disorders Clinic, UNMC Neurosurgery Lab, and UNO Biomechanics Research Building, Gait Lab. Subjects will receive research stimulation patterns and the effect on PD motor symptoms will be assessed via Unified Parkinsons Disease Rating Scale (UPDRS)-part III and gait measures. Videotaping of patient UPDRS-III testing and gait will be obtained.",[260],"Parkinson's Disease","2026-07-20",{"date":239,"type":40},{"date":264,"type":40},"2021-05-10",{"date":266,"type":23},"2028-04",{"name":46,"class":47},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":24,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":48},"100587417","heat-therapy-and-mobility-in-covid-19-survivors-100587417","NCT06928116","Heat thErapy And mobiLity in COVID-19 Survivors","Physical Rehabilitation of Long COVID by Heat Therapy","HEAL","Inclusion Criteria:\n\n* Between the ages of 50 and 90 years\n* Free from orthopedic limitations that would prohibit performing leg exercise\n* BMI \\\u003C 40 kg\u002Fm2 and weigh \\\u003C 400lbs\n* Previously contracted Covid-19 and have persistent symptoms such as a fatigue or decline in physical function, for at least 2 months following SARS-CoV-2 infection\n\nExclusion Criteria:\n\n* Unable to give written informed consent\n* Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months\n* Women who are taking hormone therapy\n* Claustrophobia\n* Orthopedic limitations that would prohibit them from walking\n* Currently enrolled in an exercise-based or respiratory muscle rehabilitation program.","50 Years","90 Years",{"count":279,"type":23},99,[26],"Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC. This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic and vascular health in late-middle aged and older adults with PASC, also known as \"long COVID\".",[283],"Long COVID",[285,286,287],"Heat Therapy","mobility limitations","Post-acute sequelae of SARS-CoV-2 infection (PASC)","2026-07-15",{"date":290,"type":40},"2026-07-17",{"date":292,"type":40},"2025-01-16",{"date":294,"type":23},"2029-08",{"name":46,"class":47},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":315,"locationsCount":48},"100645715","modulating-locomotor-respiratory-coupling-through-adaptive-exoskeleton-assistance-in-patients-with-copd-100645715","NCT07703527","Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD","Inclusion Criteria:\n\n* COPD Diagnosis \\& Severity: Documented FEV1\u002FFVC ratio of \\\u003C 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD).\n* Age Requirement: Must be between 45 and 75 years old.\n* Body Mass Index (BMI): Must have a BMI of less than 35 kg\u002Fm\\^2.\n* Medical Clearance \\& Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician.\n\nExclusion Criteria:\n\n* Failing to pass the initial spirometry test.\n* Not being formally cleared for participation by a physician.\n* Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.","45 Years","75 Years",{"count":256,"type":23},[26],"1\\) Purpose: To improve pulmonary rehabilitation outcomes for individuals with COPD by evaluating the effectiveness of a hip-assisted exoskeleton during a single pulmonary rehabilitation session. 2) Eligibility criteria: Participants must be between 45-75 years old, any gender, but must have a BMI of less than 35 kg\u002Fm\\^2, free from co-morbidities that may affect walking patterns, and must have moderate to severe COPD with no other pulmonary or cardiac issues. (Eligible participants will undergo a screening process which includes 6-minute walking test, medical history exam, and spirometry evaluation.) 3) Intervention and evaluation: The experimental collection will be conducted at the Biomechanics Research Building at the University of Nebraska at Omaha. Participants are required to participate in two sessions on two separate days, both including a 30-minute walking session with one session wearing the hip exoskeleton and the other session without the device.",[308],"COPD (Chronic Obstructive Pulmonary Disease)","2026-07-08",{"date":311,"type":40},"2026-07-14",{"date":124,"type":23},{"date":314,"type":23},"2028-09",{"name":46,"class":47},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":17,"sex":18,"minAge":323,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":48},"100459964","phase-2-safety-and-efficacy-of-cannabidiol-cbd-for-symptoms-of-ptsd-in-adults-100459964","NCT05269459","Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults","Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).","Inclusion Criteria All Participants\n\n* Ability and willingness to provide informed consent\n* Stated willingness to comply with all study procedures and availability for duration of the study\n* Aged 21-65 years\n* Able to read and communicate in English\n* Tetrahydrocannabinol (THC) use less than 3 days per week\n\nPTSD Participants\n\n* Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder (PTSD) on the Mini-Mental State examination (MMS), with symptoms present for at least 1 month\n* Clinician administered Clinical Assessment of Pragmatics (CAPs) score ≥27 at study enrollment and start of Cannabidiol (CBD) observation\n* Stable psychopharmacologic and\u002For psychotherapeutic intervention for 4 weeks prior to enrollment\n\nExclusion Criteria All Participants\n\n* Current use of prescribed or commercially available CBD products, including Epidiolex®\n* Suicidal ideation (as defined by answer of \"yes\" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6 months prior to enrollment)\n* Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)\n* Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the Mini-Mental State examination (MMS); nicotine dependence permitted\n* Self-reported cannabis use on \\> 3 days\u002Fweek starting 4 weeks prior to enrollment\n* Positive urine drug screen for illicit substances other than cannabis\n* Pregnant \\[confirmed by serum human chorionic gonadotropin (hCG) test\\], or breastfeeding\n* Co-morbid medical conditions or concomitant treatments that may adversely impact ability to participate in the trial in the clinical judgment of the investigator \\[e.g., significant immunosuppression due to active chemotherapy, recent organ transplant, uncontrolled diabetes, glomerular filtration rate (GFR) \\\u003C 25ml\u002Fmin or on dialysis, recent acute myocardial infarction (MI), Class IV heart failure, or taking any high-risk drugs for drug-drug interactions\\]\n* Treatment with another investigational drug or other intervention within 3 months prior to enrollment\n* History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis), active bipolar disorder, or borderline personality disorder diagnosed by a mental health professional\n* History of open head injury\n* Self-report of exposure to trauma within 30 days prior to enrollment\n* Active military service in the 30 days prior to enrollment\n* Inpatient psychiatric hospitalization within 6 months prior to enrollment\n* Seizure in the last 6 months\n* Use of concomitant anti-viral human immunodeficiency virus (HIV) medications (PrEP permitted)\n\nControl Participants\n\n* History of diagnosed PTSD\n* Pregnant (self-reported) or breastfeeding\n\nParticipants who consent to functional magnetic resonance imaging (fMRI) procedures\n\n* Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning, in the clinical judgment of the investigator\n* Presence of metal objects in or on the body (e.g., pacemakers, aneurysm clips, metallic prostheses, bone plates, braces, orthodontic devices, cochlear implants\u002Fhearing aids, non-removable piercings\u002Fimplants or metallic-ink tattoos, or shrapnel fragments)\n* Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning, in the clinical judgement of the investigator\n\nPTSD Participants\n\n* Index trauma before age 18 and no other traumatic experiences which could relate\u002Fidentify as part of PTSD\n* History of allergic reaction or significant adverse events (AE) related to cannabis, CBD, or THC\n* Currently involved in events giving rise to PTSD\n* Alanine transaminase (ALT)\u002FAspartate transaminase (AST)\u002FBilirubin \\> 2 x upper limit of normal (ULN) at screening (abnormalities on the comprehensive metabolic panel or complete blood count deemed to be of clinical significance in the judgement of the investigator and clinical team will be evaluated in the clinical context of the participant's history and physical examination to determine eligibility and testing may be repeated if clinically appropriate at the discretion of the investigator)\n* Refusal to use at least one form of birth control throughout study participation \\[including, but are not limited to, male or female condoms, diaphragm, or cervical cap (all with or without spermicide) abstinence, or hormonal\u002Fimplanted birth control, e.g., pill, injection, intra-uterine device (IUD), implant\\] by participants who can become pregnant","21 Years","65 Years",{"count":326,"type":23},180,[60],"Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness\u002Fhospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance).\n\nThis trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).",[330],"PTSD",[330,332,333,334,335,336,337],"CBD","Nantheia ATL5","Quality of Life","Mobility","Tolerability","Cannabidiol","2026-07-07",{"date":340,"type":40},"2026-07-09",{"date":342,"type":40},"2022-12-01",{"date":344,"type":23},"2029-04",{"name":46,"class":47},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":277,"enrollmentInfo":352,"targetDuration":354,"studyType":164,"phases":4,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":48},"100300530","early-rheumatoid-arthritis-lung-disease-study-100300530","NCT03192267","Early Rheumatoid Arthritis Lung Disease Study","Inclusion Criteria:\n\n* 19-90 years of age\n* Able to give informed consent\n* Diagnosis of RA by a Rheumatologist using 2010 American College of Rheumatology (ACR) criteria within the past 2 years\n\nExclusion Criteria:\n\n* Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)\n* Pregnant",{"count":353,"type":23},125,"10 Years","Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.",[357],"Rheumatoid Arthritis",[359,360],"newly diagnosed rheumatoid arthritis","lung disease",{"date":340,"type":40},{"date":363,"type":40},"2017-03-31",{"date":365,"type":23},"2030-03",{"name":46,"class":47},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":276,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":377,"conditions":378,"keywords":385,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":48},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412","NCT07292272","Halt Aging in Survivors of Blood Cancers","Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study","HALTAging-1","Inclusion Criteria:\n\n1. Age ≥50 years\n2. A history of hematological malignancy\n3. Participants must be able to and willingly give informed consent\n\nExclusion Criteria:\n\n1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.\n2. Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.\n3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.\n4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 \\\u003C10 ml\u002Fkg\u002Fmin).\n5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).\n6. Self-reported pregnancy or the possibility of pregnancy.\n7. Participants who do not plan to follow up at the participating center.",{"count":326,"type":23},[26],"Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.",[379,141,380,143,381,382,383,384],"Hematological Malignancy","Lymphoid Leukemia","Myeloid Leukemia","Monocytic Leukemia","Non-hodgkin Lymphoma","Other Hematologic Condition",[386,141,380,143,381,382,383,384,387,388,389,390],"Hodgkin Lymphoma","Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","2026-06-29",{"date":393,"type":40},"2026-07-01",{"date":395,"type":40},"2026-04-09",{"date":397,"type":23},"2033-03-25",{"name":46,"class":47},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":24,"phases":408,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":48},"100640530","phase-2-whole-versus-partial-gland-boost-during-prostate-sbrt-100640530","NCT07574489","Whole Versus Partial Gland Boost During Prostate SBRT","Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)","Inclusion Criteria:\n\n1. Adults ≥19 years of age\n2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered\n3. Prostate gland volume \\\u003C100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)\n4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI\n5. IPSS\u002FAUA symptom score less than 16\n\nExclusion Criteria:\n\n1. Prior treatment for prostate cancer\n2. Prior solid cancer diagnosis within the last 5 years\n3. Any history of anal or rectal cancer\n4. Any history of invasive carcinoma of the bladder\n5. History of prior circumferential resection of the rectum (such as LAR or APR)",{"count":407,"type":23},186,[60,409],"PHASE3","This phase 2\u002F3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.",[90,412],"Prostate Adenocarcinoma",[414,415,416,417,418,95,419,420,421,422,423],"Prostate SBRT","Stereotactic Body Radiotherapy","Dose Escalation","Dominant Intraprostatic Lesion","DIL","Genitourinary Toxicity","Gastrointestinal Toxicity","CTCAE","RTOG","EPIC","2026-06-25",{"date":391,"type":40},{"date":427,"type":23},"2026-07-25",{"date":429,"type":23},"2035-08-25",{"name":46,"class":47},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":438,"enrollmentInfo":439,"targetDuration":254,"studyType":164,"phases":4,"briefSummary":441,"conditions":442,"keywords":489,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":505},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals","110 Years",{"count":440,"type":23},999999,"The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[443,444,445,446,447,448,63,449,450,451,452,453,454,455,456,457,458,459,460,461,462,90,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,141,480,481,482,143,483,484,485,486,487,488],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Melanoma","Sarcoma","Unknown Primary Tumor","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[443,444,490,491,492,493,494,495,496,497,479,498,487,488],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":391,"type":40},{"date":501,"type":40},"2013-11-01",{"date":503,"type":23},"2099-12",{"name":46,"class":47},42,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":48},"100643879","phase-1-coq10-and-vitamin-e-for-off-target-radiation-toxicity-100643879","NCT07668284","COQ10 and Vitamin E for Off-Target Radiation Toxicity","Evaluating the Safety and Efficacy of Coenzyme Q10 and Vitamin E Dual Therapy in Mitigating Chronic Off-Target Radiation Toxicity","Inclusion Criteria:\n\n1. Pathologically confirmed post-prostatectomy prostate, uterine (endometrial and cervical), or anal cancer.\n2. Scheduled for curative-intent, multi-fraction (at least 15 fractions) external-beam radiotherapy +\u002F- chemotherapy at the study site which does not involve re-irradiation to the same field.\n3. Age ≥ 19 years at the time of consent.\n4. Eastern Cooperative Oncology Group Performance Status ≤ 2.\n5. Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician.\n6. Participants must be able to swallow soft-gel capsules.\n7. Participants must not have a disease significantly affecting drug absorption (e.g., resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction).\n8. Participants must agree to limit alcohol consumption to ≤ 2 standard drinks (14 g of pure ethanol) within 6 hours before and 6 hours after vitamin administration.\n9. Participants must agree to discontinue current vitamin\u002Fmineral supplements, including multivitamins, that contain Vitamin E (α-tocopherol) or CoQ10 (ubidecarenone) and abstain from taking these supplements while on study, including during the follow-up period. Participants must also agree to discontinue and abstain from high-dose vitamin\u002Fmineral supplementation while on-study and during the study follow-up period. NOTE: Participants for whom high-dose vitamin\u002Fmineral supplementation is medically necessary are eligible if the principal investigator determines that continuing treatment will not impact safety or study outcomes.\n10. Women of childbearing potential and male participants with partners of childbearing potential must agree to use two forms of medically effective contraception (at least one of which must be a barrier method) while on study until one month following the last dose of vitamin supplements.\n11. As determined by the enrolling physician, the participant must be able to understand and comply with study procedures for the entire length of the study. There must not be psychological, familial, sociological, or geographical conditions potentially hampering protocol compliance, including alcohol dependence or drug abuse.\n12. The participant or the participant's legally authorized representative must provide documented informed consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n13. Participant must have adequate hematological, organ, and clotting function as defined below. Screening labs must be obtained prior to the end of radiation therapy.\n\n    * Absolute Neutrophil Count (ANC) ≥ 500\u002Fmm3\n    * Platelets ≥ 50,000\u002Fmm3 • Hemoglobin ≥ 8.0 g\u002FdL. The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable.\n    * Calculated creatinine clearance (CrCl (mL\u002Fmin); Cockcroft-Gault formula) ≥ 30 mL\u002Fmin.\n    * Total bilirubin ≤ 1.5X institutional upper limit of normal (ULN) or ≤3 X ULN for patients with known Gilbert's syndrome\n    * AST (SGOT) and ALT (SGPT) ≤ 3X institutional ULN\n    * PT\u002FINR and PTT (in the absence of lupus anticoagulant) ≤ 2X institutional ULN.\n\nExclusion Criteria:\n\n1. Participants who do not receive ≥ 80% of the planned total radiation.\n2. Participants who are scheduled to receive SBRT\u002FSRS\n3. Participant's treatment plan must not include anti-cancer pharmaceutical therapies during the period of vitamin administration (\\~3 months after completion of radiation therapy).\n4. Participants must not receive any other investigational agents while on study.\n5. Participants must not have contraindications to Vitamin E or CoQ10 supplementation, including:\n\n   1. Anticoagulation or antiplatelet therapy that cannot be stopped. NOTE: To be eligible, participants must be able to discontinue contraindicated medications at least 2 weeks prior to the initiation of study treatment. These medications may be resumed 1 month after completing study treatment.\n   2. Underlying bleeding conditions (e.g., hemophilia or von Willebrand disease)\n   3. Retinitis pigmentosa\n   4. Hepatobiliary dysfunction\n   5. Vitamin K deficiency\n   6. Preexisting severe fibrosis\n   7. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage.\n   8. Uncontrolled Grade 2 hypertension defined as ≥ 140 mm Hg systolic blood pressure or ≥ 90 mm Hg diastolic blood pressure.\n   9. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).\n   10. Uncontrolled systemic bacterial, fungal, parasitic, mycobacterial, viral, or other infections, despite appropriate antibiotics or other treatments.\n   11. Any other uncontrolled comorbidities that, in the opinion of the treating investigator, would compromise subject safety or study outcomes.\n6. Participant must not have a history of allergic reactions to Vitamin E or CoQ10 or any of the vitamin excipients (soybean oil, soy lecithin, gelatin, glycerin).\n7. Not pregnant or lactating. A negative pregnancy test (serum hCG) is required for participants of childbearing potential. Female participants who are permanently sterilized (hysterectomy\u002Fbilateral oophorectomy) or postmenopausal (12 months of consecutive amenorrhea, \\> 45 years-of-age in the absence of other biological or physiological causes; females \\\u003C 55 years-of-age with serum FSH level \\> 40 mIU\u002FmL) are exempt",{"count":514,"type":23},200,[187,60],"The goal of this supportive care study is to learn if high-dose Vitamin E and CoQ10 in combination can reduce the negative sub-acute and chronic side effects of radiation to the pelvis in adults treated for prostate, uterine, cervical, or anal cancer.\n\nThe main questions it aims to answer are:\n\n* Is taking high doses of Vitamin E (dl-α-tocopherol acetate, 900mg) and CoQ10 (ubidecarenone, 200 mg) each day safe and tolerable?\n* Does a 90-day course of vitamin supplementation with high-dose Vitamin E and CoQ10 reduce the incidence and severity of late radiation-associated toxicities?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 improve patient reported measure of quality of life?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 change the trajectory of recovery after radiation therapy?\n* Is there evidence that suggests high-dose vitamin supplementation with Vitamin E and CoQ10 impairs oncologic outcomes?\n* Can longitudinal biomarkers of oxidative stress be correlated with Vitamin E and CoQ10 concentrations or radiation-associated toxicity?\n* Will subjects adhere to the vitamin administration schedule?\n* Are there demographic differences in systemic exposure to the vitamins?\n* Are there differences in toxicity outcomes across tumor types or radiation dose fractionation schemes?\n\nParticipants will be asked to:\n\n* Take Vitamin E and CoQ10 every day for 90 days by mouth.\n* Fill out quality of life questionnaires to assess treatment impacts.\n* Come for clinic visits every 2-4 weeks for around 4 months, then every 3-6 months for around 2 years.\n* Have blood draws more frequently than standard-of-care for clinical laboratory examinations and the collection of research samples.\n* Undergo Computed Tomography (CT) imaging of the chest, abdomen, and pelvis more frequently than standard of care.\n* Agree to lifestyle changes that ensure adequate vitamin absorption including intermittent abstinence from alcoholic beverages.",[90,518,519,450],"Uterine Cancer","Cervical Cancer",[521,522,523,524],"radiation","toxicity","subacute","antioxidant","2026-06-19",{"date":424,"type":40},{"date":393,"type":23},{"date":529,"type":23},"2030-12-15",{"name":46,"class":47},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":17,"sex":18,"minAge":276,"maxAge":303,"enrollmentInfo":538,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":48},"100540630","early-phase-1-impact-of-nrf2-activation-on-macrovascular-microvascular--leg-function--walking-capacity-in-peripheral-artery-disease-100540630","NCT06319339","Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease","Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease","Inclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* Diagnosed as Fontaine stage II-III\n* History of exercise-induced claudication\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin) or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL) or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nAge-matched control participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* No evidence of peripheral occlusive disease (ankle-brachial index \\> 0.90)\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin), or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL ), or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nExclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* • Pain at rest and\u002For tissue loss due to PAD (Fontaine stage IV PAD)\n* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma\n* Limited walking capacity from conditions other than PAD\n* No physical exam to assess exercise limitations in the past year\n* Currently pregnant or nursing\n* Blood work and medical history NOT demonstrating:\n\n  * Normal renal function (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n  * Normal hepatic function (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL),\n* Diagnosis of multiple sclerosis or psoriasis\n* Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc.\n* Concomitant use of dimethyl fumarate\n* Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY\n* Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n\nAge-matched control participants:\n\n* Positive diagnosis of PAD\n* No physical exam to assess exercise limitations in the past year\n* Any exercise limitations as determined at last physical exam\n* Limited walking capacity from musculoskeletal injury\n* Currently pregnant or nursing\n* Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n* Hepatic function not within normal ranges (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL",{"count":185,"type":23},[540],"EARLY_PHASE1","Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.",[543,544,545,546],"Peripheral Artery Disease","Peripheral Vascular Diseases","Peripheral Arterial Disease","Peripheral Arterial Occlusive Disease",{"date":548,"type":40},"2026-06-24",{"date":550,"type":40},"2024-11-14",{"date":552,"type":23},"2026-12",{"name":46,"class":47},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":24,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":48},"100317580","phase-3-treatment-of-rheumatoid-arthritis-with-dmards-predictors-of-response-100317580","NCT03414502","Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response","INCLUSION CRITERIA:\n\n* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria\n\n  * Morning stiffness for at least 1 hour for at least 6 weeks\n  * Swelling of 3 or more joints for at least 6 weeks\n  * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks\n  * Symmetric joint swelling\n  * Hand x-rays with erosions or bony decalcifications\n  * RA nodules\n  * Rheumatoid factor (RF) positive\n* \\>19 yrs old at RA diagnosis\n* Active disease with at least 1 swollen joint\n* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)\n* If on other DMARDS, must be on stable dose for ≥ 6 wks\n* If on glucocorticoids, must be on stable dose for 2 wks (\\\u003C 10mg of Prednisone\u002Fday or equivalent)\n* Able to adhere to study visit schedule: enrollment (8 wks \\& 16 wks +\u002F- 2 wks)\n* Hemoglobin (Hgb) \\> 9g\u002Fdl\n* Platelets \\>100\n* Creatinine \\\u003C1.6\n* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit\n* Albumin up to 1.0 g\u002FdL below lower limit of normal\n\nEXCLUSION CRITERIA:\n\n* Pregnant or breastfeeding women\n* Men and women of child bearing potential unwilling to practice effective method of contraception",{"count":562,"type":23},400,[409],"Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.\n\nThis study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.",[357],[567,568],"Methotrexate","DMARD","2026-06-15",{"date":571,"type":40},"2026-06-17",{"date":573,"type":40},"2007-12-10",{"date":575,"type":23},"2029-03",{"name":46,"class":47},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":584,"maxAge":20,"enrollmentInfo":585,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":48},"100631923","inflammation-in-clear-aligners-with-and-without-attachments-100631923","NCT07506993","Inflammation in Clear Aligners With and Without Attachments","Molar-Specific Inflammatory Biomarkers in Adolescents Using Clear Aligners With and Without Attachments","Inclusion Criteria:\n\n* orthodontic patient at the UNMC College of dentistry\n* clear aligner therapy\n\nExclusion Criteria:\n\n* pregnancy","14 Years",{"count":208,"type":23},"Problem: Clear aligner therapy is widely used in orthodontics due to improved periodontal outcomes compared to fixed appliances. However, composite attachments are frequently bonded to molars to enhance biomechanics, potentially creating plaque-retentive areas that may increase localized inflammatory responses. Currently, no studies have directly compared periodontal inflammatory biomarker levels in molars treated with clear aligners with versus without attachments. This gap limits understanding of the biological impact of attachments on periodontal tissues.Hypothesis:First molars treated with clear aligners and composite attachments will demonstrate higher levels of inflammatory biomarkers in gingival crevicular fluid (GCF) compared to molars treated with clear aligners without attachments. Biomarker levels are expected to be lower in the non-attachment group. Methods: This study will include 30 orthodontic patients divided into two groups (15 per group):1. Clear aligners with molar attachments 2. Clear aligners without molar attachments. GCF samples will be collected from first molars at a routine orthodontic appointment at the UNMC College of Dentistry Graduate Orthodontic Clinic. Primary biomarkers include IL-1β, IL-6, TNF-α, and MMP-8 measured via ELISA. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Depth) will also be recorded.",[588],"Periodontal Inflammation",[590,591],"inflammation","orthodontics","2026-06-12",{"date":594,"type":40},"2026-06-16",{"date":596,"type":40},"2026-05-01",{"date":598,"type":23},"2027-05-01",{"name":46,"class":47},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":608,"maxAge":56,"enrollmentInfo":609,"targetDuration":4,"studyType":24,"phases":610,"briefSummary":611,"conditions":612,"keywords":620,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":48},"100608922","parents-helping-parents-for-youth-vaping-cessation-100608922","NCT07207850","Parents Helping Parents for Youth Vaping Cessation","Parents Helping Parents for Youth Vaping Cessation (PhP-VX)","PhP-VX","ADOLESCENT INCLUSION:\n\n* 15-18\n* Report vaping in the previous 30 days\n* English literacy\n\nPARENT INCLUSION:\n\n* Biological, adoptive, stepparents, or adult guardian of adolescent participating\n* Have face-to-face contact with the adolescent at least one day per week during the study period\n* Access to a computer or mobile phone at home\n* Interested in helping adolescent quit e-cigarette\u002Fvape use","15 Years",{"count":514,"type":23},[26],"The goal of this randomized controlled study is to test if this new intervention works to help adolescents quit vaping. A key feature of the program is the use of peer support for parents, delivered by trained parent coaches. Participants will complete baseline and follow up surveys. Parents in the intervention arm will receive peer support as part of the program.",[613,614,615,616,617,618,619],"Implementation Science","Engagement, Patient","E Cigarette Use","Peer Support","Vaping Teens","Vaping Cessation","Parent Support",[621,622,623,624,625],"Vaping","Tobacco","vaping cessation","Parent support","adolescent vaping","2026-05-20",{"date":628,"type":40},"2026-05-26",{"date":630,"type":40},"2026-05-18",{"date":632,"type":23},"2027-08-31",{"name":46,"class":47},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":642,"minAge":19,"maxAge":276,"enrollmentInfo":643,"targetDuration":4,"studyType":24,"phases":645,"briefSummary":646,"conditions":647,"keywords":652,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100638145","community-support-and-mobile-apps-to-help-black-women-control-high-blood-pressure-after-pregnancy-100638145","NCT07606027","Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy","Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure","PRIME CARE","Inclusion Criteria:\n\n* Black\u002F African American patients\n* Age: 19 and 50 years of age\n* Diagnosis: Hypertension Disorders of Pregnancy\n* Enrolled in STAMPP-HTN for first 6 weeks postpartum\n\nExclusion Criteria:\n\n* Age: \\\u003C19 years\n* Significant Kidney or Liver disease that may limit antihypertensive medication adjustment","FEMALE",{"count":644,"type":23},404,[26],"The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.",[648,649,650,651],"Hypertensive Disorders of Pregnancy (HDP)","Hypertension, Pregnancy Induced","Severe Maternal Morbidity","Postpartum Hypertension",[653,654,655,656,657,658],"Hypertension, Pregnancy-Induced","Postpartum Period","Remote Blood Pressure Monitoring","Community Health Workers","Postpartum Care","African American Women","2026-05-19",{"date":628,"type":40},{"date":393,"type":23},{"date":663,"type":23},"2031-06-30",{"name":46,"class":47},{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":24,"phases":673,"briefSummary":674,"conditions":675,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":4},"100607906","feasibility-and-performance-of-continuous-glucose-monitoring-to-guide-computerized-insulin-infusion-therapy-in-non-icu-patients-receiving-corticosteroid-therapy-and-specialized-nutrition-100607906","NCT07194642","Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Non-ICU Patients Receiving Corticosteroid Therapy and Specialized Nutrition","Inclusion Criteria:\n\n* Age \\>19 years old\n* Patients with diabetes or stress induced hyperglycemia requiring continuous insulin infusion therapy, with anticipated duration of this therapy being \\> 24 hours. Specifically, we will include\n* Patients with Type 2 diabetes; or if not previously diagnosed as having diabetes, HbA1c \\>7.0% (laboratory-measured at or since hospital admission or within prior 3-months).\n* Type 1 diabetes, as well as atypical forms of diabetes (including pancreatectomy and pancreatitis) and\n* Stress hyperglycemia defined as at least 1 blood glucose measurement \\>180 mg\u002FdL since admission in a patient without history of diabetes, if CII is indicated per treating physician\n* Insulin drip (CII) already initiated since admission or planned to be initiated\n* Non-critical hospitalization with expected duration of CII \\> 24 hours at time of randomization\n* Oncology and post-transplant population receiving IV insulin therapy\n\nExclusion Criteria:\n\n* Inability to provide written consent\n* Medically unstable patients receiving pressor therapy and ICU level of care.\n* Patients transferred from ICU with an expected requirement for CII \\> 24 hours on a non-ICU floor are eligible)\n* For women of childbearing potential: currently pregnant or breastfeeding\n* Hypoxia (O2 saturation \\\u003C 90 %) present at time of potential enrollment\n* Hemoglobin \\\u003C 7 mg\u002FdL;\n* Anasarca present at time of potential enrollment\n* Use of hydroxyurea or high dose acetaminophen use of \\>4g daily as those are substances known to interfere with CGM system.\n* eGFR \\\u003C 20 mL\u002Fmin or dialysis being received or planned\n* Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion\n* Admission for Diabetic ketoacidosis or hyperosmolar hyperglycemic state\n\nNurse Participants:\n\n* Adults aged 19 and older involved in the routine care of the patient participants\n* Adequate proficiency to understand and provide informed consent in English",{"count":672,"type":23},80,[26],"The objective of this pilot study is to assess the feasibility and performance of real-time CGM for titrating CII via: (1) evaluation of CGM glucose accuracy in oncology and post-transplant population receiving IV insulin therapy, and (2) assessing both nursing acceptance\u002Fconvenience and patient satisfaction with CGM use. A randomized prospective trial model will be used comparing glucose control (glucometrics hypoglycemia), patient experience and nursing satisfaction in cancer patients receiving IV insulin therapy where monitoring is done via: a) hybrid protocol originally developed by Faulds et al. integrating CGM with periodic POC-BG tests to monitor and ensure the ongoing accuracy of CGM measurements (available at http:\u002F\u002Fwww.covidindiabetes.org). b) standard care with hourly POC testing and blinded professional CGM.Inclusion criteria: Eligible patients include oncology and post-transplant patients receiving IV insulin therapy while on corticosteroid treatment and receiving specialized nutrition. Exclusion criteria: medically instable patients receiving pressor therapy and ICU level of care. Outcome evaluation; Patients' characteristics were collected through the EHR. Glucometrics will be collected throughout the study to include mean BS, % in range ( 80-180) , patient day hypoglycemia , patient stay hypoglycemia . Nursing surveys: Survey will be provided for nurses to assess nursing burden, acceptability. Nurses will complete a survey before starting the project and again after being involved in the initial and ongoing validation phases of CGM at the end of the project. The purpose is to report their convenience with using CGM and their preferred glucose monitoring method, which included POC arterial blood, POC finger sticks, and CGM. Nursing surveys will be administrated electronically to nursing staff and the results will be uploaded automatically. Patient survey: Patients will be approached by the team members to inquire about the willingness to provide feedback. The questionnaire will assess their experiences of care with CGM (options: very good, good, fair, poor), glucose check without pain and disruptions of sleep (yes\u002Fno), and overall confidence of care with CGM process (very confident, quite confident, somewhat confident, little confident). Patient surveys will handed out by the team members, and the results were subsequently entered into database (See both nursing and patient surveys in Supplementary Material.)",[676],"Diabetes",{"date":626,"type":40},{"date":679,"type":23},"2026-05-30",{"date":681,"type":23},"2026-11-30",{"name":46,"class":47},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":24,"phases":693,"briefSummary":694,"conditions":695,"keywords":697,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":48},"100588221","eras-protocols-in-breast-conserving-surgery-100588221","NCT06938581","ERAS Protocols in Breast Conserving Surgery","The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial","ERAS","Inclusion Criteria:\n\n* Males or females 19 years of age or older\n* Able to provide study-specific informed consent\n* Histologic confirmation of breast cancer on core needle biopsy\n* Clinical or radiographic cT1-T3 N0 disease\n* Undergoing breast conserving surgery with lumpectomy \\& sentinel lymph node biopsy\n* No prior definitive treatment or intervention\n* Able to swallow and retain oral carbohydrate drinks and medication\n\nExclusion Criteria:\n\n* Pregnant\n* Contraindications to ERAS protocol components\n* Undergoing lumpectomy without sentinel lymph node biopsy, mastectomy, or other specified procedures\n* Diagnosed with cT4 or N1-3 disease\n* Metastatic disease at presentation\n* Taking opioid pain medications for other indications\n* History of substance use disorder\n* Any condition where ERAS could compromise safety",{"count":692,"type":23},260,[26],"Enhanced Recovery After Surgery (ERAS) protocols have been of increasing interest in the surgical community for decades. The emphasis has been development of protocols to maximize pain control post-operatively without the use of opioids. While this approach has been studied extensively in the oncology surgery literature, little data exists on the utility of ERAS protocols in the setting of breast conserving surgery (BCS), which is a type of surgery to remove breast cancer while saving as much of the breast as possible. The purpose of this study is to determine the utility of implementing ERAS protocols in breast cancer patients undergoing breast conserving surgery. Study participants will be randomized to either ERAS protocol or standard peri-operative care without ERAS. The study will assess the how many opioid prescriptions are given in the first week after surgery and how much pain participants report right after surgery. Investigators will also look at how long participants stay in the recovery room and if medicine for nausea is needed.",[479,696],"Postoperative Recovery",[698,699,700,701,702,703],"Eras","Opioid Use","Pain Management","Breast Conserving Surgery","Sentinel Lymph Node Biopsy","Perioperative Care","2026-05-15",{"date":659,"type":40},{"date":707,"type":40},"2025-07-11",{"date":709,"type":23},"2029-02",{"name":46,"class":47},""]