[{"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:":705},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,55,93,172,198,223,247,272,297,332,363,381,409,434,456,482,502,519,543,572,598,620,640,661,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412",false,"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.","ALL","50 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31,32,33,34,35],"Hematological Malignancy","Leukemia","Lymphoid Leukemia","Multiple Myeloma","Myeloid Leukemia","Monocytic Leukemia","Non-hodgkin Lymphoma","Other Hematologic Condition",[37,29,30,31,32,33,34,35,38,39,40,41],"Hodgkin Lymphoma","Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","RECRUITING","2026-06-29",{"date":45,"type":46},"2026-07-01","ACTUAL",{"date":48,"type":46},"2026-04-09",{"date":50,"type":22},"2033-03-25",{"name":52,"class":53},"University of Nebraska","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":62,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":54},"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)","MALE","19 Years",{"count":65,"type":22},186,[67,68],"PHASE2","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.",[71,72],"Prostate Cancer","Prostate Adenocarcinoma",[74,75,76,77,78,79,80,81,82,83,84],"Prostate SBRT","Stereotactic Body Radiotherapy","Dose Escalation","Dominant Intraprostatic Lesion","DIL","Radiation Therapy","Genitourinary Toxicity","Gastrointestinal Toxicity","CTCAE","RTOG","EPIC","NOT_YET_RECRUITING","2026-06-25",{"date":43,"type":46},{"date":89,"type":22},"2026-07-25",{"date":91,"type":22},"2035-08-25",{"name":52,"class":53},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":18,"minAge":63,"maxAge":101,"enrollmentInfo":102,"targetDuration":104,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":155,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"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",true,"110 Years",{"count":103,"type":22},999999,"80 Years","OBSERVATIONAL","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.",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,71,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,29,146,147,148,31,149,150,151,152,153,154],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal 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",[108,109,156,157,158,159,160,161,162,163,145,164,153,154],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":43,"type":46},{"date":167,"type":46},"2013-11-01",{"date":169,"type":22},"2099-12",{"name":52,"class":53},42,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":54},"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":180,"type":22},200,[182,67],"PHASE1","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.",[71,185,186,116],"Uterine Cancer","Cervical Cancer",[188,189,190,191],"radiation","toxicity","subacute","antioxidant","2026-06-19",{"date":86,"type":46},{"date":45,"type":22},{"date":196,"type":22},"2030-12-15",{"name":52,"class":53},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":100,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":54},"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","75 Years",{"count":207,"type":22},20,[209],"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.",[212,213,214,215],"Peripheral Artery Disease","Peripheral Vascular Diseases","Peripheral Arterial Disease","Peripheral Arterial Occlusive Disease",{"date":217,"type":46},"2026-06-24",{"date":219,"type":46},"2024-11-14",{"date":221,"type":22},"2026-12",{"name":52,"class":53},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":54},"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":231,"type":22},400,[68],"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.",[235],"Rheumatoid Arthritis",[237,238],"Methotrexate","DMARD","2026-06-15",{"date":241,"type":46},"2026-06-17",{"date":243,"type":46},"2007-12-10",{"date":245,"type":22},"2029-03",{"name":52,"class":53},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":254,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":54},"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","35 Years",{"count":257,"type":22},30,"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.",[260],"Periodontal Inflammation",[262,263],"inflammation","orthodontics","2026-06-12",{"date":266,"type":46},"2026-06-16",{"date":268,"type":46},"2026-05-01",{"date":270,"type":22},"2027-05-01",{"name":52,"class":53},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":100,"sex":18,"minAge":63,"maxAge":255,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":296,"locationsCount":54},"100623233","development-of-a-real-time-controller-to-estimate-walking-performance-using-a-bilateral-ankle-exoskeleton-100623233","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",{"count":280,"type":22},6,[25],"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.",[284],"Healthy Young Adults",[286,287,288,289,290],"robotic ankle exoskeleton","human-in-the-loop optimization","wearable robotics","musculoskeletal modeling","muscle activation analysis","2026-06-01",{"date":293,"type":46},"2026-06-02",{"date":291,"type":22},{"date":221,"type":22},{"name":52,"class":53},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":305,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":318,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":54},"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","18 Years",{"count":180,"type":22},[25],"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.",[311,312,313,314,315,316,317],"Implementation Science","Engagement, Patient","E Cigarette Use","Peer Support","Vaping Teens","Vaping Cessation","Parent Support",[319,320,321,322,323],"Vaping","Tobacco","vaping cessation","Parent support","adolescent vaping","2026-05-20",{"date":326,"type":46},"2026-05-26",{"date":328,"type":46},"2026-05-18",{"date":330,"type":22},"2027-08-31",{"name":52,"class":53},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":340,"minAge":63,"maxAge":19,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":350,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"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":342,"type":22},404,[25],"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.",[346,347,348,349],"Hypertensive Disorders of Pregnancy (HDP)","Hypertension, Pregnancy Induced","Severe Maternal Morbidity","Postpartum Hypertension",[351,352,353,354,355,356],"Hypertension, Pregnancy-Induced","Postpartum Period","Remote Blood Pressure Monitoring","Community Health Workers","Postpartum Care","African American Women","2026-05-19",{"date":326,"type":46},{"date":45,"type":22},{"date":361,"type":22},"2031-06-30",{"name":52,"class":53},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"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":370,"type":22},80,[25],"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.)",[374],"Diabetes",{"date":324,"type":46},{"date":377,"type":22},"2026-05-30",{"date":379,"type":22},"2026-11-30",{"name":52,"class":53},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":54},"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":390,"type":22},260,[25],"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.",[145,394],"Postoperative Recovery",[396,397,398,399,400,401],"Eras","Opioid Use","Pain Management","Breast Conserving Surgery","Sentinel Lymph Node Biopsy","Perioperative Care","2026-05-15",{"date":357,"type":46},{"date":405,"type":46},"2025-07-11",{"date":407,"type":22},"2029-02",{"name":52,"class":53},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":100,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":54},"100610331","detecting-peripheral-artery-disease-with-the-pulse-100610331","NCT07226193","Detecting Peripheral Artery Disease With the Pulse","Pulse Arrival Time as an Alternative Biomarker to Detect Lower-Extremity Peripheral Artery Disease","Inclusion Criteria:\n\n1. be able to provide written informed consent\n2. be 19 years of age or older\n3. having or not having a diagnosis of peripheral artery disease\n\nExclusion Criteria:\n\n1. having a current or pervious aortic aneurysm with or without previous intervention\n2. having previous revascularization surgeries (open or endovascular) of the legs or aorta\n3. having walking impairments independent of lower-limb ischemia (e.g., musculoskeletal injury)\n4. having gangrene or ulcers of the toes\u002Ffeet\n5. being currently pregnant or breastfeeding",{"count":417,"type":22},60,[25],"1\\) The purpose of this study is to assess segmental pulse arrival time (PAT) as an alternative biomarker to detect lower-extremity peripheral artery disease (PAD), and to investigate the impacts of local skin heating and foot elevation. The secondary purpose will be to investigate the impacts of age on segmental PAT. The subject population will include any adults 19 years of age or older with or without PAD. Exclusion criteria include having an aortic aneurysm with or without previous intervention, previous revascularization surgeries of the arteries in the legs\u002Faorta, walking impairments independent of PAD, gangrene or ulcers of the toes\u002Ffeet, and currently pregnant or breastfeeding. 3) All aims of the present study will be completed with a single laboratory visit. Descriptive measurements will include height, weight, age, sex, body fat percentage, and self-reported medication and health history. Subjects will lie in the supine position for 20-min. After rest, either the ankle-brachial index (ABI) or PAT will be assessed. After 10-min of further rest, the other measurement will be performed. ABIs will be assessed according to current guidelines: blood pressures will be assessed in the dorsal pedis and tibialis posterior arteries of both legs and the brachial arteries of both arms using a blood pressure cuff and Doppler ultrasound. PAT will be simultaneously assessed in both arms and legs using an investigational device with a 3-lead electrocardiogram sensor and four photoplethysmography (PPG) sensors. A PPG sensor will be applied to a finger on each hand and both big toes. Signals will be collected for 15-min with finger and toe sensor temperatures at 30 C. Toe sensor temperature will then be elevated to 45 C for 15-min. Finally, toe sensor temperature will remain at 45 C, and the feet will be elevated 8-in with a soft cushion for 15-min. Blood pressure in the arm and legs will be assessed at the end of each stage. Thermal images of the fingers and toes will be assessed before using the investigational device and after each stage. Subjects will then participate in a 6-min walking test (6MWT) to objectively establish walking capacity. The 6MWT will be performed in accordance with current guidelines. Segmental PATs will be compared with ABI and 6-min walking time to determine if segmental PATs can predict lower-extremity PAD (ABI) and the associated walking impairment (6MWT). This study is expected to last \\~2.5hrs. 4) There will be no follow-up.",[421],"Peripheral Artery Disease (PAD)",[423,424,425,426],"pulse arrival time","atherosclerosis","peripheral artery disease","portable peripheral artery disease detection","2026-05-14",{"date":357,"type":46},{"date":430,"type":46},"2026-02-05",{"date":432,"type":22},"2027-01-01",{"name":52,"class":53},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":54},"100540757","phase-1-chemoprevention-with-tamoxifen-in-pre-invasive-pancreas-mucinous-cystic-neoplasms-not-undergoing-immediate-resection-100540757","NCT06320990","Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection","A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection","MCN_Tam","Inclusion Criteria:\n\n* Age ≥ 19 years\n* Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging\n* Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference\n* Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and\u002For both ovaries.\n* Estimated glomerular filtration rate (eGFR) \\> 30mL\u002Fmin\u002F1.73m2\n* Willing and able to provide informed consent to and abide by the protocol\n\nExclusion Criteria:\n\n* Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia\n* Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy\n* Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment.\n* Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted.\n* Contraindications to tamoxifen include:\n\n  * Pregnancy or nursing\n  * Known allergy or hypersensitivity to tamoxifen\n  * Cataracts which affect visual acuity (ie. symptomatic)\n  * Retinopathy which affects visual acuity (ie. symptomatic)\n  * Current warfarin use\n  * History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism\n  * History of stroke\n  * Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma\n* History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications\n* Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures\n* Elective surgery planned for the study period\n* Participation in another clinical study with an investigational product during the last 28 days\n* Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions and requirements",{"count":443,"type":22},15,[182],"Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection. The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits the spread and normal life cycle in MCN epithelial cells and fibroblasts. Investigators hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection. Up to 15 participants not undergoing immediate resection will be enrolled and take tamoxifen orally for up to 24 weeks. The study will assess the feasibility of tamoxifen as a treatment for pancreatic MCN.",[447,448],"Pancreatic Cyst","Pancreatic Mucinous Cystic Neoplasm","2026-05-11",{"date":427,"type":46},{"date":452,"type":46},"2025-01-22",{"date":454,"type":22},"2029-05",{"name":52,"class":53},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":479,"leadSponsor":481,"locationsCount":54},"100632747","phase-2-mrd-adapted-low-dose-radiation-therapy-during-frontline-chemoimmunotherapy-for-diffuse-large-b-cell-lymphoma-100632747","NCT07517705","MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma","Feasibility of MRD-Adapted Mid-Cycle Low-Dose Radiation Combined With Frontline R-Chemoimmunotherapy in Diffuse Large B-Cell Lymphoma (MRD XRT)","Inclusion Criteria:\n\n1. Adults ≥19 years of age\n2. Biopsy-proven newly diagnosed DLBCL, transformed from indolent lymphoma, Follicular lymphoma grade 3B, post-transplant lymphoproliferative disorder, or any other subtypes of Large B-cell lymphoma under WHO-HAEM5 classification who are eligible and plan to receive 6 cycles of R-chemoimmunotherapy. Note: patients may receive up to one cycle of R-chemoimmunotherapy prior to enrollment.\n3. Planned to receive 6 cycles of frontline R-chemoimmunotherapy for diseases mentioned in criterion 2\n4. Presence of measurable disease on imaging, nodal lesion \\>1.5cm or extra-nodal lesion \\>1 cm prior to initiation of R-chemoimmunotherapy\n5. Availability of sufficient and viable baseline FFPE tumor tissue to allow development of a personalized MRD assay\n\nExclusion Criteria:\n\n1. Limited stage (Ann Arbor stage I-II) DLBCL, requiring less than 6 cycles of R-chemoimmunotherapy\n2. Primary or secondary CNS lymphoma\n3. Subject has exceeded maximum lifelong cumulative doses of radiation therapy or is unsafe for radiation therapy as determined by the investigator and\u002For radiation oncologist\n4. Pregnant and lactating patients\n5. Has received two or more cycles of R-chemoimmunotherapy relating to this disease",{"count":464,"type":22},50,[67],"This prospective feasibility study evaluates a minimal residual disease (MRD)-adapted treatment strategy in patients with diffuse large B-cell lymphoma (DLBCL) receiving frontline chemoimmunotherapy. Circulating tumor DNA (ctDNA)-based MRD testing and interim positron emission tomography (PET) imaging after two cycles of therapy are used to guide treatment decisions. Patients with detectable MRD may receive low-dose radiation therapy (LDRT) to residual PET-avid disease sites in addition to standard systemic therapy, while patients with undetectable MRD continue standard frontline chemoimmunotherapy. The study aims to assess the feasibility and safety of integrating MRD-guided radiation therapy into frontline treatment of DLBCL.",[468],"Diffuse Large B-Cell Lymphoma",[470,471,472,473,474],"Minimal Residual Disease","ctDNA","PET-CT","MRD-guided therapy","Low-Dose Radiation Therapy","2026-05-08",{"date":477,"type":46},"2026-05-13",{"date":264,"type":22},{"date":480,"type":22},"2032-11-12",{"name":52,"class":53},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":205,"enrollmentInfo":489,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":54},"100588223","post-operative-outcomes-of-anterior-cervical-discectomy-and-fusion-surgery-with-and-without-drain-placement-100588223","NCT06938607","Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement","Post-operative Outcomes Comparing Drain vs No Drain Placement Following Anterior Cervical Discectomy and Fusion Surgery","Inclusion Criteria:\n\n* 19-75 years of age\n* Having elective anterior cervical discectomy and fusion (ACDF) surgery\n\nExclusion Criteria:\n\n* Unable to stop anticoagulation medication\n* Cervical (neck) cancer or tumor\n* Combined anterior cervical discectomy and fusion, and posterior cervical fusion\n* Active infection or trauma",{"count":490,"type":22},360,"Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft\u002Fautograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.\n\nThis study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups.",[493],"ACDF Surgery",[493],{"date":496,"type":46},"2026-05-12",{"date":498,"type":22},"2026-06",{"date":500,"type":22},"2029-06",{"name":52,"class":53},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":100,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":518,"locationsCount":54},"100518949","coagulopathy-of-immunodermatologic-diseases-100518949","NCT06037187","Coagulopathy of Immunodermatologic Diseases","Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases","Inclusion Criteria:\n\n1. For the study group: diagnosis of immune-mediated skin disease including but not limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, dermatomyositis\n2. For control group: no diagnosis of immune-mediated skin\n3. For study group: receiving care from one or more of the Principal or Secondary Investigators\n\nExclusion Criteria:\n\n1. Unfit to provide consent\n2. P2Y12 inhibitor use in the past 4 weeks\n3. History of internal malignancy prior to enrolling in the study or suspected internal\u002Fsystemic malignancy during time of the study (i.e. will not exclude pre-malignant or local, early stage cutaneous malignancies)\n4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study\n5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks\n6. If patient is unable to provide detailed history and if we do not have sufficient history on record.\n7. Less than 19 years of age",{"count":510,"type":22},39,"This study will examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. Blood samples will be collected from participants with active\u002Fpoorly controlled immune-mediated skin diseases and mild\u002Flatent\u002Fwell-controlled immune-mediated skin diseases. A one-time sample from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy will also be collected to serve as control. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.",[513],"Autoimmune Bullous Dermatosis",{"date":496,"type":46},{"date":516,"type":46},"2023-05-09",{"date":221,"type":22},{"name":52,"class":53},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":100,"sex":18,"minAge":527,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":54},"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":530,"type":22},65,[25],"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.",[534,535],"Cerebral Palsy Children","Healthy Adults","2026-05-06",{"date":475,"type":46},{"date":539,"type":22},"2026-05",{"date":541,"type":22},"2029-07",{"name":52,"class":53},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":100,"sex":18,"minAge":63,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":559,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":54},"100585181","attention-and-eye-movement-in-parkinsons-disease-100585181","NCT06899022","Attention and Eye Movement in Parkinson's Disease","Investigating the Role of Attention in Perceptual and Cognitive Consequences of Parkinson's Disease","Inclusion Criteria\n\n* All Participants (Aim 1):\n\n  * Ability and willingness to provide signed informed consent for this study\n  * Ability to express perceptual judgments through a button press or mouse- controlled computerized slider\n  * Age 19 - 90 years\n* DBS Participants (Aim 1):\n\n  * Diagnosis of idiopathic Parkinson's disease (PD), essential tremor (ET) or dystonia (DT).\n  * Scheduled for new implantation of a therapeutic DBS device targeted to subthalamic nucleus (STN), ventral intermediate nucleus of thalamus (VIM) or internal globus pallidus (GPi)\n* Comparison Participants (Aim 1):\n\n  o Selection by age matching to participants in PD group\n* Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 2):\n\n  * Ability and willingness to provide signed informed consent for this study\n  * Ability to express perceptual judgments through a button press or mouse- controlled computerized slider\n  * Age 19 - 90 years\n  * Scheduled for awake DBS implantation with clinical micro-electrode recordings (MER)\n  * Willing and able to engage in tasks during an awake surgical procedure\n* Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 3):\n\n  * Ability and willingness to provide signed informed consent for this study\n  * Ability to express perceptual judgments through a button press or mouse- controlled computerized slider\n  * Age 19 - 90 years\n  * Willing to undergo acute manipulations of DBS\n  * Able to tolerate acute changes of DBS\n\nExclusion Criteria\n\n* All Participants (Aim 1):\n\n  * Corrected visual acuity insufficient to perceptually judge face stimuli\n  * Inability to understand task instructions or complete task requirements\n* DBS Participants (Aim 1):\n\n  o Insufficient therapeutic control of motor symptoms to engage in tasks requiring button press or use of a mouse to control a slider\n* Healthy Comparison Participants (Aim 1):\n\n  o History of neurodegenerative disorder\n* Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 2):\n\n  * Corrected visual acuity insufficient to perceptually judge face stimuli\n  * Inability to understand task instructions or complete task requirements\n  * Not undergoing awake DBS implantation\n  * Uncorrected visual acuity insufficient to perceptually judge face stimuli\n* Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 3):\n\n  * Corrected visual acuity insufficient to perceptually judge face stimuli\n  * Inability to understand task instructions or complete task requirements\n  * Failure of DBS to achieve a therapeutic effect on motor symptoms","90 Years",{"count":552,"type":22},138,[25],"The goal of this observational and interventional study is to understand how therapeutic deep brain stimulation (DBS) affects attention, perception and cognition in participants with Parkinson's disease (PD) and non-PD movement disorders, including essential tremor (ET) and dystonia (DT). The main questions it aims to answer are:\n\n* Does impaired control of attention and eye movement in PD alter how social cues are perceived and interpreted?\n* Does therapeutic DBS improve or worsen attentional and perceptual deficits for social cues in PD, ET and DT?\n* Can DBS be optimized to restore normal attentional control in PD while remaining an effective therapy for other aspects of the disorder.\n* What do parts of the brain targeted by DBS contribute to the control of attention?\n\nUsing an eye tracking camera, investigators will study how participants with PD, ET and DT look at and perceive facial expressions of emotion before and after starting DBS therapy, in comparison to a group of healthy participants without ET, PD, DT or DBS. Participants with PD, ET and DT will see and rate morphed facial expressions on a computer screen in three conditions:\n\n* Before starting DBS therapy (over approximately 1 hour).\n* In the operating room, during the standard procedure to implant DBS electrodes, while the participant is awake (for no more than 15 minutes).\n* After starting DBS therapy, with brief experimental changes of DBS stimulation level and frequency (over approximately 1 hour).",[556,557,558],"Essential Tremor","Parkinson&#39;s Disease (PD)","Dystonias",[560,561,562,563],"Deep Brain Stimulation","Attention","Perception","Eye movement","2026-04-30",{"date":566,"type":46},"2026-05-05",{"date":568,"type":46},"2025-09-22",{"date":570,"type":22},"2028-08",{"name":52,"class":53},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":100,"sex":340,"minAge":19,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":54},"100544080","phase-2-intranasal-oxytocin-intervention-for-caregivers-to-persons-with-dementia-100544080","NCT06364228","Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia","Inclusion Criteria:\n\n* Females 50 years of age or older\n* Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months\n* Normal or corrected to normal vision and hearing\n* Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging\n* Right-handed\n* Capacity to read and write English\n\nExclusion Criteria:\n\n* Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)\n* History of allergic reaction to oxytocin (OXT) and its nasal spray product\n* History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis\n* Currently pregnant or planning to become pregnant during the course of the study\n* Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing\u002Fimplants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning\n* Mini-mental status exam score of 25 or lower which suggests possible cognitive issues\n* History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)\n* History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)\n* History of, or current drug or alcohol abuse\n* Currently breastfeeding\n* Current coronavirus disease-19 (COVID-19) illness\n* Left-handed due to brain structural difference between right and left-handed individuals\n* Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams\u002Fpills",{"count":579,"type":22},32,[67],"More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults.\n\nThere are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.",[583],"Stress",[585,586,587,588,589,590,591],"Oxytocin","Stress level","Caregivers","Dementia","fMRI","Neuroimaging","Quality of Life",{"date":566,"type":46},{"date":594,"type":22},"2026-06-20",{"date":596,"type":22},"2027-06",{"name":52,"class":53},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},"100379552","phase-2-a-study-comparing-gliadel-to-stereotactic-radiosurgery-in-metastatic-brain-disease-100379552","NCT04222062","A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease","A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease","Inclusion criteria:\n\n* Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)\n* Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of \\>\u002F 60\n* Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site\n* Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)\n* Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and\u002For both ovaries)\n* Normal coagulation studies (international normalized ratio, INR, ≤ 1.3)\n* Estimated survival time of ≥ 3 months (determined by the participant's primary oncologist)\n* Participant is willing and able to consent and abide by the protocol\n\nExclusion criteria:\n\n* Prior treatment to the area of planned resection (surgery, radiation)\n* Prior whole brain radiation therapy\n* Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer\n* Leptomeningeal disease\n* Neurodegenerative disorder (e.g. dementia)\n* Tumor size \\> 4 cm\n* Karnofsky Performance Status (KPS) \\\u003C 60\n* Inability or unwillingness to co-operate with the requirements of the protocol\n* Any other clinically significant medical disease or condition, laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent\n* Simultaneous participation in other therapeutic clinical trials\n* Severe pulmonary, cardiac or other systemic disease, specifically:\n\n  * New York Heart Association \\> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication\n  * Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to Common Terminology Criteria for Adverse Events 5.0)\n* Participants having any other disease, either metabolic or psychological, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications\n* Participant has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including non-steroidal anti-inflammatory drugs (NSAIDs) at the time of scheduled resection that cannot be stopped for surgery\n* Inability to obtain MRI studies",{"count":606,"type":22},100,[67],"This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.",[610],"Brain Tumor - Metastatic","2026-04-27",{"date":613,"type":46},"2026-04-28",{"date":615,"type":46},"2020-11-06",{"date":617,"type":22},"2029-12",{"name":52,"class":53},2,{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":54},"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":257,"type":22},[25],"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.",[31,631],"Lymphoma","2026-04-14",{"date":634,"type":46},"2026-04-20",{"date":636,"type":46},"2022-06-07",{"date":638,"type":22},"2028-07",{"name":52,"class":53},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":62,"minAge":647,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":650,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":54},"100611007","phase-2-psma-pet-guided-de-escalation-of-salvage-radiation-treatment-in-recurrent-prostate-cancer-100611007","NCT07234981","PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer","PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Patients With Recurrent Prostate Cancer After Prostatectomy","Inclusion Criteria:\n\n1. Prior biopsy proven prostate cancer for which they underwent a radical prostatectomy with curative intent.\n2. Evidence of biochemical recurrence as defined by NCCN: Persistent positive PSA post-radical prostatectomy (RP) or an undetectable PSA after RP with a subsequent detectable PSA that increases on ≥2 determinations (PSA recurrence) or increases to PSA \\>0.1 ng\u002FmL.\n3. Targetable PSMA-avid lesion within the prostate bed, pelvic lymph nodes, or both and\u002For targetable lesion in prostate bed defined on MRI suspicious for local recurrence.\n4. If lesions are amenable for biopsy this may be attempted, but biopsy proven recurrence\u002Fpersistence is not required for trial enrollment.\n5. Life expectancy greater than 5 years.\n6. Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group performance status ≤ 2 within 14 days prior to registration.\n7. Age ≥ 30 years.\n8. Patient must be able to provide study-specific informed consent prior to study entry.\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.","30 Years",{"count":649,"type":22},54,[67],"Purpose: Prospective, single-site Phase II study testing whether PSMA-PET\u002FMRI-guided, de-escalated salvage radiation reduces acute Grade ≥2 toxicity versus a 44% historical rate, while maintaining cancer control after prostatectomy.Population\u002FEligibility: Adult men ≥30 years with prior radical prostatectomy and biochemical persistence\u002Frecurrence per NCCN (persistent positive PSA after RP, or undetectable PSA that becomes detectable and rises on ≥2 determinations, or PSA \\>0.1 ng\u002FmL). Must have a targetable PSMA-avid lesion in the prostate bed and\u002For pelvic lymph nodes and\u002For an MRI-defined lesion suspicious for local recurrence. KPS ≥80 or ECOG ≤2; life expectancy \\>5 years; able to consent. Exclude: Evidence of distant metastatic disease outside pelvic nodes (including osseous involvement), conditions that preclude radiation, or factors preventing protocol compliance.Interventions \\& Evaluations: Baseline history\u002Fphysical, vitals, performance status, labs (PSA, CBC w\u002Fdiff, CMP\u002Fcreatinine), pelvic MRI and PSMA-PET\u002FCT; optional biopsy if feasible. External beam radiation therapy (LINAC\u002FVMAT) with daily image guidance: pelvis 45 Gy in 25 fractions, followed by a sequential boost to PSMA\u002FMRI-defined disease to 63-70.2 Gy in 10-14 additional fractions, with protocolized OAR constraints. All participants receive standard-of-care androgen deprivation therapy (ADT) for 6-24 months at the treating clinician's discretion. Weekly on-treatment visits; physician-assessed toxicities graded by CTCAE v5. Patient-reported outcomes (IPSS; FACT-P) at baseline and each in-person follow-up.Follow-up: Phone toxicity check 1 month post-RT; clinic at 4 months post-RT, then every 3 months thereafter until 24 months after completion of ADT. At each visit: H\\&P, CTCAE toxicity assessment, and PSA. If biochemical failure occurs, imaging (PSMA-PET\u002FCT, CT and\u002For MRI) is obtained per standard of care to assess clinical progression.Endpoints\u002FDesign: Primary endpoint: acute (≤4 months post-RT) Grade ≥2 toxicity (all types). Secondary endpoints: 2-year biochemical progression-free survival; chronic toxicity and patient-reported outcomes from 4-24 months; 24-month local control, locoregional control, distant metastasis, and overall survival. Simon optimal two-stage design with interim analysis after the first 18 patients complete RT (stop if ≥8 have Grade ≥2 acute toxicity); total planned enrollment up to 54.",[71],"2026-04-13",{"date":655,"type":46},"2026-04-17",{"date":657,"type":46},"2026-03-31",{"date":659,"type":22},"2029-10-05",{"name":52,"class":53},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":54},"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":207,"type":22},[182,67],"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.",[673,674,675,676],"Carbon Monoxide Poisoning","Carbon Monoxide Intoxication","Carbon Monoxide Encephalopathy","Carbon Monoxide-induced Parkinsonism",{"date":655,"type":46},{"date":679,"type":22},"2026-07",{"date":681,"type":22},"2028-01",{"name":52,"class":53},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":4,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":23,"phases":692,"briefSummary":693,"conditions":694,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":700,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":704,"locationsCount":54},"100492928","phase-1-a-study-of-temodar-with-abexinostat-pci-24781-for-patients-with-recurrent-glioma-100492928","NCT05698524","A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma","A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma","Inclusion Criteria:\n\n* Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma)\n* Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are allowed)\n* Three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression\n* 19 years of age or older (the age of consent in Nebraska)\n* Fully recovered from any toxicity of prior therapy that, in the opinion of the investigator, could impact tolerance to the study drug\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Adequate bone marrow reserve (ANC count ≥1,500\u002Fmm3, hemoglobin \\> 8 g\u002FdL, platelet count ≥100,000\u002Fmm3)\n* Adequate renal function (a serum creatinine that is at or below 2.0 mg\u002FdL)\n* Adequate hepatic function (serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline phosphatase less than 2.5 times the upper limits of normal)\n* Able to provide written, informed consent\n* Females of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and\u002For both ovaries)\n* Females of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and up to 6 months following treatment\n\nExclusion Criteria:\n\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-24781\u002FAbexinostat, or put the study outcomes at undue risk\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \\> 20 mg\u002Fday) or experimental therapy (other than PCI-24781\u002FAbexinostat PO) within 4 weeks before first dose of study drug\n* Concurrent use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate and oxcarbazepine)\n* Any other active malignancy other than nonmelanoma skin cancer or controlled prostate cancer\n* Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection (no testing is required for eligibility)\n* Creatinine \\> 1.5 x institutional upper limit of normal (ULN); total bilirubin \\> 1.5 x ULN (unless from Gilbert's disease), and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 x ULN\n* Pregnant or breast-feeding\n* Baseline ECG duration of the ventricular action potential corrected for heart rate (QTc interval) prolongation based on Fridericia's formula is \\> 450 ms in males and \\> 470 ms in females\n* Concomitant valproic acid use, or another histone deacetylases (HDAC) inhibitor\n* Receiving treatment with following medications and unable to discontinue treatment or switch medications prior to study enrollment:\n\n  * Amiodarone (Cordarone, Pacerone)\n  * Arsenic trioxide (Trisenox)\n  * Chlorpromazine (Aralen)\n  * Cisapride (Propulsid)\n  * Clarithromycin (Biaxin)\n  * Disopyramide (Norpace)\n  * Dofetilide (Tikosyn)\n  * Doperidol (Inapsine)\n  * Erythromycin (EryTab, Erythrocin)\n  * Flecanide (Tambocor)\n  * Haloperidol (Haldol)\n  * Ibutilide (Corvert)\n  * Methadone (Methadose, Dolophine)\n  * Moxifloxacin (Avelox)\n  * Pentamidine (Pentam, Nebupent)\n  * Pimozide (Orap)\n  * Procainamide (Procan, Pronestyl)\n  * Quinidine (Cardioquin, Quinaglute)\n  * Sotalol (Betapace)\n  * Thioridazine (Mellaril)\n  * Vandetanib (Zactima)",{"count":691,"type":22},24,[182],"Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781\u002FAbexinostat with metronomic temozolomide.",[695,696,697,698,699],"Recurrent High Grade Glioma","Anaplastic Astrocytoma","Anaplastic Oligodendroglioma","Glioblastoma","Gliosarcoma",{"date":655,"type":46},{"date":702,"type":46},"2023-06-26",{"date":541,"type":22},{"name":52,"class":53},""]