[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oregon Health and Science University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":682},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,106,0,25,[9,49,80,107,137,161,185,218,240,260,287,314,342,368,395,423,451,472,500,523,551,581,607,639,664],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652104","phase-2-efficacy-of-bimekizumab-in-adults-with-pyoderma-gangrenosum-100652104",false,"NCT07767864","Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum","A Single-arm Open-label Study Assessing Efficacy of Bimekizumab in Adult Participants With Pyoderma Gangrenosum Over 24 Weeks","BEAT-PG","Inclusion Criteria:\n\n* At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)\n* Have a diagnosis of at least one PG ulcer defined by the investigator on the basis of results from clinical and\u002For histological and\u002For laboratory assessments: Classic PG defined as deep ulceration with undermining violaceous borders and PARACELSUS score \\>10. If multiple ulcers are present, the largest ulcer (defined by greatest surface area) will be designated the target ulcer and followed throughout the study.\n* Subject has a minimum of 1 evaluable ulcer (4cm2 - 225cm2) at screening.\n* Be a candidate for systemic therapy.\n* Undergoing at least once a week wound care at home or at a wound care facility.\n* Participants must be on a stable dose of prednisone of 20 mg\u002Fday for at least two weeks prior to first drug administration (baseline) and must follow the baseline Prednisone tapering algorithm.\n* Subjects on existing immunosuppression and systemic therapies for managing underlying comorbidities associated with PG but are not intended to treat PG specifically will be included in trial and allowed to continue these medications while on trial. The comorbidity must be on a stable clinical course and clinical treatment must be stable for at least 1 month prior to screening. Dosage of medication used to treat underlying comorbidities will be documented at each visit.\n* Males ages 18 and above must agree to not father a child or donate sperm while on study and for at least 12 weeks following last dose of the study drug. A subject who is a sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a reliable form of birth control and confirm that female partner(s) are using birth control, or remain abstinent.\n* Females ages 18 and above must be either of non-childbearing potential or of childbearing potential who test negative for pregnancy at screening, agree to urine pregnancy testing before receiving study intervention administration and agree to use at least two reliable methods of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of bimekizumab Female subjects must agree to not donate eggs while on study or for 12 weeks after the last dose of bimekizumab.\n* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n* Be willing to travel to site for all study visits, and willing\u002Fable to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.\n* Be willing to undergo perilesional and nonlesional skin biopsy at week 0 and week 24 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies (perilesional and nonlesional) at week 16. Refusal to give consent for any of the optional research samples does not exclude a participant from participation in the study.\n\nExclusion Criteria:\n\n* Any drug treatment specifically for PG including but not limited to biologicals (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:\n\n  1. 4 weeks for any therapeutic agent directly targeted to IL-17 including, but not limited to, secukinumab, brodalumab, ixekizumab\n  2. 8 weeks for infliximab;\n  3. 6 weeks for adalimumab;\n  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK\u002FTYK pathway and PD4 inhibitors;\n  5. 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).\n* If not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.\n* Intralesional corticosteroids within 4 weeks of screening.\n* Individuals with active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.\n* Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for rheumatoid arthritis), are allowed as combination therapy except for MTX and Leflunomide which are allowed individually but not in combination.\n* Individuals will be screened for IBD using a calprotectin test at screening. Individuals with inflammatory bowel disease (IBD) will be excluded from study.\n* Concurrent skin disease that is deemed to interfere with assessment of ulcer.\n* Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg.\n* Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.\n* Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Participants with pyoderma gangrenosum with comorbid necrotizing ulcer features or disease will be excluded from study.\n* Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities:\n\n  1. Neutrophil count \\\u003C1500 cells\u002FµL\n  2. Lymphocyte count \\\u003C500 cells\u002FµL\n  3. Platelet count \\\u003C100,000 cells\u002FµL\n  4. AST or ALT or alkaline phosphatase \\> 2 times the upper limit of normal\n  5. Hemoglobin \\\u003C10 g\u002FdL\n  6. Serum creatinine ≥1.5 mg\u002FdL (SI: ≤137 μmol\u002FL)\n  7. White blood cells \\\u003C3500 cells\u002F µL\n* Participant has known allergies, hypersensitivity, or intolerance to bimekizumab or its excipients (refer to Investigator's brochure)\n* Individuals who are pregnant, lactating or breastfeeding.\n* History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.\n* Have signs or symptoms suggestive of active TB upon medical history and\u002For physical examination.\n\n  1. Have had recent close contact with a person with active TB for which a physician specializing in TB has not ruled out latent TB or has not received appropriate treatment before the first study drug administration.\n  2. Have a positive QuantiFERON®-TB Gold test result within 2 months before the first administration of study drug in which active TB has not been ruled out and for which appropriate treatment for latent TB has not been initiated before the first administration of study dug.\n  3. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation. IGRA testing is not required at screening for participants with a history of treated latent TB or ongoing treatment for latent TB.\n* Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).\n* Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.\n* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate families (spouse, parent, child, or sibling).\n* Are currently enrolled in or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.","ALL","18 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of the study is to learn more about an experimental drug bimekizumab that may be helpful for Pyoderma Gangrenosum (PG). Bimekizumab will be referred to as the study drug throughout this form. The investigators are hoping to find out if bimekizumab helps in healing PG wounds. The study drug is experimental. It has been approved by the FDA for use in adults with psoriatic conditions but not for Pyoderma Gangrenosum (PG).",[28],"Pyoderma Gangrenosum",[30,31,28,32,33,34,35],"PG","Pyoderma","Chronic wounds","Chronic ulcers","Non-healing ulcers","Wound","NOT_YET_RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-17","ACTUAL",{"date":42,"type":22},"2026-09-01",{"date":44,"type":22},"2028-09",{"name":46,"class":47},"Oregon Health and Science University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100638900","precision-t1d-platform---new-therapies-for-cardio-renal-complications-100638900","NCT07594145","Precision T1D Platform - New Therapies for Cardio-Renal Complications","Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)","Inclusion Criteria:\n\n1. Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:\n\n   1. presence of circulating T1D-associated autoantibodies, or\n   2. history of hospitalization for diabetic ketoacidosis, or\n   3. documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \\>100 mg\u002FdL)\n2. Aged 18-75 years, inclusive\n3. T1D duration \\>10 years\n4. HbA1c: 7-10%\n5. Meets one of the following, either\n\n   1. UACR \\> 30 mg\u002Fdl with eGFR ≥ 60mL\u002Fmin\u002F1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or\n   2. Early (Stage B HF) defined as NT-proBNP ≥125 pg\u002FmL\n6. Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease\n2. Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms\n3. Current use of GLP-1 receptor agonists or other non-glucose lowering agent\n4. Use of aldosterone inhibitors within 2 months prior to screening\n5. Immunosuppressive medications within 3 months prior to screening\n6. Systolic BP\\>160 or diastolic BP \\>95 mmHg at screening\n7. History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening\n8. Evidence of any episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening\n9. Serum potassium \\> 5.0 mmol\u002FL at screening\n10. Absolute neutrophil count \\\u003C 2.0 × 109 per L at screening\n11. Platelet count \\\u003C 120 × 109 per L at screening\n12. Known active tuberculosis, hepatitis B or C at screening, or history of HIV\n13. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and\u002For AST or ALT \\>2 times upper limit of normal, and\u002For total bilirubin \\>1.3 times upper limit of normal at screening\n14. History of severe acquired immune deficiency syndrome or severely immunocompromised status in the opinion of the study site investigator\n15. History of biopsy-proven non-diabetic CKD\n16. History of any other cause of HF (viral, congenital, valvular)\n17. History of heart or renal transplant or currently on chronic dialysis\n18. Cancer treatment, excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer, within one year prior to screening\n19. Illicit drug abuse within 6 months prior to screening in the opinion of the study site investigator\n20. Current heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week)\n21. Participation in another interventional clinical research study within 30 days prior to screening\n22. Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial\n23. Presence of a clinically significant medical history, physical examination, laboratory finding or other identified study site investigator concern that may interfere with any aspect of study conduct or interpretation of results","75 Years",{"count":58,"type":22},57,[25],"Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \\& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.",[62,63,64,65],"Type 1 Diabetes","T1D Heart Failure","Cardio-renal Vascular Function and Failure","Diabetic Chronic Kidney Disease",[62,67,68,69,70],"T1D","DKD","Heart Failure","Platform Trial","2026-08-05",{"date":73,"type":40},"2026-08-10",{"date":75,"type":22},"2026-11-01",{"date":77,"type":22},"2031-12-31",{"name":46,"class":47},2,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":86,"minAge":19,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":48},"100592045","phase-1-psilocybin-for-chronic-pelvic-pain-cpp-in-women-a-pilot-feasibility-study-100592045","NCT06988319","Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study","Inclusion Criteria:\n\n* Assigned female at birth, age 18-45 years (pre-menopause)\n* CPP for at least 6 months or longer with central sensitization, diagnosed by a provider who specializes in CPP (e.g. MD, DO, NP)\n* CPP with central sensitization includes endometriosis, adenomyosis, uterine fibroids, pelvic congestion, other pelvic inflammatory diseases, irritable bowel syndrome, inflammatory bladder disorders, myalgias, or any combination of the aforementioned1,3\n* Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations, neuromodulation, trigger point injections, anesthetic blocks, surgery), physical therapy, and\u002For psychotherapy (e.g. Cognitive Behavioral Therapy)\n* Participants will be generally healthy with no exclusionary physical or mental health conditions.\n\nExclusion Criteria:\n\n* Pelvic pain that is not defined as chronic (e.g. acute pelvic or vaginal infections such as sexually transmitted infections, urinary tract infections, pregnancy)\n* Have a history of or a current primary psychotic disorder or bipolar disorder type 1\n* Current use of lithium.\n* Ketamine-assisted therapy within 12 weeks of the baseline visit (V3) or hallucinogen use within 6 months of study enrollment (e.g. psilocybin at a dose of 10 mg or 1 gram mushroom or greater, LSD, MDMA, DMT)\n* Cannabis use (THC, CBD). If willing to taper before the baseline visit (V3) the participant can be included.\n* A positive urine drug test for illicit substance use\n* a score of 5 or greater on the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) indicating heavy alcohol use\n* Suicidal ideation or serious suicide risk as determined by C-SSRS, if baseline score is 4 or greater.\n* Uncontrolled hypertension, cardiovascular disease, chronic neurologic disorders (e.g. Parkinson's disease, dementia, multiple sclerosis, epilepsy)\n* Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation","FEMALE","45 Years",{"count":21,"type":22},[90],"PHASE1","The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).",[93],"Chronic Pelvic Pain",[95,96,97,98],"psilocybin","women","chronic pelvic pain","psilocybin assisted therapy","2026-07-31",{"date":101,"type":40},"2026-08-03",{"date":103,"type":22},"2026-10-01",{"date":105,"type":22},"2027-12-31",{"name":46,"class":47},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":18,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":48},"100424225","sleep-duration-and-cardiovascular-health-100424225","NCT04804124","Sleep Duration and Cardiovascular Health","Goldilocks","Inclusion Criteria:\n\n* Men and women ages 25-65y\n* Lean and overweight (BMI 18.5-40 kg\u002Fm2)\n* No acute, chronic, or debilitating medical conditions\n* No prescription\u002Fnon-prescription medications or drugs of abuse\n* Current non-smoker (tobacco and marijuana)\n* Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, and additional sleep and health profiling questionnaires may be eligible to participate.\n\nExclusion Criteria:\n\n* Persons with any acute, chronic, or debilitating medical condition except pre-hypertension will be excluded.\n* Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.\n* Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.\n* Persons with a history of regular night\u002For rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.\n* Pregnant women, decisionally impaired adults, and prisoners will be excluded.",true,"25 Years","65 Years",{"count":118,"type":22},24,[120],"NA","This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.",[123,124],"Sleep","Cardiovascular Risk Factor",[126,127,128],"cardiovascular","sleep duration","vascular endothelial function","RECRUITING",{"date":131,"type":40},"2026-08-04",{"date":133,"type":40},"2021-06-09",{"date":135,"type":22},"2027-09-15",{"name":46,"class":47},{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":114,"sex":86,"minAge":19,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":160,"locationsCount":48},"100491083","phase-4-disparities-in-emergency-contraceptive-metabolism-dictate-efficacy-100491083","NCT05674513","Disparities in Emergency Contraceptive Metabolism Dictate Efficacy","Inclusion Criteria:\n\n* Generally healthy women\n* Aged 18-40\n* regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng\u002FmL or greater during the luteal phase of the screening cycle.\n\nExclusion Criteria:\n\n* Pregnant, seeking pregnancy, or breastfeeding\n* Known allergy to study medication\n* Recent use of hormonal contraception\n* Irregular periods (\\\u003C21 days or \\>35 day cycles)\n* Routine use of nonsteroidal anti-inflammatory drugs\n* Metabolic disorders\n* Smoking\n* Any condition that would preclude the provision of informed consent\n* Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates","40 Years",{"count":145,"type":22},140,[147],"PHASE4","The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.",[150],"Contraceptive Usage",[152,153],"Ulipristal acetate","Emergency contraception","2026-07-08",{"date":156,"type":40},"2026-07-09",{"date":158,"type":40},"2023-01-09",{"date":105,"type":22},{"name":46,"class":47},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100646557","phase-4-extended-post-operative-oral-txa-in-primary-tha-100646557","NCT07685743","Extended Post-operative Oral TXA in Primary THA","Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years\n* Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis\n* Ability to provide written informed consent\n* Willingness to comply with study protocol\n\nExclusion Criteria:\n\n* History of venous thromboembolism (DVT or PE)\n* Active malignancy\n* Allergy or contraindication to tranexamic acid (TXA)\n* Post-operative anticoagulation therapy other than aspirin\n* History of color blindness or retinal disease",{"count":169,"type":22},170,[147],"The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.",[173,174],"Osteoarthritis (OA) of the Hip","Osteoarthritis (OA) of the Knee",[176,177,178],"Tranexamic acid","Patient Reported Outcomes","Arthroplasty","2026-07-06",{"date":154,"type":40},{"date":42,"type":22},{"date":183,"type":22},"2028-09-01",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":204,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100609900","implementing-powered-mobility-in-early-childhood-settings-for-children-with-cerebral-palsy-100609900","NCT07220590","Implementing Powered Mobility in Early Childhood Settings for Children With Cerebral Palsy","Bridging the Gap: Implementing A Powered Mobility Intervention Into Early Childhood Settings for Young Children With Cerebral Palsy (GMFCS IV-V)","Inclusion Criteria:\n\nChildren:\n\n1. Diagnosis of cerebral palsy or similar motor impairment\n2. Gross Motor Function Classification System (GMFCS) Levels IV-V\n3. Age 12 to 32 months at enrollment\n4. Enrolled in early intervention services\n\nCaregivers:\n\n1. Parent or legal guardian of an enrolled child participant\n2. Age 18 years or older\n3. English- or Spanish-speaking\n4. Able and willing to participate in home-based data collection, including caregiver coaching sessions, completion of surveys, and video-recorded sessions\n5. Able to provide informed consent\n\nTherapists:\n\n1. Licensed physical therapist or occupational therapist\n2. Employed at participating early intervention or early childhood special education settings\n3. Provide services to children with cerebral palsy or motor delays\n4. No prior powered mobility intervention training required\n5. Willing to complete powered mobility implementation training and participate in study assessments\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide informed consent\n2. Inability to complete required study procedures","12 Months",{"count":194,"type":22},70,[120],"The goal of this clinical trial is to learn if a therapist training program can help providers in Part C Early Childhood Settings use powered mobility (PM) with young children who have cerebral palsy (Gross Motor Function Classification System Levels IV-V). The study will also look at whether this training is practical and useful for therapists, families, and children.\n\nThe main questions it aims to answer are:\n\n1. Can therapists successfully use the training to provide powered mobility interventions in home and early childhood settings?\n2. Do families and children find the intervention acceptable and helpful?\n3. What benefits do children show in mobility, participation, and engagement after using powered mobility?\n\nIn this study, therapists and families will:\n\n1. Take part in a training program about how to use powered mobility with young children\n2. Use powered mobility devices (Permobil Explorer Mini) with children during everyday routines\n3. Complete surveys, interviews, and observations about their experiences",[198,199,200,201,202,203],"Cerebral Palsy Children","Motor Disabilities","Developmental Disability","Rehabilitation","Early Intervention","Assistive Technology",[205,206,207,208,209],"Power Mobility","Implementation Science","Community-engaged research","Caregiver coaching","Pediatric Rehabilitation","2026-07-02",{"date":179,"type":40},{"date":213,"type":40},"2025-10-01",{"date":215,"type":22},"2029-06-30",{"name":46,"class":47},3,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":79},"100535977","treatment-of-obstructive-sleep-apnea-with-personalized-surgery-in-children-with-small-tonsils-100535977","NCT06258837","Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils","TOPS-ST","To be in the study:\n\n* Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).\n* Child age is 2.00 to 17.99 years of age.\n* Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.\n* Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.\n* Caregiver can speak, read, and write in English or Spanish.\n* Caregiver is primary caretaker of the child.\n* Child is not expecting their own child.\n* Child is eligible for surgical treatment\n\nCannot be in the study if:\n\n* Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.\n* Child has any contraindication to surgery (e.g. bleeding disorders).\n* Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.\n* Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly.\n* Caregiver is unwilling or unable to comply with study procedures.\n* Child is or plans to become a parent themselves.","2 Years","17 Years",{"count":228,"type":22},175,[120],"The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.",[232,233],"Otolaryngological Disease","Obstructive Sleep Apnea",{"date":179,"type":40},{"date":236,"type":40},"2024-10-04",{"date":238,"type":22},"2028-09-30",{"name":46,"class":47},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":225,"maxAge":226,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},"100478361","treatment-of-obstructive-sleep-apnea-with-personalized-surgery-in-children-with-down-syndrome-tops-ds-100478361","NCT05508971","Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)","TOPS-DS","Requirements to participate in study:\n\nChild has a diagnosis of Down syndrome (Trisomy 21). Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5). Child age is 2.00 to 17.99 years of age. Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.\n\nCaregiver can speak, read, and write in English or Spanish. Caregiver is primary caretaker of the child. Child is not expecting their own child. Child is eligible for surgical treatment\n\nCannot participate in study if:\n\nChild has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.\n\nChild has any contraindication to surgery (e.g. bleeding disorders). Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.\n\nCaregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.",{"count":248,"type":22},304,[120],"The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT.\n\nIt is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT.",[233,252],"Down Syndrome",{"date":179,"type":40},{"date":255,"type":40},"2023-08-02",{"date":257,"type":22},"2028-06-30",{"name":46,"class":47},7,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":114,"sex":18,"minAge":225,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":48},"100645165","a-kinder-coaching-program-with-community-health-workers-ready-100645165","NCT07677618","A Kinder Coaching Program With Community Health Workers \"READY\"","Promoting School Readiness in Primary Care: A Kinder Coaching Program With Community Health Workers","READY","Inclusion Criteria:\n\n* Parent or caregiver is 18 years of age or older with no intellectual disability and can speak and understand Spanish and\u002For English. Participants unable to read will be eligible as data will be verbally collected by bilingual research staff.\n* Child is between 3 and 4 years of age at enrollment and receives primary care at a study site.\n* Child is from a low-income household on Medicaid insurance.\n* Child has no significant developmental disability or serious medical condition that limits communication with the Kinder Coach. Children with mild developmental delays including speech delay, gross motor delay, autism spectrum disorder, mild cerebral palsy, and ADHD will be included to capture a heterogenous, real-world sample from primary care.\n\nExclusion Criteria:\n\n* Parent or child with significant intellectual disability.\n* Teen parents under the age of 18.\n* Child is in foster care or other situation in which consent cannot be obtained from a legal guardian.\n* Child with a significant developmental disability that limits participation including cerebral palsy, non-verbal autism spectrum disorder, Down's syndrome, global developmental delay, or other serious medical condition impacting ability to participate in a Kinder Coaching visit. Developmental conditions will be defined as children who screen negative on the Children with Special Health Care Needs (CSHCN) screener for developmental and\u002For behavioral special needs \"above and beyond what would be expected\" for a child of that age.",{"count":269,"type":22},480,[120],"In this study, the investigators compare two novel primary care interventions (School Readiness Checklist vs. Kinder Coaching) for low-income parents, which were co-developed by parent, clinical, and educational stakeholders. This R01 builds evidence on a low touch (low intensity, lower cost intervention) School Readiness Checklist compared to high touch (higher intensity, embedded program) Kinder Coaching with Community Health Workers in a hybrid effectiveness-implementation RCT.",[273,274,275],"School Readiness","Parent School Readiness Confidence and Skills","Preschool Enrollment",[277,278],"school readiness","Kinder Coaching","2026-06-24",{"date":281,"type":40},"2026-07-01",{"date":283,"type":22},"2027-07-01",{"date":285,"type":22},"2031-07-01",{"name":46,"class":47},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":114,"sex":18,"minAge":294,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":313,"locationsCount":48},"100599392","empowering-cardiovascular-health-in-custodial-grandparents-100599392","NCT07083895","Empowering Cardiovascular Health in Custodial Grandparents","ECG","Grandparent (inclusion):\n\n* Provides full-time care to at least one grandchild (\\\u003C 18 years old) for at least 6 months, with no biological parent residing in the household or providing substantial care to the children\n* Lives in Oregon\n* Has English proficiency sufficient for informed consent and completion of study measures\n* Provides signed informed consent\n\nGrandparent (exclusion)\n\n* Plans for transfer of care to other caregivers or setting for the next 12 months\n* Has significant physical or emotional impairment, or psychiatric illness that might interfere with engagement in their own self-management or that is likely to result in their needing a caregiver in the next 12 months\n* Chronic drug abuse\n* Current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer","21 Years",{"count":194,"type":22},[120],"In this study, the investigators will tailor an existing intervention (Rural Caregiver Heart Health Education (RICHH)) protocol and test its feasibility, acceptability, and initial effect with grandparent caregivers.",[299],"Cardiovascular Disease (CVD) Risk Factors",[301,302,303,304,305,306],"Rural Caregiver Heart Health Education (RICHH)","Custodial grandparents","Grandparent caregivers","Cardiovascular disease (CVD) risk factors","Community health workers","Grandchildren","2026-05-22",{"date":309,"type":40},"2026-05-27",{"date":42,"type":22},{"date":312,"type":22},"2028-07-31",{"name":46,"class":47},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":48},"100491551","balance-tele-rehab-in-parkinsons-disease-100491551","NCT05680597","Balance Tele-Rehab in Parkinson's Disease","Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease","Inclusion Criteria:\n\n1. Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions\n2. responsive to levodopa (self-reported)\n3. Hoehn \\& Yahr stages I-III;\n4. ages 55-85 years old\n5. ability to follow directions in order to participate in testing procedures and exercise classes\n6. free of any medical conditions or medication that contraindicates participation in an exercise program\n7. willing and able to participate in rehabilitation intervention approximately 3x\u002Fweek for 4 weeks while also refraining from making changes to medications (as reasonable) or to other exercise programs during the study period.\n\nExclusion Criteria:\n\n1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.)\n2. medical condition that precludes exercise\n3. cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions\n4. recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)\n5. excessive use of alcohol or recreational drugs\n6. recent change in medication\n7. inability to stand and walk for ISAW without an assistive device.","55 Years","85 Years",{"count":324,"type":22},80,[120],"This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.",[328],"Parkinson Disease",[330,331,332,333,334],"Tele-rehabilitation","Balance","Mobility","Tele-assessment","Wearable-sensors","2026-05-19",{"date":307,"type":40},{"date":338,"type":40},"2022-09-19",{"date":340,"type":22},"2027-06",{"name":46,"class":47},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":48},"100638745","light-therapy-to-improve-sleep-in-tbi-sleep-active-biomarkers-and-glymphatic-function-100638745","NCT07601841","Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function","Light Therapy to Improve Sleep in Veterans With TBI: Sleep-active Biomarkers and Glymphatic Function","GLIMPSE-LION","All subjects must:\n\n1. Male and female; any race; 18-89 years of age.\n2. Be English speaking.\\*\n3. Be accessible via phone.\n4. Be non-decisionally impaired. Determined by assessing the subject's ability to verbalize their understanding of the protocol back to us during the informed consent process.\n5. Not have a history of macular degeneration.\n6. Not have a history of bipolar disorder.\n7. Not be currently using a lightbox or a negative ion generator.\n8. Not be a shift worker.\n9. Have a documented history of TBI via the Head Trauma Events Characteristics (HTEC) or OHIO conducted in accordance with VA\u002FDoD Clinical Practice Guidelines.88\n10. Present with self-reported sleep-wake disturbances.\n11. Remain clinically stable for current pharmacologic treatment related to depression\u002Fanxiety, sleep, and pain.\n12. MRI specific compatibility requirements:\n\n    * No pacemaker, wires, defribrillator or implanted heart valves\n    * No history of head surgery requiring aneurysm clips\n    * No history of other orthopedic or general surgery requiring the implantation of ferrous pins, joints, electric devices\u002Fpumps, or other foreign metal objects\n    * History of eye exposure to metal (unprotected welding\u002Fmetalworking\u002Fshrapnel) is allowable provided the participant screens negative for metal in the eyes on an orbital x-ray or is able to provide clinical documentation of having screened negative.\n    * No history of non-removable hearing aids, middle\u002Finner ear prosthesis, or dentures\n    * No history of claustrophobia; if unsure participant will be pre-screened in our mock scanner\n    * Not currently pregnant, breastfeeding, or have an implanted IUD. Participants who are unsure of their pregnancy status will be administered an hCG urine pregnancy test the day of their scan.\n    * Able to lay flat on their back comfortably without a thick pillow for an extended period of time.\n    * Shoulder width does not exceed width for safety fitting in the MRI bore.\n\n      * This study is limited to English-speaking participants because all assessments, interventions, and consent materials are currently validated and approved only in English. Expanding to other languages would require translation and psychometric validation, which are beyond the scope and budget of this study. This limitation is acknowledged and will be addressed in future research as resources permit. Finally, the study team is only fluent in English, making it infeasible to accurately consent or interact with non-English speakers without interpreting services which again is outside of the scope of this projects budget and timeline. Proceeding without formal translation services would risk miscommunication in informed consent, data collection, or participant support and thus protects participants informed consent and participant understanding.","89 Years",{"count":352,"type":22},300,[120],"This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.",[123,356,357,358,359,360],"Phototherapy","Glymphatic System","Mitochondrial Dynamics","Brain Injuries, Traumatic","Inflammation","2026-05-18",{"date":307,"type":40},{"date":364,"type":40},"2025-12-12",{"date":366,"type":22},"2030-09-30",{"name":46,"class":47},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":79},"100640080","phase-4-mavacamten-to-aficamten-transition-in-patients-with-obstructive-hypertrophic-cardiomyopathy-100640080","NCT07600177","Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy","CMI-SWITCH","Inclusion Criteria:\n\n* Documented history of oHCM with documented resting and\u002For Valsalva LVOT obstruction ≥ 50 mmHg who are currently receiving mavacamten commercially.\n* Echo-derived LVEF ≥55% on mavacamten at the time of enrollment.\n* Patient willing to consent for the study and undergo the study procedures.\n\nExclusion Criteria:\n\n* Severe aortic stenosis or sub-aortic obstruction\n* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).\n* History of LVEF \\\u003C30%.\n* Paroxysmal atrial fibrillation (AF) with documented episode within 3 months.\n* Atrial fibrillation (paroxysmal or permanent) not on systemic anticoagulation.\n* Documented history of current obstructive coronary artery disease (\\> 70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.","90 Years",{"count":377,"type":22},40,[147],"This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).",[381],"Hypertrophic Cardiomyopathy (HCM)",[383,384,385,386],"aficamten","mavacamten","cardiac myosin inhibitor","CMI","2026-05-14",{"date":389,"type":40},"2026-05-20",{"date":391,"type":40},"2026-05-05",{"date":393,"type":22},"2027-03-15",{"name":46,"class":47},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":48},"100626196","phase-2-a-phase-ii-study-with-exploratory-outcomes-of-fucose-supplementation-in-glut1-deficiency-syndrome-100626196","NCT07432490","A Phase II Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome","A Phase II Randomized, Double-blind, Placebo-controlled, Cross-over Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Confirmed diagnosis of GLUT1DS, including at least 2 out of the following 3: molecular genetic testing showing a pathogenic or likely pathogenic variant in SLC2A1; documented hypoglycorrhachia with a CSF:blood glucose ratio ≤ 0.6; clinical features consistent with GLUT1DS (epilepsy, movement disorders, ataxia, intellectual disability, dysarthria)\n3. Presence of ataxia\n\nExclusion Criteria:\n\n1. Inability to swallow liquids\n2. Change in neurological medications (either medication itself or medication dosages) in the past 90 days\n3. Use of fucose- or mannose-containing supplements within one year of enrollment\n4. Presence of hepatic, renal, hematological, or concomitant metabolic disorders, as assessed by the presence of a previous diagnosis of such disorders (for instance, chronic kidney disease, liver cirrhosis, diabetes mellitus) or by the following laboratory values, which will be considered if obtained clinically up to 90 days before enrollment (if this is not available, laboratory tests will be obtained prior to first study visit):\n\n   1. Any degree of hepatic impairment based on the Child-Pugh classification\n   2. eGFR (as measured by serum creatinine or cystatin C) \\\u003C 60 mg\u002Fmin\u002F1.73m2\n   3. Hemoglobin A1c \\> 6.5%\n   4. Hemoglobin level below the lower limit of normal (LLN) for sex and age\n   5. Platelet counts below the LLN for sex and age\n5. Subjects who are pregnant, breastfeeding, or planning to become pregnant within one year of enrollment\n6. Enrollment in an investigational new drug trial for G1DS within one year of enrollment",{"count":403,"type":22},16,[25],"This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of L-fucose supplementation in subjects with GLUT1 deficiency syndrome (GLUT1DS).",[407,408],"Glut1 Deficiency","GLUT1DS1",[410,411,412,413,414,415],"GLUT1 Deficiency","GLUT1 Deficiency Syndrome","GLUT1DS","SLC2A1","Fucose","L-fucose","2026-05-08",{"date":418,"type":40},"2026-05-13",{"date":391,"type":40},{"date":421,"type":22},"2027-08",{"name":46,"class":47},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":79},"100635195","postural-motor-activation-deficits-after-mtbi-translating-laboratory-findings-to-clinical-care-100635195","NCT07549529","Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care","Inclusion Criteria:\n\n* Diagnosed mTBI (concussion)\n* 18-60 years of age\n* More than 2 weeks from the date of the most recent mTBI\n* Less than 6 months from the most recent mTBI\n* Persisting symptoms from the mTBI\n\nExclusion Criteria:\n\n* Injury, medical, or neurological illness that could explain balance issues\n* Moderate to severe substance abuse in the past month\n* Display behavior that would interfere with safety during data collection\n* Significant pain during the study period (\\> 7\u002F10)\n* Pregnancy\n* Persistent use of medications that cause balance impairment during the study\n* Active in physical therapy services for mTBI symptoms","60 Years",{"count":324,"type":22},[120],"This work will address an important gap in physical therapy rehabilitation after concussion. Physical therapy usually focuses on how the brain processes sensory information such as inner ear and vision for balance rehabilitation, but our recent research shows that people with imbalance more often have a problem with how they can respond to imbalance (i.e., motor activation). While there are complex laboratory tools to test motor activation for balance, these tests are not practical for the clinic. The goal of this study is to create both an exercise intervention focused on motor activation after concussion and simple, but objective and instrumented (wearable sensors), clinical measures of motor activation. Objectives: This research study has three aims. 1) The investigators and study team will develop an exercise program to improve the problems with how one's body responds to imbalance (i.e., improve motor activation) after a concussion. The study team will use a Community Based Participatory Research (CBPR) approach by collaborating with a team of people with a broad range of experience related to concussion. The study team will form a Community Advisory Board (CAB) that will include patients who have had a concussion, healthcare professionals with expertise in concussion, and healthcare administrators. The CAB will contain people working in the military and civilians. 2) The investigators will compare our new motor-focused physical therapy intervention to the standard sensory focused balance intervention. The goal is to determine which intervention program is more effective in treating balance problems after a concussion. The investigators hypothesize that the motor-focused program will help patients more compared to the sensory program. 3) The investigators and study team will create and test several balance tests that can be used in the clinical without expensive research equipment to our standard research-based motor activation tests. This aim will allow the study team to determine if the clinical tests perform as well as the research-grade tests. To make the test useful to clinicians, the study team will use simpler technology like smart-phone applications, wearable sensors, and virtual reality goggles that are both affordable and practical for healthcare providers.",[434,435],"Mild Traumatic Brain Injury (mTBI)","Concussion, Mild Traumatic Brain Injury",[437,438,439,440,441,442],"mTBI","concussion","motor activation","reaction time","physical therapy","vestibular rehabilitation","2026-04-23",{"date":445,"type":40},"2026-04-29",{"date":447,"type":22},"2026-06-30",{"date":449,"type":22},"2029-08-30",{"name":46,"class":47},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":143,"maxAge":375,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":48},"100497534","phase-2-characterizing-iodine-124-evuzumitide-at-01-in-systemic-amyloidosis-100497534","NCT05758493","Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis","Inclusion Criteria:\n\n1. Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance\n2. Patient willing to consent for the study and undergo the study procedures.\n\nExclusion Criteria:\n\n1. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol\n2. Has a known allergy to potassium iodide treatment or to gadolinium.\n3. Patients on dialysis or those with eGFR \\\u003C30 cc\u002Fmin\u002F1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.\n4. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration",{"count":458,"type":22},150,[25],"This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET\u002FMRI). In a subgroup of patients who are unable to undergo PET\u002FMR, computed tomography will be used instead of MRI (i.e. PET\u002FCT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.",[462,463],"Amyloidosis","Transthyretin Amyloidosis","2026-04-06",{"date":466,"type":40},"2026-04-13",{"date":468,"type":40},"2023-01-10",{"date":470,"type":22},"2028-03-10",{"name":46,"class":47},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":4},"100632949","using-the-adaptive-behavioral-counseling-decision-framework-to-guide-single-session-intervention-for-preschool-behavioral-concerns-in-pediatric-primary-care-a-feasibility-trial-100632949","NCT07520331","Using the Adaptive Behavioral Counseling Decision Framework to Guide Single-Session Intervention for Preschool Behavioral Concerns in Pediatric Primary Care: A Feasibility Trial","Adaptive Behavioral Counseling Decision Framework in Pediatric Primary Care","ABD-DeF","Inclusion Criteria:\n\n* Caregivers of children ages 18-65 months who screen positive on the Preschool Pediatric Symptom Checklist (PPSC) or otherwise identify a child behavior concern.\n* Caregivers must be at least 18 years old.\n* Caregivers must speak English or Spanish sufficiently to complete study procedures. Study procedures in other languages are not feasible.\n\nExclusion Criteria:\n\n* Children with moderate to severe intellectual disabilities.\n* Child and caregiver are already receiving more intensive behavioral parent training intervention (either at OHSU or in the community).",{"count":481,"type":22},60,[120],"The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial effectiveness of using the Adaptive Behavioral Counseling Decision Framework to provide behavioral counseling for common preschool behavior problems in pediatric primary care. The interventions will be provided by integrated behavioral health clinicians and provided to primary caregivers of children aged 18-65 months who screen positive on the Preschool Pediatric Symptom Checklist (PPSC) or otherwise identify a child behavior concern. Participants will receive behavioral guidance based on the Adaptive Behavioral Counseling Decision Framework during their child's medical visit or a single behavioral health visit. The main question\\[s\\] it aims to answer are:\n\n* What is the feasibility and acceptability of using a decision framework to guide selection and delivery of a single-session intervention for early childhood behavior concerns in pediatric primary care?\n* What is the initial effectiveness of framework-guided brief interventions in reducing parent-reported behavior concerns based on caregiver report?\n\nThe hypotheses are that the intervention will be delivered with fidelity in the time allotted, and that caregivers will rate the intervention as feasible and acceptable.",[485],"Early Childhood Emotional and Behavioral Concerns",[487,488,489,490,491],"primary care","integrated behavioral health","pediatrics","early childhood","feasibility trial","2026-04-03",{"date":494,"type":40},"2026-04-09",{"date":496,"type":22},"2026-06",{"date":498,"type":22},"2028-06",{"name":46,"class":47},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":48},"100590666","brief-sleep-intervention-for-bedtime-resistance-100590666","NCT06970392","Brief Sleep Intervention for Bedtime Resistance","Inclusion Criteria:\n\n* Caregiver of a child aged 3-7 years who receives primary care services who endorses their child demonstrating bedtime resistance; English-speaking; receiving primary care at the study locations.\n\nExclusion Criteria:\n\n* Existing receipt of more intensive sleep intervention; severe intellectual disability or other condition precluding participation.",{"count":377,"type":22},[120],"This is non-controlled feasibility study testing the delivery of a brief sleep intervention for children aged 3-7 who struggle to fall asleep independently. The interventions is designed to be delivered by a behavioral health consultant during routine primary care visits. The treatment components consist of education about good sleep hygiene and the \"Bedtime Pass.\" The hypotheses are that the intervention will be delivered with fidelity in the time allotted, and that parents will rate the intervention as feasible and acceptable.",[510],"Child Sleep",[512,513,514,515,516],"Feasibility trial","Bedtime Resistance","Bedtime Pass","Primary Care","Integrated Care",{"date":494,"type":40},{"date":519,"type":40},"2025-05-29",{"date":521,"type":22},"2026-09",{"name":46,"class":47},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":540,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":79},"100559376","phase-2-guselkumab-in-the-treatment-of-adults-with-pyoderma-gangrenosum-pg-100559376","NCT06563323","Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)","A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum","GEORGE","Inclusion Criteria:\n\n* Willingness to comply with study procedures\u002Frequirements\n* Capable of giving informed consent\n* Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.\n* Undergoing at least once a week standard of care wound care at home or at a wound care facility\n* Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg\u002Fday for at least two weeks prior to first drug administration.\n* Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.\n* Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.\n* Willingness to travel to study site for all study visits or living \\>30 miles from study site and willing\u002Fable to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.\n* Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.\n\nExclusion Criteria:\n\n* Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab\n* Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:\n\n  1. 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;\n  2. 8 weeks for infliximab;\n  3. 6 weeks for adalimumab;\n  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK\u002FTYK pathway and PD4 inhibitors;\n  5. 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).\n\nIf not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.\n\n* Intralesional corticosteroids within 4 weeks of screening.\n* Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.\n* Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for Methotrexate (MTX) and Leflunomide which are allowed individually but not in combination.\n* Concurrent skin disease that is deemed to interfere with assessment of ulcer.\n* Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg.\n* Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.\n* Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil count \\\u003C1500 cells\u002FµL, Lymphocyte count \\\u003C500 cells\u002FµL, Platelet count \\\u003C100,000 cells\u002FµL, AST or ALT or alkaline phosphatase \\> 2 times the upper limit of normal, Hemoglobin \\\u003C10 g\u002FdL, Serum creatinine ≥1.5 mg\u002FdL (SI: ≤137 μmol\u002FL), White blood cells \\\u003C3500 cells\u002F µL\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.\n* Individuals who are pregnant, lactating or breastfeeding.\n* History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.\n* Have signs or symptoms suggestive of active Tuberculosis (TB) upon medical history and\u002For physical examination. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention.\n* Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).\n* Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.\n* Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate families (spouse, parent, child, or sibling).\n* Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.","99 Years",{"count":533,"type":22},17,[25],"A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)",[28,537,538,31,539],"Skin Diseases","Wound Heal","Skin Ulcer",[541,542],"Guselkumab","IL-23 Inhibitor","2026-03-04",{"date":545,"type":40},"2026-03-06",{"date":547,"type":40},"2025-02-01",{"date":549,"type":22},"2027-08-13",{"name":46,"class":47},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":567,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":48},"100580466","the-moud-plus-pilot-counseling-and-peer-support-to-support-retention-for-medically-complex-patients-with-opioid-use-disorder-seen-in-primary-care-100580466","NCT06837662","The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care","Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The \"MOUD PLUS (MOUD+)\" Study","MOUD+","Inclusion Criteria:\n\n* Eligibility\u002FInclusion Criteria. For Aim 3, criteria we seek to recruit include:\n* Patient participants 18 years and older\n* Have an OUD-related diagnosis (e.g. Opioid Use Disorder in remission, Opioid Dependence, Opioid Abuse, Substance Use Disorder - opioids, etc.), or have used fentanyl or heroin over the past 30 days\n* Who meet at least one of the following criteria:\n\n  * Present to primary care at Central City Concern (CCC) within 8 weeks of starting or re-starting a treatment episode (defined as starting MOUD after not having received prescribed MOUD in an outpatient setting for OUD in the prior 30 days).\n  * Who present to primary care at CCC and are not seeking treatment with MOUD and have not engaged in counseling services (e.g. harm reduction counseling) in the prior 30 days\n  * Have been receiving MOUD in prior 30 days but had a return to use (used fentanyl or heroin) within the past 30 days\n* Medical complexity (e.g. self-reported or verified in patient's electronic health record)\n* Have access to phone and\u002For computer for follow-up activities\n* Desire to engage in counseling and\u002For peer services\n\nExclusion Criteria:\n\n* Patient participants who present for addiction treatment but are ineligible to receive on-going services at Central City (i.e. they have existing primary care at another location, or are currently receiving opioid use disorder treatment at another clinic, such as methadone clinic) may not participate in the study.\n* Patient participants who are not able to verbally consent may not participate in the study.\n* Patients who do not have addiction to opioids may not participate in the study.\n* Patients who participated in Aim 2 would not be eligible for Aim 3\n* Patients who lack stable phone access may not participate in the study.",{"count":194,"type":22},[120],"The goal of this pilot clinical trial is to learn if a community informed designed program of addiction counseling with coordinated community peer navigator for people with Opioid Use Disorder (OUD) and other medical conditions can improve engagement in primary care and retention on buprenorphine.\n\nThe main questions it aims to answer are:\n\n* Does the addition of a counseling and peer referral interventions in addition to usual primary care with low-threshold buprenorphine increase retention on medications for opioid use disorder?\n* Does the addition of counseling and peer referral intervention in addition to usual primary care with low-threshold buprenorphine increase engagement in primary care?\n\nResearchers will compare the MOUD \"Plus\" intervention compared to primary care treatment as usual low-threshold buprenorphine prescribing practice to see if MOUD \"Plus\" improves retention and engagement.\n\nParticipants will upon screening and enrollment:\n\n* Meet with prescribers who will determine dose of buprenorphine and assess other medical issues as per treatment as usual with visits every 2-4 weeks\n* Meet with the integrated addictions counselor to develop rapport and support around clinic engagement, brief counseling intervention, and coordination of care in support of their MOUD\n* Be referred to a community based peer who meets with participants outside the clinic for support and advocacy for patient directed recovery goals\n* Meet with the research coordinator at 2, 3, and 6 months to complete follow-up surveys about their care and experiences",[563,564,565,566],"Opioid Dependence","Substance Abuse Disorders","Complex Medical Patients","Primary Care Patients With Chronic Conditions",[568,569,570,571,572],"opioid use disorder","medications for opioid use disorder","recovery capital","collaborative care model","addiction treatment","2026-02-23",{"date":575,"type":40},"2026-02-25",{"date":577,"type":40},"2025-03-24",{"date":579,"type":22},"2026-12-01",{"name":46,"class":47},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":114,"sex":18,"minAge":294,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":48},"100626156","assessing-construction-execution-under-sleep-impairment-100626156","NCT07431970","Assessing Construction Execution Under Sleep Impairment","Feasibility of VR Construction Simulations for Detecting Sleep-Related Impairments","ACES","Inclusion Criteria:\n\n* Fluent in English\n* Tolerate virtual reality system\n\nExclusion Criteria:\n\n* Recent shiftwork\n* Recent travel across time zones (\\>2 in last month)\n* Underlying health conditions (high blood pressure, diabetes, cancer, heart attack, heart failure, angioplasty, heart surgery, etc.)\n* Use of nicotine products such as tobacco or e-cigarettes\n* Use of illicit drugs in the past year\n* Pregnancy\n* Sleep disorders (obstructive sleep apnea)","49 Years",{"count":591,"type":22},12,[120],"The goal of this study is to learn whether virtual reality (VR) construction tasks can detect performance changes associated with prior sleep, and to determine the extent to which these changes can be distinguished from interacting repetitively with VR itself.",[123],[596,597,123,598,599],"Occupational Health","Construction","Virtual Reality","Sleep Impairment","2026-02-17",{"date":575,"type":40},{"date":603,"type":22},"2026-03-01",{"date":605,"type":22},"2026-08-31",{"name":46,"class":47},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":623,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":48},"100453468","sleep-and-circadian-mechanisms-in-hypertension-100453468","NCT05184933","Sleep and Circadian Mechanisms in Hypertension","Inclusion Criteria:\n\n* Ages 25-64\n* BMI 18.5-42kg\u002Fm2\n* Hypertension (average resting blood pressure between 130\u002F80 mmHg and 160\u002F100 mmHg)\n\nExclusion Criteria:\n\n* Over 5 pack-years of smoking;\n* Prior shift work within 12 months prior to the study;\n* Travel greater than three time zones for at least 3 months;\n* History of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction;\n* Acute or chronic diseases (except hypertension) that may affect outcome measures;\n* History of psychological conditions;\n* Sleep disorders, like severe sleep apnea, insomnia, etc.;\n* Prescription medications (Contraceptives and anti-hypertensive medications are permissible);\n* History of Illicit drug use and alcohol dependency;\n* 30 days free of cannabis use prior to the study;\n* Pregnancy;\n* Upper cut-off of 160\u002F100 mmHg for BP","64 Years",{"count":615,"type":22},32,[120],"This study is a mechanistic clinical trial designed to investigate the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN).",[619,620,621,622,123],"Hypertension","Cardiovascular Diseases","Cardiovascular Risk Factors","Circadian Rhythms",[126,624,625,626,627,628,629,630],"circadian rhythms","sleep","blood pressure","constant routine","microneurography","hypertension","sleep regularization","2026-02-09",{"date":633,"type":40},"2026-02-11",{"date":635,"type":40},"2022-08-04",{"date":637,"type":22},"2029-03-30",{"name":46,"class":47},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":86,"minAge":19,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":648,"phases":4,"briefSummary":649,"conditions":650,"keywords":653,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":217},"100620389","stelo-real-time-continuous-glucose-monitor-use-postpartum-for-lifelong-optimal-wellness-100620389","NCT07356986","Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness","STELO-GLOW","Inclusion Criteria:\n\n* Gestational Diabetes Mellitus (GDM) diagnosis by 1- or 2-step Oral Glucose Tolerance Test (OGTT) during pregnancy or \\>= 200 mg following any glucose challenge (50g, 75g, 100g)\n* Has a smart phone compatible to support Dexcom Stelo app\n* Able to read, write, and understand English\n* Meet Stelo Glucose Biosensor Indications for Use (IFU) per approved commercial labeling\n* Willing to follow all study procedures\n\nExclusion Criteria:\n\n* Greater than 6 weeks and 6 days postpartum at enrollment\n* Preexisting Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D)\n* End-stage renal failure (on dialysis)\n* Heart failure\n* Other uncontrolled high-risk condition as determined exclusionary by site investigators\n* Extensive skin changes\u002Fdiseases that preclude wearing the required system on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites\n* Known severe allergy to medical-grade adhesives\n* Any condition that, in the opinion of the investigator, would interfere with their participation in the trial\n* Obesity surgery\n* Insulin use prior to discharge home from the delivery admission\n* Current participation in another postpartum Continuous Glucose Monitoring (CGM) or lifestyle intervention trial",{"count":647,"type":22},50,"OBSERVATIONAL","The purpose of this prospective observational study is to gather exploratory and practical use data of the Dexcom Stelo Glucose Biosensing System (Stelo), an over-the-counter (OTC) real-time Continuous Glucose Monitoring (CGM) system among patients with Gestational Diabetes Mellitus (GDM) in their most recent pregnancy.",[651,652],"Gestational Diabetes","Postpartum",[654,655],"Continuous Glucose Monitoring","Postpartum Glucose Management","2026-01-12",{"date":658,"type":40},"2026-01-21",{"date":660,"type":22},"2026-01",{"date":662,"type":22},"2027-12",{"name":46,"class":47},{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":114,"sex":86,"minAge":294,"maxAge":143,"enrollmentInfo":670,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":681,"locationsCount":48},"100601496","phase-4-insights-in-endocervical-mucus-secretion-100601496","NCT07111247","Insights in Endocervical Mucus Secretion","Inclusion Criteria:\n\n* Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles\n* BMI \\>18 and \\\u003C35\n* Serum p4 \\>= 3 ng\u002Fml on single sample collected between days 18-25 of self-reported menstrual cycle\n* Flexible schedule allowing blood draws on less than 48 hour notice\n* In good general health\n* Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol\n* No objections to taking study drugs\n* No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse\n\nExclusion Criteria:\n\n* Oral contraceptive use or other hormone supplement within the preceding 2 months\n* Current cervical infection\n* Evidence of abnormal cervical cytology\n* Use of any IUD for contraception\n* Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera)\n* Contraindications to study drugs\n* Current or past pregnancy within the previous 6 months or currently trying to conceive\n* Desiring to conceive in the next 8 months\n* Breastfeeding in the past 2 months\n* Diagnosed diabetes or metabolic syndrome\n* Diagnosed Polycystic Ovary Syndrome\n* History of, or self-reported, substance abuse\n* Smoker\n* Previous infertility treatment excluding male factor issues\n* Use of an investigational drug within the past 2 months\n* History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone)\n* Current treatment for a vaginal infection such as bacterial vaginosis\n* History of venous thromboembolism (VTE) or inherited thrombophilias",{"count":21,"type":22},[147],"Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.",[674],"Cervical Mucus","2026-01-06",{"date":677,"type":40},"2026-01-08",{"date":679,"type":40},"2026-01-02",{"date":421,"type":22},{"name":46,"class":47},""]