[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of North Carolina, Chapel Hill\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,126,0,25,[9,51,76,99,122,145,165,211,232,253,279,308,328,363,396,418,438,471,491,509,530,548,571,607,634],{"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":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054091","clearance-in-primary-ciliary-dyskinesia-100054091",false,"NCT07699302","Clearance in Primary Ciliary Dyskinesia","Evaluating Non-ciliary Mechanisms of Airway Clearance in Muco-obstructive Lung Disease","CLIP","Inclusion Criteria:\n\n* 18 years old or older\n* Diagnosis of PCD with supporting genetics\n* Lung function with forced expiratory volume in 1 second (FEV1) percent predicted \\>30%\n* Ability to exercise for 20 minutes (Exercise Assessment performed at screening visit)\n\nExclusion Criteria:\n\n* Intolerance to 7% HS\n* Failure of HS tolerance test (HSTT) at visit 1 (V1), defined as a decline of 10% in FEV1 from baseline pre-bronchodilator (BD) FEV1 after 7% HS\n* Intolerance to levalbuterol\n* Exercise-induced asthma\n* Complex congenital heart disease or other exercise limitation\n* Lung transplantation or listed for lung transplantation\n* History of lung resection of the lung analyzed by MCC (depending on situs status)\n* Pregnancy or unwillingness to use approved birth control during study period\n* Recent hemoptysis (\\>60 ml in the last 3 months)\n* Pulmonary exacerbation in preceding 4 weeks\n* Change in pulmonary therapies within preceding 4 weeks\n* Resting or exertional O2 requirement (nocturnal acceptable)\n* Tobacco \u002F smoking history (any within last year, and \\>10 pack year history in past)\n* More than 2 chest computed tomography (CT) scans in the past year or a combination of procedures believed to have exposed the lungs to \\>150 millisieverts (mSv), including from other research studies\n* Participation in another interventional trial within 30 days","ALL","18 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"NA","Understanding mechanisms of mucus clearance from the airways may lead to treatments in muco-obstructive lung conditions. Mucociliary clearance (MCC) scans are a way to measure the rate at which a person's lungs can clear inhaled particles. Through a single-arm pilot study in participants with primary ciliary dyskinesia (PCD), the investigators will evaluate the effect of exercise as a way to increase clearance through a mechanism called gas liquid transport (GLT) where the faster flow of air through the lungs during exercise is able to clear more particles. The investigators will repeat MCC measures with exercise after administering hypertonic saline (HS) to evaluate the effects of mucus hydration on both GLT and cough clearance (CC).\n\nAim 1. To quantify non-ciliary, non-cough mechanisms of mucus clearance (i.e., GLT) in PCD through an MCC protocol that introduces a standardized exercise intervention after isotope delivery.\n\nAim 2. To evaluate whether exercise-induced GLT and\u002For CC are responsive to hydrator intervention, using a short acting bronchodilator with 7% HS prior to isotope delivery followed by MCC with exercise intervention.",[28,29],"Primary Ciliary Dyskinesia","PCD",[31,32,33,34,35,36,37],"exercise","primary ciliary dyskinesia","airway clearance","mucociliary clearance","hypertonic saline","cough clearance","gas liquid transport","NOT_YET_RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":22},"2026-07-30",{"date":46,"type":22},"2027-01",{"name":48,"class":49},"University of North Carolina, Chapel Hill","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100054054","developing-and-strengthening-cannabis-warnings-warning-message-testing-100054054","NCT07699198","Developing and Strengthening Cannabis Warnings: Warning Message Testing","Inclusion Criteria:\n\n* Age 18 years of age and older\n* Live in the United States\n\nExclusion Criteria:\n\n* Age less than 18 years of age\n* Does not live in the United States",true,{"count":59,"type":22},1500,[25],"The purpose of this activity is to identify promising cannabis warning messages from different themes. Participants will be adults who live in the United States, including both people who use cannabis and those who do not use cannabis. In an online within-subjects experiment, participants will be randomly assigned to view 7 cannabis warning messages from different themes developed as part of previous study activities. After viewing each cannabis warning message, participants will rate the message on awareness, clarity, believability, cognitive elaboration, perceived message effectiveness, and reactance. The survey will take 15-20 minutes.",[63,64],"Cannabis","Marijuana Use",[63,64,66,67,68,69],"Product Packaging","Product Labeling","Warnings","Health Communication","2026-07-08",{"date":41,"type":42},{"date":41,"type":22},{"date":74,"type":22},"2026-11-30",{"name":48,"class":49},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":50},"100520526","quantitation-and-spatial-registration-of-airways-dysfunction-with-dynamic-19f-mri-in-cystic-fibrosis-100520526","NCT06057714","Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis","Inclusion Criteria:\n\n1. Subjects must be ≥18 years of age\n2. Non-smokers (\\\u003C10 pack\u002Fyear history and no active smoking in the past year)\n3. Diagnosis of cystic fibrosis via standard sweat chloride\u002Fphenotypic features\u002Fgenotyping\n4. No use of supplemental oxygen\n5. Stable lung function (within 10% of personal best in the last 6 months) with no pulmonary exacerbations in the past 4 weeks and baseline FEV1≥60% of predicted\n6. Evidence of a personally signed and dated consent indicating that the subject has been informed of all pertinent aspects of the trial\n7. Subjects must be willing and able to comply with scheduled visits and other trial procedures\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the trial:\n\n1. Active or past smokers or vapers with less than 1 year since quitting or \\>10 pack-year smoking history\n2. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including\n\n   1. Occupation (past or present) of machinist, welder, or grinder;\n   2. Injury to the eye involving a metallic object\n   3. Injury to the body by a metallic object (bullet, bullet ball, shrapnel)\n   4. Presence of a cardiac pacemaker or defibrillator\n   5. Presence of aneurysm clips\n   6. Presence of carotid artery vascular clamp\n   7. Presence of neurostimulator\n   8. Presence of insulin or infusion pump\n   9. Presence of implanted drug infusion device that is not known to be MRI compatible (i.e., was placed outside of UNC or is older than 10 years)\n   10. Bone growth or fusion simulator\n   11. Presence of cochlear, otologic or ear implant\n   12. Any type of prosthesis (eye, penile, etc.)\n   13. Artificial limb or joint\n   14. Non-removable electrodes (on body, head or brain)\n   15. Intravascular stents, filters or coils\n   16. Shunt (spinal or intraventricular)\n   17. Swan-Ganz catheter\n   18. Any implant held in place by a magnet\n   19. Transdermal delivery system (e.g. Nitro)\n   20. An intrauterine device or diaphragm that is not MRI compatible\n   21. Tattooed makeup (eyeliner, lips, etc.) or tattoos covering \\>25% of body surface area\n   22. Body piercings (must be removed before MRI)\n   23. Any metal fragments\n   24. Internal pacing wires\n   25. Metal or wire mesh implants\n   26. Hearing aid (remove before MRI) aa. Dentures (remove before MRI) bb. Claustrophobia\n3. Unable to tolerate inhalation of gas mixture\n4. Presence of facial hair that may interfere with the fit of the mask (and unwillingness to shave prior to each MRI)\n5. Any changes in medications that may affect CF lung disease in the past 28 days, including any experimental therapies\n6. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.\n7. Pregnancy; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.","99 Years",{"count":84,"type":22},30,"OBSERVATIONAL","The purpose of this study is to look at lung ventilation in people with cystic fibrosis over time (1 year) using magnetic resonance imaging (MRI) with an inhaled contrast gas, and compare these measures to lung function assessed by spirometry and multiple breath nitrogen washout. This study also looks at how these measures change in response to a pulmonary exacerbation and treatment (if applicable). Over the span of a year, participants would be asked to complete 3-5 visits to the University of North Carolina at Chapel Hill (UNC). with each lasting up to 4 hours. If participants do not have a pulmonary exacerbation during the year they would be asked to complete 3 visits (one at enrollment, a second roughly 2 weeks later, and the third approximately a year later). If participants do experience a CF pulmonary exacerbation they would complete 5 visits (Visit 1, Visit 2, two exacerbation visits with one before treatment and the other after, and Visit 3 at one year after Visit 1). Only one exacerbation per participant will be tracked. Participants are eligible for this study if they are 18 years old or older, have Cystic Fibrosis (CF) with mild lung disease (FEV1 \\>\u002F= 60%), and can undergo an MRI. There are no known benefits for participating in this study.",[88,89],"Cystic Fibrosis","Ventilatory Defect","RECRUITING","2026-06-30",{"date":93,"type":42},"2026-07-02",{"date":95,"type":42},"2021-01-20",{"date":97,"type":22},"2026-08",{"name":48,"class":49},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":57,"sex":18,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":50},"100521217","19f-mri-in-healthy-children-and-children-with-mild-cystic-fibrosis-lung-disease-100521217","NCT06066723","19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease","A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease","Inclusion Criteria:\n\n* 6-17 years old\n* Non-smoker and non-vaper\n* Cystic Fibrosis (CF) Group: must have a diagnosis of CF\n* No use of supplemental oxygen\n* They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks\n* Baseline forced expiratory volume in 1 second (FEV1) \\>80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio \\>0.7\n\nExclusion Criteria:\n\n* Healthy volunteers: with any history of chronic lung disease (i.e. asthma)\n* Active or former smoker with less than 1 year of quitting\n* Unable to undergo an MRI of the lungs and chest because of contraindications, including:\n\n  * Injury to the eye involving a metallic object\n  * Injury to the body involving a metallic object\n  * Presence of an implanted drug infusion device that is not MRI safe\n  * Bone growth of fusion simulator\n  * Presence of cochlear, otologic, or ear implant\n  * Shunt (spinal or intraventricular)\n  * Any implant held in place by magnet\n  * Claustrophobia\n* Unable to tolerate the inhalation of the gas mixture\n* Facial hair preventing a tight fit of the mask used in the study\n* Pregnancy\n* Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies","6 Years","17 Years",{"count":109,"type":22},15,"This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.\n\nChildren and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel \"free-breathing\" technique that will eliminate the need for breath holds during MRI acquisition.",[112],"Cystic Fibrosis in Children",[114,115,116],"19F MRI","ventilation","pediatrics",{"date":93,"type":42},{"date":119,"type":42},"2025-06-16",{"date":97,"type":22},{"name":48,"class":49},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":18,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":50},"100154765","pharmacokinetics-of-off-label-pediatric-medications-100154765","NCT01286519","Pharmacokinetics of Off Label Pediatric Medications","Inclusion Criteria:\n\n* Children less than 8 years of age\n* Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care\n\nExclusion Criteria:\n\n* Lack of consent","1 Day","8 Years",{"count":131,"type":22},400,"The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.",[134],"Off Label Use of Medications in Pediatric Patients",[136],"pharmacokinetics","2026-06-29",{"date":139,"type":42},"2026-07-01",{"date":141,"type":42},"2010-07",{"date":143,"type":22},"2035-12",{"name":48,"class":49},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":50},"100633430","comparing-the-effects-of-front-of-package-labeling-schemes-in-indonesia-100633430","NCT07526584","Comparing the Effects of Front-of-Package Labeling Schemes in Indonesia","Comparing the Effects of Two Front-of-Package Labeling Schemes Among Indonesian Consumers","Inclusion Criteria:\n\n* 18 years of age or older\n* Lives in Indonesia\n* Able to read and write in Indonesian\n* Has purchased processed foods in the last month\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Does not live in Indonesia\n* Not able to read and write in Indonesian\n* Has not purchased processed foods in the last month",{"count":153,"type":22},1000,[25],"The goal of this study is to examine what type of front-of-package label (FOPL) would be most effective at discouraging consumption of products high in nutrients of concern in Indonesia. The main questions this experiment aims to answer are:\n\n1. Would nutrient warning labels be more effective at discouraging consumption of products high in nutrients of concern compared to the Nutri-Level label?\n2. Would nutrient warning labels improve consumers' ability to identify unhealthy products compared to the Nutri-Level label?\n\nAdditionally, this experiment also aims to determine how should nutrient warning labels be designed to most effectively discourage consumption of products high in nutrients of concern among Indonesian consumers.",[157,158],"Nutrition","Obesity & Overweight","2026-06-25",{"date":137,"type":42},{"date":162,"type":22},"2026-07",{"date":97,"type":22},{"name":48,"class":49},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":173,"minAge":19,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":201,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":50},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.","FEMALE",{"count":175,"type":22},1228,[25],"The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy","Pregnancy Complications","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Social Determinants of Health (SDOH)","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[171,202,203,204],"pregnancy-related disparities","patient support program","enhanced prenatal care",{"date":137,"type":42},{"date":207,"type":22},"2026-08-01",{"date":209,"type":22},"2029-01",{"name":48,"class":49},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":231,"locationsCount":50},"100583769","affect-based-impulsivity-in-borderline-personality-disorder-100583769","NCT06880640","Affect-based Impulsivity in Borderline Personality Disorder","Affect-based Impulsivity in Borderline Personality Disorder: Developing a Neurocomputational Phenotype","Inclusion Criteria:\n\nBorderline Personality Disorder (BPD) group:\n\n* Score of 38 or higher on Personality Assessment Inventory-Borderline Scale (PAI-BOR)\n* Participants in the BPD group will be primarily recruited from the two\n\nDEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the current study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:\n\n1. 3+ BPD symptoms, one of which must be affective instability, per clinical interview\n2. Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).\n\nHealth Control (HC) Group:\n\n* Score of 12 or lower on PAI-BOR\n* Score below 50th percentile on World Health Organization Disability Assessment Schedule (WHODAS)\n* Absence of any current or lifetime psychiatric disorder, including personality disorders as determined by diagnostic interviews (SIDP and SCID), if the participant had participated in the lab's other studies (IRB Nos. 20-1735 and 21-0602).\n\nCombined Inclusion Criteria:\n\n* Ages 18-45\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Willingness to participate in all components of the study\n* Participants must be able to speak, understand and read English.\n* Participants must have at least 20\u002F40 visual acuity (correct or uncorrected).\n\nExclusion Criteria:\n\n* Use of as needed antihypertensive agents within 12 hours prior to lab visit\n* Inability to refrain from using as needed psychotropic medications for 12 hours prior to lab visit\n* History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence\n* Family history of Bipolar I disorder in a first degree relative.\n* Participants are also excluded for any of the following: cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia.","45 Years",{"count":220,"type":22},106,[25],"The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.\n\nParticipants will complete online behavioral tasks, a stress induction procedure, self-report surveys, and a cognitive assessment. During the session, psychophysiological measures will be collected, including electrocardiogram (ECG) and cardiac impedance (ICG) to monitor heart rate and blood flow, as well as electrodermal activity (EDA), blood drop samples, and saliva collection to assess nervous system activity.",[224,225],"Borderline Personality Disorder (BPD)","Healthy Controls Group - Age and Sex-matched",{"date":227,"type":42},"2026-06-26",{"date":229,"type":42},"2025-09-21",{"date":97,"type":22},{"name":48,"class":49},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100580052","improving-parental-support-in-hypospadias-care-100580052","NCT06832280","Improving Parental Support in Hypospadias Care","Inclusion Criteria\n\nA parent must meet all of the following criteria to be included:\n\n* Age ≥ 18 years old\n* Fluent and literate in English or Spanish\n* Parent or legal guardian\n* Ability to consent\n* One eligible parent per child\n* Plan to attend urology consultation\n* Has access to a smart phone, tablet, or computer with reliable internet access\n* Has the ability and agrees to receive unencrypted communications by text or email\n\nA child must meet all of the following criteria to be included:\n\n* 0-5 years old at the time of urology consultation\n* Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias\n\nExclusion Criteria\n\nIf a parent meets any of the following criteria they will be excluded:\n\n* Previous participant in hypospadias study\n* Parent has another child with hypospadias or father of the child has a known history of hypospadias\n* Parent is unaware of any penile abnormality with child\n* A final hypospadias treatment decision has been made in discussion with a pediatric urologist\n* Investigator discretion\n\nIf a child meets any of the following criteria they will be excluded:\n\n* Prior hypospadias surgery\n* Upcoming hypospadias urology consult is less than five days away from when the patient was identified",{"count":239,"type":22},324,[25],"The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.",[243],"Hypospadias",[243,245],"Pediatric Urologists",{"date":91,"type":42},{"date":248,"type":42},"2025-05-07",{"date":250,"type":22},"2029-12-01",{"name":48,"class":49},2,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":50},"100522846","apathy-in-parkinson-disease-tms-study-100522846","NCT06087926","Apathy in Parkinson Disease TMS Study","Investigation of Non-invasive Brain Stimulation for the Treatment of Apathy","PDTMSAPATHY","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson Disease.\n* At least 5 years of symptoms.\n* On dopaminergic medication for Parkinson Disease.\n* Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain stable throughout the study period.\n* Hospital's study-specific informed consent must be obtained.\n* Must have capacity to provide informed consent in English.\n* For female participants, confirmation that they have not had a menstrual period in over 12 months, or that they will use an effective form of contraception during the study.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Inability to perform effort task (determined during the titration session).\n* Presence of dementia (Montreal Cognitive Assessment (MoCA) score \\\u003C 21).\n* History of epilepsy or brain surgery.\n* Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).\n* Patients with clinically significant medical or neurological conditions which may be an alternative cause of parkinsonism such as repeated brain injury, anti-dopaminergic medications, anoxic brain injury, or significant basal ganglia strokes.\n* Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS.\n* Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.\n* Presence of medical contraindications to TMS such as implanted stimulators, history of mania or bipolar disorder, history of epilepsy.","55 Years","80 Years",{"count":264,"type":22},60,[25],"The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease.\n\nThe main questions the study aims to answer are:\n\n1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients?\n2. Is there a link between brain signals and apathy?\n\nParticipants will\n\n* complete questionnaires and assessments\n* perform an effort task\n* have their brain activity recorded (EEG)\n* receive non-invasive brain stimulation (TMS)\n\nResearchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).",[268],"Parkinson Disease",[270,271],"Apathy","Motivation","2026-06-24",{"date":227,"type":42},{"date":275,"type":42},"2024-05-01",{"date":277,"type":22},"2027-06-30",{"name":48,"class":49},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":285,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":299,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":50},"100504462","gait-rehabilitation-to-treat-fastoa-100504462","NCT05848622","Gait Rehabilitation to Treat FastOA","Inclusion Criteria:\n\n* Have completed all other formal physical therapy\n* Are between the ages of 16 and 35\n* Underwent an anterior cruciate ligament reconstruction (ACLR) between 6 and 60 months prior to enrollment\n* Demonstrate underloading during gait (vGRF- impact peak \\\u003C1.12 x BW)\n\nExclusion Criteria:\n\n* A multiple ligament surgery (i.e., PCL)\n* A lower extremity fracture (i.e., displaced tibial plateau fracture)\n* Knee osteoarthritis","16 Years","35 Years",{"count":288,"type":22},70,[25],"The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.",[292,293,294,295,296,297,298],"Anterior Cruciate Ligament Injuries","Post-traumatic Osteoarthritis","Knee Osteoarthritis","Osteo Arthritis Knee","Knee Injuries","Cartilage, Articular","Gait",[300,301],"Biofeedback","FastOA",{"date":159,"type":42},{"date":304,"type":42},"2023-06-13",{"date":306,"type":22},"2027-06",{"name":48,"class":49},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":57,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":50},"100118401","pathogenesis-of-primary-ciliary-dyskinesia-pcd-lung-disease-100118401","NCT00807482","Pathogenesis of Primary Ciliary Dyskinesia (PCD) Lung Disease","Diagnostic and Clinical Characterization of Patients With Unusual Genetic Disorders of the Airways","Inclusion Criteria:\n\n* Patients who have a high suspicion for the diagnosis of PCD, based on clinical features\n\nHealthy Volunteers who have a family member with confirmed PCD.",{"count":316,"type":22},1800,"The overall short-term goals of this project include the following: 1) identify the genes that are key to the function of respiratory cilia to protect the normal lung; and 2) the effects of genetic mutations that adversely affect ciliary function and cause primary ciliary dyskinesia (PCD), which results in life-shortening lung disease. The long-term goal of this project is to develop better understanding of the underlying genetic variability that adversely modifies ciliary function, and predisposes to common airway diseases, such as asthma and chronic obstructive pulmonary disease.",[319],"Kartagener Syndrome",[28,321,322],"Mucociliary Clearance","Genetic Mutation",{"date":137,"type":42},{"date":325,"type":4},"2004-01",{"date":306,"type":22},{"name":48,"class":49},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":50},"100631952","cared--a-novel-rapid-treatment-paradigm-for-depression-100631952","NCT07507370","CARED : A Novel Rapid Treatment Paradigm for Depression","The Carolina Recovery From Depression Protocol (CARED) : A Novel Rapid Treatment Paradigm for Depression","CARED","Inclusion Criteria:\n\n* Any gender, aged 18 - 70\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND)\n* HDRS-17 score ≥14\n* Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the Columbia-Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.\n* Capacity to understand all relevant risks and potential benefits of the study (informed consent).\n* For people of childbearing potential: use of highly effective contraception as determined by the Investigator for at least 1 month prior to screening and agreement to use such a method during study participation\n* History of treatment resistance as indicated by previously or currently not achieving clinically significant symptom reduction on at least one antidepressant medication. This will be evaluated using the Maudsley Treatment Inventory (MTI). Participants with scores greater than or equal to 3 on the MTI will be included.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND\n* DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND\n* Lifetime history of bipolar disorder, as evidenced by DIAMOND\n* Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND\n* History of autism spectrum disorder (self-reported by participants)\n* Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks\n* Initiated a new course of psychotherapy in the 6 weeks preceding screening\n* Received any neurostimulation treatment in the 6 weeks preceding screening\n* History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)\n* Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous CNS radiation)\n* Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)\n* Prior brain surgery and\u002For brain implants\n* Personal or familia history of epilepsy\n* Previous fainting spells or syncope\n* Metal in the brain, skull or elsewhere in the body\n* Implanted medical device that uses electricity and any implanted devices in other areas of the head or neck, or implants located \\\u003C 30cm from the position of the TMS coil\n* Current pregnancy or lactation\n* Currently enrolled in another clinical trial for depression\n* Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator\n* Non-English speaking individuals are excluded because the ability to accurately and completely communicate study information, answer questions about the study, and obtain consent in the English language are necessary, and due to resource constraints it is not feasible to engage an interpreter for language services.","70 Years",{"count":84,"type":22},[25],"The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).",[341],"Major Depressive Disorder",[343,344,345,346,347,348,349,350,351,352,353,354,355],"Non-invasive Brain Stimulation","Psychotherapy","Transcranial Magnetic Stimulation","Single Session Intervention","tACS","Behavioral Activation","Depression","Transcranial Alternating Current Stimulation","Acceptance and Commitment Therapy","Mood Disorders","Brief Intervention","TMS","Neurostimulation","2026-06-23",{"date":159,"type":42},{"date":359,"type":42},"2026-04-14",{"date":361,"type":22},"2028-07-01",{"name":48,"class":49},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":371,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":384,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":50},"100628559","integrating-new-skills-into-diabetes-education-with-cgm-100628559","NCT07463209","Integrating New Skills Into Diabetes Education With CGM","Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes","INSIDE-CGM","Participant Inclusion Criteria:\n\n* Adults 65 years and older at time of consent\n* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as residing within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin\n* No continuous glucose monitor (CGM) use within the previous 365 days\n* Willing to use a smartphone to access glucose readings using CGM phone app\n* Fluent in English\n\nParticipant Exclusion Criteria:\n\n* Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)\n* Currently receiving dialysis, assessed through chart review and self-report on screening visit\n* Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit\n* The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of \\\u003C1 year, assessed at screening visit\n* Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures\n* Not fluent in English\n* Unable to consent to recording of sessions\n\nCare Partner Inclusion Criteria:\n\n* Live in the same household as the study participant\n* Age 18 years or older\n* Fluent in English\n* Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes\n* Consent to recording of sessions","65 Years",{"count":373,"type":22},144,[25],"This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program (\"intervention\") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches (\"comparators\").\n\nFollowing a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator A) will receive a one-time clinic-based CGM training. The second comparator (Comparator B) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks.\n\nThe study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.\n\nLastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.",[377,378,379,380,381,382,383],"Insulin Dependent Diabetes","Diabetes (DM)","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes Education","Diabetes Care","Type 1 Diabetes (T1D)","Type 2 Diabetes Mellitus (T2DM)",[385,386,387,388,389,380],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM",{"date":227,"type":42},{"date":392,"type":22},"2026-06",{"date":394,"type":22},"2028-06",{"name":48,"class":49},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":417,"locationsCount":50},"100543871","ultrasound-for-evaluation-of-percutaneous-g-tube-position-100543871","NCT06361498","Ultrasound for Evaluation of Percutaneous G-tube Position","Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage","Inclusion Criteria:\n\nAn individual who presents with a dislodged GT and meets one of the following minor criteria:\n\n* Surgical GT placement less than 90 days from presentation\n* Traumatic GT dislodgement\u002Fremoval\n* Recent stoma dilation\n* Clinician uncertainty about position of GT placement\n\nExclusion Criteria:\n\n* An individual \\>18 years of age\n* Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering\u002Freferring provider.",{"count":404,"type":22},10,[25],"The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.\n\nThe main questions it aims to answer are:\n\n* If ultrasound is just as accurate as fluoroscopy to assess the GT position.\n* If ultrasound takes less time than fluoroscopy to assessing the GT position.\n\nParticipants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.",[408],"Gastrostomy",[410,411,412],"gastrostomy tube","ultrasound","fluoroscopy",{"date":227,"type":42},{"date":415,"type":42},"2024-04-30",{"date":306,"type":22},{"name":48,"class":49},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":424,"maxAge":262,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":50},"100505651","targeted-motor-learning-to-improve-gait-for-individuals-with-parkinson-disease-100505651","NCT05864157","Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease","Inclusion Criteria:\n\n* idiopathic Parkinson's disease (Hoehn and Yahr Stage 2-3)\n* self-report the ability to walk uninterrupted for 10 minutes both overground and on a treadmill without therapist assistance\n* comfortable gait speed \\> 0.4 m\u002Fs and \\\u003C 1.2 m\u002Fs\n* normal (or corrected to normal \\[i.e., hearing aid\\]) hearing\n* deficits in gait continuity (e.g., shuffling, shortened strides, freezing, festination, bradykinesia, etc) based on observational gait analysis\n* Movement Disorders Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS-III) item 10 ≥1 and \\\u003C3\n* be on stable doses of orally-administered levodopa\n* age 50-80 years old\n\nExclusion Criteria:\n\n* contraindications to MRI (e.g., metal implants, claustrophobia, etc)\n* cognitive deficits (Montreal Cognitive Assessment \\[MoCA\\] \\\u003C 26)\n* concurrent Physical Therapy\n* have undergone deep brain stimulation surgery\n* cannot walk without therapist assistance\n* uncontrolled cardiorespiratory\u002Fmetabolic disease, or other neurological disorders or orthopedic injury that may affect gait.","50 Years",{"count":426,"type":22},45,[25],"The purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with Parkinson disease walk. Using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. The use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. The use of a faster frequency metronome while walking overground is intended to help participants take faster steps.This will take place over 12 training sessions. Each session will be about an hour. It will include some walking tests and pictures of the brain (using MRI) before and after training.",[268],[298,431],"Rehabilitation",{"date":159,"type":42},{"date":434,"type":42},"2023-08-16",{"date":436,"type":22},"2027-01-01",{"name":48,"class":49},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":57,"sex":18,"minAge":446,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":458,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":50},"100498831","cochlear-implants-in-young-children-with-ssd-100498831","NCT05775367","Cochlear Implants in Young Children With SSD","Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness","Little SSD","To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n\n   i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \\>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.\n3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:\n\n   1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or\n   2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.\n4. Between 7 months and 2 years, 11 months of age at implantation\n5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain\u002FInternal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.\n6. No malformation of the cochlea\n7. No evidence of progressive hearing loss of the contralateral ear\n8. Willing to\u002Fhas undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \\> .65 when fitted via Desired Sensation Level (DSL) methods.\n9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing\n10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations\n11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).\n12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.\n\nTo participate as an SSD control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)\n   3. Unable to use or benefit from traditional amplification\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).\n\nTo participate as a TH control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early SB2.\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a study subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Conductive hearing loss in either ear\n3. Cochlear nerve deficiency\n4. Ossification\u002FFibrosis of the cochlea precluding implantation\n5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)\n6. History of refractory chronic otitis media or condition that contraindicates anesthesia\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a control subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Inability to participate in testing (i.e., unwillingness)","7 Months","71 Months",{"count":264,"type":22},[25],"The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.\n\nThe main questions it aims to answer are:\n\n* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?\n* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?\n\nParticipants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.\n\nChildren will be asked to:\n\n* Undergo cochlear implantation\n* Wear their cochlear implant processor whenever they are awake.\n* Participate in traditional hearing tests\n* Participate in traditional hearing testing\n* Participate in localization testing\n* Participate in hearing in noise testing\n* Participate in word recognition testing\n* Participate in speech, language, and educational evaluations\n\nThe researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.",[452,453,454,455,456,457],"Single Sided Deafness","Unilateral Deafness","Hearing Loss, Unilateral","Hearing Loss","Congenital Hearing Loss","Deafness One Ear",[459,460,461,462,463,464],"cochlear implant","uhl","ssd","children","hearing loss","deafness",{"date":227,"type":42},{"date":467,"type":42},"2023-07-07",{"date":469,"type":22},"2030-05-30",{"name":48,"class":49},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":173,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":490},"100641551","prospective-evaluation-of-an-ai-diagnostic-ultrasound-tool-for-fetal-weight-estimation-100641551","NCT07661433","Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Inclusion Criteria:\n\n* 18 years of age or older\n* Viable intrauterine pregnancy\n* Delivery expected within one week of study procedures between 24 0\u002F7 and 42 6\u002F7 weeks, including participants with a scheduled induction or cesarean delivery on a known date, or those admitted in spontaneous labor\n* Ability and willingness to provide written informed consent\n* Willingness to comply with all study procedures\n\nExclusion Criteria:\n\n* Maternal body mass index ≥ 40 kg\u002Fm\\^2\n* Multiple gestation (i.e., twins or higher order)\n* Known major fetal malformation or anomaly\n* Any maternal condition (medical, psychological, or social) that, in the opinion of the study team, may interfere with study participation or data integrity.",{"count":153,"type":22},"Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.",[481,190,482,483],"Fetal Weight","Machine Learning","Pregnancy - Prenatal Testing","2026-06-22",{"date":159,"type":42},{"date":392,"type":22},{"date":488,"type":22},"2026-12",{"name":48,"class":49},5,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":173,"minAge":19,"maxAge":261,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":50},"100641037","mind-your-heart-intervention-for-american-indian-women-100641037","NCT07581899","Mind Your Heart Intervention for American Indian Women","MIND Your Heart Study for American Indian Women","MYH","Inclusion Criteria:\n\n* Women 18-55 years old who self-identify as Lumbee Indian and\n* Have one or more risk factors for cardiovascular disease:\n\n  * overweight\u002Fobese, defined as BMI \\>25 kg\u002Fm\\^2\n  * hypertensive as measured by study staff\n  * physical inactivity\n* Willing and able to follow study procedures\n\nExclusion Criteria:\n\n* Women currently enrolled in an organized weight-loss or mindfulness program\n* Pregnant women or women planning to become pregnant during the study period\n* Conditions that exclude study enrollment include:\n\n  * heart murmur\n  * congenital heart disease\n  * family history of sudden death\n  * or orthopedic limitations or health conditions precluding exercise",{"count":288,"type":22},[25],"The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women.\n\nThe main questions it aims to answer are:\n\n* Can this intervention realistically work for American Indian women?\n* Do American Indian women find the intervention acceptable?\n* Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves.\n\nParticipants will:\n\n* Attend 3 data collections over 3 months.\n* Be randomly assigned to either the intervention group or a control group.\n* (Intervention group participants) attend 8 weekly classes.",[503],"Cardiovascular Health",{"date":159,"type":42},{"date":506,"type":42},"2026-04-07",{"date":162,"type":22},{"name":48,"class":49},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":336,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":50},"100640474","phase-1-iap-086-1-a-phase-1-single-ascending-dose-first-time-in-human-study-100640474","NCT07596888","IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study","IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons With HIV-1 on Antiretroviral Therapy","Inclusion Criteria:\n\n1. Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures\n2. Able and willing to provide adequate locator information\n3. Able and willing to comply with all study requirements through Day 28\n4. Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans\n5. Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent\n6. HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.\n\n   NOTE: The term \"licensed\" refers to a US FDA-approved kit, which is required for all Investigational New Drug (IND) studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.\n7. Plasma HIV-1 RNA viral load must meet the following conditions:\n\n   1. \\\u003C 50 copies\u002FmL at 2 time points within 12 months prior to screening\n   2. \\\u003C 50 copies\u002FmL at screening\n   3. Not \\> 1000 copies\u002FmL at any time within 6 months prior to screening\n8. On continuous ART for at least 24 months prior to screening and must continue ART throughout the study. Permitted ART regimens include:\n\n   1. At least 3 ART drugs, one ART drug must include an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz excluded (see 5.2) or\n   2. At least 2 ART drugs including injectables, in which one drug is an integrase inhibitor that is FDA approved or recommended by Department of Health and Human Services Treatment Guidelines.\n\n   NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.\n\n   NOTE: No changes or modifications of ART dosing allowed within 30 days prior to screening.\n9. CD4 cell count \\> 350 cells\u002Fmm3 at screening\n10. Hepatitis C virus (HCV) antibody negative or HCV RNA negative at screening\n11. Hepatitis B surface antigen negative at screening\n12. Clinical laboratory parameters obtained at screening as follows:\n\n    1. Platelet count ≥ 125 × 103\u002FµL\n    2. Absolute neutrophil count ≥ 1.5 × 103\u002FµL\n    3. Absolute Lymphocyte levels ≥ 1000 cells\u002FuL\n    4. Hemoglobin ≥ 12 g\u002FdL (male) and ≥ 11 g\u002FdL (females)\n    5. Prothrombin time or international normalized ratio (INR) ≤ 1.1 × upper limit of normal (ULN)\n    6. Serum total bilirubin ≤ 1.5 × ULN. If total bilirubin is elevated, direct bilirubin ≤ 2 × ULN. If ART includes atazanavir, direct bilirubin must be ≤ 1.0 mg\u002FdL\n    7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN\n    8. Alkaline phosphatase (ALP) ≤ 1.5 × ULN\n    9. Serum glucose (fasting or non-fasting) ≤ Grade 1\n    10. Lipase ≤ 1.5 × ULN\n    11. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin as determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation (CKD-Epi equation) found at: https:\u002F\u002Fwww.mdcalc.com\u002Fcalc\u002F3939\u002Fckd-epi-equations-glomerular-filtration-rate-gfr\n    12. Negative serum pregnancy test for women of childbearing potential (WOCBP) with a sensitivity of at least 25 milli-International Units (mIU)\u002FmL at screening\n13. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) starting with screening visit through 30 days after receiving study drug\n14. WOCBP, defined as female at birth, is not pregnant, expecting to become pregnant, or breastfeeding or participant assigned male at birth is not expecting to father children, starting with screening visit through 30 days after receiving study product\n15. WOCBP, not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy), and not post-menopausal for at least 24 consecutive months, i.e., have had menses within the preceding 24 months, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug\n16. WOCBP and male participants of reproductive potential with WOCBP partners must agree to consistently use a highly effective method of contraception and a barrier method (condom, diaphragm or cervical cap) for the duration and for 30 days afterwards. Highly effective methods include the following:\n\n    Highly effective methods include:\n    * Contraceptive subdermal implant\n    * Intrauterine device or intrauterine system\n    * Combined estrogen and progestogen oral contraceptive\n    * Injectable progestogen\n    * Contraceptive vaginal ring\n    * Percutaneous contraceptive patches\n    * True sexual abstinence (only if it is the participant's consistent lifestyle choice and not just trial-related).\n    * Sterilization of male partner with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for the participant. The documentation of partner sterility can come from the site personnel's review of medical records, medical examination and\u002For semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.\n\n    Barrier method may include:\n    * Male or female condoms with or without a cream or gel that kills sperm\n    * Diaphragm or cervical cap with a cream or gel that kills sperm\n    * Sponge\n17. Participants not of reproductive potential are eligible without requiring the use of contraceptives. Acceptable documentation are specified below.\n\n    NOTE: Men who have sex with men only will not be required to use contraception NOTE: Women who have sex with women only will not be required to use contraception\n\n    NOTE: Written\u002Foral documentation communicated by clinician\u002Fclinician's staff of one of the following:\n    1. Physician report\u002Fletter\n    2. Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)\n    3. Discharge summary\n    4. Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory\n18. Willingness to defer vaccinations, including influenza and Coronavirus Disease (COVID-19) vaccines, from 30 days prior to Day -1 through Day 28 post-infusion\n19. Willingness to abstain from alcohol, illicit drugs and grapefruit juice and limit caffeine intake from 24 hours prior to study treatment through Day 7\n20. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests\n21. Body mass index of less than 35\n\nExclusion Criteria:\n\n1. Current use of moderate or strong CYP3A inhibitors or inducers for any indication including current use of a protease inhibitor, ritonavir, cobicistat, or efavirenz as part of ART regimen (See Section 6.1.1)\n2. Significant history or presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological disorders, immunodeficiency other than HIV-1, or clinical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data\n3. Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:\n\n   1. Daily steroid or long-acting beta-agonist prevention\n   2. Hospitalization in the last two years\n4. Clinically significant cardiovascular disease within 12 months prior to screening including but not limited to:\n\n   1. Myocardial infarction or unstable angina\n   2. Cardiac arrhythmias\n   3. Uncontrolled hypertension at screening: systolic blood pressure \\> 180 mmHg, diastolic blood pressure \\>100 mmHg that is sustained on repeat measurement (without intervention)\n   4. Cerebrovascular accident\n   5. Congestive heart failure, New York Heart Association class II-IV\n5. QTc \\>450 msec at screening NOTE: QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and\u002For another method, machine-read or manually over-read\n6. Diabetes mellitus ≥ Grade 3 per DAIDS criteria (defined as uncontrolled despite treatment modification or hospitalization for immediate glucose control indicated)\n7. History of malignancy within the last 3 years NOTE: History of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documentation of resolution per topical treatment or complete resection as determined by a dermatologist at least 3 months prior to screening\n8. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral antibiotic, antiviral, or antifungal treatment within 14 days prior to the initiation of study drug.\n9. History of coagulopathy or other bleeding disorder or current or anticipated need for chronic anti-coagulation\n10. An underlying skin disease or disorder including, but not limited to, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria, or tattoo that would interfere with assessment of infusion sites\n11. History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis\n12. Use of any prescription or non-prescription drugs or dietary supplements that are prohibited (See Section 6.11), within 7 days prior to dosing\n13. Use of any immunosuppressive, immunomodulatory or cytokine therapy within 90 days prior to entry. Not Exclusionary: \\[1\\] corticosteroid nasal spray; \\[2\\] inhaled corticosteroids; \\[3\\] topical steroids for mild, uncomplicated dermatitis unless it interferes with assessment of infusion site reactions; or \\[4\\] a single course of oral \u002Fparenteral prednisone or equivalent at doses \\\u003C20mg\u002Fday and length of therapy \\\u003C14 days with completion at least 30 days prior to enrollment.\n14. Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase II or higher studies of antiretroviral agents\n15. Regular use (daily to weekly) of known drugs of abuse within 3 months of enrollment\n16. Increased alcohol consumption within 6 months prior to screening, defined as an average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n17. Current tobacco use or current use of nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening\n18. Known sensitivity to any of the study interventions, or components thereof, or study drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study\n19. Any other clinical condition, behavior or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits",{"count":84,"type":22},[518],"PHASE1","Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age. People with HIV on ART with plasma HIV-1 RNA \\\u003C 50 copies\u002FmL for 12 months prior to screening.\n\nProcedures (methods):\n\nThe participant's standard of care ART regimen is continued throughout the study period.\n\nThis study requires an overnight stay in a research unit. During the overnight stay, participants will receive a single infusion (medicine given slowly through a vein in their arm) of IAP086 and be monitored for 24 hours. Each later participant receives IAP086 at the same or a higher dose decided in advance. The dose will increase as more participants receive IAP086 without concerning side effects. Study visits also occur 2, 3, 7, 14, 21 and 28 days after the study drug is given. Study procedures include review of the medical history, physical exams, and blood draws.",[521],"HIV-1-infection",[523],"HIV-1 on Antiretroviral Therapy",{"date":272,"type":42},{"date":526,"type":42},"2026-06-18",{"date":528,"type":22},"2027-05",{"name":48,"class":49},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":57,"sex":18,"minAge":536,"maxAge":107,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":50},"100633573","ultraprocessed-foods-in-colombia-100633573","NCT07528443","Ultraprocessed Foods in Colombia","Inclusion Criteria:\n\n* Children and adolescents between 12 and 17 years old\n* Colombian residents\n\nExclusion Criteria:\n\n* Children with legal blindness, partial blindness, or total blindness, since the study involves viewing images and reading questions.","12 Years",{"count":538,"type":22},1960,[25],"The study seeks to examine how characters on packaging and warning labels affect purchase intentions and risk perception among children aged 12 to 17 in Colombia and, examine whether characters' presence weakens or reduces the perceived message effectiveness of the warning labels' impact. This will be a 2x2 between-subjects experiment manipulating presence or absence of characters and presence or absence of warning labels. Participants will be randomly assigned to 1 of 4 conditions in an online survey programmed in Qualtrics.",[542],"Obesity",{"date":159,"type":42},{"date":159,"type":22},{"date":546,"type":22},"2026-09-30",{"name":48,"class":49},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":57,"sex":18,"minAge":556,"maxAge":129,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":50},"100474975","animal-assisted-therapy-in-pediatric-dentistry-100474975","NCT05464888","Animal Assisted Therapy in Pediatric Dentistry","Animal Assisted Therapy's Effects on Young Dental Patients","AAT","Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:\n\n* 4-8 years of age\n* English speaking\n* Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months\n* Stable physical health, decided at the discretion of the study coordinator and PI\n* Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment\n* Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered\n\nExclusion Criteria: Subjects presenting with any of the following will not be included in the study:\n\n* Patients \\\u003C4yo and \\>8yo\n* Non-English speakers\n* Patients unwilling to assent\u002Fparticipate or parental\u002Fguardian consent was not given\n* Self-report or parental report of patient suffering current dental pain\n* Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste\n* Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child\n* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial\n* Developmental\u002Fcognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment","4 Years",{"count":558,"type":22},225,[25],"A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.",[562],"Anxiety","2026-06-11",{"date":565,"type":42},"2026-06-12",{"date":567,"type":42},"2023-02-02",{"date":569,"type":22},"2028-02",{"name":48,"class":49},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":579,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":583,"conditions":584,"keywords":595,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":50},"100371514","orthognathic-speech-pathology-phonetic-contrasts-of-patients-with-dental-discrepancies-pre--and-post-treatment-analyses-100371514","NCT04117360","Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses","Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dentofacial Discrepancies With Pre- and Post-Treatment Analyses","OSP","Inclusion Criteria:\n\n* Jaw surgery patient at UNC with a skeletal open bite, underbite or overjet greater than 5mm.\n* Age 15-40 years\n\nExclusion Criteria:\n\n* Hearing loss\n* Learned English as a second language\n* Significant regional accent, as characterized by a speech pathologist\n* Developmental delay, performing several grade levels below age bracket\n* history of craniofacial disorder\n* genetic syndrome associated with known craniofacial presentation\n* history of craniofacial trauma\n* history of prior craniofacial surgery (excluding extractions and dental procedures)\n* Jaw surgery without fixed orthodontic appliances","15 Years","40 Years",{"count":582,"type":22},180,"The investigators are studying how speech is effected by jaw and tooth position in jaw surgery patients. Eighty percent of our jaw surgery patients have speech pathologies, compared to five percent of the general population, but speech pathologists do not understand why. The investigators hypothesize that open bites and underbites prevent most patients from being able to pronounce words normally and surgical correction will lead to improvement in speech. Patients will be audio recorded speaking and patients' tongue gestures ultrasound recorded before and after their jaw surgeries to observe what changes occur in their speech and tongue movements.",[585,586,587,588,589,590,591,592,593,594],"Dentofacial Abnormalities","Dentofacial Deformities","Dentofacial Anomalies, Including Malocclusion","Malocclusion","Malocclusion in Children","Dentofacial Disharmony","Skeletal Malocclusion","Skeletal Malformation","Speech Sound Disorder","Speech Disorders",[590,596,593,597,598,599],"Skeletal malocclusion","Spectral Moment Analysis","Tongue Ultrasound","Orthognathic Surgery","2026-06-10",{"date":565,"type":42},{"date":603,"type":42},"2019-09-11",{"date":605,"type":22},"2028-03",{"name":48,"class":49},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":57,"sex":18,"minAge":129,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":615,"conditions":616,"keywords":620,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":633,"locationsCount":50},"100638521","early-dental-risk-screening-for-pediatric-sleep-disordered-breathing-100638521","NCT07581938","Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing","Inclusion Criteria:\n\n* Ages 8-13 years old\n* American Society of Anesthesiologists Class I or II\n* Ability to read and understand the English or Spanish language\n* Ability to assent, with parent\u002Flegal guardian able to provide informed consent\n* Access to a smartphone capable of supporting the wearable monitoring application\n\nExclusion Criteria:\n\n* Diagnosis of a craniofacial syndrome or condition known to significantly alter craniofacial morphology\n* Prior diagnosis of sleep disordered breathing and\u002For obstructive sleep apnea\n* History of adenotonsillectomy\n* Prior or current orthodontic treatment\n* Prior orthognathic surgery","13 Years",{"count":264,"type":22},"This is a prospective, cross-sectional observational study designed to evaluate the Pediatric Sleep Questionnaire (PSQ) as a screening tool for sleep-disordered breathing (SDB) risk in a pediatric dental setting. Children aged 8-13 years will be classified as low- or high-risk for SDB based on PSQ scores and compared using physiologic sleep parameters obtained from a wearable, FDA-cleared home sleep monitoring device, alongside psychosocial assessments and craniofacial measurements derived from lateral cephalometric radiographs. Findings will inform the feasibility and accuracy of incorporating validated SDB screening into routine pediatric dental care.",[617,618,619],"Early Risk Screening for Sleep Disordered Breathing in a Dental Setting","Sleep Disordered Breathing (SDB)","Obstructive Sleep Apnea (OSA)",[621,622,619,618,623,624,625,626,627],"Pediatric Sleep Questionnaire","Apnea","Pediatric Dentistry","At-Home Sleep Study","Pediatric","Screening","Lateral Ceph","2026-06-02",{"date":630,"type":42},"2026-06-04",{"date":392,"type":22},{"date":528,"type":22},{"name":48,"class":49},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":23,"phases":643,"briefSummary":644,"conditions":645,"keywords":650,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":50},"100610253","mhealth-for-early-psychosis-caregivers-in-statewide-program-outreach-100610253","NCT07225179","mHealth for Early Psychosis Caregivers in Statewide Program Outreach","Bolster-NC: A Pilot Study of the Bolster mHealth Intervention Within Early Psychosis Program Outreach in North Carolina","Bolster-NC","Inclusion Criteria:\n\n* 18 years or older\n* North Carolina resident\n* Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 15 and 30, and (2) Within the past five years, the young adult first experienced hallmark symptoms: (2A) Presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2B) Definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety.\n* A positive screen according to the Caregiver Prime Screen - Revised (endorsed two or more responses of five or six (\"somewhat\"\u002F\"definitely\" agree)\n* Own an Apple iPhone\n* Have access to the internet (e.g., via WiFi or data plan)\n* Self-identify as a caregiver of the affected person\n* Are proficient in English to the degree necessary to complete study assessments and engage meaningfully in the intervention\n\nExclusion Criteria:\n\n* Participant failed to demonstrate understanding of study details in comprehension screening process.\n* Previous enrollment in a study involving Bolster.\n* Activity on screening questionnaires that indicates suspicious or dishonest participation such that the participant is likely to be a \"malicious actor\" or \"gamer\" (i.e. an individual that attempts to enroll in online research studies solely for compensation with dishonest or illegitimate responses to study questionnaires)",{"count":84,"type":22},[25],"The purpose of this study is to pilot the delivery of an mHealth intervention for caregivers to young people with early psychosis within a network of early psychosis intervention programs in the state of North Carolina. The investigators will examine the feasibility of recruitment through program outreach, develop North Carolina specific outreach resources to be used with the mHealth intervention and evaluate the effectiveness of this intervention for reducing caregiver psychological morbidity and improving family communication. The investigators will also collect pilot data to inform recruitment and development of implementation strategies for delivering Bolster within a statewide early psychosis network.",[646,647,648,649],"Caregiver","Caregiver Distress","Caregiver to a Young Adult With Early Psychosis","Family Caregivers",[646,651],"Caregiver Support","2026-05-26",{"date":654,"type":42},"2026-05-27",{"date":656,"type":42},"2025-12-01",{"date":658,"type":22},"2027-07-30",{"name":48,"class":49},""]