[{"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:":706},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,117,0,25,[9,58,82,108,135,167,193,227,270,299,324,350,380,404,428,454,481,503,532,559,583,603,632,660,682],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":4},"100659706","phase-2-post-traumatic-estradiol-administration-and-care-evaluation-peace-100659706",false,"NCT07868536","Post-traumatic Estradiol Administration and Care Evaluation (PEACE)","A Pilot Randomized, Double-Blind, Placebo-Controlled Trial of Single-Dose Oral 17β-Estradiol Administered Within 120 Hours of Sexual Assault to Evaluate Feasibility, Acceptability, and Preliminary Effects on Chronic Musculoskeletal Pain and PTSD Over the Following Three Months","PEACE","Inclusion Criteria:\n\n* Aged 18 to 45 years\n* Assigned female at birth\n* Experienced a sexual assault within the previous 120 hours and able to complete an in-person study visit within 120 hours of the assault\n* Able to read and speak English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or currently breastfeeding\n* Currently taking an estrogen-containing medication\n* Current or prior diagnosis of hypertension\n* Use of anticoagulant medications (e.g. aspirin, heparin, warfarin, enoxaparin, dalteparin, tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban)\n* Current or prior cardiomyopathy; history of heart attack or heart valve disease\n* History of deep venous thrombosis or pulmonary embolism, or genetic predisposition to clots (thrombophilia)\n* Sickle cell disease\n* History of stroke\n* Migraines with aura\n* Vascular disease due to diabetes, or diabetes of more than 20 years duration\n* Chronic kidney disease (including nephrotic syndrome or dialysis)\n* Acute hepatitis; history of liver tumors\n* History of cholestasis (unless pregnancy-related only)\n* Gallbladder disease (unless treated by cholecystectomy)\n* History of systemic lupus erythematosus\n* History of breast or endometrial cancer\n* Opioid use exceeding 30 mg daily oral morphine equivalents per day\n* Smokes more than 15 cigarettes per day","FEMALE","18 Years","45 Years",{"count":22,"type":23},30,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This pilot randomized, double-blind, placebo-controlled trial evaluates the feasibility, acceptability, and tolerability of administering a single 6 mg oral dose of 17β-estradiol (E2) to individuals assigned female at birth who have experienced a sexual assault (SA) within the previous 120 hours. Thirty participants aged 18 to 45 years will be randomized 1:1 to receive either E2 or an identical-appearing placebo and followed for three months with blood collection and standardized assessments. The study will evaluate recruitment, enrollment, retention, biological responses, and preliminary clinical outcomes, including chronic musculoskeletal pain (CMSP) and posttraumatic stress disorder (PTSD), to inform the design of a future fully powered efficacy trial.",[29,30,31],"Chronic Musculoskeletal Pain","Sexual Assault","Posttraumatic Stress Disorder (PTSD)",[33,34,35,36,37,38,39,40,41,42,43,44,45],"17β-estradiol","estradiol","estrogen","sexual assault","chronic musculoskeletal pain","chronic pain","trauma","traumatic stress","PTSD","posttraumatic stress disorder","secondary prevention","pain prevention","women's health","NOT_YET_RECRUITING","2026-10-05",{"date":49,"type":50},"2026-10-09","ACTUAL",{"date":52,"type":23},"2026-09-28",{"date":54,"type":23},"2028-07-31",{"name":56,"class":57},"University of North Carolina, Chapel Hill","OTHER",{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":19,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":24,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100615549","sugary-drink-labeling-study-100615549","NCT07294053","Sugary Drink Labeling Study","Inclusion Criteria:\n\n* 18 years and older\n* Bought sugary drinks from a store at least once during the past week\n* Willing to attend 4 in-person study appointments\n\nExclusion Criteria:\n\n* Living in the same household as someone else in the study",true,"ALL",{"count":67,"type":23},543,[69],"NA","This study aims to examine the effects of added sugar warning labels on sugary drinks. Participants will be assigned to view either added sugar warning labels or control labels, applied on sugary drinks in an experimental store. Participants will shop for beverages in the store and take a computer survey at 4 visits spaced approximately 1 week apart.",[72],"Health Behavior","RECRUITING",{"date":75,"type":50},"2026-10-08",{"date":77,"type":50},"2026-02-16",{"date":79,"type":23},"2028-02",{"name":56,"class":57},1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":24,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"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","krittenhouse","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":91,"type":23},1000,[69],"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.",[95,96,97,98],"Fetal Weight","Pregnancy","Machine Learning","Pregnancy - Prenatal Testing","2026-10-01",{"date":101,"type":50},"2026-10-06",{"date":103,"type":50},"2026-06-29",{"date":105,"type":23},"2026-12",{"name":56,"class":57},6,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100639754","phase-2-a-trial-of-upadacitinib-for-non-responsive-eosinophilic-esophagitis-100639754","NCT07588568","A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis","A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis (ATUNE)","ATUNE","Inclusion Criteria:\n\n1. Age 18-65 years.\n2. Diagnosis of EoE per 2018 AGREE consensus guidelines.\n3. Currently using topical corticosteroids (TCS) for EoE treatment (either swallowed budesonide, ≥2mg total daily dose or swallowed fluticasone, ≥1760 mcg total daily dose) for at least 8 weeks (prior to the screening endoscopy) and willing to remain on the same TCS treatment with no changes to regimen throughout the study.\n4. Have active esophageal eosinophilia (peak eosinophil count ≥15 eos\u002Fhpf \\[eosinophils per high power field\\]) as measured during the screening endoscopy despite ongoing therapy with TCS.\n5. Have active symptoms of esophageal dysfunction attributed to EoE (such as trouble swallowing, heartburn, reflux, vomiting, chest pain, painful swallowing, abdominal pain, malnutrition, etc.) in the 4 weeks prior to the screening endoscopy.\n6. Willing to continue all current EoE treatments (including medications such as proton pump inhibitors (PPIs), diet elimination, etc.) throughout participation in the study.\n7. Able to read, comprehend, and sign consent form.\n8. Ability to take oral medication (swallow a pill) and be willing to adhere to the study regimen (follow dosing instructions and complete study procedures).\n\nExclusion Criteria:\n\n1. Use of systemic corticosteroids (such as prednisone or methylprednisolone) within 4 weeks of the screening endoscopy.\n2. Use of dupilumab (dupixent) within 3 months of the screening endoscopy.\n3. Use of estrogen (including estrogen-containing contraceptives and other hormonal treatments) within 30 days of screening.\n4. Previous esophageal resection.\n5. Medical instability making it unsafe to perform an upper endoscopy.\n6. At the Screening \u002F Baseline or Enrollment Visit, meeting any of the following conditions:\n\n   6.1. Two or more prior episodes of herpes zoster (shingles), or one or more episodes of disseminated herpes zoster;\n\n   6.2. One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);\n\n   6.3. Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab\u002FAg test;\n\n   6.4. Active tuberculosis (TB) or latent TB, or meet TB exclusionary parameters;\n\n   6.5. Active infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to the visit;\n\n   6.6. Active diverticulitis within the past 3 months;\n\n   6.7. Chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;\n\n   6.8. COVID-19 infection: In participants who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the visit of asymptomatic participants. Participants with mild\u002Fmoderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics (fever reducers such as ibuprofen, aspirin, and paracetamol) for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.\n\n   6.9. Hepatitis B (HBV) and Hepatitis C (HCV) screening values that meet the following criteria at the most recent testing prior to the first dose of study drug:\n\n   6.9.1. HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for participants who are hepatitis B core antibody (HBc Ab) positive (+);\n\n   6.9.2. HCV: detectable HCV ribonucleic acid (RNA) in any participant with anti-HCV antibody (HCV Ab).\n7. At the Screening \u002F Baseline or Enrollment visit, any of the following medical diseases or disorders:\n\n   7.1. Prior history of\n   * cerebrovascular accident (stroke),\n   * myocardial infarction (heart attack),\n   * coronary stenting,\n   * coronary bypass surgery (heart bypass surgery),\n   * or thrombotic events including deep venous thrombosis (DVT) and pulmonary embolism (PE);\n\n   7.2. History of an organ transplant which requires continued immunosuppression;\n\n   7.3. History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and\u002For other products in the same class;\n\n   7.4. History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;\n\n   7.5. Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding\u002Fsegmentation (such as Lap Band or Realize Band) are not excluded;\n\n   7.6. History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;\n\n   7.7. Current uncontrolled hypertension defined as a confirmed systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg;\n\n   7.8. Known inherited or acquired conditions that predispose to hypercoagulability;\n\n   7.9. Current or past smokers;\n\n   7.10. In patients 50 years of age and older:\n   * High-density lipoprotein (HDL) cholesterol level of \\\u003C40mg per deciliter,\n   * Diabetes mellitus,\n   * Family history of premature coronary heart disease,\n   * Extraarticular rheumatoid arthritis.\n\n   7.11. Severe hepatic impairment (i.e., Child Pugh C cirrhosis).\n8. Participants of child-bearing potential who do not meet the following:\n\n   8.1. Participants must not have a positive serum pregnancy test (blood test) at the Screening Visit and must have a negative urine pregnancy test at the Enrollment visit prior to the first dose of study drug.\n\n   8.2. Participants with an abnormal or inconclusive serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.\n\n   8.3. Participants with a urine pregnancy test at the Enrollment visit that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n   8.4. Participants of childbearing potential who are not able and\u002For willing to practice at least 1 protocol-specified method of birth control that is highly effective throughout participation in the study (from Screening through at least 30 days after the last dose of study drug. Use of estrogen-containing contraception is not allowable. Participants of non-childbearing potential do not need to use birth control.\n9. Participants who are pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.\n10. Participants who received treatment with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the screening endoscopy or who are currently enrolled in another interventional clinical study.\n11. Participants with systemic use of known strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers within 30 days or five half-lives (whichever is longer) of the screening endoscopy through the end of study participation: Herbal therapies and other traditional medicines with unknown effect on CYP3A taken systemically are prohibited within 30 days prior to the screening endoscopy and throughout the study. Herbal therapies and other traditional medicines are defined as any herbal formulation intended to treat or prevent health problems and may include supplements based on which herbs the participant is taking.\n12. Participants who have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug or have expected need of vaccination with any live vaccine with replicating potential during study participation including at least 30 days after the last dose of study drug. Live vaccines that are incapable of replicating are permitted.\n13. Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study drug:\n\n    13.1. Serum aspartate transaminase (AST) \\> 2 × upper limit of normal (ULN); 13.2. Serum alanine transaminase (ALT) \\> 2 × ULN; 13.3. Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \\\u003C 30 mL\u002Fmin\u002F1.73 m2; 13.4. Total white blood cell (WBC) count \\\u003C 2,500\u002FµL; 13.5. Absolute neutrophil count (ANC) \\\u003C 1,200\u002FµL; 13.6. Platelet count \\\u003C 100,000\u002FµL; 13.7. Absolute lymphocyte count \\\u003C 750\u002FµL; 13.8. Hemoglobin \\\u003C 9 g\u002FdL.\n14. Known allergic reaction, significant sensitivity, or intolerance to Janus kinase (JAK) inhibitors or their components\n15. History of or current clinically significant medical or psychiatric conditions or any other reason that in the opinion of the Investigator would interfere with the participant's participation in this study, would place the participant at risk by participating in the study or would make the participant an unsuitable candidate to receive study drug.\n16. Inability to read or understand English.","65 Years",{"count":118,"type":23},52,[26],"The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE).\n\nThe main question it aims to answer are:\n\n\\- Does upadacitinib in addition to topical corticosteroids help reduce EoE disease activity?\n\nParticipants will:\n\n* Take upadacitinib or placebo every day for 12 weeks, followed by 12 weeks of upadacitinib\n* Fill out surveys and answer health questions\n* Visit the clinic every 4 weeks for checkups and tests",[122,123,124],"EoE","Eosinophilic Esophagitis","Eosinophilic Esophagitis (EoE)",[123,122,126,127],"upadacitinib","rinvoq",{"date":101,"type":50},{"date":130,"type":50},"2026-09-30",{"date":132,"type":23},"2030-06",{"name":56,"class":57},2,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":65,"minAge":116,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":155,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":81},"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 receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin at least once daily\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. Willing to use a loaner smartphone or receiver if personal smartphone is not compatible with 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",{"count":144,"type":23},144,[69],"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 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) 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.",[148,149,150,151,152,153,154],"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)",[156,157,158,159,160,151],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM",{"date":47,"type":50},{"date":163,"type":50},"2026-08-11",{"date":165,"type":23},"2028-06",{"name":56,"class":57},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":64,"sex":65,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":81},"100554984","leveraging-infant-visit-prep-integration--task-shifting-to-improve-post-partum-hiv-prevention-in-malawi-100554984","NCT06506188","Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi","UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi","LINK","PrEP user cohort:\n\nPrEP user cohort includes all adolescent and adult women \\>=15 years old who are on PrEP and breastfeeding, enrolled in PrEP at each of the participating 12 sites during the study follow-up period. PrEP provision and clinical management will be at the discretion of the non-study PrEP providers according to Malawi PrEP guidelines and eligibility. Data for these women are abstracted from PrEP records. We are seeking a waiver of informed consent for all health record abstraction for the LINK study.\n\nInclusion criteria:\n\n* Female enrolled in PrEP care at a study site\n* Breastfeeding documented while on PrEP\n* Living without HIV\n\nExclusion criteria:\n\n\\- None\n\nPrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting \\~6 months after initiating PrEP are eligible participation in study surveys and dried blood spot using fingerstick specimen collection. Women aged 15-17 will be asked to provide assent with parental\u002Fguardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.\n\nInclusion criteria:\n\n* Female who has presented for PrEP visit at a participating clinical site at least \\~6 months after initiating PrEP\n* Aged 15 years (assent with parental\u002Fguardian consent for women aged 15-17)\n* Living without HIV\n\nExclusion criteria:\n\n\\- Decline informed consent\n\nPostpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization appointments with their child. No identifying information will be collected from this group.\n\nInclusion criteria:\n\n\\- Female presenting with infant under 3 for under-five visit to participating clinical site\n\nExclusion criteria:\n\n\\- None\n\nPostpartum women - surveys Postpartum women 15 years and older who are presenting to under-five visits with their child under 3 will be eligible for participation in study surveys. Women aged 15-17 will be asked to provide assent with parental\u002Fguardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.\n\nInclusion criteria:\n\n* Female presenting for child vaccination to participating clinical site\n* Aged15 years and older (assent with parental\u002Fguardian consent for women aged 15-17)\n\nExclusion criteria:\n\n\\- Decline informed consent\n\nNon-patient key stakeholder Non-patient stakeholders relevant to intervention implementation at the clinic and national level, including clinical and policy stakeholders. Examples of clinical stakeholders may include key clinic staff working in PrEP, HIV testing, EPI, and CFL peer support mothers. Policy and implementing partner stakeholders may include officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe.\n\nInclusion criteria:\n\n* Aged 18 years and older\n* Involved in relevant activities pertinent to integration or provision of PrEP services such as PrEP providers, peer mothers, HIV diagnostic assistants, or clinic managers, OR policy and implementing partner stakeholders such as officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe\n\nExclusion criteria:\n\n\\- Decline informed consent","15 Years","99 Years",{"count":178,"type":23},5000,[69],"The goal of the Leveraging Infant Visit PrEP INtegration \\& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package (\"LINK model\") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is:\n\nDo women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care?\n\nResearchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.",[182,183],"Breastfeeding","HIV Prevention",[182,185],"HIV","2026-09-29",{"date":130,"type":50},{"date":189,"type":50},"2024-09-15",{"date":191,"type":23},"2028-03",{"name":56,"class":57},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":24,"phases":203,"briefSummary":205,"conditions":206,"keywords":215,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100600274","phase-4-once-daily-intrapleural-enzyme-therapy-in-complicated-parapneumonic-effusion-or-empyema-100600274","NCT07095361","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)","ONLY ONCE","Inclusion Criteria:\n\n* Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age ≥ 18 years at the time of consent.\n* Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET\n* Pleural fluid that is one of the following:\n\n  (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) \\\u003C 7.2 (iii) Pleural fluid glucose \\\u003C 60mg\u002FdL (iv) Pleural fluid Lactate Dehydrogenase (LDH) \\> 1,000 IU\u002FL\n* Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement\n\nExclusion Criteria:\n\n* Known pregnancy or lactating females\n* Prisoners\n* Age \\\u003C18 years at time of consent\n* Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission\n* Known sensitivity or allergic reaction to DNAse or tPA\n* Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days\n* Previous pneumonectomy or active bronchopleural fistula on the affected side\n* Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration\n* Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection",{"count":202,"type":23},270,[204],"PHASE4","The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.\n\nThe investigators are trying to learn:\n\n* Does using the medicine once a day work just as well as using it twice a day?\n* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?\n* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?\n\nParticipants will:\n\n* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.\n* Be asked to give permission to join the study.\n* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.",[207,208,209,210,211,212,213,214],"Pleural Infection Bacterial","Pleural Infections","Pleural Infections and Inflammations","Empyema, Pleural","Empyema","Complicated Pleural Effusion\u002F Empyema","Pleural Effusion Associated With Pulmonary Infection","Pleural Effusion",[216,217,218,219],"Lytics","Intrapleural enzyme therapy","Once daily","lytic therapy",{"date":186,"type":50},{"date":222,"type":50},"2025-09-11",{"date":224,"type":23},"2028-09-30",{"name":56,"class":57},11,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":261,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":267,"leadSponsor":269,"locationsCount":81},"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.",{"count":236,"type":23},1228,[69],"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.",[240,241,242,243,244,245,246,247,248,249,250,96,251,252,253,254,255,256,257,258,259,260],"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 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",[233,262,263,264],"pregnancy-related disparities","patient support program","enhanced prenatal care",{"date":186,"type":50},{"date":99,"type":23},{"date":268,"type":23},"2029-01",{"name":56,"class":57},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":24,"phases":281,"briefSummary":282,"conditions":283,"keywords":288,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":81},"100571757","family-centered-weight-loss-for-black-adults-fam-wel-b-ing-100571757","NCT06724406","FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)","FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)","FAM WEL B-ing","Inclusion Criteria:\n\n* self-identified as Black or African American (Index participant)\n* BMI equal to greater than 30 kg\u002Fm\\^2 (Index); BMI equal to greater than 27.5 kg\u002Fm\\^2 (family partner)\n* have a partner\u002Ffamily member willing to enroll in the study and must share a mutual goal of achieving weight loss\n* English speaking\n* ages 18-75\n* any gender\n* have access to and be able to use a smartphone, tablet, or computer that has web-access (this is required for data collection and some program components being tested)\n* able to make changes to the food you eat\n\nExclusion Criteria:\n\n* planning to move out of the area with the next 8-9 months\n* participation in an intensive weight loss program (more than 12 visits) in the prior 12 months\n* type 1 diabetes\n* significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both\n* had bariatric surgery (surgery for weight loss) in the last 2 years or considering bariatric surgery in the next 8-9 months\n* using or in the prior 3 months taking prescription weight loss medications, or planning to start medications intentionally for weight loss\n* lost more than 20 pounds of body weight in last 6 months\n* are pregnant or planning to get pregnant in the next 8-9 months\n* are breastfeeding an infant less than 3 months old\n* alcohol or substance abuse, defined as alcohol or substance use that interferes with work activities and\u002For has had a major negative impact on family\u002Fsocial function, the latter defined as more than 2 episodes per month.\n* malignancy other than non-melanoma skin cancer, unless considered cured \\> 5 years ago. Exceptions include 1) men with localized prostate cancer (treated with usual modalities or managed with \"active surveillance\"), and 2) postmenopausal women receiving adjuvant endocrine therapy (e.g., aromatase inhibitor) for non-metastatic, hormone receptor-positive breast cancer\n* self-report of advanced kidney disease (estimated glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin)","75 Years",{"count":280,"type":23},256,[69],"The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults. The main question it aims to answer is:\n\nWhat combination of four family components in combination with a standard behavioral weight loss program yields optimal weight loss among Black adults? Researchers will compare different combinations of family skills components (communication content, cohesion content, number of sessions, and mode of delivery) to see the best weight loss.\n\nParticipants will:\n\n* Participate in a 6-month behavioral weight loss intervention\n* Attend core weight loss in-person group sessions, and dyad based family sessions\n* Keep track of weight, dietary intake and physical activity",[284,285,286,287],"Obesity and Overweight","Diabetes Mellitus","Weight Loss","Behavior Change",[289,290,291],"weight loss program","African American or Black families","nutrition and physical activity behavior change","2026-09-25",{"date":186,"type":50},{"date":295,"type":50},"2025-02-03",{"date":297,"type":23},"2028-12-31",{"name":56,"class":57},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":278,"enrollmentInfo":307,"targetDuration":4,"studyType":309,"phases":4,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":81},"100653052","long-term-study-of-covid-19-infection-and-long-covid-100653052","NCT07781501","Long-Term Study of COVID-19 Infection and Long COVID","Longitudinal Study of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Post-Acute Sequelae of COVID-19 (PASC)","PASC","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Previous laboratory-confirmed SARS-CoV-2 infection.\n* Willing and able to provide informed consent.\n* Able to complete study questionnaires and study procedures.\n\nExclusion Criteria:\n\n* Current severe periodontal disease with bleeding gums.\n* Current oral herpes flare, aphthous ulcer, or oral candidiasis (thrush).\n* Oral viral or bacterial infection within the previous 30 days.\n* Dry mouth that would prevent adequate saliva collection.\n* Active alcohol or drug abuse.\n* Medical or genetic syndrome or developmental delay that would prevent completion of study procedures or questionnaires.",{"count":308,"type":23},500,"OBSERVATIONAL","This study will examine how common Long COVID is and how symptoms may persist over time in people who have previously had COVID-19. Researchers will collect information about participants' health and symptoms through questionnaires and may collect saliva and other non-invasive oral samples. The study will also examine biological factors in these samples that may be associated with persistent symptoms. The goal is to better understand why some people develop Long COVID and identify factors that may help predict who is more likely to experience persistent symptoms.",[312],"SARS CoV-2 Post-Acute Sequelae",[314,315,316],"COVID-19","SARS-CoV-2","Long COVID","2026-09-24",{"date":52,"type":50},{"date":320,"type":50},"2024-09-04",{"date":322,"type":23},"2029-12-31",{"name":56,"class":57},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":334,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":81},"100647121","phase-1-endeavor-an-exemestane-needed-dose-efficacy-and-verification-as-an-ovulation-induction-regimen-study-100647121","NCT07706374","E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study","ENDEAVOR","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Premenopausal female (ages 18-40);\n* Undergone an evaluation for infertility at UNC Fertility;\n* Previously diagnosed with polycystic ovary syndrome\u002F polyendocrine metabolic ovarian syndrome (PCOS\u002FPMOS) via established clinical diagnostic criteria with no other identifiable cause of infertility (example- endometriosis, uterine fibroids), and recommended to begin ovulation induction therapy;\n* Have patent fallopian tubes on hysterosalpingogram;\n* Male partners must have a normal semen analysis if presenting with a male partner;\n* Individuals must be ovulation induction naïve (no history of use of ovulation induction medications);\n* Individuals must be able to read, speak, and understand English or Spanish sufficiently to provide informed consent and participate in study procedures.\n\nExclusion Criteria:\n\nAny individual who meets one or more of the following criteria will be excluded from participation:\n\n* Under 18 or over 40 years of age; Individuals without the diagnosis of PCOS;\n* Body mass index \\>40 kg\u002Fm\\^2; Abnormal hysterosalpingogram;\n* Abnormal semen analysis if presenting with a male partner;\n* History of ovulation induction medication use;\n* Allergy to exemestane;\n* Individuals with abnormalities of Pap smear or breast examination;\n* Pregnant females;\n* Individuals with moderate to severe renal impairment;\n* Individuals with moderate to severe hepatic impairment;\n* Currently taking any of the following medications due to known or potential interactions with exemestane: Cytochrome P-450 3A4 (CYP3A4), Everolimus (Afinitor), Apixaban (Eliquis), Rivaroxaban (Xarelto), Aspirin, Diphenhydramine (Benadryl), Rosuvastatin (Crestor), Duloxetine (Cymbalta), Escitalopram (Lexapro), Atorvastatin (Lipitor), Pregabalin (Lyrica), Metoprolol, Semaglutide (Ozempic), Levothyroxine (Synthroid), Ondansetron (Zofran), Goserelin (Zoladex);\n* Individuals who require a Legally Authorized Representative (LAR) to provide consent on their behalf;\n* Difficulty or inability to swallow solid dosage forms (tablets\u002Fcapsules of study drug)","40 Years",{"count":333,"type":23},40,[335],"PHASE1","The goal of this clinical trial is to learn if study drug exemestane will increase chances of ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS, formerly called polycystic ovary syndrome (PCOS)). It will also learn about side effects of study drug exemestane in this study population. The main questions it aims to answer are:\n\nDoes exemestane lead to ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS- formerly called PCOS)?\n\nResearchers will compare exemestane to a placebo (a look-alike substance that contains no drug) to see if exemestane helps PMOS patients ovulate.\n\nParticipants will:\n\nTake exemestane or a placebo every day for 5-10 days Visit the clinic three times for ultrasounds, labs, and to answer questions about side effects.\n\nIf they become pregnant during this study, they will tell us how their pregnancy went after the study via a registry online.",[338],"Poly Cystic Ovary Syndrome",[340,341,342],"ovulation","androgen","aromatase","2026-09-22",{"date":345,"type":50},"2026-09-23",{"date":99,"type":23},{"date":348,"type":23},"2030-01",{"name":56,"class":57},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":64,"sex":65,"minAge":356,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":309,"phases":4,"briefSummary":360,"conditions":361,"keywords":365,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":81},"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","8 Years","13 Years",{"count":359,"type":23},60,"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.",[362,363,364],"Early Risk Screening for Sleep Disordered Breathing in a Dental Setting","Sleep Disordered Breathing (SDB)","Obstructive Sleep Apnea (OSA)",[366,367,364,363,368,369,370,371,372],"Pediatric Sleep Questionnaire","Apnea","Pediatric Dentistry","At-Home Sleep Study","Pediatric","Screening","Lateral Ceph","2026-09-21",{"date":345,"type":50},{"date":376,"type":50},"2026-06-02",{"date":378,"type":23},"2027-05",{"name":56,"class":57},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":176,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":134},"100550780","effects-of-alliance180-program-on-well-being-100550780","NCT06451523","Effects of \"Alliance180 Program\" on Well-Being","Effects of \"Alliance180 Program\" on Psychological and Physical Well-Being","Inclusion Criteria:\n\n* 18 years or older\n* Enrollment in an upcoming \"Alliance180 Program\". (Enrollment is limited to adults who currently or formerly serve as US Veterans, First Responders and\u002For Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)\n\nExclusion Criteria:\n\n\\- Individuals who have previously completed the \"Alliance180 Program\"",{"count":388,"type":23},50,[69],"The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are\u002Fwere US Veterans, First Responders and\u002For Front Line Healthcare Workers.\n\nThe study aims are:\n\n* Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are\u002Fwere US Veterans, First Responders and\u002For Front Line Healthcare Workers;\n* Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.\n\nParticipants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.",[392],"Trauma and Stressor Related Disorders",[394,395,396],"Anxiety Depression","Autonomic Reactivity","Polyvagal Theory","2026-09-18",{"date":373,"type":50},{"date":400,"type":50},"2024-06-24",{"date":402,"type":23},"2027-09",{"name":56,"class":57},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":64,"sex":65,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":427},"100553997","evaluation-of-a-differentiated-point-of-care-active-case-finding--management-model-to-eliminate-mother-to-child-transmission-of-hiv-in-malawi-100553997","NCT06493357","Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi","UNCPM 22401 - Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model for the Elimination of Mother-to-Child Transmission of HIV in Lilongwe and Mangochi, Malawi","PAC-Man","The criteria for Enumerated MIP Cohort is as follows:\n\nInclusion Criteria:\n\n* Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.\n\nExclusion Criteria:\n\n* None.\n\nThe criteria for Enumerated MIP Field Survey is as follows:\n\nInclusion Criteria:\n\n* Age 16 years or older.\n* Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.\n\nExclusion Criteria:\n\n* Documented transferred out from a site prior to the field survey.\n* Participated previously in the field survey.\n* Decline informed consent.\n\nThe criteria for In-Depth Interviews is as follows:\n\nInclusion criteria:\n\n* Age 16 years or older.\n* Met high-risk criteria for PAC-Man model.\n* Participated in a field survey.\n\nExclusion criteria:\n\n* Decline informed consent.\n\nThe criteria for Focus Group Discussions is as follows:\n\nInclusion criteria:\n\n* Age 18 years or older.\n* MOH or implementing partner professional or lay health worker at a study site (such as nurses, community health workers, health surveillance assistants, and HIV diagnostic assistants)\n* Generally familiar with the PAC-Man model and\u002For EMTCT\u002F EID service delivery at their site.\n\nExclusion criteria:\n\n* Decline informed consent.\n\nThe criteria for Key Informant Interviews is as follows:\n\nInclusion criteria:\n\n* Age 18 years or older.\n* HIV\u002F EMTCT policy maker OR MOH\u002F PEPFAR implementing partner senior manager.\n* Generally familiar with HIV and\u002For EMTCT\u002F EID service delivery.\n\nExclusion criteria:\n\n* Decline informed consent.\n\nThe criteria for Implementation Actor Questionnaires is as follows:\n\nInclusion criteria:\n\n* Age 18 years or older.\n* Professional or lay health provider at a study site.\n* Generally familiar with HIV and\u002For EMTCT\u002F EID service delivery at their site.\n* Participated in a focus group discussion.\n\nExclusion criteria:\n\n* Decline informed consent.","16 Years",{"count":414,"type":23},2426,[69],"Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:\n\n1. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing.\n2. Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing.\n3. Compare implementation outcomes between the PAC-Man model and SOC.\n\nParticipants: The total study sample size is 2,426, including 2,304 mother-infant pair (MIP) survey participants, 48 high-risk pregnant\u002Fbreastfeeding women living with HIV for in-depth interviews (from high-risk MIPs who participated in a survey); 10 PMTCT policy makers and Ministry of Health (MOH)\u002F President's Emergency Plan for AIDS Relief (PEPFAR) implementing partner senior managers for key informant interviews; and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys.\n\nTo rigorously evaluate the PAC-Man model, investigators will use a hybrid (type 3) effectiveness-implementation incomplete stepped-wedge trial design. The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental \"rollout\" of the PAC-Man model and serial measurement of both health outcomes (for infants and mothers in Objectives 1 and 2, respectively), as well as implementation outcomes (Objective 3). The incomplete stepped-wedge design is more efficient than a complete design, minimizes costs, and reduces participant burden, without sacrificing statistical precision. Using this design, sequential crossover from control (i.e., the SOC) to intervention (i.e., SOC plus the PAC-Man model) takes place at each 'step' using cluster randomization until all clusters (defined as a group of \"sites,\" or health facilities plus the surrounding communities in its catchment area) receive the intervention. The 12 sites included in our study will be divided into 4 clusters of 3 sites each.",[183],[419],"HIV Treatment","2026-09-17",{"date":397,"type":50},{"date":423,"type":50},"2025-03-27",{"date":425,"type":23},"2028-03-31",{"name":56,"class":57},3,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":134},"100616242","adolescent-mental-health-parenting-program-for-child-adult-relationship-enhancement-100616242","NCT07303062","Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement","Evaluating the Impact of Adolescent Mental Health Parenting Program for Child-Adult Relationship Enhancement (AMP-CARE)","AMP-CARE","Inclusion Criteria:\n\n* Parent or guardian of teen age 11-14 years\n* Receiving primary care at selected study sites\n* English speaking\n\nExclusion Criteria:\n\n* Parents of children with severe mental illness (indicated by psychiatric hospitalization in the last 12 months or previous diagnosis of psychosis)\n* Parents of children with severe developmental delay (indicated by prior diagnosis of severe neurodevelopmental impairment, global developmental delay, severe expressive language delay)\n* Not available at time group is scheduled",{"count":359,"type":23},[69],"The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are:\n\n* Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting?\n* Does the AMP-CARE parenting program improve parent knowledge about mental health?\n\nResearchers will compare participants who complete the parenting program to those who do not.\n\nParticipants will:\n\n* Complete 2 surveys, one at the start of the study and one 6 -12 weeks later\n* Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away.\n* The other half will have the opportunity to attend AMP-CARE after they complete the second survey.",[440],"Adolescent Behavior",[442,443,444,445,446],"teen parenting program","teen mental health","mental health stigma","positive parenting","parenting self-efficacy","2026-09-16",{"date":397,"type":50},{"date":450,"type":50},"2026-05-28",{"date":452,"type":23},"2027-03-01",{"name":56,"class":57},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":64,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":24,"phases":464,"briefSummary":465,"conditions":466,"keywords":470,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":81},"100656537","pilot-hiv-self-testing-and-self-collected-sti-testing-strategy-for-sex-worker-empowerment-study-100656537","NCT07829133","Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study","Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)","PHASES","FSW Inclusion Criteria:\n\n* Born biologically female\n* Identifies as a woman\n* Aged 18 years or older\n* Exchanged sex for money, goods, or services in the last 6 months\n* Lived and\u002For worked in Lusaka for at least the last 3 months\n* Planning to remain in Lusaka for at least the next 3 months\n* Willing and able to provide contact information, including a reachable telephone number\n* Willing and able to provide informed consent in Nyanja, Bemba, or English\n\nFSW Exclusion Criteria:\n\n* Under the age of 18 years\n* Does not identify as a woman\n* Unable and\u002For unwilling to provide contact information\n* Unable and\u002For unwilling to provide informed consent\n\nQueen Mother Eligibility Criteria:\n\n* Aged 18 years or older\n* Currently engaged as a sex work manager (\"queen mother\")\n* Lived and\u002For worked in Lusaka for at least the last 3 months\n* Planning to remain in Lusaka for at least the next 6 months\n* Willing and able to provide contact information, including a reachable telephone number\n* Willing and able to provide informed consent in Nyanja, Bemba, or English\n\nImplementer Focus Group Discussion Eligibility Criteria:\n\n* Aged 18 years old or older\n* Working as a queen mother OR civil society organization\u002FMinistry of Health\u002Fnon-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW\n* Willing and able to provide verbal informed consent in English, Nyanja, or Bemba",{"count":463,"type":23},232,[69],"The goal of this clinical trial is to find out if sex work managers (also called \"queen mothers\") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are:\n\n* Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services?\n* Can this approach increase STI diagnosis and connection to STI treatment services?\n* Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach?\n\nResearchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services.\n\nFSW participants will:\n\n* Complete questionnaires when they join the study and again about three months later.\n* Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers.\n* Agree to have their medical records reviewed.\n\nQueen mother participants will:\n\n* Complete questionnaires when they join the study and again about three months later.\n* Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites).\n\nAdditionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.",[185,467,468,469],"Syphilis","Gonorrhea","Chlamydia",[471,472,473,185],"Sexually transmitted infections","Female sex workers","Implementation science","2026-09-14",{"date":397,"type":50},{"date":477,"type":23},"2026-10",{"date":479,"type":23},"2027-06",{"name":56,"class":57},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":490,"briefSummary":491,"conditions":492,"keywords":495,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":500,"leadSponsor":502,"locationsCount":81},"100656472","light-bulb-stimuli-to-reduce-chronic-pain-100656472","NCT07825792","Light Bulb Stimuli to Reduce Chronic Pain","Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity Using Light Bulbs: A Pilot Randomized Crossover Trial","Light Bulb","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Individuals who have been diagnosed with fibromyalgia or suffer from chronic widespread pain and fatigue.\n* An average pain severity ≥4 on the 0-10 NRS over the month prior to enrollment.\n* Pain symptoms present for 3 months or longer.\n* Pain must be present in 4 out of 5 body regions.\n* A score of ≥7 on the Widespread pain index (WPI) and ≥5 on the symptom severity scale (SSS), or 4-6 on the WPI and ≥9 on the SSS in the 2016 Fibromyalgia Questionnaire.\n* Willingness to adjust light levels in home environment so that the illumination (measured in lux) provided by the light bulbs is twice the ambient room illumination (also measured in lux).\n* Willingness to use study lightbulbs for 2 consecutive hours a day for 7 consecutive days according to study specifications for both conditions (total of 14 days using lightbulbs)\n* Alert and oriented, and able to provide informed consent\n* Ability to read and speak English to complete validated questionnaires.\n\nExclusion Criteria:\n\n* Vision disorders or conditions resulting in severe vision impairment or blindness\n* Individuals with self-report of color blindness, uveitis or cataracts.\n* Prisoner Status\n* Pregnancy\n* History of photosensitivity or sensitivity to scintillating (mildly flickering) light.\n* History of seizure disorder.\n* Individuals living in households with people who have a history of seizure disorders.\n* Analgesic treatment plan changes anticipated in the next 3 months (surgery, analgesic medication changes, injections, pain procedures, etc.).\n* Other history or condition that would, in the investigator's judgment, indicate that the individual would highly likely be non-compliant with the study or unsuitable for the study",{"count":333,"type":23},[69],"This pilot randomized, double-blind, crossover clinical trial will evaluate the feasibility and preliminary efficacy of chromatic (colored) light exposure for reducing pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue. Participants will complete daily symptom surveys throughout the study and undergo patient-reported outcome assessments and quantitative sensory testing at multiple timepoints.\n\nParticipants will be randomized to receive either S-cone stimulating chromatic light or equal-energy white light for 2 hours daily over a 7-day treatment period. Following a 1-week washout, participants will cross over to the alternate condition. Outcomes will examine feasibility, changes in pain severity, pain interference, and measures of pain sensitivity. Total study duration is approximately 35 days.",[493,494],"Fibromyalgia","Musculoskeletal Pain",[493,494,496],"Analgesia","2026-09-11",{"date":420,"type":50},{"date":373,"type":23},{"date":501,"type":23},"2028-01-01",{"name":56,"class":57},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":64,"sex":65,"minAge":19,"maxAge":176,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":81},"100586789","comparing-a-workplace-resilience-and-a-physical-activity-intervention-on-early-childhood-educators-well-being-100586789","NCT06919952","Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being","A Cluster-randomized Control Trial of a Workplace Resilience Intervention for Child Care Providers' Mental Health & Well-being","OnWARD","Inclusion Criteria:\n\nChild Care Centers\n\n* Licensed with no plans to close in the next 2 years\n* Been in operation for at least 1 year\n* Has at least 4 employees\n\nECE Staff\n\n* Must be at least 18 years old\n* Be able to read and speak English\n* Must have access to an online resource (e.g., smartphone, tablet, computer)\n* Must be willing to receive text messages\n\nExclusion Criteria:\n\n* None",{"count":512,"type":23},640,[69],"The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time.\n\nThe study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff.\n\nSome ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training.\n\nThere will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.",[516],"Resilience",[518,519,520,521,522,523],"child care provider well-being","child care centers","early childhood education","physical activity","resilience","behavior change","2026-09-04",{"date":526,"type":50},"2026-09-08",{"date":528,"type":50},"2025-08-11",{"date":530,"type":23},"2029-02",{"name":56,"class":57},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":64,"sex":18,"minAge":539,"maxAge":20,"enrollmentInfo":540,"targetDuration":4,"studyType":24,"phases":542,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":81},"100653973","daily-upgrade-trial-100653973","NCT07792603","Daily Upgrade Trial","TONE UP: Daily Upgrade Trial: Tone, Oxygenation, Neuromood, Energy - Upgrade Evaluation","Inclusion Criteria:\n\n* Participant is an adult between the ages of 25-45 years\n* Participant has a recorded BMI between 18.5-30 kg\u002Fm\\^2\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire\n* Participant is a biological female\n* Participant is naturally menstruating or uses a form of hormonal contraceptive\n* Participant is recreationally active, based on the International Physical Activity Questionnaire- Short Form\n* Participant agrees to abstain from caffeine (12 hours), tobacco, alcohol, and exercise for 24 hours prior to testing days\n* Participant is willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* Participant has been diagnosed with chronic heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire.\n* Participant has a musculoskeletal disorder or injury that would prohibit them from being able to safely complete the study protocol.\n* Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement\n* Participant is using, or has consistently used one of the following dietary supplements within 1 month prior to enrollment: whey protein, creatine, essential amino acids\n* Participant has a known allergy or sensitivity to the placebo or active ingredients\n* Participant is pregnant or planning to become pregnant\n* Participant does not speak English or is hearing impaired","25 Years",{"count":541,"type":23},44,[69],"This study evaluates the acute and chronic effects of an essential amino acid supplement (Daily Upgrade EAA+) on metabolomics, amino acid kinetics, metabolic rate, body composition in active adult women. The study consists of an acute randomized double-blind crossover phase comparing EAA+, whey protein isolate, and placebo before high-intensity interval training (HIIT), and a chronic randomized double-blind parallel-arm phase evaluating 3 weeks of EAA+ or placebo supplementation combined with twice-weekly HIIT.",[545],"Healthy Women",[547,548,549,550],"Dietary Supplement","Exercise training","Amino Acid","Body composition","2026-09-02",{"date":553,"type":50},"2026-09-03",{"date":555,"type":50},"2026-08-31",{"date":557,"type":23},"2027-04",{"name":56,"class":57},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":65,"minAge":567,"maxAge":176,"enrollmentInfo":568,"targetDuration":4,"studyType":24,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":582,"locationsCount":81},"100561213","teachers-leading-the-front-lines---north-carolina-tealeaf-nc-100561213","NCT06587230","Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)","Building Teachers Mental Health Skills to Support Students With Mental Health Needs in Elementary and Middle Schools in North Carolina: Program Implementation and Prospective Data Collection","Tealeaf-NC","Inclusion Criteria:\n\nSchools:\n\n* Have been trained in either Tealeaf or RE-SEED in Summer 2024 or 2025 after being randomized programmatically\n* Be a school in the State of North Carolina\n* Have an eligible principal\n\nPrincipals:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nTeachers:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Primary teaching responsibility for a single academic class (for a minimum of 1 hour per day and a minimum of 4 days per week) in any grade level Kindergarten to Grade 8\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nCounselors:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Hold a school counselor position at an enrolled school for at least 10 hours per week\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nStudents:\n\n* Enrolled in Kindergarten-Grade 8\n* Student of an enrolled teacher\n* Has a parent or guardian who can provide consent\n* Positive\u002FClinical-level score on the Strengths and Difficulties Questionnaire (SDQ)\n\nGuardians:\n\n* \\>18 years old\n* Guardian of enrolled student\n\nExclusion Criteria:\n\n* Exclusion criteria will be set as each participant does not meet the inclusion criteria as set for their group.","5 Years",{"count":569,"type":23},312,[69],"Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care.\n\nParticipants: \\~300 estimated\n\nProcedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \\& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \\& Maintenance (Secondary Outcomes, clinically-based).",[573,574,575,576,577],"Child Behavior","Mental Health Issue","Psychosocial Functioning","Depression","Anxiety",{"date":553,"type":50},{"date":580,"type":50},"2024-10-08",{"date":479,"type":23},{"name":56,"class":57},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":65,"minAge":590,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":24,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":81},"100541529","3-d-tractography-fus-ablation-for-essential-tremor-100541529","NCT06331052","3-D Tractography FUS Ablation for Essential Tremor","3-D Tractography Focused Ultrasound Ablation for Essential Tremor","Inclusion Criteria:\n\n* Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians\n* Symptoms refractory to at least two medications\n* Stable essential tremor medication regimen for at least 4 weeks prior to screening\n* Willing and able to participate in all follow-up visits\n* Willing and able to undergo MR imaging.\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Medically unstable coronary artery disease\n* Coagulopathy with inability to temporarily stop any antithrombotic medication\n* Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)\n* Unwilling or unable to undergo tremor surgery while awake\n* Significant and non-correctible motion artifact in imaging\n* Pregnant at the time of enrollment or preoperative evaluation\n* Dementia\n* History of psychosis\n* Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation\n* Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA\n* does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study\n* Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.\n* non-English speaking","22 Years",{"count":592,"type":23},24,[69],"The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes.",[596],"Essential Tremor",{"date":526,"type":50},{"date":599,"type":50},"2024-02-28",{"date":601,"type":23},"2028-02-28",{"name":56,"class":57},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":611,"targetDuration":4,"studyType":24,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":4},"100654374","single-session-personalized-aperiodic-transcranial-alternating-current-stimulation-panda-tacs-for-antenatal-depression-100654374","NCT07799480","Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression","Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression: A Randomized, Sham-Controlled Trial (R61 Phase)","PandA","Inclusion Criteria:\n\n* Aged 18 - 45\n* Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of informed consent) Stated willingness to comply with all study procedures and availability for the duration of the study\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 C-SSRS screen and triage version with further exploration of positive responses.\n* Between weeks 14-32 of viable singleton pregnancy\n* Currently meet DSM-5 criteria of unipolar, non-psychotic MDD which is confirmed by the DIAMOND\n* HDRS-17 score ≥8\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\n* Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change or discontinuation 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* Implanted medical device that uses electricity\n* Currently enrolled in another clinical trial for depression\n\nHistory of any of the following conditions:\n\n* Diabetes (gestational or general history)\n* Pre-term delivery (\\\u003C37 weeks)\n* Eclampsia\n* Pre-eclampsia with severe features\n* Asthma requiring daily medication\n* Chronic hypertension\n* Immune thrombocytopenia (ITP)\n* Hyperthyroidism requiring medication\n* Pre-pregnancy BMI 40 or more\n* In vitro fertilization (IVF)\n* Mullerian anomaly of uterus\n* Organ transplant\n* Prior history of deep vein thrombosis\u002Fpulmonary embolism (DVT\u002FPE) or plan for anticoagulation during pregnancy\n* Fetus with autoimmune hydrops\n* Abnormal placenta\n\nCurrent pregnancy:\n\n* HIV\u002FHep B\u002FHep C with detectable viral loads\n* Anemia \\[Hemoglobin under 11.0\\] upon entry to pre-natal care\n* No scheduled pre-natal visits by 15 weeks\n* Placenta previa\n* Placenta accreta spectrum (PAS)\n* Pre-eclampsia\n* Gestational diabetes\n* Gestational hypertension\n* Fetus with abnormal chromosomes\n* Cervical length \\\u003C 2.5 cm\n* Presence of cerclage or vaginal progesterone to decrease chance of pre-term labor\n* Fetal growth restriction\n* Macrosomia\n* Polyhydramnios\n* Oligohydramnios\n* Rupture of membranes\n* Hyperemesis Gravidarum (HEG)\n* Confirmation testing for Tri 13\u002F18\u002F21\n* Congenital anomalies on anatomy ultrasound that do not resolve with follow-up ultrasound",{"count":359,"type":23},[69],"The purpose of this pilot trial is to primarily assess safety, feasibility, and tolerability of PandA-tACS in antenatal depression and determine whether a single PandA-tACS session produces greater left dlPFC aperiodic slope flattening (reduction) from pre- to post-stimulation than IAF-tACS and sham.",[615],"Antenatal Depression",[617,618,619,620,576,621,622,623,624,625],"Non-invasive brain stimulation","tACS","Neurostimulation","Mood Disorders","Transcranial Alternating Current Stimulation","EEG","IAF-tACS","Individual Alpha Frequency tACS","Antenatal","2026-09-01",{"date":551,"type":50},{"date":629,"type":23},"2026-09",{"date":165,"type":23},{"name":56,"class":57},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":65,"minAge":357,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":24,"phases":642,"briefSummary":643,"conditions":644,"keywords":649,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":81},"100543272","caring-connections-youth-suicide-detection-and-intervention-study-100543272","NCT06353711","Caring Connections Youth Suicide Detection and Intervention Study","CA-LINC Randomized Control Trial Study","CA-LINC","Inclusion Criteria:\n\nYouth:\n\n* 13 - 19 years old\n* Current or recent history (\\\u003C90 days) of suicide ideation, planning, or attempts or nonsuicidal self-injurious behaviors per youth or caregiver self-report or positive screen on the Patient Health Questionnaire Adolescent (PHQ-A), C-SSRS, or Ask Suicide-Screening Questions (ASQ).\n* Able to fluently speak and read English\n* Youth with a prior history of difficulty accessing services.\n* Written assent to participate in the study (\\\u003C18 years old)\n* Written consent from a parent\u002Flegal guardian\u002Fcaregiver to participate in the study (\\\u003C18 years old)\n* Written consent if the youth is ages 18-19\n\nParents\u002FLegal Guardians\u002FCaregivers:\n\n* The primary caregiver of a youth who meets the above inclusion criteria for the study\n* Over the age of 18\n* Able to fluently speak and read English\n* Without intellectual disabilities\n* Provide written consent to participate\n\nMental Healthcare and\u002For Healthcare Providers and\u002For Community Stakeholders:\n\n* Mental Health, behavioral health, substance use and\u002For health-related professionals who screen\u002Fassess for mental health and\u002For suicide risk or provide referrals, treatment, or follow-up care to youth with a prior history of difficulty accessing services in the surrounding treatment areas based on this risk or community stakeholder (i.e., faith-based leaders, agency directors, advocates, school administrators, hospital\u002Fcrisis directors, topical experts, etc.).\n* Over the age of 18\n* Able to fluently speak and read English\n* Without intellectual disabilities\n* Provide written consent to participate\n\nCare Coordinators:\n\n* Care coordinators who screen\u002Fassess for mental health and\u002For suicide risk or provide referrals, treatment, or follow-up care to underserved youth in the surrounding treatment areas.\n* Over the age of 18\n* Able to fluently speak and read English\n* Without intellectual disabilities\n\nExclusion Criteria:\n\nYouth:\n\n* Youth at imminent suicide risk (reported verbally and\u002For indicated on C-SSRS)\n* Youth who exhibit severe cognitive, language, or developmental delays\n* Youth not meeting inclusion criteria\n\nParents\u002FLegal Guardians\u002FCaregivers:\n\n* Not meeting the inclusion criteria listed above.\n\nMental Healthcare and\u002For Healthcare Providers and\u002For Community Stakeholders:\n\n* Not meeting the inclusion criteria listed above.",{"count":641,"type":23},180,[69],"The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that integrates engagement and follow-up strategies to assess\u002Fmonitor suicide risk, facilitate service use referrals\u002Flinkages, develop\u002Frefine safety plans, and create villages of care. The intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include:\n\nIs Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth?\n\nFor the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and\u002For Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.",[645,646,647,648],"Suicide","Suicide Prevention","Suicide Ideation","Suicide Attempt",[650,651,652,653],"Black youth","suicide","ideation","attempts",{"date":524,"type":50},{"date":656,"type":50},"2025-08-14",{"date":658,"type":23},"2027-05-31",{"name":56,"class":57},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":667,"enrollmentInfo":668,"targetDuration":4,"studyType":24,"phases":670,"briefSummary":671,"conditions":672,"keywords":674,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":81},"100654455","evaluation-of-the-melanin-adjusted-blood-oxygen-sensor-mabos-in-icu-settings-100654455","NCT07799454","Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings","Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings: Improving the Accuracy in Critical Conditions for Patients of Color","Inclusion Criteria:\n\n* Age ranges from 18 to 85 years.\n* Individuals admitted to one of UNC Hospital's intensive care units (Medical Intensive Care Unit or Cardiovascular and Thoracic Intensive Care Unit).\n* Individuals with a medical condition necessitating a minimum of two arterial blood gas measurements within a 24-hour period.\n* Participant, or Legally Authorized Representative (LAR) must be able to read, write, and speak English fluently.\n\nExclusion Criteria:\n\n* History of active (clinically significant) skin disorders that make skin vulnerable to contact with conventional electronic devices.\n* History of allergic response to silicones, adhesives (such as 3M Tegaderm), or acetone.\n* Broken, damaged or irritated skin or rashes near the sensor application sites.\n* Presence of tattoos on the fingers, hands, or forearms.\n* History of a genetic condition or skin disorder that variably impacts the amount of melanin pigmentation (e.g., Vitiligo).\n* Pregnant or lactating individuals\n* Individuals given methylene blue within the last 24 hours or Hydroxocobalamin within the last 2 weeks.\n* Individuals experiencing carbon monoxide poisoning.\n* History of conditions that may affect ABG readings (e.g., lipemic specimens).\n* History of hematological conditions affecting red blood cell morphology (e.g., sickle cell disease)\n* Patients on Venoarterial extracorporeal membrane oxygenation (VA-ECMO), durable left ventricular assist device (LVAD), or Impella.","85 Years",{"count":669,"type":23},120,[69],"Purpose: Investigate the accuracy of the investigators' novel pulse oximeter across a broad range of skin-pigmentations and oxygen saturations.\n\nParticipants: Up to 120 adult participants admitted to Medical Intensive Care, or Cardiovascular Thoracic Critical Care, Units.\n\nProcedures (methods): Participants will have their skin tone measured on each finger using a spectrophotometer. During the study, participants will wear one of the investigators' custom devices - MABOS - on one finger of each hand. Additionally, they will wear a variant of the investigators' device on an additional finger and outer side of the associated wrist. The study team will continuously acquire data from all devices until either 4 Arterial Blood Gas tests have been collected, or 24 hours have elapsed.",[673],"Hypoxemia",[675],"Pulse Oximetry",{"date":551,"type":50},{"date":678,"type":50},"2026-01-06",{"date":680,"type":23},"2026-12-15",{"name":56,"class":57},{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":688,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":65,"minAge":19,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":24,"phases":691,"briefSummary":692,"conditions":693,"keywords":695,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":703,"leadSponsor":705,"locationsCount":81},"100654458","mediterranean-dietary-intervention-for-hs-100654458","NCT07800416","Mediterranean Dietary Intervention for HS","Pilot Feasibility Study of a Mediterranean Diet Intervention for Hidradenitis Suppurativa","HSMDS","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of hidradenitis suppurativa confirmed by a board-certified dermatologist\n* Hurley stage I, II, or III\n* Baseline abscess and inflammatory nodule (AN) count of at least 3, so that disease activity is measurable in every enrolled participant\n* Reliable access to Zoom by laptop, tablet, or smartphone\n* Able to provide written informed consent in English\n\nExclusion Criteria:\n\n* Systemic antibiotic use (oral, intramuscular, or intravenous) within 28 days before the planned enrollment visit\n* Topical antibiotic use within 5 days before the planned enrollment visit\n* Background HS therapy that has not been stable for the 28 days before enrollment, or that is not expected to remain stable through the 16-week study period\n* Currently pregnant or breastfeeding\n* Unable to complete study procedures in English",{"count":22,"type":23},[69],"The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). The study will also look at whether participants' Mediterranean diet adherence changes during the program.\n\nThe main questions it aims to answer are:\n\n* Do participants find the program feasible and practical to follow?\n* Does adherence to a Mediterranean-style diet change from the beginning to the end of the 16-week program?\n* Do participants find the program acceptable? All participants will receive the same program; there is no comparison group.\n\nParticipants will:\n\n* Take part in individual nutrition counseling and shorter support calls, mostly by video or telephone\n* Complete a cooking education session and receive written nutrition materials\n* Receive Mediterranean-style food support, including pantry staples and prepared meals\n* Attend two in-person study visits, at the beginning and end of the 16-week program\n* Complete questionnaires and study assessments and provide biological samples Because this is a pilot study, the information collected will primarily be used to improve the program and help plan a larger future clinical trial.",[694],"Hidradenitis Suppurativa",[696,697,698,699],"Mediterranean diet","Feasibility study","Dietary counseling","Pilot study","2026-08-28",{"date":551,"type":50},{"date":629,"type":23},{"date":704,"type":23},"2027-08",{"name":56,"class":57},""]