[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"George Washington University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":674},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,48,78,127,154,177,207,231,260,281,305,325,345,373,394,418,443,474,498,524,546,574,598,626,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100600857","phase-2-efti-in-patients-with-hormone-receptor-positiveher2-neg-breast-cancer-100600857",false,"NCT07102940","Efti in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Eftilagimod Alpha in Combination With Neoadjuvant Chemotherapy in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Inclusion Criteria:\n\n* Have histologically documented HR+\u002FHER2 neg (defined as ER expression \\>10% by IHC and\u002For PR expression \\> 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio \\\u003C2 or HER2 gene copy number of \\\u003C6).\n* Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.\n* Be informed of the investigational nature of the trial and all pertinent aspects of the trial.\n* Have ECOG performance status of 0-2.\n* Have the ability to understand and the willingness to sign a written informed -consent document in accordance with institutional and federal guidelines.\n* Be ≥ 21 years of age.\n* Have serum creatinine \\\u003C 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml\u002Fmin (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an SGOT\u002FSGPT\u002Falkaline phosphatase ≤ 2.0 x IULN.\n* Have adequate bone marrow function (ANC \\>1000\u002FμL, Platelets \\>100,000\u002Fml, Hemoglobin \\>10gm\u002FdL).\n* Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the trial and for at least 6 months after the last dose of trial treatment. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of treatment with IP.\n\nExclusion Criteria:\n\n* Receiving concurrent anti-neoplastic therapy for another malignancy\n* Known documented or suspected hypersensitivity to the components of the trial drug or analogs.\n* Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned.\n* A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1.\n* Breastfeeding\n* Serious infection within 4 weeks prior to Day 1 or active acute or chronic infection needing IV antibiotics. Note: Subjects treated for moderately severe infections with oral antibiotics only, may be included, based on consultation with trial Investigator.\n* Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation \\> grade 2 not controlled by a pacemaker, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Receives continuous systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to Day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease.\n* Live vaccine within 30 days of planned Day 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Note: non-live vaccines (e.g., non-live influenza vaccine, non-live COVID-19 vaccine) can be given until 3 days prior to planned Day 1.\n* Prior anti-LAG-3 therapy (e.g. anti-LAG-3 antibodies).\n* Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","21 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+\u002FHER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.",[27,28,29,30],"Breast Cancer","HER 2 Negative Breast Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","Stage 1-3",[32,33,34,35],"breast","cancer","HER2","HR positive","NOT_YET_RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":21},"2026-09-01",{"date":44,"type":21},"2028-08",{"name":46,"class":47},"George Washington University","OTHER",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100508724","prisma-maternal-and-newborn-health-study-100508724","NCT05904145","PRISMA Maternal and Newborn Health Study","Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health","PRiSMA-MNH","A woman who meets the following inclusion criteria during screening may be enrolled:\n\n* Lives within the study catchment area;\n* Meets minimum age requirement in study site country:\n\n  * Ghana: 15 years of age;\n  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;\n  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;\n  * Zambia: 15 years of age;\n  * India: 18 years of age\n* Intrauterine pregnancy \\\u003C20 weeks gestation verified via ultrasound;\n* Provides informed consent.\n\nA woman who meets the following exclusion criteria during screening may NOT be enrolled:\n\n* Nonviable (e.g. ectopic or molar) pregnancy;\n* Plans to relocate outside of the study catchment area during pregnancy and\u002For postpartum.",true,"FEMALE","15 Years",{"count":60,"type":21},267897,"OBSERVATIONAL","Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.\n\nAdditionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.\n\nThe Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.",[64],"Pregnancy, High Risk",[66,67,68],"Antenatal Care (ANC)","Postnatal Care (PNC)","Maternal Newborn Health","RECRUITING","2026-06-09",{"date":39,"type":40},{"date":73,"type":40},"2022-08-01",{"date":75,"type":21},"2028-12-31",{"name":46,"class":47},5,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100576992","phase-1-a-basket-clinical-study-to-assess-glycerol-tributyrate-in-patients-with-mitochondrial-encephalopathy-lactic-acidosis-stroke-like-episodes-melas-or-lebers-hereditary-optic-neuropathy-plus-lhon-plus-100576992","NCT06792500","A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)","Investigational Study of Glycerol Tributyrate in MELAS and LHON-Plus","Inclusion Criteria:\n\n* Participants must be aged 18 to 65 years\n* A confirmed molecular diagnosis of MELAS or LHON-Plus\n* Symptomatic participants with MELAS harboring the m.3243A\\>G variant or a mitochondrial pathogenic variant solely mapping in a mitochondrial gene encoding a mitochondrial subunit of Complex I\n* Symptomatic participants with LHON-Plus harboring the m.11778G\\>A or a mitochondrial pathogenic variant only mapping in a mitochondrial gene encoding a mitochondrial subunit of Complex I\n* Normal enzymatic Complex II activity\n* Participants able to swallow capsules and comply with the requirements of the study according to the opinion of the investigator\n* Able to give written, informed consent\n* Participants who are sexually active and\u002For fertile must use an effective birth control during the study\n\nExclusion Criteria:\n\n* • History of another primary mitochondrial disorder\n\n  * Participants acutely ill\n  * Positive urine pregnancy test for female subjects of childbearing potential within seven days prior to the first dose of the investigational drug\n  * Pregnancy and\u002For breastfeeding\n  * Participating in another mitochondrial disorder trial\n  * Participated in another mitochondrial disorder trial within the last six months\n  * On a current therapy with other investigational agents\n  * Absence of neurological symptoms, muscle weakness, or exercise intolerance\n  * Presence of any of the following signs or symptoms in the past six months at grade 3 or higher based on the CTCAE version 4.03: nausea, vomiting, diarrhea, hypoglycemia, hyperglycemia, dizziness, blurred vision, or syncope\n  * A known hypersensitivity to any excipient contained in the drug formulation\n  * Current abuse of drugs and\u002For alcohol\n  * Unable to consent for themselves\n  * Participants with an enteral feeding tube\n  * Inability to travel to the study site","18 Years","65 Years",{"count":88,"type":21},24,[90,24],"PHASE1","This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic neuropathy-Plus (LHON-Plus) participants will undergo simultaneous enrollment in two disease-based arms and receive daily oral doses of glycerol tributyrate to assess its safety and potential for efficacy using clinical, biochemical, and molecular evidence.\n\nThis study will utilize a two-month baseline lead-in phase to establish and document the clinical baseline for each participant in both arms in order to compare the molecular and clinical parameters. This is clinically relevant in light of the high clinical heterogeneity among subjects affected by the same mitochondrial disease (MELAS or LHON-Plus). For ethical concerns prompted by the lack of treatment for these two intractable and progressive mitochondrial diseases, there will not be a placebo control group. Thus, each participant will act as their own control and receive oral doses of glycerol tributyrate, eliminating the need for a placebo. Considering the high clinical heterogeneity among participants affected by MELAS or LHON-Plus and some clinical divergence between MELAS and LHON-Plus, this strategy is beneficial to every enrolled participants, as each will receive the investigational drug, glycerol tributyrate. In addition, this approach will determine the subject-specific maximal optimized dose in a personalized medicine-based approach.\n\nAfter approval of the IRB protocol from the Institutional Review Board Data and signed consent form from all participants, this investigational basket clinical trial has three phases spanning over 20 months:\n\n* A baseline lead-in phase (2 months) to collect participant-specific baseline for clinical, biochemical, molecular and metabolic biomarkers that will be monitored throughout the subsequent dose-escalation and clinical phases.\n* A dose-escalation phase (6 months) to determine the participant-specific maximum tolerated dose (MTD) during which participant-specific clinical and biochemical biomarkers are collected every month.\n* A clinical phase at a fixed subject-specific MTD dose (12 months) to collect participant-specific clinical, biochemical, molecular and metabolic biomarkers and to perform three scheduled skin biopsies: at the outset, mid-point, and the end of this clinucal phase. We have planned for a 12-month-long clinical phase at a fixed participant-specific MTD considering the absence of reliable predictors that makes idiosyncratic disease-specific symptoms for MELAS and LHON-Plus impossible to forecast among participant for assessing the potential efficacy of glycerol tributyrate by monitoring clinical symptoms specific for each disease. During the 12-month-long time-frame, disease-specific clinical symptoms will be collected as preliminary evidence of efficacy of glycerol tributyrate using disease-specific biomarkers.\n\nFinally, discharge procedure during which the clinical investigator will record non-serious adverse events or serious adverse events for 7 or 30 days, respectively, after the last day of study participation.",[93,94],"MELAS Syndrome","Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)",[96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117],"Mitochondrial Disease","Pathogenic mitochondrial variants","ATP deficiency","Maternal inheritance","Stroke-like episodes","Chronic energy deficit","Deficient oxidative phosphorylation","Seizures","Extreme tiredness","Myopathy","Migraines","Gastrointestinal dysmotility","visual loss","Dystonia","Anxiety","Hearing loss","Tremors","Lactic Acidosis","Cognitive deficit","Neuropathy","m.3243 variant","m.11778 variant","2026-06-03",{"date":120,"type":40},"2026-06-04",{"date":122,"type":21},"2026-10",{"date":124,"type":21},"2028-03",{"name":46,"class":47},1,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":56,"sex":57,"minAge":85,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100521458","phase-3-multiple-micronutrient-supplementation-mms-vs-ifa-acceptability-crossover-trial-100521458","NCT06069856","Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial","Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania","MIFA-ACT","Inclusion Criteria:\n\n* Attending first ANC visit at the study clinic\n* Pregnant women ≤ 15 weeks of gestation\n* Aged ≥ 18 years\n* Intending to stay in the study area for the duration of study\n* Provides informed consent\n\nExclusion Criteria:\n\n* Severe anemia (defined as Hb \\\u003C8.5 g\u002FdL per Tanzania standard of care)\n* Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC\n* Concurrent participation in other nutritional supplementation trial\n* Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.",{"count":136,"type":21},130,[138],"PHASE3","This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.",[141],"Pregnancy Related",[143,144,145,146,147],"Acceptability","Multiple Micronutrient Supplementation","Iron","IFA","Tanzania",{"date":120,"type":40},{"date":150,"type":21},"2027-06-01",{"date":152,"type":21},"2027-12",{"name":46,"class":47},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100493512","phase-1-controlled-human-infection-study-of-orally-administered-trichuris-trichiura-eggs-in-nave-adults-100493512","NCT05706116","Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults","A Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults","Inclusion Criteria:\n\n1. Males or females between 18 and 45 years, inclusive.\n2. Good general health as determined by means of the screening procedures.\n3. Available for the duration of the trial (approximately 7.5 months).\n4. Willingness to participate in the study as evidenced by signing the informed consent document.\n5. Ability to sign and understand the informed consent document.\n\nExclusion Criteria:\n\n1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).\n2. Participant unwilling to use reliable contraception methods while participating in the study (if female of reproductive potential who is engaging in sexual activity that could lead to pregnancy); being of reproductive potential is defined as not being surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile.\n3. Currently lactating and breast-feeding (if female).\n4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and\u002For laboratory studies.\n5. Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits\u002Fprocedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).\n6. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment.\n7. Laboratory evidence of liver disease (alanine aminotransferase \\[ALT\\] greater than 1.25-times the upper reference limit).\n8. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit).\n9. Laboratory evidence of hematologic disease (hemoglobin \\\u003C11.1 g\u002Fdl \\[females\\] or \\\u003C12.5 g\u002Fdl \\[males\\]; absolute leukocyte count \\\u003C3.4 or \\>11.0 x 103\u002Fmm3; absolute eosinophil count \\>0.6 x 103\u002Fmm3 or platelet count \\\u003C125 x 103\u002Fmm3).\n10. Positive fecal occult blood test.\n11. Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites.\n12. History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit).\n13. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the participant unable to comply with the protocol.\n14. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months.\n15. Positive ELISA for hepatitis B surface antigen (HBsAg).\n16. Positive confirmatory test for HIV infection.\n17. Positive confirmatory test for hepatitis C virus (HCV) infection.\n18. Using or intends to continue using oral or parenteral corticosteroids, high-dose inhaled corticosteroids (\\>800 μg\u002Fday of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days of the volunteer's expected enrollment in this study or planned use during the study.\n19. Known allergy to albendazole.\n20. History of previous infection with T. trichiura or continuous residence for more than 6 months in a T. trichiura-endemic area.\n21. Inability to speak English.\n22. Current\u002Fplanned simultaneous participation in another study of an investigational agent or device for the duration of their study participation.","45 Years",{"count":163,"type":21},18,[90],"A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging them with the investigational product, Trichuris trichiura Egg Inoculum, to assess their ability to result in detectable infection. The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of T. trichiura eggs) that is safe, well-tolerated and results in consistent infection.",[167,168,169],"Whipworm","Trichuriasis","Controlled Human Infection",{"date":120,"type":40},{"date":172,"type":40},"2025-09-10",{"date":174,"type":21},"2028-04-30",{"name":46,"class":47},2,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":198,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":126},"100638376","support-your-heart-phase-1-100638376","NCT07623733","Support Your Heart, Phase 1","Support Your Heart: Feasibility Trial of a Cardiovascular Health Intervention for Young Adults, Phase 1","SYH","Inclusion Criteria:\n\n1. 18-39 at time of enrollment\n2. Living in Washington DC area\n3. At least two risk factors for cardiovascular disease:\n\n   1. not enough sleep\n   2. insufficient physical activity\n   3. tobacco and nicotine product use\n   4. elevated body mass index\n   5. poor diet\n   6. high cholesterol\n   7. high blood pressure; and\u002For\n   8. elevated HbA1c.\n\nExclusion Criteria:\n\n* 1\\. Major medical condition or chronic disease that would impede physical activity or increase the risk of the intervention (e.g., reported type 1 or type 2 diabetes, cerebrovascular accident, systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg, renal disease, pulmonary disease dependent on oxygen, recent orthopedic injury, significant surgery within the last 6 months, HbA1c \\>6.5%, total cholesterol \\>240 mg\u002FdL); 2. Plan to become pregnant during study duration; 3. Psychiatric hospitalization, psychosis or suicide attempt within the last 12 months; 4. Alcohol or substance use disorder; 5. An eating disorder; 6. Conditions or behaviors that are likely to interfere with the conduct of the trial (e.g., inability to communicate with study staff, unwillingness to accept any of the three treatment assignments by randomization, current participation in another physical activity or lifestyle intervention research program)","39 Years",{"count":187,"type":21},20,[189],"NA","This is a pilot feasibility study designed to establish the feasibility and acceptability of the \"Support Your Heart\" (SYH) study's phone-based protocols regarding AHA's LE8, social isolation, loneliness, and stress.\n\nThe age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco\u002Fnicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c , and\u002For poor diet).\n\nParticipants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention. This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which represent significant burdens to individual health.",[192,193,194,195,196,197],"Cardio Vascular Disease","Obesity & Overweight","Physical Activity","Sleep","Diet, Healthy","Nicotine",[199],"Life's Essential 8","2026-05-28",{"date":118,"type":40},{"date":203,"type":21},"2026-06-01",{"date":205,"type":21},"2026-10-01",{"name":46,"class":47},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":126},"100599039","chatgpt-supported-text-messaging-program-for-smoking-cessation-100599039","NCT07079306","ChatGPT-Supported Text Messaging Program for Smoking Cessation","Engagement and Satisfaction With a ChatGPT-Supported Text Messaging Program for Smoking Cessation","Inclusion Criteria:\n\n* lives in the US\n* smoked a cigarette within the last 7 days\n* has a mobile phone\n* willing to receive text messages about the health effects of smoking on their mobile phone for 30 days\n\nExclusion Criteria:\n\n* none",{"count":215,"type":21},150,[189],"The current research proposal aims to explore how a purpose driven LLM ChatGPT chatbot, BeFreeBot, might enhance an evidence-based text messaging smoking cessation program, BeFree. The research will consist of a formative evaluation comparing quitting related outcomes among users of BeFree+Bot and BeFree.",[219],"Smoking Cessation",[221,222,223],"smoking cessation","ai","text messaging","2026-05-20",{"date":226,"type":40},"2026-05-22",{"date":205,"type":21},{"date":229,"type":21},"2027-01-30",{"name":46,"class":47},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":56,"sex":239,"minAge":85,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":126},"100592982","phase-4-hiv-self-testing-and-long-acting-injectables-for-hiv-treatment-and-prevention-among-commercial-minibus-drivers-i-test-lais-in-nigeria-100592982","NCT07000513","HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria","Innovative Tools to Expand HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs)","ITEST-LAI","Inclusion Criteria:\n\n1. Male commercial minibus drivers who have worked as a driver for at least 6 months\n2. 18 years old or older\n3. Currently and planning on residing in one of the LGAs during the next 12 months\n4. Owning a mobile phone\n\nExclusion Criteria:\n\n1. Known HIV positivity\n2. Not ability to provide informed consent3\n3. No access to a cell phone","MALE",{"count":241,"type":21},400,[243],"PHASE4","Long-acting injectable antiretroviral therapy (LAI ART) and Pre-Exposure Prophylaxis (LAI PrEP) have the potential to transform HIV treatment and prevention, especially in reaching individuals such as commercial minibus drivers who have minimal or no contact with traditional health facilities. The project proposes to use a culturally appropriate and community-engaged approach to promote the uptake of HIV self-testing, LAI-ART, and LAI-PrEP among commercial minibus drivers in Nigeria by engaging commercial minibus drivers as peer educators\u002Fresearch facilitators.",[246],"HIV",[246,248,249,250,251],"PrEP","Long-acting Injectables","Nigeria","Minibus drivers","2026-05-13",{"date":254,"type":40},"2026-05-15",{"date":256,"type":21},"2027-02-01",{"date":258,"type":21},"2029-08-01",{"name":46,"class":47},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":267,"maxAge":58,"enrollmentInfo":268,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":187},"100556450","discovery-of-risk-factors-for-type-2-diabetes-in-youth-100556450","NCT06525259","DISCOVERY of Risk Factors for Type 2 Diabetes in Youth","DISCOVERY","Inclusion Criteria:\n\nScreening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset T2D and include those with all of the following criteria:\n\n* Overweight or obesity with BMI ≥85th percentile\n* Age 8-13 year for girls, 9-15 year for boys (inclusion younger for girls as puberty tends to start a year earlier in girls)\n* Tanner Stage 2, 3, or 4\n* Elevated HbA1c 5.5-6.4%\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Diabetes based on history, or HbA1c ≥6.5% in the medical record or at screening\n* Unable\u002Funwilling to provide consent\u002Fparticipate fully\n* Conditions predisposing to diabetes or altering the trajectory of puberty\n* Medications affecting glucose dynamics during the screening and enrollment period\n* Prior treatment with insulin\n* Use of glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications in the 6 weeks prior to enrollment\n* Planning treatment with glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications\n* Use of metformin or any glucose lowering medication for a reason other than treatment of diabetes (e.g., for PCOS) in the 6 weeks prior to enrollment\n* Planning treatment with metformin or any glucose lowering medication or planning to use such medications for a reason other than treatment of diabetes (e.g., for PCOS)\n* Known syndromic\u002Fmonogenic obesity\n* Blood disorders impacting HbA1c (e.g., anemia, hemoglobin variants)\n* Major systemic organ disease\n* History of bariatric surgery or currently planning bariatric surgery\n* Current pregnancy or currently planning pregnancy\n* Use of GnRH agonist, estrogen, or testosterone\n* Individuals who do not speak English or Spanish, given validation of the questionnaires to be utilized","8 Years",{"count":269,"type":21},3600,"The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.",[272],"Diabetes Mellitus Type 2, Childhood-Onset","2026-05-06",{"date":275,"type":40},"2026-05-07",{"date":277,"type":40},"2024-10-01",{"date":279,"type":21},"2028-01-31",{"name":46,"class":47},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":56,"sex":17,"minAge":288,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":126},"100612086","nss-grocery-store-brazil-100612086","NCT07249008","NSS Grocery Store Brazil","Effects of a Non-sugar Sweetener Label on Parents' Selection of Foods and Beverages in Brazil: a Randomized Clinical Trial.","Eligible participants include:\n\n* Adults aged 20 years or older,\n* Living in Brazil\n* Parents or guardians of children between 2 and 12 years old\n* Primarily responsible for the household grocery shopping (more than 50%)\n* Can read and understand Portuguese\n\nRecruitment will occur nationwide through an online panel, with quotas for education, race, and geographic distribution to approximate the national profile.\n\nIndividuals will be excluded if\n\n* Not a parent or guardian of a child aged 2-12 years\n* Younger than 20 years\n* Not primarily responsible for more than half of the household grocery shopping\n* Unable to read or understand Portuguese\n* Do not provide informed consent.","20 Years",{"count":290,"type":21},1068,[189],"The purpose of this study is to assess the impact of non-sugar sweeteners (NSS) front-of-package labels (FOPL) on Brazilian parents' food and beverage selections for their children. The study includes three arms: 1. no NSS FOPL control group, 2. a group exposed to a NSS FOPL modeled after the Mexican warning label for NSS, and 3. a group exposed to a NSS FOPL using the magnifying glass symbol currently implemented in Brazil for nutrients of public health concern. Participants will be instructed to select products for their child, including one yogurt, three beverages (for breakfast, lunch, and dinner), one granola, and one cereal bar.",[294,295,296],"Control Group","Mexico-based NSS FOPL","Brazil-based NSS FOPL","2026-04-13",{"date":299,"type":40},"2026-04-15",{"date":301,"type":40},"2026-02-15",{"date":303,"type":21},"2026-06-30",{"name":46,"class":47},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":126},"100633255","self-help-plus-pilot-study-colombia-train2care-100633255","NCT07524309","Self-Help Plus Pilot Study, Colombia: Train2Care","Self-Help Plus Pilot Study, Colombia: Training to Care: Global Mental Health With a Territorial Approach","T2C","Inclusion Criteria:\n\n* 18 years old and living in the study area\n\nExclusion Criteria:\n\n* Current risk of self-harm or suicide that requires a higher level of care\n* Significant cognitive impairment that would interfere with the ability to participate in the intervention or provide informed consent\n* Severe mental health conditions requiring specialized care (for example, psychosis)\n* Severe substance use or substance use disorders that would interfere with participation or require specialized treatment",{"count":314,"type":21},40,[189],"This project will strengthen local capacity for mental health care in high-need settings in Colombia by culturally and linguistically adapting the Self-Help+ intervention and delivering participatory, supervised training. Local community leaders will be trained to implement Self Help+ for their own well-being and to train others in their communities. The project will deliver a structured program with hands-on practice, ongoing technical support, and participatory evaluation of psychosocial outcomes and sustainability.",[318],"Wellbeing","2026-04-06",{"date":297,"type":40},{"date":254,"type":21},{"date":323,"type":21},"2026-10-31",{"name":46,"class":47},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":126},"100578367","phase-3-erector-spinae-versus-intercostal-nerve-blocks-with-liposomal-bupivacaine-for-analgesia-in-thoracic-surgery-100578367","NCT06810375","Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery","Inclusion Criteria:\n\n* Video assisted pulmonary resection, pleurodesis or decortication\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Patient undergoing bilateral surgery\n* Surgery is emergent as deemed by the principal investigator","90 Years",{"count":333,"type":21},120,[138],"This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.",[337],"Lung Cancers",{"date":339,"type":40},"2026-04-09",{"date":341,"type":40},"2025-03-01",{"date":343,"type":21},"2029-02-28",{"name":46,"class":47},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":57,"minAge":85,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":362,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":126},"100631553","what-works-to-prevent-violence---malawi-moyo-olemekeza-100631553","NCT07502183","What Works to Prevent Violence - Malawi Moyo Olemekeza","What Works to Prevent Violence Against Women and Girls: Impact at Scale: A Cluster Randomized Controlled Trial to Assess the Effectiveness of a Community-mobilisation Intervention to Prevent Violence Against Women in Malawi","WW-M-MO","Inclusion Criteria:\n\n1. The household has a woman aged 18-49 who are in monogamous relationships\n2. The household is food insecure, where food insecurity is scored on a scale of (0-7) and constructed from responses on 3 questions related to the household's food sufficiency (a) How does the household meet its food needs (b) How often does the household has food surplus and (c) How many times do you eat a full meal on a typical day over a year.\n3. The primary decision maker of the household is male\n4. Household is willing to participate in community meetings","49 Years",{"count":355,"type":21},1700,[189],"Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi as one of the most common forms of VAW experienced in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together (community mobilisation model) and Moyo Olemekeza (MO) (gender norms and behaviour change and economic empowerment approach). The institutional strengthening component of these evaluations is meant to create an enabling environment.\n\nThe cRCT described in this protocol will assess the added value of the women's social and economic empowerment programme (MO) when layered on top of SASA! Together for eligible at-risk households.",[359,360,361],"Intimate Partner Violence (IPV)","Earning Outcomes","Norms, Social",[363,364],"Intimate Partner Violence","Economic Empowerment","2026-03-30",{"date":367,"type":40},"2026-04-03",{"date":369,"type":40},"2025-10-15",{"date":371,"type":21},"2029-01",{"name":46,"class":47},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":126},"100528873","implementing-a-scalable-smoke-free-home-intervention-in-armenia-and-georgia-100528873","NCT06166433","Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia","SFHAMGE","Inclusion Criteria:\n\n1. be greater than or equal to 18 years old\n2. smoke in the home and have a child and-or nonsmoker in the home, or be a non-smoker and live with someone who smokes in the home\n3. speak Armenian or Georgian\n4. live in a selected community\n\nExclusion Criteria:\n\nN\u002FA",{"count":381,"type":21},550,[189],"Tobacco use and secondhand smoke exposure represent critical health disparities in low- and middle-income countries; Armenia and Georgia represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively), but have low rates of smoking in women (1.8% and 7.8%) and few smoke-free homes (38.6%), which can reduce secondhand smoke exposure and tobacco use rates. This study builds on ongoing collaborations between George Washington University, Emory, and national public health organizations in Armenia and Georgia and advancements in local public health infrastructure; it aims to adapt an evidence-based smoke-free home intervention for homes in Armenia and Georgia, develop capacity to deliver the intervention via local community partners and the national quitlines, and test the intervention in a hybrid effectiveness-implementation randomized clinical trial. This work will advance the knowledge base informing strategies to reduce global tobacco-related disparities, as well as the implementation and scale-out of evidence-based interventions in low- and middle-income countries.",[385],"Second Hand Tobacco Smoke","2026-03-19",{"date":388,"type":40},"2026-03-23",{"date":390,"type":40},"2025-02-01",{"date":392,"type":21},"2027-07-31",{"name":46,"class":47},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":409,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":126},"100578102","phase-2-predicting-response-to-neoadjuvant-endocrine-therapy-neo-predict-100578102","NCT06806930","Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)","Inclusion Criteria:\n\n* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study\n* Be capable of signing and providing written consent in accordance with institutional and federal guidelines\n* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast\n* Clinical stage 1 to 3 breast cancer\n* Candidate for surgical resection\n* Estrogen receptor \\> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.\n* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.\n* Ability to take oral medication\n* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff\n* Age ≥ 21 years\n\nExclusion Criteria:\n\n* Inability to comply taking NET\n* Inability to comply to study procedures",{"count":401,"type":21},90,[24],"The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called \"neoadjuvant\" treatment) affects breast cancer. The main questions the trial aims is answer are:\n\n1. How breast cancer responds to endocrine therapy given prior to surgery?\n2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C\n\nParticipants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:\n\n* receive endocrine therapy as part of regular care for breast cancer\n* consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor\n* participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed",[405,406,407,408],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Carcinoma, Breast",[32,33,34,410],"carcinoma","2026-02-27",{"date":413,"type":40},"2026-03-03",{"date":277,"type":40},{"date":416,"type":21},"2028-10",{"name":46,"class":47},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":331,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":126},"100479346","phase-4-erector-spinae-block-for-thoracic-surgery-100479346","NCT05521789","Erector Spinae Block for Thoracic Surgery","Erector Spinae Blocks for Thoracic Surgery","Inclusion Criteria:\n\n* pulmonary resection\n* 18\\\u003Cage\\\u003C90\n\nExclusion Criteria:\n\n* pleurodesis\n* decortication\n* emergent surgery\n* local anesthetic allergy\n* intraoperative complication (inadvertent hemorrhage or conversion to open surgery)\n* bilateral pulmonary resection",{"count":426,"type":21},70,[243],"The aim of this study is to determine if erector spinae injections with bolus infusions with local anesthetic decrease postsurgical pain and opioid consumption in patients undergoing pulmonary resection surgery.",[430,431,432,433,434],"Pulmonary Neoplasm","Pulmonary Cancer","Thoracic Diseases","Thoracic Cancer","Thoracic Neoplasms","2026-02-23",{"date":437,"type":40},"2026-02-25",{"date":439,"type":40},"2022-07-22",{"date":441,"type":21},"2027-07-21",{"name":46,"class":47},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":56,"sex":57,"minAge":85,"maxAge":161,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":458,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":126},"100558262","effects-of-a-non-nutritive-sweetener-reduction-intervention-in-pregnancy-and-lactation-on-maternal-and-infant-outcomes-100558262","NCT06548828","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)","Inclusion Criteria:\n\n* Pregnant\n* ≤ 16 weeks gestation\n* Singleton pregnancy\n* Report frequent NNS beverage consumption (≥ 7 servings\u002Fweek)\n* 18-45 years of age\n* Able to read English at a 5th grade level; and\n* Intend to breastfeed for at least the first 6 months of life.\n* For infants: The mother must be enrolled and provide assent for the infant to participate.\n\nExclusion Criteria:\n\n* Physical or mental concerns preventing study participation;\n* Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;\n* Tobacco or drug use during pregnancy;\n* Alcohol consumption (\\&gt;1 drink per week) during pregnancy;\n* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;\n* Known suspected\u002Fconfirmed genetic fetal abnormalities or suspected or known congenital birth defects.\n* History of prior gastric bypass surgery.",{"count":451,"type":21},324,[189],"The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and\u002For lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.",[455,456,457],"Gestational Diabetes Mellitus in Pregnancy","Glucose Intolerance During Pregnancy","Non-nutritive Sweeteners Consumption in Pregnancy and\u002For Lactation",[459,460,461,462,463,464,465],"Non-nutritive sweeteners (NNS)","Pregnancy","Lactation","Infant fat mass","Gestational diabetes (GDM)","Glucose tolerance","PeaPod","2026-02-16",{"date":468,"type":40},"2026-02-18",{"date":470,"type":40},"2024-08-19",{"date":472,"type":21},"2029-02-01",{"name":46,"class":47},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":56,"sex":17,"minAge":481,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":126},"100588358","changing-youth-narratives-on-firearm-violence-run-it-up-intervention-100588358","NCT06940362","Changing Youth Narratives on Firearm Violence (\"Run It Up\") Intervention","Changing Youth Narratives on Firearm Violence: A Community Collaborative Intervention - Phases 1 and 2","Inclusion Criteria:\n\n• Resident of intervention community, within age limits\n\nExclusion Criteria:\n\n• Not resident of intervention community, outside of age limits","12 Years",{"count":483,"type":21},1000,[189],"The Run It Up project is an experimental, theory-driven effort to address a specific connection between structural factors, youth identity development, and violence, where structural factors in some communities may limit adolescent beliefs about potential life-trajectories (\"possible selves\"), and foreground potential trajectories that include violence as integral. The intervention seeks to counter that dynamic by: 1) identifying alternative, non-violent identity trajectories that have attributes meaningful for youth and actualizing those trajectories through a community support structure; and 2) developing and disseminating multiple media products featuring narratives about these alternative trajectories. The goal is to change the calculation of possible selves for adolescents in the identity development stage through the introduction, and actualization, of desirable, tangible trajectories that do not involve violence or pro-violence norms, resulting in a reduction of youth involvement in firearm violence. The intervention and research is being conducted through a partnership between the George Washington University Milken Institute School of Public Health and the Washington, DC community of Washington Highlands, and is funded through a grant from the National Institute on Minority Health and Health Disparities (NIMHD). In the first phase, formative research was completed to identify attributes and alternative non-violent trajectories, determine intervention elements, develop an intervention \"brand\" representing the attributes, develop a baseline-follow-up survey measuring theoretical mediators\u002Fmoderators, outcomes, and other potential influencing factors, and identify community data to be used for a time-series analysis. Now in the second phase, the baseline data from a sample of community youth and parents\u002Fguardians are currently being collected prior to implementing the intervention. Evaluation is a two group, quasi-experimental community cohort design using survey and community-level data.",[487],"Injury Prevention",[489],"Community intervention, quasi-experimental design, youth firearm violence prevention","2026-02-10",{"date":492,"type":40},"2026-02-12",{"date":494,"type":40},"2025-04-07",{"date":496,"type":21},"2027-11-30",{"name":46,"class":47},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":353,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":126},"100576292","what-works---malawi-sasa-together-100576292","NCT06783400","What Works - Malawi SASA! Together","What Works to Prevent Violence Against Women and Girls: Impact at Scale: A Cluster Randomized Controlled Trial to Assess the Effectiveness of a Community-mobilisation Intervention to Prevent Violence Against Women in Malawi - SASA! Together","WW-M-SASA!","Inclusion Criteria:\n\n* Women and men aged 18-49 who have ever been in an intimate (romantic) relationship.\n* Living in selected Group Village Heads (GVHs) in Lilongwe or Balaka districts for at least a year. The specific Traditional Authorities (TAs) in Lilongwe are: Kalolo, Chimutu, Kabudula; The TAs in Balaka are: Msamala and Nyanyala.\n\nExclusion Criteria:\n\n* Women and men younger than 18 years or older than 49 years old\n* Women who have never had an intimate relationship.\n* Not living in selected TAs and GVHs in Lilongwe or Balaka districts, or living in selected GVHs for less than one year\n* Paid employees of the PKN programme (any element), including SASA! Together community activists who deliver the programme activities.",{"count":507,"type":21},4800,[189],"Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi as one of the most common forms of VAW experienced in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together (community mobilisation model) and Moyo Olemekeza (MO) (gender norms and behaviour change and economic empowerment approach).\n\nA cluster randomised controlled trial (cRCT) will evaluate the effectiveness of the PKN programme, assessing the effectiveness of the SASA! Together programme at shifting individual behaviours and reducing violence in intimate relationships while also tackling community norms that drive these forms of violence against women. The cRCT will also assess the added value of combining SASA! Together and a women's social and economic empowerment programme (MO) for most at-risk households.\n\nThis protocol focuses on the evaluation of the SASA! Together programme.",[359,361,511],"Gender Inequitable Behavior",[513,514,515,516,517],"intimate partner violence","gender","social norms","community mobilization","behavior change",{"date":492,"type":40},{"date":520,"type":40},"2024-08-27",{"date":522,"type":21},"2029-12",{"name":46,"class":47},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":126},"100489275","phase-1-impact-of-early-adl-participation-on-outcomes-post-drf-100489275","NCT05650996","Impact of Early ADL Participation on Outcomes Post DRF","The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture","Inclusion Criteria:\n\nEnglish Speaking\n\nDRFs treated with a cast\n\nIndividuals over the age of 18\n\nLess than 3 weeks from DRF\n\nExclusion Criteria:\n\nIndividuals with pre-existing neurological conditions affecting the upper limb\n\nIndividuals with cognitive deficits that would limit the ability to correctly report information on outcome measures\n\nIndividuals with psychological deficits which would limit the ability to correctly report information on outcome measures\n\nIndividuals with multiple injuries to the affected upper limb\n\nIndividuals with multiple injuries to both upper limbs\n\nIndividuals requiring surgery to fixate the distal radius fracture\n\nPrior distal radius fracture involving the same wrist\n\nIndividuals receiving hand therapy for another injury at enrollment into study",{"count":532,"type":21},64,[90],"This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated conservatively in a cast. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.",[536],"Distal Radius Fracture",[538,539],"Activities of Daily Living","Patient Education",{"date":492,"type":40},{"date":542,"type":40},"2023-04-18",{"date":544,"type":21},"2026-09-30",{"name":46,"class":47},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":56,"sex":17,"minAge":554,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":176},"100623846","haven-connect-youth-suicide-prevention-100623846","NCT07401940","HAVEN-Connect Youth Suicide Prevention","A Multi-Generational Suicide Prevention Program in African American Churches","HAVEN","Inclusion Criteria: For churches:\n\n1. 75% of members self-identify as Black or African American,\n2. 75% are fluent in English.\n\nExclusion Criteria for Youth:\n\n1. self-identify as Black\u002FAfrican American,\n2. 13-19 years old, are fluent in English\n\nExclusion Criteria: Churches:\n\n1. 25%+ of members self-identify as non-Black or African American\n2. 25%+ are not fluent in English.\n\nExclusion Criteria for Youth:\n\n1. do not self-identify as Black\u002FAfrican American,\n2. are younger than 13 or older than 19.","13 Years","19 Years",{"count":557,"type":21},240,[189],"HAVEN=CONNECT is a comprehensive depression and suicide prevention intervention that is designed to be integrated into predominantly Black churches, a strategically ideal location for mental health intervention for Black youth. HAVEN=CONNECT has three components: (1) Church Community Engagement: an interactive process of introducing the program to key church leaders and stakeholder groups. (2) Faith-Based Curriculum: educational overview for pastors, other ministerial staff and youth lay leaders on how to integrate the program into the church using communication mediums that have cultural and religious relevance in the Black Church context. (3) Youth-Connect Intervention: The goals of this project are to test the impact of HAVEN=CONNECT (HAVEN) on key intervention targets, hypothesized mediators, and build a research-informed implementation strategy for future large-scale testing.",[561],"Suicide Prevention",[563,564,565],"suicide prevention","Black youth","church based prevention","2026-02-03",{"date":568,"type":40},"2026-02-11",{"date":570,"type":40},"2023-06-01",{"date":572,"type":21},"2026-05-31",{"name":46,"class":47},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":56,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":597},"100148682","the-dc-cohort-longitudinal-hiv-status-neutral-study-100148682","NCT01206920","The DC Cohort Longitudinal HIV Status Neutral Study","Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort","DC Cohort","Treatment Cohort Inclusion Criteria:\n\n* Patient is receiving care for HIV at one or more of the twelve participating clinics in the DC Cohort.\n* Patient is either age 18 years or older, or seeks HIV care independently and is able to understand and sign informed consent.\n* Patient is a minor who is consented by a parent or legal guardian.\n\nTreatment Cohort Exclusion Criteria:\n\n* Patient is unable or refuses to provide informed consent.\n* Minor children ages 12 through 17 who are unaware of their HIV status\n\nPrevention Cohort Inclusion Criteria:\n\nPersons receiving any antiretroviral prescription without evidence of HIV or Hepatitis B infection\n\n* PrEP (e.g., TDF\u002FFTC, Descovy, Apretude)\n* Combination ART indicative of nPEP in an HIV-uninfected person\n* Persons receiving an antiretroviral prescription indicative of DoxyPEP Doxycycline 200mg PO taken within 72 hrs of unprotected sexual encounter (or variations thereof where clearly not prescribed as a treatment course)\n* Test positive for ≥1 bacterial STI (positive gonorrhea (GC\u002FNG) or chlamydia (CT) test or positive syphilis test requiring treatment within one year)\n\n  * 2 bacterial STI (GC, chlamydia, syphilis) tests at 2 or more different encounters\n  * 2 HIV tests at 2 or more different encounters\n* Patient requesting PrEP at their clinical visit\n* Patient requesting nPEP at their clinical visit\n* People who identify as injecting drugs\n\nPatients with a Z29.81 Encounter for HIV pre-exposure prophylaxis",{"count":583,"type":21},19000,"The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for patients diagnosed with Human Immunodeficiency Virus\u002FAcquired Immune Deficiency Syndrome (HIV\u002FAIDS) or at higher risk for acquiring HIV and receiving care in Washington, DC.",[246,586],"AIDS",[246,586,588],"Co-morbidities","2026-01-29",{"date":591,"type":40},"2026-02-02",{"date":593,"type":40},"2011-01",{"date":595,"type":21},"2041-01",{"name":46,"class":47},14,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":176},"100486588","texts-for-diabetes-control-among-homeless-persons-100486588","NCT05616026","Texts for Diabetes Control Among Homeless Persons","Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness","Inclusion Criteria:\n\n* Homeless person age ≥ 21\n* Diagnosed with type 2 DM\n* Most recent visit HbA1c ≥ 8%\n* English\u002FSpanish speaking\n* Connected to study sites' shelter-clinics for care\n\nExclusion Criteria:\n\n* Pregnant or within 3 months postpartum\n* Has an uncontrolled severe illness\n* Has had a heart attack or stroke in the previous 6 months\n* Inability to read\u002Frespond to texts\n* Inability to provide informed consent\n* Receiving inpatient care for severe substance abuse",{"count":606,"type":21},100,[189],"This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.",[610],"Diabetes Mellitus",[612,613,614,615,616,617],"Diabetes","Homelessness","SMS text","mobile Health","Clinical trial","Health disparities","2026-01-13",{"date":620,"type":40},"2026-01-14",{"date":622,"type":40},"2023-02-07",{"date":624,"type":21},"2026-11-15",{"name":46,"class":47},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":56,"sex":57,"minAge":85,"maxAge":161,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":126},"100589008","phase-2-effectiveness-study-of-a-lifestyle-intervention-versus-metformin-in-mothers-with-recent-gestational-diabetes-100589008","NCT06948825","Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes","GooDMomS2","Inclusion Criteria:\n\n* Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women who are at least 8 weeks postpartum to provide time to describe the study and answer any questions. Mothers who want to participate will be enrolled in the study between 12 weeks and 12 months postpartum.\n* BMI of 25 kg\u002Fm2 to 45 kg\u002Fm2\n* Singleton delivery\n* Participants must also have a working cell phone, be willing to accept email or text messages attend Zoom calls, and be willing to be potentially randomized to drug therapy with Metformin.\n\nExclusion Criteria:\n\n* Pregnant or planned pregnancy within the next 6 months.\n* Participation in any other weight loss program or taking weight loss medication.\n* Normal or underweight BMI (BMI \\\u003C 24.9 kg\u002Fm2)\n* Multi-fetal (twins or triplets) gestation\n* Women with type 1 or type 2 diabetes, malignancy, other serious co-morbidities (advanced kidney disease, NYHA class 3-4 CHF, advanced COPD), schizophrenia or other major psychiatric disease, and substance abuse or AIDS.\n* Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.",{"count":634,"type":21},60,[24],"The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is:\n\nIs a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes?\n\nResearchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes.\n\nParticipants will:\n\n* Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.\n* Track diet, physical activity, and weight using the Fitbit and Looseit! apps.\n* Attend weekly online group sessions for the first 4 weeks, then biweekly sessions.\n* If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study.\n* If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication.\n* Continue with biweekly group sessions or have regular check-in calls.\n* If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study.\n* Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm.\n* At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.",[638,455,639],"Weight Loss","Postpartum Care",[641,642,643],"diabetes prevention","gestational diabetes","lifestyle intervention","2026-01-12",{"date":618,"type":40},{"date":647,"type":40},"2025-10-27",{"date":649,"type":21},"2026-11",{"name":46,"class":47},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":56,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":176},"100614402","phase-1-decision-support-tool-to-integrate-prep-into-emergency-departments-100614402","NCT07279129","Decision Support Tool to Integrate PrEP Into Emergency Departments","A Pilot Feasibility Study to Integrate PrEP Into Emergency Departments Using Decision Support Tools","Inclusion Criteria:\n\n* English-speaking\n* Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)\n* Medically stable ED\u002FUC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)\n\nExclusion Criteria:\n\n* Currently taking PEP, PrEP, or present with signs\u002Fsymptoms of acute HIV infection\n* Pregnant\n* Currently taking a nephrotoxic medication\n* Diagnosed with medical conditions that are contraindicated with use of TDF\u002FFTC or TAF\u002FFTC\n* Have a comorbid medical or psychiatric condition that would make PrEP adherence or ongoing follow-up care difficult\n* Admission to the hospital\n* Are in police custody\u002Fprisoner during the ED visit",{"count":333,"type":21},[90],"This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.",[246],[248,663,664,665],"Emergency departments","Decision support tools","HIV prevention","2025-12-08",{"date":668,"type":40},"2025-12-12",{"date":670,"type":21},"2027-01-15",{"date":672,"type":21},"2028-09-09",{"name":46,"class":47},""]