[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Hawaii\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":445},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,49,75,98,121,164,187,216,237,256,280,295,327,348,369,388,425],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627251","poi-for-mama-a-pilot-to-improve-maternal-microbiome-and-gestational-diabetes-risk-100627251",false,"NCT07446205","Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk","Inclusion Criteria:\n\n* Be at least 10 weeks into their pregnancy\n* have no pre-existing health conditions\n* Be able to read and write in English\n* be at least18 years of age\n* Own a smartphone\n* Live on the windward side of O'ahu\n* Be able to complete study activities\n\nExclusion Criteria:\n\n* Less than 10 weeks pregnant or already in third trimester\n* Have pre-existing health conditions\n* Not able to read and write in English\n* Under 18 years of age\n* Do not own a smartphone\n* Do not live on the windward side of O'ahu\n* Unable to complete study activities","FEMALE","18 Years",{"count":18,"type":19},50,"ESTIMATED","INTERVENTIONAL",[22],"NA","This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and gestational diabetes risk during pregnancy. Fifty pregnant participants between approximately 12 and 24 weeks of gestation will receive one pound of poi daily for four weeks, accompanied by culturally tailored nutrition education delivered via secure text messaging. Changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes will be assessed and compared with matched controls derived from an existing cohort. This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.",[25,26],"Gestational Diabetes Mellitus (GDM)","Pregnancy",[28,25,26,29,30,31,32,33,34,35],"Gestational diabetes mellitus","Maternal microbiome","Vaginal microbiome","Fermented foods","Poi","Dietary intervention","Nutrition education","Native Hawaiian and Pacific Islander (NHPI)","RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2026-06-12",{"date":44,"type":19},"2027-01-31",{"name":46,"class":47},"University of Hawaii","OTHER",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":16,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":20,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100595889","a-text-messaging-trial-to-test-vaping-health-messages-optimized-to-young-adults-vaping-status-100595889","NCT07038317","A Text Messaging Trial to Test Vaping Health Messages Optimized to Young Adults' Vaping Status","Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers","Inclusion Criteria:\n\n* 18-24 years old\n* Fluent in English\n* Not currently using tobacco products other than e-cigarettes at the time of enrollment\n* Have a mobile phone to send and receive text messages\n\nExclusion Criteria:\n\n* Age below 18 or above 24\n* Not being fluent in English\n* Currently using tobacco products other than e-cigarettes\n* Not having a mobile phone",true,"ALL","24 Years",{"count":60,"type":19},120,[22],"The goal of this study is to examine if e-cigarette education messages delivered using a source and presentation tailored to one's vaping status influences young adults' vaping behaviors. The main questions it aims to answer are:\n\n1. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the current vaper group influence vaping cessation among young adults who vape daily?\n2. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the non-vaper group influence vaping initiation among young adults who are susceptible to vaping? Participants will be randomly assigned to either the treatment (receiving messages tailored to one's vaping status) or the control (receiving non-tobacco messages) condition and receive SMS three times per week over the course of 6 months. They will complete self-report assessment and show salivary cotinine results for nicotine testing at 4 timepoints.",[64,65,66],"Vaping Behaviors","Message Exposure","Young Adults","NOT_YET_RECRUITING","2026-06-10",{"date":42,"type":40},{"date":37,"type":19},{"date":72,"type":19},"2028-01-31",{"name":46,"class":47},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":56,"sex":57,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":20,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100587525","the-development-and-evaluation-of-a-culturally-grounded-ends-intervention-for-rural-hawaiian-youth-100587525","NCT06929520","The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth","Inclusion Criteria:\n\n* 6th-8th grade students attending a public or public-charter school on Hawaii Island.\n\nExclusion Criteria:\n\n* K-5th grade students and 9th-12th grade students on Hawaii Island.","10 Years","14 Years",{"count":84,"type":19},500,[22],"The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle\u002Fintermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and\u002For difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography\u002Fproduction stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social\u002Fprint media campaign) across all middle\u002Fintermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.",[88,89],"E-cigarette Use","Substance Use","2026-06-03",{"date":92,"type":40},"2026-06-05",{"date":94,"type":40},"2025-10-15",{"date":96,"type":19},"2027-05-15",{"name":46,"class":47},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":20,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":74},"100588011","phase-2-effects-of-tirzepatide-on-weight-loss-and-chronic-inflammation-in-people-with-hiv-100588011","NCT06935838","Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV","Age ≥ 18 years\n\nHIV-1 infection (well controlled)\n\n* Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western blot or HIV-1 RNA) AND\n* HIV-1 RNA \\\u003C200 copies\u002FmL for ≥ 6 months\n\nStable ART\n\n· Receiving a stable antiretroviral regimen for at least 1 year prior to study entry\n\nOverweight\n\n* BMI ≥27 kg\u002Fm2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) OR Obese\n* BMI ≥ 30 kg\u002Fm2",{"count":105,"type":19},12,[107],"PHASE2","This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race\u002Fethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.",[110,111,112],"Obesity and Overweight","HIV","Chronic Inflammation","2026-05-22",{"date":115,"type":40},"2026-05-27",{"date":117,"type":40},"2025-11-12",{"date":119,"type":19},"2026-07-31",{"name":46,"class":47},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":57,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":20,"phases":131,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":48},"100634834","navigating-hypertension-and-food-insecurity-100634834","NCT07544836","Navigating Hypertension and Food Insecurity","Navigating Hypertension and Food Insecurity: A Produce Prescription Program to Improve Health Outcomes for Native Hawaiian and Pacific Islander Communities","Inclusion Criteria:\n\n* patient of the participating health center clinic\n* age 20 years and older\n* positive screen for food insecurity using a validated two-question tool\n* physician diagnosed HTN and continued indications of SBP \\>130 mmHG\n\nExclusion Criteria:\n\n* prior history of cardiovascular disease\n* unable to provide informed consent and complete study procedures in English","20 Years",{"count":130,"type":19},250,[22],"This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness.\n\nThe study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and\u002For the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities.\n\nTo test the effectiveness of the added CHW support, there will be two groups of participants:\n\nGroup 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges.\n\nGroup 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW.\n\nThe investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes.\n\nUpon providing informed consent and enrolling into the program, produce prescription program participants will:\n\n* Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months.\n* Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure.\n* Answer surveys about their demographic background, health habits, diet, and culture.\n* Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer.\n* Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program.\n* Group 2 will receive monthly reminders to use their vouchers but no CHW meetings.\n\nAfter the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.",[134,135],"Hypertension (HTN)","Food Insecurity",[137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155],"hypertension","high blood pressure","produce prescription","food insecurity","cardiovascular disease prevention","community health worker","fruit and vegetable vouchers","Randomized Controlled Trial","Community-Based Participatory Research","Social Determinants of Health","cost-effectiveness analysis","Native Hawaiian health","Pacific Islander health","Federally Qualified Health Center","Food as Medicine","Hypertension self-management support","cost-effectiveness","healthcare cost reduction analysis","quality-adjusted life year","2026-05-18",{"date":158,"type":40},"2026-05-20",{"date":160,"type":19},"2026-09-01",{"date":162,"type":19},"2028-03",{"name":46,"class":47},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100598717","phase-1-ipilimumab-and-nivolumab-with-sbrt-in-locally-advanced-hepatocellular-cancer-100598717","NCT07075120","Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer","Pilot Study of Ipilimumab and Nivolumab With Response-adapted Stereotactic Body Radiotherapy Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Cancer","Main Criteria for Inclusion\u002FExclusion\n\n* Inclusion Criteria:\n\n  * Histologically or cytologically confirmed hepatocellular cancer\n  * Locally advanced\u002Fborderline resectable HCC as defined by:\n\n    * Solitary tumor \\>5 cm, OR\n    * Unilobar multifocal disease either with \\>3 tumors or one tumor \\>3 cm, OR\n    * Bilobar disease with adequate future liver remnant, still technically resectable, OR\n    * High risk disease features (tumor \\>3 cm with macrovascular invasion or tumor \\>3 cm with AFP\\>400).\n  * No extrahepatic spread, no nodal disease, no bilateral left and right branch portal vein involvement, no hepatic vein \u002F IVC involvement. Unilateral hepatic vein involvement is not exclusionary.\n  * Measurable disease per RECIST 1.1 as determined by the investigator\n  * Age ≥ 18 years old on the day of consent\n  * ECOG performance status ≤1 (Appendix XX)\n  * Adequate organ and marrow function, as defined below. Criteria \"a,\" \"b,\" \"c,\" and \"f\" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.\n\n    * Hemoglobin ≥9 g\u002FdL\n    * Absolute neutrophil count ≥1000\u002FμL\n    * Platelet count ≥90,000\u002FμL\n    * Total bilirubin (TBL) \\\u003C2.0 mg\u002FdL\n    * ASTandALT≤5×ULN\n    * Albumin≥2.8g\u002FdL\n    * International normalized ratio(INR)≤2xULN\n    * Calculated creatinine clearance ≥ 40 mL\u002Fminute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance\n* Exclusion Criteria:\n\n  * Prior systemic therapy for hepatocellular carcinoma\n  * Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).\n  * Ascites that requires ongoing paracentesis, within 6 weeks prior to the first scheduled dose, to control symptoms.\n  * Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 60 days prior to registration; adequate endoscopic therapy according to institutional standards is required for patients with history of esophageal variceal bleeding or assessed as high risk for esophageal variceal by the treating investigator.\n  * Hepatic encephalopathy within 12 months of trial registration\n  * Patient currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \\>90 mmHg or systolic blood pressure \\>140 mmHg.\n  * Prior external beam radiation therapy to the liver, prior yttrium-90 radioembolization\n  * HBV viral load \\>100 IU\u002FmL, ongoing corticosteroid therapy \\>10 mg prednisone daily, and active autoimmune disease requiring systemic therapy in the past 2 years.\n  * Direct tumor extension into stomach, duodenum, small or large bowel\n  * Active or untreated central nervous system (CNS) and leptomeningeal metastases\n  * History of another primary malignancy except for:\n\n    * Malignancy treated with curative intentand with no known active disease ≥ 5years before the first dose of study drug(s) and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n  * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n  * Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), or human immunodeficiency virus (positive human HIV 1\u002F2 antibodies).",{"count":172,"type":19},15,[174],"PHASE1","Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses. NHPI patients are also underrepresented in clinical trials, limiting the relevance of treatment advances for this population.\n\nThe standard treatment for HCC is surgical resection; however, many NHPI patients present with unresectable disease. Recent advances with immune checkpoint inhibitors (ICIs), such as nivolumab and ipilimumab, have shown promise in treating advanced HCC and improving survival in previously untreatable cases. Additionally, stereotactic body radiotherapy (SBRT) has been shown to enhance survival and local control when combined with systemic therapies like ICIs. However, without surgery, outcomes remain suboptimal, with response rates for ICIs alone at 20-30%, and combination ICI-SBRT treatment showing slightly better results but still a high risk of progression.\n\nDespite improvements in HCC treatment, significant gaps remain in managing borderline resectable disease, especially in NHPI patients. This study aims to evaluate the safety and efficacy of combining ICIs and SBRT with curative surgery for patients with borderline resectable HCC, focusing on NHPI populations. The study will also explore the use of biomarkers such as cell-free DNA (cfDNA), CD8+ T-cell infiltration, and serum cytokine markers to guide personalized treatment strategies. Preliminary findings suggest that this multimodal approach may improve outcomes and enable surgical resection for patients previously considered inoperable.\n\nThis study seeks to address the unmet need for effective treatment strategies in borderline resectable HCC and to improve survival outcomes for underserved NHPI populations.",[177],"Hepatocellular Carcinoma (HCC)","2026-04-24",{"date":180,"type":40},"2026-04-30",{"date":182,"type":19},"2026-04-01",{"date":184,"type":19},"2027-12-31",{"name":46,"class":47},2,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":57,"minAge":16,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":20,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":74},"100598752","quit-smoking-study-for-native-hawaiians-100598752","NCT07075575","Quit-Smoking Study for Native Hawaiians","Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling","Inclusion Criteria:\n\n* Self-identifies as full or part Native Hawaiian\n* Between the ages of 18 and 80 years, inclusive, at eligibility screening\n* Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening\n* Has smoked more than 100 cigarettes in his\u002Fher lifetime (self-report)\n* Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing\n* Willing to make a smoking cessation attempt the day after the first study visit (i.e., date of consent)\n* Willing to engage in use of nicotine replacement therapy gum (NRT gum) and\u002For smoking cessation-focused cognitive-behavioral group therapy (CBGT)\n* Participant must agree to not use any form of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking during the 12-week study period, except as specifically assigned to his or her study condition and distributed by the research team\n* Participant must agree to not use other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) during the 12-week study period\n* Participant must agree to not smoke or vape cannabis (i.e., marijuana) during the 12- week study period\n* Participant must agree to not use other illicit drugs, including prescription opioid medications, during the 12-week study period\n* Participant must be able to speak, read, and write English\n* Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months\n* Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening\n* Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening\n* Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening\n* Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening","80 Years",{"count":196,"type":19},75,[22],"This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.",[200,201],"Tobacco Use Disorder","Smoking Cessation",[203,204,205,206,207,208],"Native Hawaiian","Smoking cessation","Nicotine replacement therapy","Nicotine gum","Cigarette Smoking","Tobacco Dependence","2026-03-29",{"date":211,"type":40},"2026-03-31",{"date":182,"type":19},{"date":214,"type":19},"2028-04-01",{"name":46,"class":47},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":56,"sex":223,"minAge":16,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":20,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":74},"100590224","the-ku-ola-project-enhancing-health-promotion-among-native-hawaiian-men-100590224","NCT06964633","The Ku Ola Project: Enhancing Health Promotion Among Native Hawaiian Men.","The Ku Ola Project","* Inclusion Criteria Self-identified as male At least 18 years of age Hawaii residency Able to read and understand English\n* Exclusion Criteria Under 18 years of age Not proficient in English Any medical condition or situation that, in the investigator's judgment, would make continued participation not in the participant's best interest","MALE",{"count":225,"type":19},600,[22],"The Ku Ola Project: The goal of this study is to determine if community-based discussion groups and small educational sessions enhance health awareness and behaviors among Native Hawaiian men. The study will examine if these interventions improve participants' health knowledge, attitudes, and self-efficacy while fostering local networks to support ongoing health promotion. Participants will engage in group discussions and educational sessions designed to build capacity and encourage healthy lifestyle choices.",[229,230],"Health Promotion","Health",{"date":211,"type":40},{"date":233,"type":19},"2026-05-01",{"date":235,"type":19},"2028-05-31",{"name":46,"class":47},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":56,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":20,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":48},"100534360","ctnow-a-clinical-trials-education-program-for-rural-cancer-patients-and-oncology-providers-100534360","NCT06237816","CTNow: A Clinical Trials Education Program for Rural Cancer Patients and Oncology Providers","Inclusion Criteria:\n\n* Patients must have been diagnosed with any cancer.\n* Patients who have received treatment, are receiving cancer treatment at the time of enrollment, or estimated to start treatment within 90 days.\n* Patients must be ≥ 18 years of age. Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.\n\nPatients must be residents of Hawaii, Kauai, or Maui counties.\n\nExclusion Criteria:\n\n* Patients must not have previously participated in a cancer clinical trial. Those who have participated in a cancer clinical trial are not eligible for the study.",{"count":18,"type":19},[22],"The overall goal of the project is to pilot test CTNow, a multilevel intervention designed to facilitate access and referrals to cancer clinical trials in rural areas through patient and provider education and teleconference resources.",[247,248],"Cancer","Oncology",{"date":250,"type":40},"2026-04-03",{"date":252,"type":40},"2025-05-01",{"date":254,"type":19},"2026-12",{"name":46,"class":47},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":56,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":20,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":186},"100556557","ai-pono-cooking-demonstrations-100556557","NCT06526650","'Ai Pono Cooking Demonstrations","The PILI 'Āina Project","Inclusion Criteria:\n\n* Age 18+ (looking for older adults)\n* Native Hawaiian resident in a participating homestead\n* Overweight or obese (BMI ≥ 25 kg\u002Fm\\^2)\n* Prior diagnosis of type 2 diabetes or pre-diabetes, hypertension, and\u002For dyslipidemia (LDL cholesterol ≥ 130 mg\u002FdL)\n* Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week\n* Willing and able to participate in all aspects of the individual and household-level intervention\n* Fluent in written and spoken English\n\nExclusion Criteria:\n\n* No children\n* Pregnancy\n* Serious illness such as cancer or chronic pain that may contraindicate full participation",{"count":264,"type":19},1780,[22],"Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.",[268,269,270,271],"Type 2 Diabetes","Hypertension","Dyslipidemias","Overweight and Obesity","2026-03-02",{"date":274,"type":40},"2026-03-04",{"date":276,"type":40},"2025-02-12",{"date":278,"type":19},"2028-08",{"name":46,"class":47},{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":261,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":20,"phases":288,"briefSummary":266,"conditions":289,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":294,"locationsCount":186},"100556528","pili-ina-household-100556528","NCT06526273","PILI 'Āina Household","Inclusion Criteria:\n\n* Age 18+ (looking for older adults)\n* Native Hawaiian resident in a participating homestead\n* Overweight or obese (BMI ≥ 25 kg\u002Fm\\^2)\n* Prior diagnosis of T2D or pre-diabetes, hypertension, and\u002For dyslipidemia (LDL cholesterol ≥ 130 mg\u002FdL)\n* Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week\n* Willing and able to participate in all aspects of the individual and household-level intervention\n* Fluent in written and spoken English\n\nExclusion Criteria:\n\n* No children\n* Pregnancy\n* Serious illness such as cancer or chronic pain that may contraindicate full participation",{"count":287,"type":19},210,[22],[268,269,270,271],{"date":274,"type":40},{"date":276,"type":40},{"date":293,"type":19},"2029-02-26",{"name":46,"class":47},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":57,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":20,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":74},"100602194","mobile-health-dietary-intervention-for-stroke-survivors-with-prediabetes-or-type-2-diabetes-100602194","NCT07120334","Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes","mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D","Inclusion Criteria:\n\n* Aged 30 to 65 years\n* Recent stroke (ischemic, hemorrhagic or Transient Ischemic Attack), within 1-14 days prior to enrollment\n* Confirmed diagnosis of prediabetes or type 2 diabetes, based on HbA1c results\n* Medically stable and cleared for oral diet and physical activity by the attending physician\n* Cleared for thin liquids and regular textures by physician\n* Capable of providing informed consent\n* Able to speak and read English\n* Owns a smartphone OR is willing to use a study-provided iPhone\n* Has sufficient cognitive and physical function to use a mobile app\n* Willing to participate in all study procedures and available for the 12-week duration\n\nExclusion Criteria:\n\n* Severe dysphagia that prevents oral intake\n* Type 1 diabetes\n* Cognitive impairment (e.g., dementia, post-stroke confusion) that precludes consent or compliance, as judged by the clinical care team\n* Current participation in another interventional clinical trial\n* Pregnant or breastfeeding, or planning to become pregnant during the study period\n* Unwilling or unable to provide written informed consent\n* Serious comorbid conditions that, in the opinion of the","30 Years","65 Years",{"count":305,"type":19},40,[22],"Objectives: This study aims to test whether a mobile app called PortionSize Ed can help adults who have had a recent stroke and also have prediabetes or type 2 diabetes improve their diet. Specifically, we want to see if the app can help people follow a Mediterranean-style diet, which may lower the risk of future strokes and improve overall health.\n\nThe main goals are to:\n\n* Test if the app is easy to use and acceptable to participants.\n* See whether the app helps people follow a healthier diet.\n* Look at changes in health indicators like blood sugar, cholesterol, blood pressure, and body fat.\n\nDesign and Outcome:\n\nThis is a randomized controlled pilot study that will involve 40 participants. All participants will be recruited from Queen's Medical Center after a recent stroke and will be randomly assigned to one of two groups:\n\nIntervention Group: Uses the full PortionSize Ed app, gets weekly reminders and educational videos, and has 3 sessions with a registered dietitian (RDN) over 12 weeks.\n\nControl Group: Uses a basic version of the app without feedback or RDN support, and receives usual care for stroke recovery.\n\nAll participants will continue to receive standard care from Queen's, including the My Stroke Recovery Guide. The study lasts 12 weeks, with visits at the beginning and end to collect health data and feedback on the app.\n\nSchedule and Type of Evaluations\u002FInterventions:\n\nParticipants will complete the following:\n\nBaseline and Week 12 Visits: In-person assessments for blood sugar (HbA1c), cholesterol, blood pressure, height, weight, and body composition (using DXA, BIA, and 3D imaging), as well as surveys about their diet and activity levels.\n\nIntervention Group Only:\n\n* Three virtual counseling sessions with a registered dietitian (Week 1, 6, 12)\n* Weekly nutrition goal tracking and texting with the dietitian\n* Watching short educational videos through the app\n* Receiving app-based feedback on how well their diet follows Mediterranean Diet recommendations\n\nDuration of Study: The study will last 12 weeks for each participant, with an optional long-term follow-up using medical records.\n\nSample Size and Population: The study will include 40 adults, ages 30 to 65, who:\n\n* Recently experienced a stroke\n* Have a history of prediabetes or type 2 diabetes\n* Are medically stable and able to use a smartphone (or willing to use a study-provided iPhone)\n* People will be excluded if they have severe swallowing issues, cognitive problems, or dietary needs that would make it hard to follow a Mediterranean-style diet.",[309,268,310],"Stroke Recurrence","Prediabetes",[312,313,314,310,268,315,316,317,318],"PortionSize Ed","Stroke","Diabetes","T2D","Mediterranean Diet","mHealth","Hawaii","2026-01-20",{"date":321,"type":40},"2026-01-21",{"date":323,"type":19},"2026-02-01",{"date":325,"type":19},"2026-12-31",{"name":46,"class":47},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":56,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":20,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100591312","generative-artificial-intelligence-nurse-staffing-study-100591312","NCT06978790","Generative Artificial Intelligence Nurse Staffing Study","Generative Artificial Intelligence Nurse Staffing (GAINS) Study","GAINS","Inclusion Criteria:\n\n* Registered nurses, nursing assistants, or key stakeholders\n* Employed by The Queen's Medical Center\n* Working at least 24 hours per week\n* Position associated with medical-surgical units where float pool nurses work\n\nExclusion Criteria:\n\n* Employees working less than 24 hours per week at The Queen's Medical Center\n* Employees whose roles are not related to medical-surgical units",{"count":336,"type":19},660,[22],"This study is guided by Maslach's Burnout Theory and with Normalization Process Theory supporting the implementation of the GAINS intervention by facilitating its integration into routine system-level practice. In Year 1, the investigative team will collaborate with hospital-based nursing leadership and key stakeholders to identify staffing-specific factors essential for operationalizing the GAINS AI model\u002Fintervention. In Year 1, the investigators will also conduct a survey amongst nursing staff to measure baseline burnout. In Year 2, the AI-staffing intervention will be implemented with the medical-surgical nursing float pool team. In Year 3, the investigators will first repeat the nurse burnout survey and second, expand the intervention to include the nursing assistant float pool team. In Year 4, the investigators will conduct the final burnout survey with nurses, assess feasibility of GAINS (target vs. actual staffing- nurses and nursing assistants), and assess preliminary efficacy of GAINS to reduce costs related to staffing. the investigators will compare outcomes at three time points (pre, mid, and post-intervention). Interviews with nurses, nursing assistants, unit nurse managers, and leadership will further explicate the intervention's acceptability, feasibility, and impact on burnout.",[340],"Burnout, Healthcare Workers","2025-05-15",{"date":343,"type":40},"2025-05-18",{"date":182,"type":19},{"date":346,"type":19},"2029-03-31",{"name":46,"class":47},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":20,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":74},"100580922","barriersfacilitators-and-care-coordination-of-native-hawaiians--kidney-disease-100580922","NCT06843603","Barriers\u002FFacilitators and Care Coordination of Native Hawaiians & Kidney Disease","AIM 1 and AIM 2: Inclusion Criteria: Native Hawaiian (NH) participants from the NKFH KEDS program are:\n\n* greater or equal to 18 years\n* self-reported as Native Hawaiian\n* eGFR less than 60 ml\u002Fmin\u002F1.73m2 (Stage 3a-3b CKD) and\u002For greater or equal to 30 mg\u002Fg UACR\n* have participated in the NKFH KEDS Program within 3 months\n* able to read, write, and speak English.\n\nAIM 1 and AIM 2: Inclusion Criteria: NKFH and PCP staff are :\n\n* able to read, write, and speak English,\n* greater or equal to 18 years.\n\nExclusion Criteria: None",{"count":60,"type":19},[22],"Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant compared to Whites. They have the highest end-stage kidney disease (ESKD) incidence rates in the nation, begin dialysis at younger ages (30-50 years), and one of the most under-studied racial\u002Fethnic groups in chronic kidney disease (CKD) research. This project's outcome is to improve kidney disease follow-up among early stage NHs at high risk by aligning health equity with a culturally appropriate care coordination systems model.",[358],"Kidney Disease, Chronic",[360],"kidney disease, chronic","2025-02-18",{"date":363,"type":40},"2025-02-25",{"date":365,"type":19},"2025-09-01",{"date":367,"type":19},"2027-08-31",{"name":46,"class":47},{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":56,"sex":57,"minAge":16,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":20,"phases":378,"briefSummary":266,"conditions":379,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":186},"100561475","household-participants-100561475","NCT06590649","Household Participants","PILI 'Āina 2 Household Participants","Inclusion Criteria:\n\n* Current resident of the household in which an index participant lives\n* Willing to complete data collection protocols\n* Fluent in written and spoken English\n\nExclusion Criteria:\n\n\\-",{"count":377,"type":19},168,[22],[268,269,270,271],"2024-09-09",{"date":382,"type":40},"2024-09-19",{"date":384,"type":19},"2024-10",{"date":386,"type":19},"2027-11",{"name":46,"class":47},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":56,"sex":57,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":20,"phases":400,"briefSummary":401,"conditions":402,"keywords":405,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":48},"100480332","natives-engaged-in-alzheimers-research---ike-kupuna-100480332","NCT05534607","Natives Engaged in Alzheimers Research - 'Ike Kupuna","Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project","NEAR","Inclusion Criteria:\n\n1. self-reported Native Hawaiian or other Pacific Islander ancestry;\n2. ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);\n3. has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);\n4. have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg\u002Fm2);\n5. physically able and willing to engage in moderate physical activity necessary for Hula; and\n6. physician's approval to participate in moderate physical activity\n\nExclusion Criteria:\n\n1. currently pregnant;\n2. already actively practicing Hula at least once per week; or\n3. clinical diagnosis of ADRD (mild to severe); or\n4. current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).","50 Years","75 Years",{"count":399,"type":19},192,[22],"This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.",[403,404],"Mild Cognitive Impairment","Subjective Cognitive Impairment",[406,407,408,409,410,411,412,413,414,415,416],"MCI","Alzheimer's disease","Alzheimer's disease and related dementias","Vascular dementia","ADRD","SCI","Native Hawaiian and Pacific Islander","NHPI","Hula","cultural based intervention","behavioral intervention","2024-07-30",{"date":419,"type":40},"2024-08-01",{"date":421,"type":40},"2022-09-15",{"date":423,"type":19},"2027-04-30",{"name":46,"class":47},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":15,"minAge":128,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":433,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":48},"100467651","lesion-composition-and-quantitative-imaging-analysis-on-breast-cancer-diagnosis-100467651","NCT05369546","Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis","Inclusion Criteria:\n\n* Had a recent diagnostic mammogram with a BI-RADS diagnostic score 4 or 5 assigned by a radiologist (BIRADS are standardized mammography assessment categories: 4 is for \"Suspicious abnormality\", 5 is for \"Highly suggestive of malignancy\".\n* Have not had biopsy\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).","85 Years",{"count":225,"type":19},"OBSERVATIONAL","The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.",[436],"Breast Cancer","2023-01-31",{"date":439,"type":40},"2023-02-02",{"date":441,"type":40},"2022-08-01",{"date":443,"type":19},"2026-07",{"name":46,"class":47},""]