[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"informed-consent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:informed-consent":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,92,126,156,180,207,235,262],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100645186","consent-understanding-and-propofol-requirement-during-endobronchial-ultrasound-100645186",false,"NCT07677982","Consent Understanding and Propofol Requirement During Endobronchial Ultrasound","Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective endobronchial ultrasound\n* ASA physical status I to III\n* Ability to read and understand Turkish\n* Provision of written informed consent for study participation\n\nExclusion Criteria:\n\n* Active psychiatric disease that may affect the informed consent process, anxiety assessment, or communication\n* Cognitive impairment, including dementia or delirium\n* Contraindication or known allergy to propofol, midazolam, or remifentanil\n* Emergency EBUS procedure\n* Regular anxiolytic or sedative drug use within the last month\n* Illiteracy\n* Turkish language barrier\n* Advanced organ failure or decompensated systemic disease that may significantly affect sedative drug response, hemodynamic stability, communication, or consent assessment","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether a participant's understanding of the informed consent information is related to the amount of propofol needed during endobronchial ultrasound (EBUS). EBUS is a procedure that uses a thin camera and ultrasound to look at lymph nodes and other areas inside the chest. Propofol is a sedative medicine used to help participants stay comfortable during the procedure.\n\nBefore EBUS, all participants will receive the usual information about the procedure as part of routine care. After this routine consent process, participants will answer short questions about what they understood. They will also answer questions about their anxiety before the procedure. The study will not change the usual consent process, sedation plan, or medical care.\n\nDuring EBUS, participants will receive usual sedation and monitoring according to routine clinical practice. The research team will record how much sedative medicine is used, whether extra sedation is needed, whether any important clinical events occur, and how participants recover after sedation. The main question is whether participants who understand the consent information better need less propofol during EBUS.",[24,25,26],"ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION","Procedural Sedation and Analgesia","Informed Consent",[28,29,30,31,32,33],"EBUS-TBNA","Informed consent understanding","Procedural sedation","Preoperative anxiety","Sedative requirement","Propofol consumption","NOT_YET_RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":37,"type":20},{"date":41,"type":20},"2027-07-01",{"name":43,"class":44},"Uludag University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":72,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100635793","supporting-just-in-time-consent-for-prenatal-screening-the-inform-study-100635793","NCT07557303","Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study","Inclusion Criteria:\n\n* Currently pregnant and receiving care at a participating collaborative site - University of North Carolina, Chapel Hill; Zuckerberg Chan San Francisco General Hospital; University of Florida Health, Jacksonville.\n* 18 years of age and older\n* Able to read, speak, and understand English or Spanish\n* Has not previously been offered prenatal genetic screening for the current pregnancy\n* 24 weeks (6 months) gestational age or less\n\nExclusion Criteria:\n\n* Not pregnant, not a patient at a partner clinical site\n* Younger than 18 years of age\n* Not being able to read, speak, and understand English or Spanish\n* Has previously been offered prenatal genetic screening for the current pregnancy\n* Greater than 24 weeks gestational age (6 months)",true,"FEMALE",{"count":55,"type":20},1400,"INTERVENTIONAL",[58],"NA","This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor.\n\nThe study has one main question:\n\n* Do participants who use the intervention feel more confident when they make a decision about screening?\n\nResearchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor.\n\nWhat will participants do?\n\n* Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening.\n* Some participants will use the intervention before their first doctor's visit. Other participants will not use it.\n* All participants will talk with a researcher on the phone after their first doctor's visit.\n* Participants who use the intervention will answer a short survey on their phone.\n* A few participants who use the intervention will talk with a researcher a second time on the phone.",[61,62,63,64,65,26,66,67,68,69,70,71],"Delivery of Health Care","Genetic Testing","Humans","Pregnancy","Noninvasive Prenatal Testing","Internet-Based Intervention","Self Efficacy","Pregnant People","Decision Making","Health Education","Patient Education as Topic\u002FMethod",[73,74,75,76,77,78,79,80,81,82,83],"Non-invasive prenatal screening (NIPS)","Non-Invasive Prenatal Testing (NIPT)","Cell-free DNA (cfDNA)","Prenatal genetic screening","Informed consent","Decision making","Surveys and Questionnaires","Informed choice","Educational intervention","Decision Regret","Decision Satisfaction",{"date":37,"type":38},{"date":86,"type":20},"2026-08-01",{"date":88,"type":20},"2028-06-30",{"name":90,"class":44},"Case Western Reserve University",3,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":56,"phases":102,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100642020","qr-code-based-video-supported-anesthesia-information-and-preoperative-anxiety-100642020","NCT07647588","QR Code-Based Video-Supported Anesthesia Information and Preoperative Anxiety","The Effect of QR Code-Based Video-Supported Anesthesia Information on Preoperative Anxiety, Comprehensibility of Information, and Patient Satisfaction: A Prospective Randomized Controlled Study","QR-AID","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective surgery\n* Evaluated in the anesthesia outpatient clinic\n* Able to understand the study information and questionnaires\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Impaired consciousness\n* Advanced dementia\n* Severe psychiatric illness\n* Severe visual, hearing, or cognitive impairment\n* Inability to understand the digital educational content\n* Refusal to participate\n* Inability to read or understand Turkish",{"count":101,"type":20},284,[58],"This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery.\n\nParticipants will be randomly assigned in a 1:1 ratio to either a control group receiving standard written informed consent and routine verbal anesthesia information or an intervention group receiving the same standard information plus a standardized video-based educational intervention accessed through a QR code.\n\nThe primary outcome is the change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score before and after the information process. Secondary outcomes include comprehensibility of information and patient satisfaction assessed using a structured Likert-type questionnaire.\n\nThe findings may contribute to the standardization of patient information processes in anesthesia outpatient clinics through a low-cost and easily implementable digital educational approach.",[105,106,26,107],"Preoperative Anxiety","Anesthesia","Patient Education",[109,110,111,112,113,114,26,115,116,105],"QR Code","Video-Supported Education","Amsterdam Preoperative Anxiety and Information Scale","APAIS","Anesthesia Information","Patient Satisfaction","Randomized Controlled Trial","Digital Health","2026-06-13",{"date":119,"type":38},"2026-06-16",{"date":121,"type":20},"2026-06-10",{"date":123,"type":20},"2026-07-10",{"name":125,"class":44},"Elazıg Fethi Sekin Sehir Hastanesi",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100616277","ai-driven-consent-simplification-study-100616277","NCT07303517","AI-Driven Consent Simplification Study","ACCESS: AI-Driven Consent Simplification Study","ACCESS","Inclusion Criteria:\n\nGroup 1:\n\n* Age 60 years and above\n* UCLA patient\n* English speaking\n* Ability to provide informed consent\n\nGroup 2:\n\n* UCLA investigators who are health providers that perform clinical trials\n* Must be clinical research investigatory and staff actively involved in research operations at UCLA\n* English speaking\n\nGroup 3:\n\n* Individuals involved in IRB activities (chairs, committee members, staff)\n* Must be a director or staff at UCLA\n* English speaking\n\nExclusion Criteria:\n\n* Group 1: None\n* Group 2: PI and co-PIs of the study \"Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)\"\n* Group 3: Individuals from the IRB who have reviewed the study submission for \"Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)\"",{"count":135,"type":20},230,"The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses.\n\nSimplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks.",[26,138,139,140],"Comprehension","Communication","Disclosure",[142,143,144,145],"Informed Consent Readability","Plain language","Simplified consent forms","Research ethics","RECRUITING","2026-05-04",{"date":149,"type":38},"2026-05-08",{"date":151,"type":38},"2026-01-08",{"date":153,"type":20},"2026-12-01",{"name":155,"class":44},"University of California, Los Angeles",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":56,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":45},"100601992","optimizing-timing-of-cesarean-delivery-consent-on-labor-and-delivery-100601992","NCT07117708","Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery","The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery","Inclusion Criteria:\n\n* 18 years of age or older\n* Receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates\n* Between 34 weeks 0 days and 41 weeks 0 days of gestation\n* Scheduled for induction of labor OR are eligible\u002Fintend to be scheduled for an induction of labor\n\nExclusion Criteria:\n\n* Trial of labor after cesarean delivery\n* Multiple gestation\n* Major fetal anomalies\n* Presenting for induction of labor as a transfer from the antepartum inpatient service\n* Non-English speaking\n* Those who do not intend to labor\n* Patients who are ineligible for vaginal delivery for other reasons, including fetal malpresentation or abnormal placentation",{"count":164,"type":20},200,[58],"Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated.\n\nThis study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.",[64,26],[169,170],"pregnancy","informed consent","2026-04-22",{"date":173,"type":38},"2026-04-23",{"date":175,"type":38},"2025-08-27",{"date":177,"type":20},"2027-05",{"name":179,"class":44},"Duke University",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":45},"100584796","patient-preferences-on-same-day-bilateral-intravitreal-dexamethasone-injections-100584796","NCT06894017","Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections","Inclusion criteria\n\n* Having received at least one intravitreal dexamethasone implant in either eye\n* \\>18 years of age\n* Capacity to comprehend and answer questions in Danish language\n* Signed informed consent\n\nExclusion criteria\n\n• No intravitreal dexamethasone implant received within the last 12 months",{"count":164,"type":20},"Intravitreal injections with dexamethasone implant (Ozurdex®) provide a reasonable and long-lasting treatment option in the cases of diabetic macular edema, as well as macular edema resulting from retinal vein occlusion and noninfectious posterior uveitis. During the course of these diseases, both eyes may be affected and may need therapy. The treatment burden associated with frequent medical visits associated with treatments in both eyes and follow-ups can be significant for patients and caregivers alike. Same-session bilateral ophthalmic procedures have proven safe and cost-effective, with patients consistently expressing a strong preference for this approach, particularly in the cases of cataract surgery and anti-VEGF injections when given the choice. The safety profile of same-day bilateral dexamethasone injections aligns with those of unilateral injections.\n\nThis patient preference study will focus on addressing the practical aspects of same-day bilateral dexamethasone injections from the patients' perspective and aims to explore the impact of personal and socio-economic variables, and the overall perspective of patients on choosing same-day bilateral dexamethasone injections. Understanding and mitigating the challenges patients face can lead to a more patient-friendly and resource-saving approach. Based on the outcomes of this study, considerations may be made to introduce bilateral injections at our department, potentially optimizing patient experience and clinical resources.\n\nThe aim of the study is to establish patient preferences regarding the administration of intravitreal dexamethasone implant injections in both eyes on the same day, in the same session and to identify key motivating and limiting factors from the patients' perspective.",[26,189],"Preference, Patient",[191,192,193,194,195,196,197],"Intravitreal","dexamethasone","injections","implant","questionnaire","patient preference","bilateral","2025-07-22",{"date":200,"type":38},"2025-07-24",{"date":202,"type":38},"2025-01-13",{"date":204,"type":20},"2026-01",{"name":206,"class":44},"Rigshospitalet, Denmark",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":56,"phases":217,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100530878","implementing-a-novel-consent-process-for-biospecimen-research-after-newborn-screening-100530878","NCT06192511","Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening","Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients","MICI","Inclusion Criteria:\n\n* Adult (\\> 18 years)\n* English, Spanish or Arabic speaking\n* Just gave birth and currently a patient in the Mother \\& Baby Unit in the hospital\n\nExclusion Criteria:\n\n* Parents of infants who are born pre-term (\\\u003C 37 weeks gestation)\n* Parents of infants in the Neonatal Intensive Care Unit\n* Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth",{"count":216,"type":20},5980,[58],"The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.",[220,26,221],"Implementation Science","Neonatal Screening",[223,170,224],"newborn screening","biobanking","2025-06-16",{"date":227,"type":38},"2025-06-19",{"date":229,"type":38},"2024-05-15",{"date":231,"type":20},"2028-04-30",{"name":233,"class":44},"Erin Rothwell",2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":56,"phases":245,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100580613","effectiveness-of-immersive-virtual-reality-in-nursing-students-learning-100580613","NCT06839573","Effectiveness of Immersive Virtual Reality in Nursing Students' Learning","Effectiveness of Immersive Virtual Reality to Improve Learning Outcomes in Nursing Degree Students: A Randomized Clinical Trial","UBUJIRV25","Inclusion Criteria:\n\n\\- having completed the scheduled in-person simulation in previous years of the degree .\n\nExclusion Criteria:\n\n-the student does not sign the informed consent to participate in the study.",{"count":244,"type":20},140,[58],"Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.",[26],[249,250,251,252],"Virtual reality","nursing students","Learning Outcomes","Inmersive virtual reality","2025-02-19",{"date":255,"type":38},"2025-02-21",{"date":257,"type":20},"2025-03-05",{"date":259,"type":20},"2025-05-08",{"name":261,"class":44},"Universitat Jaume I",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100497059","analysis-of-the-persistence-reservoir-and-hiv-latency-100497059","NCT05752318","Analysis of the Persistence, Reservoir and HIV Latency","APRIL Study: Analysis of the Persistence, Reservoir and HIV Latency","APRIL","Inclusion Criteria:\n\n* HIV-infection\n* Adults (\\>18 years)\n* Social insurance\n* Informed consent\n\nExclusion Criteria:\n\n* HIV-uninfected\n* \\\u003C18 years\n* Lack of social insurance\n* Lack or withdraw of consent",{"count":271,"type":20},500,"The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.",[274,26],"HIV Infected Individuals",[276,277,278,279],"HIV","Reservoir","Latency","Persistence","2023-02-28",{"date":282,"type":38},"2023-03-02",{"date":284,"type":20},"2023-02-27",{"date":286,"type":20},"2027-02-25",{"name":288,"class":44},"University Hospital, Strasbourg, France"]