[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Minnesota\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":623},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,189,0,25,[9,40,72,102,120,140,173,198,231,256,279,307,327,350,369,393,412,436,456,482,500,522,540,574,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100563688","assessment-of-usability-and-satisfaction-with-a-take-home-device-presenting-sound-and-body-stimulation-for-back-pain-100563688",false,"NCT06619418","Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain","Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Must be within commuting distance to the University of Minnesota\n* Able to provide consent and follow study instructions\n* Must be able to understand English\n* Must have chronic LBP, which is defined as lower back pain for more than 3 months\n* A score of 4 or higher on the PEG\n* Must be willing to commit to full duration of the study\n* Not currently taking any benzodiazepines or sedative hypnotics\n\nExclusion Criteria:\n\n* Back Pain associated with:\n* Spondylolisthesis or spinal stenosis\n* Sciatica or radiculopathy\n* Rhematologic or inflammatory disease\n* Trauma, fracture, dislocation, or previous back surgery\n* A score of 10 on the PEG\n* Pregnant\n* Have an electrically implanted device, such as a pacemaker.\n* Heart Disease\n* Epilepsy\n* Cancer\n* Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder\n* A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.\n* Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.\n\nThis pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.",[26],"Chronic Lower Back Pain","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":31},"2024-11-18",{"date":35,"type":20},"2027-08-11",{"name":37,"class":38},"University of Minnesota","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":39},"100652655","monitoring-for-cardiotoxicity-using-wearable-devices-while-undergoing-cancer-treatments-mct-wave-100652655","NCT07776964","Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)","Inclusion Criteria:\n\n* Diagnosis of breast cancer, hematologic malignancy including leukemia or lymphoma, or multiple myeloma\n* At least 18 years of age\n* Capable of understanding and willing to sign a consent form for this study\n\nExclusion Criteria:\n\n* Known allergy to adhesive patches used for ambulatory EKG monitoring\n* Children\n* Cognitively challenged individuals\n* Prisoners\n* Active service military personnel",{"count":47,"type":20},72,[23],"This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.\n\nParticipants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers.\n\nParticipants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.",[51,52,53,54,55,56],"Cardiotoxicity","Cancer","Cardiac Arrhythmia","Left Ventricular Dysfunction","Breast Cancer","Multiple Myeloma",[58,59,60,61,62,63],"MCT-WAVE","Mobile cardiac telemetry","Wearable cardiac monitor","Cardio-oncology","Ventricular arrhythmia","Breast cancer","NOT_YET_RECRUITING","2026-08-17",{"date":30,"type":31},{"date":68,"type":20},"2026-09-01",{"date":70,"type":20},"2028-09-01",{"name":37,"class":38},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100652153","pace-cognition-proof-of-concept-study-100652153","NCT07769424","PACE Cognition Proof-of-Concept Study","Impact of Physiologic Pacemaker Programming on Cognitive Function and Health Status in Patients With Symptomatic Bradycardia","Inclusion Criteria:\n\n\\- Patient requiring a pacemaker for bradycardia\n\nExclusion Criteria:\n\n* Vulnerable adult unable to give consent\n* Unable to answer questionnaire\n* Children\n* Pregnant women\u002Fpersons\n* Prisoners\n* Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent\n* Non-English speakers\n* Individuals unable to read\n* Employees or students of the researcher\n* Active members of the military or DoD personnel",{"count":80,"type":20},110,[23],"This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.\n\nParticipants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit.\n\nThe primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.",[84,85,86,87],"Symptomatic Bradycardia","Cognitive Function","Pacemaker","Health Status",[89,90,91,92,93],"PACE Cognition","Symptomatic bradycardia","Physiologic pacing","Pacemaker programming","myPACE algorithm",{"date":95,"type":31},"2026-08-19",{"date":97,"type":20},"2026-10-01",{"date":99,"type":20},"2028-10-01",{"name":37,"class":38},2,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":39},"100637024","validation-and-feasibility-of-noninvasive-oxygen-delivery-index-monitoring-in-cardiac-surgery-patients-100637024","NCT07573306","Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients","Inclusion Criteria:\n\n* Adults ≥ 18 years undergoing cardiac surgery\n* Placement of pulmonary artery catheter with continuous cardiac output (CCO) as part of routine clinical care\n* Placement of arterial line with FloTrac as part of routine clinical care\n* Availability of ≥ 3 arterial blood gas samples at specified timepoints\n\nExclusion Criteria:\n\n* Mechanical circulatory support planned or in use (IABP, Impella, ECMO)\n* Patients without BOTH pulmonary artery catheter with CCO and arterial line with FloTrac\n* Patients who are Research Opt-Out",{"count":109,"type":20},150,"OBSERVATIONAL","This study will establish the feasibility and preliminary validity of real-time oxygen delivery index (DO₂i) monitoring using noninvasive hemoglobin (SpHb, Masimo) and minimally invasive cardiac output (FloTrac, Edwards) in cardiac surgery patients.",[113],"Cardiac Surgery",{"date":28,"type":31},{"date":116,"type":20},"2026-10-15",{"date":118,"type":20},"2027-08-01",{"name":37,"class":38},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100526869","happiness-changing-the-perceived-pain-intensity-in-populations-with-spinal-cord-injury-and-with-health-disparities-a-feasibility-study-100526869","NCT06140355","cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury","HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study","Inclusion Criteria:\n\n* 18+ years old\n* medically stable\n* with neuropathic pain 4 or above on the numeric pain rating scale + screened with painDETECT\n* willing to participate in a remote Qigong intervention (from any location with internet connection)\n* fluent in English or Spanish\n* access to the internet and a computer\u002FiPad or smartphone\n\nExclusion Criteria:\n\n* uncontrolled seizure disorder\n* cognitive impairment and\u002For communicative disability (e.g., due to brain injury) preventing them from following directions or from learning\n* ventilator dependency\n* major medical complications\n* pressure ulcers hindering prolonged sitting or lying down\n* (planning to become) pregnant or planning a major surgery during the study (given study duration, regular Qigong practice, and frequent check-ins)\n* regular Tai Chi or Qigong practice in the past 6 months (3x\u002Fweek or more)\n* currently engaged in other rehabilitation programs that would influence outcomes",{"count":128,"type":20},40,[23],"Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain, but there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established.\n\nTo support our feasibility study, we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong 138% of the required intensity (which was, at least 3x\u002Fweek with Qigong video through the internet). Their pain was reduced by 44% after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up. However, three key elements need to be addressed before performing a larger effectiveness study: (1) feasibility\u002Facceptability of Qigong from adults with SCI of diverse backgrounds; (2) feasibility of the study design with control group); and (3) objective outcome measures.\n\nThis R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous protocol. We will address the following aims: AIM 1. Identify the facilitators\u002Fbarriers to participating in a Qigong study through focus groups\u002Finterviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM 2. Establish the feasibility of study design\u002Fmethods of the HAPPINESS trial in adults with SCI (at least 50% of diverse backgrounds) through pre-specified targets for recruitment\u002Fenrollment, feasibility, and acceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phone\u002FiPad\u002Fcomputer + 6-month follow-up. The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronic\u002Fneurological disorders.",[132],"Spinal Cord Injuries",{"date":95,"type":31},{"date":135,"type":31},"2024-08-20",{"date":137,"type":20},"2027-01-31",{"name":37,"class":38},3,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":156,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":39},"100652450","a-mobile-informatics-solution-to-assist-caregivers-in-care-coordination-and-monitoring-social-engagement-100652450","NCT07773493","A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement","Inclusion Criteria:\n\n* Persons with memory concerns must be English speaking.\n* Persons with memory concerns must self-report a healthcare provider visit due to memory concerns or memory related diagnosis by a physician or other qualified health care provider consistent with having mild-to-moderate memory impairment.\n* Persons with memory concerns must be over the age of 65.\n* Persons with memory concerns must be able to formally consent or assent to participate in the study.\n* Persons with memory concerns must have internet access.\n* Care partners of persons with memory concerns must speak English.\n* Care partners must be 18 years of age and over.\n* Care partners must self-identify as the primary caregiver for the person with memory concerns.\n* Care partners must indicate a willingness to use the Social Reminder System as well as to being randomized to a control group.\n* Care partners must have a mobile phone with internet access in order to install and use the care partner app.\n\nExclusion Criteria:\n\n* Those who do not meet the criteria above will be excluded.\n* Persons with memory concerns with severe or no dementia are not eligible.\n* Individuals who score below 6 and above 24 on the TICS-40 will not be eligible.",{"count":147,"type":20},200,[23],"This study will evaluate the Social Reminder System, a mobile informatics system designed to support persons with memory concerns and their care partners. The system is intended to aid social integration for persons with memory concerns and improve care coordination and reduce caregiver burden among caregivers.\n\nResearchers will enroll 100 persons with memory concerns and their care partners. Half of the dyads will be randomly assigned to receive the Social Reminder System technology for a 6-month period, and the other half will be randomly assigned to the usual care control group. Participants will complete baseline, 3-month, and 6-month surveys. A subset of participants who receive the technology will also be asked to complete a semi-structured interview after the 6-month survey.",[151,152,153,154,155],"Memory Disorders","Mild Cognitive Impairment","Dementia","Social Isolation","Caregiver Burden",[157,158,159,160,161,162,163,164,165],"Social Reminder System","SRS","Persons with memory concerns","Social engagement","Mobile health","Care coordination","Alzheimer's disease and related dementias","Mild-to-moderate memory impairment","Caregiver stress","2026-08-14",{"date":95,"type":31},{"date":169,"type":20},"2026-11-01",{"date":171,"type":20},"2028-06",{"name":37,"class":38},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":180,"sex":16,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":39},"100603277","vaped-phenanthrene-100603277","NCT07134426","Vaped Phenanthrene","Investigating Vaped Phenanthrene Biomarkers in Former Smokers","Inclusion Criteria:\n\n* \\> 21 years of age\n* In good physical \\& mental health\n* In stable physical \\& mental health\n* Have tried vaping\n* Former daily cigarette smokers who quit 1-20 year ago\n* Non-smokers who have not used tobacco or nicotine products\n\nExclusion Criteria:\n\n* Has any respiratory disease (ex - asthma, COPD, etc...)\n* Has\u002Fhad high blood pressure\n* Has\u002Fhad liver disease\n* Has\u002Fhad cancer\n* Has experience negative effects when vaped previously\n* Pregnant or nursing",true,"21 Years",{"count":183,"type":20},100,[23],"Some people who used to smoke cigarettes continue to be at higher risk of developing lung cancer, even years after quitting. This study will look to see if a specific chemical, phenanthrene, is broken down in the lungs of former smokers through more harmful pathways than never-smokers. If former smokers break down chemicals that enter their lungs through more harmful pathways this might be putting them at higher risk for developing lung cancer even though they quit smoking. This information may help find better ways to prevent or treat cancer in the future.\n\nThis study is under an IND, but the drug is not being studied; instead, it is being used as a marker for drug metabolism.",[187,188],"Former Smoker","Non-Smoker",[190,191,192,187,188],"Smoking","Tobacco","Vaping",{"date":65,"type":31},{"date":68,"type":20},{"date":196,"type":20},"2028-06-30",{"name":37,"class":38},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":39},"100652469","phase-3-evaluation-of-a-disability-focused-sexual-and-reproductive-health-curriculum-for-health-students-in-tanzania-100652469","NCT07772778","Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania","Tanzabilities Aim 3: Randomized Controlled Trial of a Sexual and Reproductive Health Curriculum for Persons With Disabilities","Inclusion Criteria:\n\n* Current student at Muhimbili University of Health and Allied Sciences in midwifery, nursing, or medicine\n* Able to attend the full 3-day training\n* Fluent in English and Kiswahili\n* Willing to complete all evaluation procedures\n\nExclusion Criteria:\n\n* Unable to attend all days of the seminar at Muhimbili University of Health and Allied Sciences\n* Expresses reservations about attending, including religious objections\n* Expresses fear of violence due to attending, including fear of violence from a spouse or relative\n* Prior exposure to the Training Health Professionals curriculum or either of the Tanzabilities pilots\n* Younger than 18 years of age\n* Unable to provide consent\n* Non-English speaker\n* Unable to read\n* Employee of the researcher\n* Prisoner",{"count":206,"type":20},412,[208],"PHASE3","This randomized controlled trial will evaluate the efficacy of a three-day sexual and reproductive health curriculum focused on persons with disabilities and tailored to the Tanzanian context.\n\nThe intervention will be delivered to medical, nursing, and midwifery students at Muhimbili University of Health and Allied Sciences in Dar es Salaam, Tanzania. Participants will be randomized to either receive the curriculum during the initial intervention period or to a waitlist control group that will receive the curriculum approximately 12 months later.\n\nParticipants will complete surveys at baseline and at 3-month follow-up to assess changes in knowledge, attitudes, skills, comfort, and advocacy related to sexual and reproductive health care for persons with disabilities. Participants in the intervention group will also complete an immediate post-intervention survey after the three-day curriculum.",[211,212,213,214],"Sexual and Reproductive Health","Disability","Health Knowledge, Attitudes, Practice","Health Education",[216,217,218,219,220,221,222,223],"Tanzabilities","Sexual and reproductive health","Persons with disabilities","Disability-inclusive care","Health professional students","Medical students","Dar es Salaam","Healthcare provider training","2026-08-13",{"date":95,"type":31},{"date":227,"type":20},"2026-09-03",{"date":229,"type":20},"2027-09-30",{"name":37,"class":38},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":139},"100652288","evaluating-the-effects-of-reproductive-health-training-on-provider-behavior---aim-3-100652288","NCT07770438","Evaluating the Effects of Reproductive Health Training on Provider Behavior - Aim 3","THP-2 Aim 3","Inclusion Criteria:\n\n* Current pre-final year student at the State University of Zanzibar, Kilimanjaro Christian University, or the University of Dodoma in midwifery, nursing, or medicine\n* Able to attend the full 4-day training\n* Fluent in English and Kiswahili\n* Willing to volunteer to complete all evaluation procedures\n\nExclusion Criteria:\n\n* Unable to attend all days of the seminar at SUZA, KCMC, or UDOM\n* Unable to be on the SUZA, KCMC, or UDOM campus for the follow-up dates\n* Expresses reservations about attending, including religious objections\n* Expresses fear of violence due to attending, including fear from a spouse or relative\n* Prior exposure to the Training for Health Professionals curriculum or either of the previous pilots\n* Younger than 18 years of age\n* Non-English speaker\n* Unable to read\n* Employee of the researcher\n* Prisoner\n* Adult lacking capacity to consent or with diminished capacity to consent\n* Active member of the military or DoD personnel",{"count":239,"type":20},650,[23],"This study will evaluate the real-world effectiveness of a four-day Afrocentric sexual and reproductive health curriculum for health professional students in Tanzania.\n\nMedical, nursing, and midwifery students from the State University of Zanzibar, Kilimanjaro Christian University, and the University of Dodoma will receive the curriculum. The curriculum covers sexual health across the lifespan, sexual dysfunctions, key populations, sexual violence, clinical skills training, ethics, policy writing, community resources, and cultural considerations.\n\nStudent outcomes will be assessed using surveys at baseline, immediately after the curriculum, and at 3-month and 12-month follow-up to examine changes in sexual health knowledge, attitudes, and sexual history and counseling skills.",[211,213,243,214,244],"Provider Behavior","Sexual Health",[246,217,247,221,248,249],"THP-2","Training for Health Professionals","Afrocentric curriculum","Sexual health curriculum","2026-08-12",{"date":28,"type":31},{"date":65,"type":20},{"date":254,"type":20},"2027-08-17",{"name":37,"class":38},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":39},"100563540","endogenous-pain-inhibition-deficiency-in-chronic-tmd-pain-100563540","NCT06617494","Endogenous Pain Inhibition Deficiency in Chronic TMD Pain","The Role of Endogenous Pain Inhibition Deficiency in Chronic TMD Pain Pathophysiology","TMD-CPM","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Provide informed consent, documented in a signed and dated form.\n2. Will comply with all study procedures, including daily ratings filling before and after the in-person study visit, and be available for the study duration.\n3. All participants of both genders between ages 18 to 74 years.\n4. Cases and controls will be matched for age within ±5 years, and all participants must understand English commands to follow study procedures (e.g., during CPM testing).\n\nPain-free controls:\n\n1. Age matching (within ±5 years)\n2. No previous diagnosis for the most common pain-related TMD as defined in the DC\u002FTMD criteria (myalgia, arthralgia, headache attributed to TMD)\n3. No significant orofacial pain (jaw pain, TMJ pain) in the past 3 months (\"\"significant\"\" meaning 5 or more days in any month or any pain during the past month)\n4. No report of significant pain in the last 3 months elsewhere in the body (\"\"significant\"\" meaning 5 or more days in any month or any pain during the past month), e.g., low back pain, fibromyalgia, migraine headaches\n5. Not meeting any of the most common pain-related TMD diagnoses as described in the DC\u002FTMD criteria (myalgia, arthralgia, headache attributed to TMD) upon clinical exam following the DC\u002FTMD protocol\n\nChronic painful TMD cases:\n\n1. Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical exam following the DC\u002FTMD protocol\n2. Concurrent arthralgia (TMJ pain) and\u002For headache attributed to TMD allowed\n3. Myofascial pain must meet the following criteria:\n\n   1. Onset \\>3 months, occurring \\>15 days\u002Fmonth on average for \\>3 months\n   2. Minimum of 10 jaw pain episodes since onset, each lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting.\"\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Traumatic facial injury or surgery on the face\u002Fjaw, arms, or hands\n2. Presence of pain related to dental and periodontal pathology\n3. Pregnant\n4. Has any of the following medical conditions by self-report:\n\n   1. Renal failure or dialysis\n   2. Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure\n   3. Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)\n   4. Diabetes (type I or II) that is not controlled with medication or diet\n   5. Hyperthyroidism\n   6. Uncontrolled seizures\n5. Used any injection therapy (e.g., tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for managing facial\u002Fjaw pain within 2 weeks before the screening assessment.\n6. If undergoing botulinum toxin injections in the head and neck area, must be 3 months since the last set of injections, and refrain from this treatment until study participation has ended\n7. History of major depression or other major psychiatric disorder requiring inpatient hospitalization within the last 6 months before the screening assessment\n8. History of treatment for drug or alcohol abuse within the last 12 months\n9. Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped \\\u003C24 hours before each study visit\n10. Other conditions\u002Fdiseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia\n11. Adults lacking the capacity to provide informed consent for themselves\n12. Unable to understand instructions for sensory testing in English.\n13. Thermal threshold for Pain-50 (pre-determined at the beginning of visit 1) is outside the temperature range of 40ºC to 49ºC\n14. Inability to complete at least four daily ratings between the Informed consent, Pre-visit 1 procedures, and in-person visit 1\n15. Lack of access to electronic devices with internet connection during the study participation\n16. Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study. \"","74 Years",{"count":128,"type":20},"Temporomandibular disorders (TMDs) involve a range of conditions with varied causes, affecting a large portion of the U.S. population and posing challenges for diagnosis and management, especially in chronic cases. Despite advances in understanding TMD pathophysiology, the role of central sensitization, particularly deficient endogenous pain inhibition, remains unclear. The conditioned pain modulation (CPM) test, used to assess pain inhibition in chronic TMD pain, has produced inconsistent results due to varying testing parameters. The proposed cross-sectional study will investigate the efficiency of endogenous pain inhibition in individuals with chronic TMD pain compared to controls by applying noxious and non-noxious stimuli to facial and non-facial sites. The findings aim to clarify the impact of weaker pain inhibition over the face, how the conditioning stimulus' painfulness affects inhibition and the relationship between pain inhibition and fluctuations in TMD pain intensity.",[268],"Chronic Temporomandibular Disorders (TMD)",[270,271,272],"Temporomandibular disorders (TMD)","Chronic pain","Healthy volunteers",{"date":166,"type":31},{"date":275,"type":31},"2024-09-16",{"date":277,"type":20},"2026-12-31",{"name":37,"class":38},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":16,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":101},"100177240","natural-history-and-structural-functional-relationships-in-fabry-renal-disease-treatment-outcomeschangesin-fabry-renal-disease-study-100177240","NCT01581424","Natural History and Structural Functional Relationships in Fabry Renal Disease Treatment Outcomes(Changes)in Fabry Renal Disease Study","Natural History and Structural Functional Relationships in Fabry Renal Disease Natural History, Structural Functional Relationships and Determinants of Renal Structural Responses (Changes) With Enzyme Replacement Therapy in Fabry Disease","LDN6702","Inclusion Criteria:\n\n* Patients diagnosed with Fabry disease who have\u002Fhave not received enzyme replacement therapy where a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies or where patients have previously completed clinical trials which included measures of renal function and renal biopsies.\n\nExclusion Criteria:\n\n* Patients with serum creatinine more than 2.5 mg\u002FdL or known to have a renal disease other than Fabry.","1 Year","75 Years",{"count":290,"type":20},50,"The investigators will perform a study with two major components. The first is a natural history study of untreated Fabry patients. This study component will detail kidney microscopic structural changes in Fabry patients before starting enzyme replacement therapy and will correlate these changes with kidney function, including glomerular filtration rate and urinary albumin excretion rate. The investigators will perform studies on samples obtained at baseline, or before enzyme replacement therapy is initiated. The goal of our study is to find kidney microscopic changes in the biopsies that are associated with kidney disfunction. Our hypotheses for this study are:\n\n1. Much of the natural history of Fabry renal structural changes will occur without detectable renal functional alterations.\n2. Structural changes associated with the initial onset of proteinuria and those associated with the subsequent progressive loss of filtration function will differ and will be best described by non-linear models.\n3. There will be sufficient precision of Fabry renal structural-functional relationships to support renal structure as an acceptable clinical trial surrogate endpoint for later renal functional deterioration.\n\nThe second component examines the effects of age and gender at start of enzyme replacement therapy (ERT), as well as dosage levels of ERT on the renal cellular clearance of GL3 from Fabry patients by comparing baseline to follow-up kidney biopsies performed 5, 11, and 60 months later, with all comparisons matched for ERT treatment duration. Our hypotheses for this component of the study are as follows:\n\n1. Enzyme Replacement Therapy(ERT) instituted at younger ages is more effective in reducing podocytes(PC),distal tubular cells(DTC),and arterial smooth muscle cells (ASMC)GL-3 than in older Fabry patients.\n2. Earlier institution of ERT will stabilize PC numbers while later ERT institution, especially in proteinuric adults, may not prevent progressive decline in PC numbers and associated glomerular sclerosis, tubulointerstitial injury, and GFR loss.\n3. Whereas lower ERT dose may effectively clear GL-3 from endothelial and mesangial cells, it will be less effective in clearing GL-3 from PC and also from DTC and ASMC.\n4. Affected cells will be cleared of GL-3 equivalently in females and males.",[293],"Fabry Disease",[295,296,297,298,299],"Fabry disease","kidney function","kidney structure morphometry","Fabry kidney disease","Podocytes","2026-08-11",{"date":166,"type":31},{"date":303,"type":4},"2010-10",{"date":305,"type":20},"2030-07-31",{"name":37,"class":38},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":288,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":324,"leadSponsor":326,"locationsCount":39},"100650834","phase-1-microbiota-transplant-with-antibiotic-preconditioning-and-fiber-supplementation-in-pah-100650834","NCT07751120","Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in PAH.","A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH).","Inclusion Criteria:\n\n* Provision of signed and dated consent form\n* Ages 18-75\n* Diagnosis of PAH\n* On stable treatment for PAH for one month prior to enrollment\n* Able to swallow capsules\n* Able to provide blood sample and fecal sample\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence.\n\nExclusion Criteria:\n\n* Dysphagia to pills\n* Clinically active inflammatory bowel disease\n* Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of MTT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTT. Patients will be counseled to avoid pregnancy which is the standard of care for patients with PAH.\n* Life expectancy of \\\u003C 6 months\n* Presence of ileostomy or colostomy\n* Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg\u002Fday, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).\n* Patients with neutropenia (an absolute neutrophil count \\\u003C 0.5 x 10 9 cells\u002FL)",{"count":315,"type":20},24,[317],"PHASE1","This pilot clinical trial analysis will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (PAH). This trial will inform development of future trials of MTT as a treatment for PAH. 24 PAH patients will be randomized to receive either MTT with antibiotic preconditioning + fiber supplementation, MTT with antibiotic preconditioning + placebo supplementation, or placebo + placebo supplementation. MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. Fiber supplementation will be 10-14 gm oral fiber supplement. Patients will be followed at week 1, week 2, week 4, week 12, and week 24. Patient will undergo stool sample collection at baseline, week 1, week 4, and week 12, blood sample collection at baseline, week 4, and week,12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.",[320],"Pulmonary Arterial Hypertension","2026-08-10",{"date":224,"type":31},{"date":68,"type":20},{"date":325,"type":20},"2030-04-30",{"name":37,"class":38},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":288,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":39},"100555783","listening-effort-in-cochlear-implant-users-100555783","NCT06516575","Listening Effort in Cochlear Implant Users","Inclusion Criteria:\n\nTo be eligible for this study, a participant must:\n\n* Be an adult between the age of 18 to 75 years\n* Have had normal hearing and speech\u002Flanguage development as a young child\n* For younger NH listeners: have normal audiometric thresholds below 25 dB HL at frequencies between 250 and 8000 Hz\n* for cochlear implant listeners: at least 6 months experience with a cochlear implant\n* For older (55+ years) age-matched listeners with no cochlear implant: normal audiometric thresholds below 25 dB HL at frequencies between 250 and 2000 Hz and thresholds below 35 dB HL (hearing level) between 4000 and 8000 Hz\n* For cochlear implant listeners: be able to recognize spoken words in English at a rate of at least 50%\n* Be a competent speaker of north American English\n* Lack language-learning or other cognitive disabilities\n* Lack of auditory neuropathy spectrum disorder\n\nExclusion Criteria:\n\n* unable to fix gaze position\n* eye disease preventing typical changes in pupil dilation\n* lack of perceptual and productive fluency in English",{"count":334,"type":20},450,[23],"People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.",[338,339,340],"Auditory Perception; Abnormal","Hearing Loss, Sensorineural","Hearing Loss",[342,343],"cochlear implants","listening effort",{"date":224,"type":31},{"date":346,"type":31},"2023-09-01",{"date":348,"type":20},"2028-08-31",{"name":37,"class":38},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":39},"100487524","evaluation-of-the-scaled-scaling-acceptable-cds-100487524","NCT05628207","Evaluation of the SCALED (SCaling AcceptabLE cDs)","Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data","Inclusion Criteria:\n\n* age 18 and older\n* admitted with a TBI\n\nExclusion Criteria:\n\n* Patients who die within 24 hours of hospital admission and patients documented as \"comfort cares\" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.",{"count":358,"type":20},15000,"This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.",[361,362],"Traumatic Brain Injury","Venous Thromboembolism",{"date":250,"type":31},{"date":365,"type":31},"2023-05-16",{"date":367,"type":20},"2026-09-30",{"name":37,"class":38},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":392,"locationsCount":39},"100647351","sustained-release-oral-formulation-for-treatment-of-parkinsons-disease-100647351","NCT07709741","Sustained Release Oral Formulation For Treatment Of Parkinsons Disease","Inclusion Criteria:\n\n* Adult healthy male or female\n* Age 18 to 65 years\n* Willingness and ability to complete study procedures\n\nExclusion Criteria:\n\n* medical conditions that require taking medications regularly.","65 Years",{"count":377,"type":20},32,[317,379],"PHASE2","LD\u002FCD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral\u002Fbuccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. The combination of CD\u002FLD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.",[382],"Healthy Volunteers",[384,385,386],"Parkinson's","Levidopa","Carbidopa","2026-08-06",{"date":321,"type":31},{"date":367,"type":20},{"date":391,"type":20},"2027-06-30",{"name":37,"class":38},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":181,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":101},"100600189","torque-device-evaluation-100600189","NCT07094256","Torque Device Evaluation","Evaluation of Novel Torque Device During Electrophysiology Study Procedure","Inclusion Criteria:\n\n* Pediatric patient (≤21 years of age)\n* Undergoing clinically-indicated electrophysiology study and\u002For ablation procedure\n\nExclusion Criteria:\n\n* Adult patient (\\>21 years)",{"count":7,"type":20},[23],"This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and\u002For ablation procedure in a pediatric patient. All electrophysiology studies and\u002For ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.",[404,405],"Electrophysiology Study","Ablation","2026-08-05",{"date":387,"type":31},{"date":409,"type":31},"2025-08-25",{"date":277,"type":20},{"name":37,"class":38},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":21,"phases":422,"briefSummary":424,"conditions":425,"keywords":429,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":39},"100536967","stellate-ganglion-block-100536967","NCT06271707","Stellate Ganglion Block","Left Sided Stellate Ganglion Blocks Impact on the Rate of Post-operative Atrial Fibrillation in Patients Undergoing Thoracic Surgery: A Pilot Study","Inclusion Criteria:\n\n* Patients undergoing esophagectomy, pneumonectomy, or lobectomy aged 18-85.\n\nExclusion Criteria:\n\n* Patients who have an exclusion to regional anesthesia.\n* Patients who have exclusion to stellate blockade.\n* Patients who are pregnant assessed via self-report or pregnancy test if they have taken one","85 Years",{"count":421,"type":20},48,[423],"PHASE4","The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care.",[426,427,428],"Esophagectomy","Pneumonectomy","Lobectomy",[426,427,428,416],{"date":321,"type":31},{"date":432,"type":31},"2025-05-19",{"date":434,"type":20},"2028-12-30",{"name":37,"class":38},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":39},"100643682","mri-and-local-anesthesia-100643682","NCT07602686","MRI and Local Anesthesia","MRI Evaluation of Local Anesthesia Administration","MRI and LA","Inclusion Criteria:\n\n* Adult age 18 or older\n* Health status of American Society of Anesthesiologists (ASA) class 1 or 2\n* Able to provide informed consent\n* Able to appear in person at OMRIC on the days indicated for the study\n\nExclusion Criteria:\n\n* ASA class 3 or higher\n* Pregnant patients\n* Taking any medication that would affect pain perception or interact with local anesthetic\n* Allergic\u002Fhistory of adverse reaction to local anesthetic or any component in the local anesthetic\n* Paresthesia in the area of innervation of Cranial Nerve V3\n* Active infection or abscess in the oral and maxillofacial region\n* History of temporomandibular disorder, maximum incisal opening less than 15mm\n* History of recent dental trauma (within the past 6 months)\n* Dental hypersensitivity\n* Claustrophobia and\u002For conditions of anxiety or motion disorder (for MRI purposes)\n* Metallic, electronic, or magnetic implants or devices classified as MR Unsafe or Conditional by the American College of Radiology\n* Unable to give informed consent",{"count":445,"type":20},102,[23],"The purpose of this research is to investigate the utility of using dental-dedicated MRI as a measurement tool to observe and evaluate the administration of local anesthesia in dental patients.",[449],"Dental Anesthesia","2026-08-04",{"date":387,"type":31},{"date":30,"type":20},{"date":454,"type":20},"2029-07-01",{"name":37,"class":38},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":16,"minAge":463,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":39},"100556614","phase-2-choline-and-iron-deficiency-100556614","NCT06527391","Choline and Iron Deficiency","Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study","Inclusion Criteria:\n\n* Age 6 months +\u002F- 28 days\n* Hb \\\u003C 11.0 g\u002FdL\n* ZPP \\> = 80\n* T\\\u003C37.5°C\n* Malaria-negative based on Rapid Diagnostic Test (RDT)\n* Mother is HIV-negative.\n\nExclusion Criteria:\n\n* Developmental disorder\n* Severe malnutrition (severe wasting or bipedal edema)\n* Known sickle cell disease\n* Neurologic disorder, brain injury, or other condition affecting brain development\n* Not currently breastfeeding\n* Birthweight \\\u003C 2000 g","5 Months","7 Months",{"count":466,"type":20},300,[379,208],"BACKGROUND:\n\nIron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.\n\nGAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.\n\nHYPOTHESIS:\n\nInfants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.\n\nMETHODS:\n\nThis randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.\n\nRESULTS: Pending\n\nIMPACT:\n\nIf our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.",[470,471],"Pediatric Iron Deficiency","Anemia",[473,474,475],"iron deficiency","choline","anemia",{"date":406,"type":31},{"date":478,"type":31},"2025-08-11",{"date":480,"type":20},"2027-09-21",{"name":37,"class":38},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":21,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":4},"100632959","microbiome-targeted-diet-therapy-in-ulcerative-colitis-100632959","NCT07520461","Microbiome-targeted Diet Therapy in Ulcerative Colitis","Inclusion Criteria:\n\n* Ability and willingness to provide informed consent\n* Age at least 18 years old\n* Diagnosis of UC based on clinical and endoscopic criteria\n* UC duration of at least 3 months\n* Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization\n* On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).\n\n  1. ≥4 weeks if no medication, 5-ASA\n  2. ≥8 wk for immunomodulatory therapy\n  3. ≥12 wk for biologics\n* Ability to comply with study requirements in the opinion of the primary investigator\n\nExclusion Criteria:\n\n* Moderate or severe UC as defined by UCEIS ≥5\n* History of stomach surgery or bowel resection\n* Antibiotic use within 3 months\n* Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)\n* Pregnancy or breastfeeding\n* History of anaphylactic food allergies\n* Intolerance of high dietary fiber content\n* Ongoing alcohol or drug abuse\n* Habitual vegan diet pattern\n* Insufficient freezer space to accommodate meal delivery",{"count":128,"type":20},[23],"The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.",[492],"Ulcerative Colitis","2026-08-03",{"date":406,"type":31},{"date":496,"type":20},"2026-09-07",{"date":498,"type":20},"2029-06-01",{"name":37,"class":38},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":39},"100600877","evaluation-of-decision-making-fatigue-after-traumatic-brain-injury-100600877","NCT07103200","Evaluation of Decision-Making Fatigue After Traumatic Brain Injury","Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)","EDIFY","Inclusion Criteria for TBI Participants:\n\n* Adults 18 years and older\n* Diagnosis of a mild to moderate TBI (GCS \\> 8 on admission)\n* Able to perform a computerized assessment\n* Willing to attend all scheduled appointments\n* Able to undergo the informed consent process\n\nInclusion Criteria for Healthy Participants:\n\n* Adults 18 years and older\n* Able to perform a computerized assessment\n* Willing to attend all scheduled appointments\n* Able to undergo the informed consent process",{"count":128,"type":20},[23],"This is a preliminary, prospective, cohort study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls.",[512],"TBI (Traumatic Brain Injury)",[514,515],"Mild TBI","Decision-Making Fatigue",{"date":406,"type":31},{"date":518,"type":31},"2025-09-24",{"date":520,"type":20},"2029-07-15",{"name":37,"class":38},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":539,"locationsCount":39},"100484300","magnetic-resonance-spectroscopy-biomarkers-in-type-3-gaucher-disease-gd3-100484300","NCT05586243","MAGNETIC RESONANCE SPECTROSCOPY BIOMARKERS IN TYPE 3 GAUCHER DISEASE (GD3)","Inclusion Criteria:\n\n* All participants must be 18 years or older.\n* All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.\n* Individuals with GD3 who are medically stable for participation in study in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Medically unstable conditions as determined by the investigators.\n* Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.\n* Women who are pregnant or lactating or of child-bearing age that are not using acceptable forms of contraception.\n* Patients enrolled in another interventional study.\n* Patients who cannot or are unwilling to have blood drawn.\n* Inability to undergo Magnetic Resonance Imaging (MRI) scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.\n* Unable to adhere to study protocol for whatever reason.","80 Years",{"count":530,"type":20},5,"Recent studies have has shown that magnetic resonance spectroscopy (MRS) can provide validated neuronal markers in patients with Type 1 GD (GD1) who are on stable therapy. However, alterations in neurometabolites in adult patients with GD3, who have established neurological involvement, are not well understood. The goal of this study is to characterize neurometabolite profiles in adult patients with GD3 using MRS to identify novel biomarkers that can demonstrate treatment response. Additionally, a secondary aim is to evaluate relationships between neurometabolites and disease parameters, such as genotype, enzyme levels and Gaucher disease (GD) biomarkers.",[533],"Gaucher Disease, Type 3","2026-07-31",{"date":450,"type":31},{"date":537,"type":31},"2023-01-01",{"date":277,"type":20},{"name":37,"class":38},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":21,"phases":548,"briefSummary":549,"conditions":550,"keywords":555,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":571,"leadSponsor":573,"locationsCount":39},"100650292","phase-3-optimizing-care-for-cryptococcal-antigenemia-evaluation-of-short-course-fluconazole-and-art-timing-among-crag-persons-with-low-titers-100650292","NCT07743593","Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers","Inclusion Criteria:\n\n* HIV-1 infection\n* Age greater than 18 years\n* Ability and willingness to give informed consent\n* Plasma or serum cryptococcal antigen positive with titer less than 1:160\n\nExclusion Criteria:\n\n* Cannot or unlikely to attend regular clinic visits\n* History of cryptococcal infection\n* Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity\n* More than 10 weeks of fluconazole therapy\n* Pregnancy confirmed by urinary or serum pregnancy test\n* Current breastfeeding",{"count":547,"type":20},505,[208],"This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.\n\nParticipants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.\n\nParticipants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.",[551,552,553,554],"Cryptococcal Antigenemia","HIV-1-infection","Cryptococcal Infection","Cryptococcal Meningitis",[556,557,558,559,560,561,562,563,564,565,566,567],"Cryptococcal antigen","CrAg","Fluconazole","Fluconazole Short-course fluconazole","Low CrAg titer","Immediate ART","Advanced HIV disease","Cryptococcal meningitis-free survival","Hospitalization-free survival","Uganda","ART initiation","Antiretroviral therapy","2026-07-30",{"date":450,"type":31},{"date":68,"type":20},{"date":572,"type":20},"2031-08-30",{"name":37,"class":38},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":139},"100572572","multicenter-als-imaging-study-100572572","NCT06735014","Multicenter ALS Imaging Study","Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development","For participants with ALS:\n\n* \\\u003C 36 months since onset of symptoms\n* Definite, probable, lab-supported probable, or possible ALS by El Escorial criteria OR definite, probable, or possible ALS per Awaji-Shima criteria OR meets Gold Coast criteria\n* Forced vital capacity within the last 90 days ≥ 60% of the predicted value\n* Able to consent for themselves\n* Able to read and speak English\n* Clear of any contraindications for MRI\n\nExclusion Criteria:\n\n* Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.\n* All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.",{"count":582,"type":20},90,"This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.",[585,586],"Amyotrophic Lateral Sclerosis","ALS",[588,589,590,591,592,593],"Magnetic Resonance Imaging","MRI","ALSFRS-R","ECAS","plasma neurofilament light","NfL",{"date":534,"type":31},{"date":596,"type":31},"2024-09-15",{"date":348,"type":20},{"name":37,"class":38},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":21,"phases":608,"briefSummary":609,"conditions":610,"keywords":613,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":39},"100604714","r01pilot-jaw-muscle-phenotypes-100604714","NCT07153107","R01_Pilot Jaw Muscle Phenotypes","R01_PilotStudy2_Jaw Muscle Metabolic and Brain-Derived Phenotypes of Chronic TMD Pain","Inclusion Criteria:\n\n* Provide signed and dated informed consent form.\n* Willing to comply with all study procedures and be available for the duration of study participation.\n* Be 18 years or older.\n* Have a minimum set of teeth present, be it natural, implant-supported or fixed prosthodontics: all anterior teeth (incisors, canines), at least one premolar, at least one molar (first or second molar; third molars not considered).\n* TMD-Pain screener score equal to or greater than 3\n* Myalgia (masticatory muscle pain) based on clinical exam following the DC\u002FTMD protocol\n* Concurrent arthralgia (TMJ pain) and\u002For headache attributed to TMD allowed\n* Myofascial pain must meet the following criteria:\n\n  1. Onset \\>3 months, occurring \\>15 days\u002Fmonth on average in the last three months from the screening session\n  2. Minimum of 10 jaw pain episodes since onset, each episode lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting\n\nExclusion Criteria:\n\n* Traumatic facial injury or surgery on the face\u002Fjaw, arms or hands;\n* Presence of pain related to dental and periodontal pathology;\n* Currently undergoing active orthodontic treatment;\n* Pregnant;\n* Has any of the following medical conditions by self-report:\n\n  1. Renal failure or dialysis,\n  2. Heart disease (examples: uncontrolled arrythmia or hypertension, cardiomyopathy) or heart failure, Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema),\n  3. Diabetes (type I or II) that is not controlled with medication or diet,\n  4. Hyperthyroidism,\n  5. Uncontrolled seizures;\n* Used any injection therapy (e.g., tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for the management of facial\u002Fjaw pain within 2 weeks prior to the screening assessment; If undergoing botulinum toxin injections in the head and neck area, must be 3 months since last set of injections and refrain from this treatment until study participation has ended\n* History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessment;\n* History of treatment for drug or alcohol abuse within the last 12 months;\n* Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped \\\u003C24 hours prior to each study visit;\n* Current use of medically prescribed muscle relaxants for the duration of study participation;\n* Other conditions\u002Fdiseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia;\n* Adults lacking capacity to provide informed consent for themselves;\n* Unable to understand instructions for study procedures in English.\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study.\"",{"count":607,"type":20},10,[23],"The proposed study will assess the effect of local heat therapy on jaw pain and jaw fatigue secondary to a teeth clenching task in chronic TMD pain cases. Researchers expect that most participants will respond to heat therapy and consequently experience reduced jaw pain and fatigue during teeth clenching. The study will assess the clinical characteristics of those participants who respond and do not respond to local heat therapy, in order to determine the common clinical characteristics for those in each response category.",[611,612],"Chronic TMD Pain","Temporomandibular Disorder",[614,615],"Jaw Pain","Local Heat Therapy","2026-07-29",{"date":534,"type":31},{"date":619,"type":20},"2026-08-15",{"date":621,"type":20},"2027-01-12",{"name":37,"class":38},""]