[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Henry M. Jackson Foundation for the Advancement of Military Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":481},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,47,74,105,140,170,204,219,249,271,300,336,362,382,413,437,459],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100642002","toxin-exposure-and-immune-dysregulation-in-non-hodgkin-lymphoma-100642002",false,"NCT07652580","Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma","Toxin Exposure and Immune Dysregulation in Non-Hodgkin Lymphoma Across the Military Healthcare System","TOXNHL","Inclusion Criteria:\n\n* Age 4 years old and older with a clinical diagnosis of B-cell NHL.\n* Must be willing to undergo phlebotomy and\u002For skin punch biopsy.\n* Must be willing to undergo whole genome sequencing, which includes return of primary and secondary findings.\n\nExclusion Criteria:\n\n* Has any condition that, in the opinion of the Principal Investigator, contraindicates participation in this study. Examples of situation that may contraindicate participation include but are not limited to a) some cases of cerebral vascular accidents where an individual no longer has the capacity to make their own medical decisions and a conservator or responsible family member is not available and b) an individual has active suicidal ideation and is a danger to themselves at the time of enrollment.\n* Does not have access to health care and primary care clinician.\n* Actively undergoing induction treatment for NHL.","ALL","4 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The goal of this observational cohort study is to learn how toxin and occupational exposures, germline genetic variation, and immune dysregulation relate to B-cell non-Hodgkin lymphoma among active-duty service members and other Military Health System beneficiaries. The main questions are whether specific exposures and germline variants are associated with B-cell NHL subtype, immune dysfunction, and clinical outcomes. Participants will complete exposure and medical-history surveys, provide biospecimens for immune and genomic testing, and may be followed annually for up to 3 years.",[25,26,27,28],"Non-Hodgkin Lymphoma","Lymphoma Non-Hodgkin","B-cell Lymphoma","Immune Dysregulation",[30,31,32,33],"Immunodeficiency","Lymphoma","Exposure","Genetics","RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2025-05-01",{"date":42,"type":21},"2028-05-01",{"name":44,"class":45},"Henry M. Jackson Foundation for the Advancement of Military Medicine","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100450594","protocol-rv-583-multinational-observational-cohort-of-hiv-and-other-infections-100450594","NCT05147519","Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections","Multinational Observational Cohort of HIV and Other Infections (MOCHI)","MOCHI","Step 1 Inclusion Criteria: Female or male aged 14-55 years; Documented negative HIV test according to site-specific HIV testing procedures at entry\u002Fscreening; Able and willing to provide informed consent; Willing to provide biometric identification; Available for follow-up for the planned study duration; Understands English or the local language as approved by the IRB, including people who are illiterate; Willing to provide contact information for themselves and one personal contact who would know their whereabouts during the study period; Willing to provide information regarding HIV risk behaviors and to undergo testing for HIV and other STIs; Considered to be vulnerable to HIV and other STIs based on any one or more of the following test results and\u002For self-reported behaviors:\n\n1. Documented history of newly diagnosed syphilis, gonorrhea, chlamydia, Mycoplasma genitalium, herpes simplex virus, or acute hepatitis C virus infection in the 24 weeks prior to screening\n2. Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular source of income in the 24 weeks prior to screening\n3. Self-reported condomless vaginal or anal intercourse with at least three different partners living with HIV or of unknown status in the 24 weeks prior to screening\n4. Self- reported injection drug use (IDU) in the 24 weeks prior to screening\n5. Self-reported insertive or receptive anal intercourse with one or more different male or transgender partners in the 24 weeks prior to screening Step 1 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the judgement of the study investigator, would interfere with adherence to study requirements; Current or past participation in a preventive or therapeutic HIV vaccine study, unless known placebo recipient; Positive β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) at screening for people of child-bearing potential and people who are amenorrheic for less than 12 consecutive months.\n\nStep 2 Inclusion Criteria: New diagnosis of HIV in the last 90 days during Step 1 as determined by site-specific HIV testing procedures; Able and willing to continue follow-up for the planned study duration Step 2 Exclusion Criteria: Any significant condition (medical, psychologic\u002Fpsychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements","14 Years","55 Years",{"count":58,"type":21},2500,"Multinational Observational Cohort of HIV and other Infections (MOCHI). This observational study is to gain information regarding the number of new HIV infections among people who engage in behaviors that make them vulnerable to acquiring HIV across multiple international sites.",[61],"HIV Infections",[63,64],"STI","Observational","2026-05-26",{"date":67,"type":38},"2026-05-28",{"date":69,"type":38},"2021-11-05",{"date":71,"type":21},"2032-06-30",{"name":44,"class":45},4,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":56,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":46},"100472060","rtms-for-military-tbi-related-depression-100472060","NCT05426967","rTMS for Military TBI-related Depression","ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols","ADEPT","Inclusion Criteria:\n\n* Age 18-55 at the time of consent. Older individuals will not be enrolled in this initial trial for reasons of safety and expected reduced efficacy.\n* Current or former US military service member eligible for care at a Military Treatment Facility (MTF) or Veterans Administration Medical Center (VAMC.)\n* Able to provide written, informed consent in English .\n* Self-reported or medically diagnosed history of concussion (synonymous with \"mild TBI.\") \\>6 months, but \\\u003C26 years prior to consent, defined based on the DoD\u002FVA definition:\n\n  1. Positive Loss of Consciousness of \\\u003C30 minutes as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  2. Positive Alteration of Consciousness of \\\u003C24 hours as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  3. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and\u002For medical records.\n\n     * Note: Neuroimaging data or documentation from medical records is not required.\n* Baseline MADRS \\>13 at the time of screening indicating at least mild-moderate depressive symptoms.\n* Maintained a steady psychotropic medication regimen for six weeks and a steady behavioral therapy regimen for twelve weeks prior to enrollment in the study.\n* Female participants with child-bearing potential must agree to use an effective method of birth control during the course of the study.\n* Under the care of a primary care and\u002For behavioral health provider.\n\nExclusion Criteria:\n\n* Elevated risk of seizures at the time of rTMS including any of the following:\n\n  1. History of unprovoked seizures.\n  2. History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.\n  3. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).\n  4. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and\u002For medical records.\n  5. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.\n  6. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.\n* Contraindications to awake 3T MRI without contrast at the time of the Baseline MRI according to site radiology department criteria.\n* Severe claustrophobia interfering with medication\u002Fsedation-free 3T closed-bore MRI.\n* Intracranial lesion that would produce an artifact that would compromise the integrity of rsfMRI data.\n* History of severe or recent uncontrolled heart disease.\n* Presence of a cardiac pacemaker or intracardiac lines.\n* Any implant, prosthesis or other permanent alteration of the body (such as implanted neurostimulators and medication pumps) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data.\n* Presence of rapidly progressive illnesses such as late-stage cancer, neurodegenerative conditions, major organ failure, etc.\n* History of Bipolar Disorder or Schizophrenia Spectrum Disorders.\n* Current evidence of substance-induced mood disorder, active psychosis, or depression secondary to general medical illness other than TBI.\n* Severe or uncontrolled substance use.\n* Concomitant or lifetime history of receiving open-label TMS, due to issues preserving blinding.\n* Concomitant or recent history (within 12 weeks prior to enrollment) of receiving other neurostimulatory treatment, including but not limited to transcranial direct current (tDCS), transcranial alternating current (tACS), alpha stim, or electroconvulsive therapy.\n* Suicide attempt within six months prior to enrollment.\n* Right upper extremity amputation or other condition precluding left motor threshold calibration.\n* Unable to complete timeline of study (e.g., planned hospitalization partway through the study period.)\n* Prisoner, or other legally restricted freedom of movement and participation.\n* Any other considerations that, in the opinion of the investigators, may adversely affect participant safety, participation, or the scientific validity of the data being collected (e.g., erratic or unreliable responses, inconsistent communication, inability to remain on a steady neurotropic medication and\u002For behavioral therapy regimen over the course of the Randomization phase of the study.)","18 Years",{"count":84,"type":21},198,"INTERVENTIONAL",[87],"NA","The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion\u002Fmild traumatic brain injury (TBI).",[90,91,92],"Depressive Symptoms","Mild Traumatic Brain Injury","Concussion",[94,90,92,95,96],"Transcranial Magnetic Stimulation (TMS)","Mild Traumatic Brain Injury (TBI)","Functional Magnetic Resonance Imaging (fMRI)","2026-04-24",{"date":99,"type":38},"2026-04-29",{"date":101,"type":38},"2024-12-16",{"date":103,"type":21},"2026-12-31",{"name":44,"class":45},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":85,"phases":115,"briefSummary":116,"conditions":117,"keywords":125,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100586924","pilot-trial-for-woundx-clinical-decision-support-tool-100586924","NCT06921707","Pilot Trial for WounDx™ Clinical Decision Support Tool","SC2i-WounDx-001-WounDx™ Pilot Trial: Proof of Concept Feasibility for the Clinical Operations of WounDx™ in Aiding Clinicians Identify Wounds That Are Ready For Surgical Closure","Inclusion Criteria:\n\n* Wound surface area ≥75cm 2\n* Extremity injury (including shoulder and buttock - without visceral communication)\n* Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack\n\nExclusion Criteria:\n\n* Insulin Dependent Diabetes\n* Peripheral Vascular Disease\n* Connective Tissue Disorders\n* Preexisting immunosuppressive conditions or immunosuppression therapy\n* Pregnancy\n* Prisoners","65 Years",{"count":114,"type":21},40,[87],"The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.",[118,119,120,121,122,123,124],"Wounds","Wounds and Injuries","Extremity Injury","Traumatic Wounds and Injuries","Amputation, Traumatic\u002FSurgery","Amputation, Wound","Open Fracture Wounds",[118,120,126,127,128,129,130],"Clinical Decision Support Tool","Delayed Wound Closure","Cytokine Biomarkers","Wound Effluent","Traumatic Extremity Wounds","2026-04-14",{"date":133,"type":38},"2026-04-17",{"date":135,"type":21},"2026-03-21",{"date":137,"type":21},"2026-09-20",{"name":44,"class":45},5,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":56,"enrollmentInfo":148,"targetDuration":4,"studyType":85,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},"100581752","phase-2-lacripep-for-corneal-wound-healing-study-100581752","NCT06854393","Lacripep for Corneal Wound Healing Study","Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis","Inclusion Criteria:\n\n1. Male or female, of any race, 21 years old and older\n2. Active-duty U.S. military service members or their dependents eligible for care at Alexander T. Augusta Military Medical Center for 6-month period postoperatively\n3. Desiring refractive correction of myopia up to -4.00 diopters (D) sphere with or without astigmatism 0 to -1.50 D and up to -4.00 D manifest spherical equivalent in both eyes\n4. Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes\n5. CDVA of at least 20\u002F20 in both eyes\n6. Elected to undergo bilateral PRK\n7. Able to meet follow up requirements for up to 6-month period post-operatively\n\nExclusion Criteria:\n\n1. Calculated ablation depth of greater than 75 microns or other conditions in either eye which in the judgement of the investigators will require use of prophylactic MMC\n2. Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye\n3. Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration\n4. Treatment targeted for monovision\n5. Signs and symptoms of dry eye based on: (a) Corneal fluorescein staining total score ≥4 in the National Eye Institute (NEI)\u002FIndustry Workshop scale in either eye, (b) Anethetized Schirmer test score ≤5 mm\u002F5 minutes in either eye, (c) Symptom score ≤40 using the Symptom Assessment in Dry Eye (SANDE) questionnaire in either eye\n6. Female subjects who are pregnant, breastfeeding or intend to become pregnant during the study. Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not.\n7. Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts\n8. Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes\n9. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane®), amiodarone hydrochloride (Cordarone®) and\u002For sumatriptan (Imitrex®) (other medications in the same family as Imitrex will still be allowed)\n10. Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.\n11. Individuals not legally competent to provide informed consent (e.g., incapacitated individuals, cognitively impaired) will not be enrolled. All subjects must provide consent to participate in the study","21 Years",{"count":149,"type":21},88,[151],"PHASE2","The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK).",[154],"Corneal Epithelial Wound Healing",[156,157,158,159,160],"Cornea","Wound healing","PRK","Lacritin","Lacripep","2026-03-24",{"date":163,"type":38},"2026-03-25",{"date":165,"type":38},"2025-05-23",{"date":167,"type":21},"2027-09",{"name":44,"class":45},1,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":46},"100612144","surgical-critical-care-initiative-sc2i-tissue-and-data-acquisition-protocol-tdap-in-burn-patients-improving-the-robustness-and-generalizability-of-post-burn-sepsis-prediction-with-the-post-burn-sepsis-digital-twin-group-1-100612144","NCT07249762","Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin. Group 1","Inclusion Criteria:\n\n* Burn Injury \\>10% TBSA with who have a recognized concurrent or impending risk for clinical decompensation.\n* Male and female ages 18 years and older (maximum age of 80 years old) with burn injury or related illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at an SC2i-member clinical care facility (Emory\u002FGrady, USF and USAISR) will be considered for study.\n* Ability to understand the purposes and risks of the study and to provide informed consent, either through written documentation or in accordance with the IRB-approved Waiver of Documentation of Consent procedures. In the case of incapacitated patients, a willing Legally Authorized Representative (LAR) may provide informed consent in accordance with written documentation or under the provisions of the approved Waiver of Documentation of Consent.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, or technical considerations that would prevent acquisition of sufficient tissue for clinical use.\n* Pregnant patients\n* Minors \\\u003C 18 years of age\n* Prisoners","80 Years",{"count":114,"type":21},"This study is following adult patients with serious burn injuries to better understand how their bodies respond to treatment and recovery. Researchers will collect small amounts of blood and tissue samples, along with information already recorded in the medical record, such as vital signs, lab results, and details of surgeries or complications. The goal is to identify patterns that may help predict who is at higher risk for infections or other problems after a burn injury. This information could lead to new tools, including computer-based models, to improve burn care and outcomes in the future. Participation involves providing samples and allowing researchers to review medical records during the hospital stay and up to one year after discharge.",[180,181,182,183,184],"Sepsis","Burn Injury","Wound Healing","Critical Illness","Multiple Organ Dysfunction Syndrome",[186,180,183,187,188,189,190,182,191,192,193,194],"Burn Infection","Thermal Injury","Infection","Multiple Organ Dysfunction Syndrome (MODS)","Acute Respiratory Distress Syndrome (ARDS)","Biomarkers","Digital Twin Model","Predictive Analytics","Surgical Critical Care","NOT_YET_RECRUITING","2026-02-02",{"date":198,"type":38},"2026-02-04",{"date":200,"type":21},"2026-05-15",{"date":202,"type":21},"2027-12-15",{"name":44,"class":45},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":176,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":178,"conditions":213,"keywords":214,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":217,"leadSponsor":218,"locationsCount":46},"100610138","tdap-in-burn-patients-group-2-100610138","NCT07223684","TDAP in Burn Patients (Group 2)","Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-Burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin","Inclusion Criteria:\n\n* Male and female ages 18 years and older (maximum age of 80 years old) with burn injury or related illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at an SC2i-member clinical care facility (Emory\u002FGrady, USF and USAISR) will be considered for study.\n* Burn Injury \\>10% TBSA\n* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing legally authorized representative (LAR) is able to give written informed consent.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, or technical considerations that would prevent acquisition of sufficient tissue for clinical use.\n* Pregnant patients\n* Minors \\\u003C 18 years of age\n* Prisoners",{"count":212,"type":21},80,[180,181,182,183,184],[186,180,183,187,188,189,190,182,191,192,193,194],{"date":198,"type":38},{"date":200,"type":21},{"date":202,"type":21},{"name":44,"class":45},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":85,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},"100581813","symptom-targeted-approach-to-rehabilitation-for-concussion-star-c-100581813","NCT06855186","Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)","Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control","STAR-C","Inclusion Criteria:\n\n* mTBI defined per the VA\u002FDoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.\n* a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.\n* a score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.\n\nExclusion Criteria:\n\n* History of a moderate, severe, or penetrating TBI as defined by DoD\u002FVA guidelines.\n* Lifetime diagnosis of schizophrenia or other psychotic\u002Fthought disorder.\n* Current participation in intensive behavioral health treatment (≥3 appointments \u002Fencounters per week) for any psychiatric or substance use disorder.\n* Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital\u002Fgame-based format of more than 4 hours per week).\n* History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease.\n* Current, active suicidal or homicidal ideation.\n* Daily use of narcotic pain medications.\n* Lack of access to technology or internet\u002Fcell phone service that supports telemedicine.\n* Current participation in other therapy targeting cognition (Note: This is not the same as Cognitive Behavioral Therapy\u002FCBT which addresses psychological issues and may continue during participation in this research project).","64 Years",{"count":229,"type":21},222,[87],"Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment.\n\nHypothesis\u002FObjectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.",[233],"Mild Traumatic Brain Injury (mTBI)",[235,236,237,238,239],"concussion","brain injury","cognitive rehabilitation","military","adults","2026-01-07",{"date":242,"type":38},"2026-01-08",{"date":244,"type":38},"2025-09-18",{"date":246,"type":21},"2028-08-31",{"name":44,"class":45},2,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":227,"enrollmentInfo":255,"targetDuration":4,"studyType":85,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":46},"100584147","adjustment-disorders-in-the-us-military-disease-trajectories-and-adnm-20-mil-validation-100584147","NCT06885554","Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation","Inclusion Criteria:\n\n* Age 18-64\n* Serving as active duty in the US Military\n* Diagnosed with adjustment disorder (with or without depression and\u002For anxiety) within the last 3 months\n* No other mental health diagnosis (e.g., schizophrenia spectrum and other psychotic disorders, substance use disorder, bipolar and related disorders, TBI)\n* No current thoughts of or serious risk of suicide\n* Willing and available (e.g., no upcoming deployments or station changes within the next 6 months) to be participate in all study activities if eligible and enrolled\n* Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study\n* Must have and be willing to use an internet-enabled smartphone or tablet for the study\n* Provision of appropriate storage and charging for study equipment in a generally safe and dry condition\n* In treatment through the Military Health System for adjustment disorder\n\nExclusion Criteria:\n\n* Significant medical conditions or other circumstances which would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.\n* Does not meet the eligibility criteria\n* Unable to read, speak, or comprehend English\n* Unable or unwilling to give informed consent\n* No current pregnancy or intention\u002Fplanned pregnancy during study duration, or lactation\n* Study participants of childbearing potential who are unwilling to use an effective method of contraception during the use of SANA device\n* History or presence of photo-sensitive epilepsy or other photo-sensitive condition\n* History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo\n* History or presence of severe and continuous tinnitus\n* History or presence of migraine headaches\n* Surgery or trauma requiring rehabilitation within the last 12 weeks\n* Presence of cancer pain, acute pain following injury or other severe pain that would be anticipated to change during the course of the study\n* Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes\n* Deafness in one or both ears, perceived differences in hearing between ears\n* Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion)\n* Presence of inflammation or broken skin around the eyes in the area of the mask\n* Presence of narcolepsy or untreated sleep apnea. Note: presence of sleep apnea is permitted, so long as patients feel comfortable to use both apnea mask and Sana device in conjunction.\n* Participation in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.\n* Current thoughts of suicide",{"count":256,"type":21},60,[87],"Adjustment disorders (AjDs) - a group of mental health diagnosis given following exposure to a stressor that results in preoccupation, failure to adapt, and\u002For functional impairments - have consistently remained the most common mental health diagnoses in the US military across branches for more than a decade. AjDs can be dangerous and negatively affect military readiness by reducing availability of members and through use of resources to allow evacuations from combat. Diagnosing AjDs can be challenging as it is closely related to other well-defined mental health disorders and assessment and research on AjDs have historically been difficult due to the lack of clarity in the disorder's diagnostic criteria. However, the Adjustment Disorder New Module (ADNM-20) is a recently developed instrument that has shown promise.\n\nIn previous work, our team adapted the ADNM-20 to the US military population after finding that there was a need for an AjD-specific diagnostic instrument in this population; this instrument is referred to as the ADNM-20-Mil. The principal focus of this study is the longitudinal psychometric validation of the ADNM-20-mil. However, another goal of the proposed study is to pilot test the audio-visual stimulation device SANA for AjD as pilot testing such a device for AjD is a needed next step. Furthermore, the proposed, longitudinal study provides an ideal platform to test the ADNM-20-Mil's sensitivity to change in the context of this pilot trial to address this critical area of need.",[260],"Adjustment Disorders",[260,262],"Military","2025-11-18",{"date":265,"type":38},"2025-11-21",{"date":267,"type":38},"2025-10-06",{"date":269,"type":21},"2028-01-01",{"name":44,"class":45},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":85,"phases":280,"briefSummary":281,"conditions":282,"keywords":286,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":169},"100609687","stepped-care-intervention-of-music-and-imagery-to-assess-relief-scimitar-trial-100609687","NCT07217821","Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial","SCIMITAR","Inclusion Criteria:\n\n* musculoskeletal pain in the low back, cervical spine, or extremities (hips, knees, or shoulders) for ≥ 3 months\n* at least moderate pain severity, defined as a PEG score ≥ 4 on a 0 (no pain) to 10 (worst pain)\n* access to computer, tablet, or smartphone\n* ability to pass a technology assessment\n\nExclusion Criteria:\n\n* Past month hospitalization for medical or psychiatric illness\n* housing insecurity\n* suicidal ideation with current intent\u002Fplan\n* hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work\n* currently receiving music therapy services",{"count":279,"type":21},180,[87],"Th Stepped-Care Intervention of Music and Imagery to Assess Relief (SCIMITAR) Trial. SCIMITAR builds on our pilot study, the Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia (FAMILIA), which demonstrated that telehealth delivery of music listening (ML) and music imagery (MI) interventions is feasible and acceptable to Veterans with chronic musculoskeletal pain. SCIMITAR leverages what we learned from FAMILIA into a fully powered trial, harnessing the benefits of sequential ML and MI into a stepped-care, music therapy intervention via telehealth for Veterans needing relief from pain.",[283,284,285],"Chronic Musculoskeletal Pain","Veterans","Music Therapy",[287,288,289,290,291],"chronic pain","veterans","musculoskeletal pain","music therapy","clinical trial","2025-10-15",{"date":294,"type":38},"2025-10-16",{"date":296,"type":38},"2023-08-30",{"date":298,"type":21},"2026-04-30",{"name":44,"class":45},{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":308,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":85,"phases":311,"briefSummary":312,"conditions":313,"keywords":321,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":169},"100600344","get-better-together-relationship-education-for-military-couples-100600344","NCT07096271","Get Better Together: Relationship Education For Military Couples","Better Together: A Relationship Enrichment Program Targeting Transdiagnostic Interpersonal Emotion Regulation Among Military Couples","GBT RCT","Inclusion Criteria:\n\n* Couple is in a committed romantic relationship of at least six months\n* At least one partner is a military Service member on active duty\n* Both partners are age 18 or older\n* Couple has not previously attended a relationship enrichment retreat or workshop together (e.g., CREDO, Strong Bonds, BSRT). This does not include couples therapy or pre-marital counseling.\n\nExclusion Criteria:\n\n* One or both partners decline to provide informed consent\n* Required command endorsement for retreat attendance is not received (for Service members E-6 and below)\n* Couple is unable or unwilling to attend any of the scheduled retreats during the study period",true,{"count":310,"type":21},1000,[87],"This study is testing a program called Get Better Together, a relationship education program designed to help military couples effectively navigate life stressors as a team. The goal is to find out if attending Get Better Together improves mental health and relationship skills, and reduces problems like alcohol misuse, aggression, and suicide risk. Couples who join the study will be randomly placed into one of two groups. One group will attend Get Better Together at a weekend retreat. The other group will continue their usual activities and later receive access to an online relationship education program. All participants will complete surveys before the retreat and again 2, 4, and 6 months later.",[314,315,316,317,318,319,320],"Emotion Regulation","Relationship Conflict","Suicide Risk","Alcohol Use","Intimate Partner Violence (IPV)","Relationship Distress","Interpersonal Emotion Regulation",[322,238,323,324,325,326,327,328],"Behavioral: Get Better Together (GBT)","intimate relationships","suicide prevention","primary prevention","emotion regulation","relationship education","interpersonal emotion regulation",{"date":330,"type":38},"2025-10-20",{"date":332,"type":38},"2025-09-22",{"date":334,"type":21},"2028-07",{"name":44,"class":45},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":85,"phases":347,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":169},"100553303","phase-1-rv630---approach-to-control-hiv-with-immune-enhancement-and-vaccination-achiev-100553303","NCT06484335","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission","ACHIEV","Inclusion\u002FExclusion Step 1 Inclusion Criteria (Groups 1 and 2 only)\n\nParticipants are eligible to be included in the protocol Step 1 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. Confirmed HIV-1 infection (nucleic acid testing \\[NAT\\] and\u002For HIV-1 serology positive with confirmatory quantitative HIV-1 viral load) and started ART during acute infection\n6. Uninterrupted treatment with ART (no interruption of ART for ≥7 consecutive days or longer) since ART initiation, for ≥ 48 weeks.\n7. Currently on integrase inhibitor-based ART regimen (excluding long-acting injectable regimens) and no recent (≤8 weeks prior to screening) changes to ART regimen.\n\n   a. There must be at least one documented plasma HIV-1 RNA \\\u003C50 cps\u002FmL after the last ART change prior to screening\n8. Must be medically stable as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening, and as per the Investigator's discretion.\n\n   a. If the results of the screening laboratory panel are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study after discussion with the Sponsor's Representative.\n9. The following laboratory values at screening:\n\n   1. CD4 T-cell count ≥400 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation.\n   6. Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin ≤1.5 x the upper limit of normal (ULN)\n   7. Hepatitis C virus (HCV) antibody negative or HCV RNA negative.\n10. HIV-1 RNA \\\u003C50 copies\u002Fml for ≥48 weeks at screening.\n\n    1. No history of virologic failure. Virologic failure is defined as having two consecutive HIV-1 RNA \\>1000 copies\u002FmL at any time after achieving HIV-1 RNA \\\u003C50 copies\u002FmL\n    2. A single viral load measurement ≥50 but \\\u003C1000 copies\u002FmL, at any time from achieving HIV-1 RNA \\\u003C50 copies\u002FmL to \\> 48 weeks from screening, is allowed provided that it is bracketed by viral loads \\\u003C50 copies\u002FmL\n    3. A single viral load measurements ≥50 but \\\u003C200 copies\u002FmL, within 48 weeks of screening is allowed provided that each is bracketed by viral loads \\\u003C50 copies\u002FmL prior to screening.\n11. Sensitivity test demonstrating the lack of detection of resistant viruses to VRC07-523LS or PGDM1400LS.\n12. For persons of childbearing potential, negative pregnancy test at the screening visit.\n13. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n14. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n15. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using preexposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n16. Passes Test of Understanding (Protocol Section 8.4)\n17. Willing to interrupt and restart ART according to study schedule\n18. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up. Step 1 Exclusion Criteria (Groups 1 and 2 only)\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg, HBV DNA, or both)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (e.g., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n\nStep 2 Inclusion Criteria (Group 3 only)\n\nGroup 3 will enter the study in Step 2. Participants are eligible to be included in the Group 3 protocol Step 2 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. The following laboratory values at screening:\n\n   1. CD4 \\> 200 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation\n   6. Aspartate aminotransferase (AST) (SGOT), Alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin \\\u003C2x the upper limit of normal (ULN)\n   7. HIV-1 RNA \\> 1,000 copies\u002FmL\n   8. HCV RNA negative\n6. For persons of childbearing potential, negative pregnancy test at the screening visit.\n7. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy. Contraception must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n8. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Passes Test of Understanding (Protocol Section 8.4)\n11. Willing to interrupt and restart ART according to study schedule\n12. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up.\n13. Experiencing early acute HIV-1 infection as defined by\n\n    1. blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test. OR\n    2. by a positive nucleic acid test or a positive 4th generation EIA in the context of a negative 2nd or negative 3rd generation HIV-1 EIA test\n14. No history of antiretroviral drug use for any indication in the last 30 days\n\nStep 2 Exclusion Criteria (Group 3 only)\n\nParticipants who meet any of the following criteria will be excluded from the study for Group 3:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (i.e., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n21. Absolute neutrophil count (ANC) \\\u003C 740 cells\u002Fmm3\n22. Severe Acute Retroviral Syndrome requiring in-patient hospitalization or interfering with participant ability to return for follow-up visits.\n\nStep 3 (ATI) Inclusion Criteria (All Groups) Step 3 will begin after the third and final vaccine (or placebo) administration (end of Step 2). Participant clinical status or laboratory tests may potentially change during Steps 1 and 2. To ensure that participants continue to meet safety criteria for proceeding to ATI, they will be screened (to include all required screening laboratory tests) for Step 3 inclusion criteria at the visit for the third and final vaccine\u002Fplacebo dose (Last Step 2 visit): Step 2, Week 20 for Groups 1 and 2; Step 2, Week 28 for Group 3.\n\nParticipants enrolled in all Groups of the study may proceed with Step 3 if they meet all the following inclusion criteria:\n\n1. Receipt of all doses of the study products and\u002For placebos per protocol in Steps 1 and 2.\n2. Plasma HIV-1 RNA \\\u003C50 copies\u002FmL at the Last Step 2 visit.\n3. CD4 T-cell count ≥400 cells\u002Fmm3 at the Last Step 2 visit. Note: The CD4 T-cell count can be repeated once, provided that the repeat is done within 4 weeks prior to Step 3 entry.\n4. No CDC Category C event after study entry\n5. Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) at the Last Step 2 visit.\n6. Documented negative hepatitis C virus (HCV) antibody (anti-HCV) or negative HCV RNA at the Last Step 2 visit.\n7. For persons of childbearing potential, negative pregnancy test at the first Step 3 visit (Step 3, Week 0).\n8. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Willingness to participate in ATI for up to 50 weeks.\n11. Willingness to restart ART according to study guidelines.\n\nStep 3 (ATI) Exclusion Criteria (All Groups)\n\nEnrolled participants who meet any of the following criteria will be excluded from moving to Step 3:\n\n1. Virologic failure (two consecutive HIV-1 RNA \\>1000 copies\u002FmL) after study entry\n2. Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.\n3. Receipt of any non-nucleoside reverse transcriptase inhibitor (NNRTI) within 60 days before Step 3 entry.\n4. Receipt of long-acting ART such as long-acting cabotegravir (CAB LA) or long-acting rilpivirine (RPV LA) at any point after study entry.\n5. Failure by the participant to attend three consecutive Step 1 or Step 2 study visits.\n6. Pregnancy or breastfeeding.\n7. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.","60 Years",{"count":346,"type":21},48,[348],"PHASE1","This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120\u002FALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).",[61,351,352,353],"PLWH","ART","Acute HIV Infection","2025-09-15",{"date":356,"type":38},"2025-09-16",{"date":358,"type":38},"2025-03-27",{"date":360,"type":21},"2027-08-01",{"name":44,"class":45},{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":308,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":73},"100223125","sc2i-tissue-and-data-repository-protocol-100223125","NCT02182180","SC2i Tissue and Data Repository Protocol","Surgical Critical Care InitiativeTissue and Data Acquisition Protocol","SC2i","Inclusion Criteria:\n\n* Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)\n* Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.\n* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.",{"count":371,"type":21},5000,"The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and\u002For wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and\u002For tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.",[183],"2025-08-28",{"date":376,"type":38},"2025-09-04",{"date":378,"type":38},"2014-09-09",{"date":380,"type":21},"2027-08",{"name":44,"class":45},{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":85,"phases":392,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":248},"100439254","a-proprioceptive-training-program-using-an-uneven-terrain-treadmill-for-patients-with-ankle-instability-100439254","NCT04999904","A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability","ROCKY REHAB","Inclusion Criteria\n\n1. Aged 18-49.\n2. Score \\\u003C 24 on the Cumberland Ankle Instability Tool.\n3. Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation.\n4. Able to attend treatment sessions for approximately a 6-week period.\n5. Passed most recent physical fitness test (Active duty only).\n6. Acute lateral ankle sprain specific inclusion criteria:\n\n   1. history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day.\n   2. chronicity of 2-6 weeks prior to consent.\n7. Chronic ankle instability specific inclusion criteria:\n\n   1. history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days.\n   2. most recent ankle sprain in the past 2-12 weeks.\n   3. history of the previously injured ankle joint \"giving way\" and\u002For recurrent sprain and\u002For ''feelings of instability.''\n8. Individual is about to start care with physical therapy.\n\nExclusion Criteria\n\n1. Unable to walk at the point of study enrollment.\n2. Non-removable casting.\n3. History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves).\n4. History of fracture in either limb of the lower extremity requiring realignment.\n5. Acute injury to musculoskeletal structures of other joints of the lower extremity within the previous three months, which impacted joint integrity and function resulting in at least one interrupted day of physical activity.\n6. Pregnant.\n7. Self-reported disability due to neuromuscular impairment in the lower extremity, neurological or vestibular impairment that affected balance.\n8. Connective tissue disorder (e.g. Marfan Syndrome or Ehlers-Danlos syndrome).\n9. Anyone separating from the military within 12 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.","49 Years",{"count":391,"type":21},312,[87],"The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability.",[395,396],"Instability; Ankle (Ligaments) (Old Injury)","Sprain of Ankle",[398,399,400,401,402,403,404],"Acute Ankle Sprain","Chronic Ankle Instability","Proprioceptive Training","Uneven Treadmill","Reinjury","Rehabilitation","Service Members","2025-07-15",{"date":407,"type":38},"2025-07-18",{"date":409,"type":38},"2021-11-23",{"date":411,"type":21},"2026-09-30",{"name":44,"class":45},{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":344,"enrollmentInfo":421,"targetDuration":4,"studyType":85,"phases":423,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":73},"100491296","phase-4-single-dose-antibiotic-treatment-of-acute-watery-diarrhea-rifaximin-versus-azithromycin-with-loperamide-adjunct-100491296","NCT05677282","Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct","A Randomized Controlled Trial Evaluating Single-dose Rifaximin Versus Azithromycin With Loperamide Adjunct for Treatment of Acute Watery Diarrhea","TrEAT_TD2","Inclusion Criteria:\n\n1. Active duty military, 18-60 years old\n2. Presence of acute watery diarrhea (3 or more loose\u002Fliquid stools in 24 hours or 2 loose\u002Fliquid stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) lasting \\\u003C96 hours in duration that impacts function in activities and\u002For performance of primary duties. Refer to recruitment decision tree below.\n3. Eligible for ambulatory management. (Note: Ambulatory management in this study means that the patient can be treated on an outpatient basis to include up to 23 hours of medical observation and IV therapies.)\n4. Able to comply with follow-up procedures.\n5. Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere.\n\nExclusion Criteria:\n\n1. Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset).\n2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine\u002Fproguanil, tafenoquine, or doxycycline).\n3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and hydroxychloroquine).\n4. Current or history of liver disease or other serious health conditions based on review by study physician.\n5. Acute dysentery and\u002For febrile illness (temperature \\> 100.4°F \\[38.1°C\\]).\n6. Presence of symptoms \\>96 hours prior to initiating treatment.\n7. Use of \\>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment. Prior use of bismuth subsalicylate or other anti-diarrheal, non-antibiotic therapy in the 48 hours prior to enrollment.\n8. Positive pregnancy test at presentation (unknown effects with rifaximin). All female participants will be administered a urine pregnancy test prior to enrollment.\n9. Previously screened or randomized in this study.",{"count":422,"type":21},150,[424],"PHASE4","The purpose of this study is to compare a single dose of rifaximin with loperamide to the current standard approach of single dose azithromycin with loperamide for the treatment of acute watery traveler's diarrhea (TD).\n\nThe study requires 1) taking a single dose antibiotic plus loperamide to treat TD, 2) providing blood and stool samples at different time points to evaluate infection and immune responses, 3) completing a daily symptom diary following treatment, 4) being seen by the study doctor to monitor illness and recovery, and 5) completing a brief electronic questionnaire at 3 months.\n\nParticipants will be randomly assigned to one of the two treatment groups. The two groups are 1) rifaximin 550 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool or 2) azithromycin 500 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool. Both groups will take the antibiotic dose and 4 mg of loperamide.",[427,428],"Diarrhoea;Acute","Diarrhea Travelers","2025-05-27",{"date":431,"type":38},"2025-05-31",{"date":433,"type":38},"2022-10-28",{"date":435,"type":21},"2025-12",{"name":44,"class":45},{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":112,"enrollmentInfo":445,"targetDuration":4,"studyType":85,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":169},"100532603","personalized-repetitive-transcranial-magnetic-stimulation-prtms-100532603","NCT06214949","Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)","Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain","PrTMS","Inclusion Criteria:\n\n* Military health care beneficiary for enrollment.\n* Over the age of 18 years.\n* Presence of chronic neck pain for at least 3 months.\n\nExclusion Criteria:\n\n* History of seizure, bipolar disorder, or schizophrenia.\n* Unstable heart or pulmonary disease.\n* Brain tumor, active brain infection, history of cerebral vascular accident (CVA), or penetrating brain injury.\n* Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs that may protect against seizure occurrence.\n\n  1. Antiviral medications and antipsychotic medications\n  2. Recent withdrawal from sedatives\n  3. Substance abuse of phencyclidine, amphetamines, ketamine, and gammahydroxybutyrate\n* Not a suitable candidate for the study as determined by the PI.\n* Pregnancy, breastfeeding, or plans to become pregnant during the course of the study.\n* Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).\n* Presence of implanted brain electrodes (cortical or deep-brain electrodes).\n* Potential participants who score above a certain suicide relevant survey score on the Suicide Behaviors Questionnaire-Revised (SBQ-R), or are judged by expert clinicians to be a serious risk of harm to self, will be excluded.\n* Participants cannot have undergone a previous TMS treatment within the last 30 days before the start of study treatment.\n* Participants must have reliable and consistent access to the internet to complete surveys when not present in the clinic.\n* Participants must not have a clinical diagnosis of insomnia.\n* Participants can not be actively partaking in a substance abuse program.",{"count":446,"type":21},120,[87],"This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.",[450],"Neck Pain","2025-03-04",{"date":453,"type":38},"2025-03-06",{"date":455,"type":38},"2024-05-01",{"date":457,"type":21},"2027-05",{"name":44,"class":45},{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":85,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":73},"100443028","phase-2-treatment-of-acute-pth-with-a-cgrp-receptor-mab-in-military-service-members-and-civilians-with-mtbi-100443028","NCT05049057","Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI","Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension","Inclusion Criteria:\n\n* Male or female ≥18 and ≤50 years of age\n* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days\n* PTH has occurred within the prior 7 days\n* Able to provide informed consent\n* Likely to stay in the same geographical area for the duration of study\n* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider\n\nExclusion Criteria:\n\n* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:\n\n  1. abnormal structural imaging\n  2. loss of consciousness for \\>30 minutes\n  3. alteration of consciousness\u002Fmental state for \\>24 hours 3. post-traumatic amnesia for \\>1 day\n* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury","50 Years",{"count":468,"type":21},404,[151],"This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).",[472,91],"Posttraumatic Headache","2024-02-21",{"date":475,"type":38},"2024-02-22",{"date":477,"type":38},"2022-07-19",{"date":479,"type":21},"2027-05-19",{"name":44,"class":45},""]