[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Emory University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":620},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,220,0,25,[9,46,69,99,123,156,177,205,230,255,275,297,320,342,367,390,410,429,454,473,498,524,545,575,595],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100405755","phase-3-safe-study-safety-of-apcc-following-emicizumab-prophylaxis-100405755",false,"NCT04563520","SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis","aPCC and Emicizumab Safety Study in Congenital Hemophilia A Patients With Inhibitors (SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis)","SAFE","Inclusion Criteria:\n\n* Moderately severe hemophilia A, defined as FVIII level \\\u003C0.05 IU\u002FmL before development of an inhibitor\n* Age ≥6 years of age at time of informed consent\n* Documented on 2 occasions a high titer inhibitor (\\>5 BU\u002FmL) with a 72-hour washout within 2 years of enrollment\n* Parent\u002Fguardian (Legally Authorized Representative) or the patient has provided written informed consent\n* Adequate hematologic function (Hgb \\>8 g\u002FdL and platelet count \\>100,000 µL)\n* Adequate hepatic function (total bilirubin ≤1.5 x ULN and both AST\u002FALT ≤3x ULN at screening (excluding known Gilbert's)\n* Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL\u002Fmin)\n\nExclusion Criteria:\n\n* Inherited or acquired bleeding disorder other than hemophilia A excluding low VWF (\\>30% VWF:RCo or VWF:GP1bm)\n* Had an active bleed requiring factor therapy at screening\n* Previous or current treatment for thromboembolic disease or signs of thromboembolic disease (excluding previously resolved line-associated thrombosis)\n* Had a surgical procedure 14 days before screening\n* Conditions that may increase the risk of bleeding or thrombosis\n* If the patient is treated with rFVIIa or aPCC seven days before screening\n* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection\n* Had current use of any medication other than emicizumab that could affect the coagulation system.\n* Known HIV infection with CD4 count \\\u003C200 cells\u002FµL within 24 weeks before screening. Testing is not required if \\\u003C35 years of age.\n* Use of systemic immunomodulators at enrollment or planned use during the study\n* Participants who are at high risk for TMA (for example, have a previous medical\u002Ffamily history of TMA), in the investigator's judgment\n* Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose an additional risk, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study","ALL","6 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.",[28],"Hemophilia A",[30,31,32],"hemostatic efficacy","safety","prothrombin complex concentrate","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":22},"2026-09",{"date":41,"type":22},"2027-03",{"name":43,"class":44},"Emory University","OTHER",2,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":45},"100644396","neuroplastic-changes-due-to-an-exercise-intervention-that-aid-in-lower-limb-recovery-after-subcortical-stroke-100644396","NCT07663292","Neuroplastic Changes Due to an Exercise Intervention That Aid in Lower Limb Recovery After Subcortical Stroke","Inclusion Criteria:\n\n* chronic left or right subcortical stroke as defined by 6 months or more after a cardiovascular accident\n* lower extremity motor impairment due to stroke that causes a walking speed of less than 0.6 m\u002Fs during a 10m walk,\n* age 18-80 years old, and\n* Screen pass of the Stress test or Physician sign-off from the participant's health care team that they are cleared for a 12 week exercise intervention\n\nExclusion Criteria:\n\n* MRI contraindications, including implanted cardiac pacemakers and severe claustrophobia\n* any neurodegenerative condition other than stroke that may lead to lower extremity impairment\n* visual or auditory impairment that may hinder study procedures, and\n* any medical condition that would preclude from participation in a physical exercise intervention program.","18 Years","80 Years",{"count":55,"type":22},55,[57],"NA","This study aims to develop imaging-based biomarkers to assess which chronic stroke participant with lower extremity disability may respond or resist high intensity interval training (HIIT).\n\nPrevious research suggests that physical exercise training is safe and could help improve the walking speed of non-ambulatory stroke survivors. However, inter-individual variability in response to exercise is extraordinarily high regardless of adherence, and predictors of response remain elusive.\n\nChronic stroke survivors with lower limb disability resulting in slow walking speeds will participate in 12 weeks of cycling exercise at Emory University under the guidance of a physical exercise instructor, 3 days a week, for 25-60 minutes. During some of the exercise sessions, the investigators will collect blood lactate with a finger prick. Brain scans with an MRI before and after the 12 weeks of exercise will be done; motor function tests that include walking, sitting down, standing up, and turning around will be collected. Participants' memory and thinking will be assessed, and participants will fill out questionnaires about their health before and after their stroke, and well as questions about their diet.\n\nThe participation will last between 14-16 weeks (up to 42 study visits).",[60,61],"Subcortical Lesions","Stroke",[63],"High intensity interval training","2026-08-18",{"date":34,"type":37},{"date":39,"type":22},{"date":41,"type":22},{"name":43,"class":44},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100640953","phase-2-jak-signaling-in-depression-and-cognition-in-male-football-players-100640953","NCT07608796","JAK Signaling in Depression and Cognition in Male Football Players","JAK DC in Play","Inclusion Criteria:\n\n* willing and able to give written informed consent\n* males\n* playing tackle football for at least 11 years\n* 30-55 years of age\n* Current Diagnostic and Statistical Manual (DSM)-V major depression or Bipolar, depressed type; or DSM-V major depression or Bipolar, depressed type in partial remission as diagnosed by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)-V\n* score of \\>10 on the PHQ-9 from screening and HAM-D score ≥16 for study entry\n* off all antidepressant or other psychotropic therapy (e.g., mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks before baseline visit (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks (and no planned changes)\n* CRP ≥3 mg\u002FL\n* PHQ-9 anhedonia (item #1) and cognitive (item #7) scores ≥2\n\nExclusion Criteria:\n\n* current or history of past autoimmune disorder\n* history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection\n* history of any type of cancer requiring treatment with more than minor surgery\n* unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG, and laboratory testing)\n* significant hematological abnormalities at screening (ANC \\\u003C 1500, Hgb\\\u003C10, platelet\\\u003C 100,000)\n* history of progressive multifocal leukoencephalopathy\n* history of deep venous thrombosis\n* history of cardiovascular disease (coronary artery disease, congestive heart failure, stroke - controlled hypertension is OK)\n* major surgery within 6 months before screening, or will require major surgery during the study\n* current or recent (\\\u003C4 weeks before study start) viral (including COVID-19), bacterial, fungal, or parasitic infection, or any other active or recent infection\n* symptomatic herpes zoster infection at or within 12 weeks of study start\n* history of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or CNS involvement)\n* cirrhosis of the liver from any cause\n* Additional exclusion criteria apply",true,"MALE","30 Years","55 Years",{"count":81,"type":22},30,[83],"PHASE2","This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.",[86,87],"Depressive Symptoms","Cognitive Symptom",[89,90,91],"Football player","Inflammation","NFL","NOT_YET_RECRUITING",{"date":34,"type":37},{"date":39,"type":22},{"date":96,"type":22},"2027-10",{"name":43,"class":44},3,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100359023","exercise-in-patients-undergoing-urologic-surgery-100359023","NCT03954678","Exercise in Patients Undergoing Urologic Surgery","Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery","Inclusion Criteria:\n\n* Patients scheduled for operative procedure with an inpatient postoperative stay are eligible for this study\n* Patients willing and able to give blood sample as part of standard of care labs\n* Patients willing and able to fill out questionnaire\n* Patients who will fill out the step log daily\n* Patients willing and able to sign informed consent\n\nExclusion Criteria:\n\n* None",{"count":107,"type":22},400,[57],"Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.",[111],"Perioperative Complication",[113,114,115],"Exercise","Nutrition supplement","Surgery",{"date":34,"type":37},{"date":118,"type":37},"2019-07-30",{"date":120,"type":22},"2028-07",{"name":43,"class":44},1,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":77,"minAge":52,"maxAge":78,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":122},"100652138","project-space-a-micro-randomized-trial-of-daily-text-messages-to-reduce-alcohol-use-and-hiv-risk-behavior-100652138","NCT07769580","Project SPACE: Testing Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior","Project SPACE (Study Pilot on Alcohol Construals Everyday)","Inclusion Criteria:\n\n* Male sex at birth and currently identify with male gender\n* Own and use a smartphone that can receive text messages daily\n* Have tested negative for HIV in the past 24 months\n* Be willing to consider a change in their drinking behavior\n* Not currently in a sexually exclusive relationship\n* In the past three months, the subject must have had at least 3 condomless sexual encounters with men and consumes ≥5 standard alcoholic drinks at least once a week.\n\nExclusion Criteria:\n\n* Involved in previous Project SPACE research (i.e., members of the Phase 1 community advisory board or Phase 2 pilot tests)\n* Participants that have sought treatment for substance use in the past month.",{"count":131,"type":22},240,[57],"Project SPACE is a micro-randomized trial evaluating the proximal effects theory-based text messages on alcohol use and sexual HIV risk behaviors among HIV-negative young adult men at the day-level.\n\nAt baseline, all participants will complete GamePlan, an existing brief online sexual health program. During the subsequent 8-week intervention period, participants will complete a brief morning assessment of the preceding day and will be randomized each afternoon, with equal probability, to receive concrete (\"how\"), abstract (\"why\"), neutral control, or no afternoon intervention messages. Participants will also complete pre- and post-intervention measures. The effects of GamePlan are not being separately evaluated in this study.",[135,136,137],"HIV","Risk Behavior","Alcohol Abuse",[139,140,141,142,143,144,145,146,147],"Men who have sex with men","Micro-randomized trial","Construal level theory","Text messaging","Mobile health","Alcohol use","HIV prevention","Young adults","Intervention optimization","2026-08-17",{"date":150,"type":37},"2026-08-19",{"date":152,"type":22},"2027-02",{"date":154,"type":22},"2027-12",{"name":43,"class":44},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":52,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":122},"100636189","assessing-molecular-mechanisms-and-effects-of-music-therapy-in-youth-with-sickle-cell-disease-using-single-cell-rna-sequencing-100636189","NCT07562451","Assessing Molecular Mechanisms and Effects of Music Therapy in Youth With Sickle Cell Disease Using Single-cell RNA-sequencing","Inclusion Criteria:\n\n* Diagnosed with SCD\n* English fluency (for survey completion)\n* Have access to a personal electronic device (e.g., phone, tablet) with access to the internet\n* Meet the criteria for chronic pain defined by the International Association for the Study of Pain (IASP). IASP defines chronic pain as pain that is both:\n\n  1. Persistent or recurrent for ≥ 3 months\n  2. is associated with significant emotional distress or functional disability.30\n\nExclusion Criteria:\n\n* Major hearing deficiency or medical condition in which listening to music may be contraindicated (e.g., reflex epilepsy).","8 Years",{"count":7,"type":22},[57],"The goal of this clinical trial is to evaluate whether a 4-week music therapy (MT) intervention can reduce chronic pain and improve psychosocial outcomes in youth with sickle cell disease (SCD).\n\nThe main questions it aims to answer are:\n\n* Does MT reduce pain intensity, frequency of pain episodes, and improve health-related quality of life (HRQoL)?\n* Does MT alter immune cell composition and gene expression in inflammatory pathways, as measured by single-cell RNA sequencing (scRNA-seq)?\n\nResearchers will compare participants randomized to music therapy versus a control condition to see if MT produces superior improvements in pain and psychosocial outcomes, and distinct molecular changes.",[167],"Sickle Cell Disease",[169,170,171],"Music therapy","Pain control","Sickle cell disease",{"date":150,"type":37},{"date":34,"type":22},{"date":175,"type":22},"2028-04",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":76,"sex":185,"minAge":4,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":196,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":122},"100615271","improving-maternal-and-child-health-through-point-of-care-sti-testing-100615271","NCT07290439","Improving Maternal and Child Health Through Point-of-care STI Testing","Improving Maternal and Child Health Through Point-of-care STI Testing (MATCH-POINT)","MATCH-POINT","Inclusion Criteria:\n\n* Pregnant and clinically indicated for STI testing (syphilis and\u002For Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) at a prenatal care (PNC ) or labor and delivery (L\\&D) triage visit at Grady Memorial Hospital (GMH). Indications for STI testing in pregnancy at GMH:\n\n  * Syphilis, CT, NG, and TV indicated at first PNC visit\n  * Syphilis serologic testing additionally indicated in 3rd trimester and at delivery\n  * CT\u002FNG\u002FTV additionally indicated in the 3rd trimester for those \\\u003C25 or with increased risk \\[1\\]\n  * Additional testing recommended based on clinical signs or symptoms (e.g., genital lesion or vaginal discharge, new exposure history)\n* English or Spanish-speaking\n* If \\\u003C16 years of age, has a parent or legal guardian present\n* Have STI risk factor:\n\n  * \\\u003C25 years of age\n  * Reports current substance use\n  * Reported or documented history of a positive STI\n  * More than one current sex partner\n  * A current sex partner who has concurrent partners\n  * A new sex partner (\\\u003C6 months )\n  * A current sex partner who has an STI\n  * Exchange of sex for money or drugs\n  * Incarceration\n  * No previous prenatal care during the current pregnancy\n* Able to follow study procedures and provide written informed consent or assent, as appropriate\n\nExclusion Criteria:\n\n* Indicated for syphilis test: negative RPR test during this pregnancy\n* Indicated for syphilis test: ever had a previous syphilis diagnosis (lifetime history)\n* Indicated for CT\u002FNG\u002FTV test: negative for all three of CT, NG, and TV within the previous 1 month\n* Indicated for CT\u002FNG\u002FTV test: positive for any of CT, NG, and\u002For TV and completed treatment \\\u003C3 weeks prior\n\nStakeholders:\n\n* GMH PNC or L\\&D providers, GMH leadership, Georgia Dept of Health leadership\n* \\>=18 years of age\n* Able to follow study procedures and provide verbal informed consent","FEMALE",{"count":187,"type":22},756,[57],"The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting.\n\nThe main questions it aims to answer are:\n\n* Do POCTs reduce delays in STI treatment compared with standard laboratory-based testing?\n* What barriers, facilitators, and processes affect POCT implementation in prenatal and obstetric care?\n* What are the costs and cost-effectiveness of POCTs compared with standard testing?\n\nParticipants will:\n\n* Complete a baseline survey and receive either POCTs (fingerstick blood draw or vaginal swab) or standard laboratory STI testing.\n* If diagnosed with an STI, complete a follow-up survey approximately one month later.\n* Stakeholders (providers, hospital leadership, and public health officials) will complete interviews to inform implementation strategies.",[191,192,193,194,195],"Treponema Pallidum Infection","Chlamydia Trachomatis Infection","Neisseria Gonorrheae Infection","Trichomonas Vaginalis Vaginitis","Sexually Transmitted Infection",[197,198],"Prenatal care","Point of care test",{"date":150,"type":37},{"date":201,"type":37},"2026-08-11",{"date":203,"type":22},"2030-06",{"name":43,"class":44},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":223,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":122},"100534015","phase-1-use-of-acu-d1-in-hpv-associated-vulvar-and-perianal-lesions-in-people-with-hiv-100534015","NCT06233331","Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV","Phase I Dose Escalation Study of the Use of ACU-D1, a Topical Proteasome Inhibitor in HPV Associated Vulvar and Perianal Lesions in People With HIV","Inclusion Criteria:\n\n* Age 21 years and older\n* HIV-infected\n* Able to provide informed consent\n* Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater\n* Combined antiretrovirals (cART) adherence\n* CD4 count \\> 200 cells\u002Fml\n* Sustained undetectable viral load for ≥ 3 months\n* If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)\n* Willingness to conform to study requirements\n* Reliable follow-up and contact information\n* No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion\n\nExclusion Criteria:\n\n* Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating","21 Years",{"count":214,"type":22},9,[216],"PHASE1","The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:\n\n* The maximum tolerated dose of ACU-D1\n* Safety and tolerability of topical ACU-D1\n* Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions\n* Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals\n\nParticipants will be asked\n\n* To apply ACU-D1 on the lesions twice daily for 4 weeks\n* 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.",[219,220,221,222],"Human Papilloma Virus","Human Immunodeficiency Virus","Anal Intraepithelial Neoplasia","High-Grade Squamous Intraepithelial Lesions",[135,224,221],"HPV",{"date":64,"type":37},{"date":227,"type":22},"2026-12",{"date":154,"type":22},{"name":43,"class":44},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":76,"sex":18,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":98},"100566080","effect-of-cognitive-empathy-training-on-dementia-caregivers-100566080","NCT06650527","Effect of Cognitive Empathy Training on Dementia Caregivers","Inclusion Criteria:\n\n* Caregivers must live with their care recipient\n* Caregivers must have a Zarit Burden Scale score of 19 or higher\n* Caregivers must have no plans to move their care recipient to an institutional setting within the next year\n* Caregivers must be able to read and write English\n* Care recipient not in hospice\n* Access to a mobile phone that can take and email photographs\n\nExclusion Criteria:\n\n* Subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse\n* Subjects with a history of psychiatric illness (excluding depression and anxiety disorders) will also be excluded\n* Subjects with a history of head trauma based on Survey\n* Subjects with MRI contra-indications","50 Years",{"count":238,"type":22},118,[57],"The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms.\n\nThe primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation\n\nThe secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being",[242,243],"Caregivers of People Living With Dementia","Dementia",[245,246,247],"Cognitive empathy","People Living With Dementia","Caregivers","2026-08-16",{"date":64,"type":37},{"date":251,"type":37},"2025-02-13",{"date":253,"type":22},"2028-11-01",{"name":43,"class":44},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":261,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":273,"leadSponsor":274,"locationsCount":122},"100629415","diabetes-multimorbidity-typology-trajectory-and-feasibility-of-an-audio-diary-mobile-application-to-support-self-management-100629415","NCT07474376","Diabetes Multimorbidity Typology, Trajectory, and Feasibility of an Audio Diary Mobile Application to Support Self-management","Inclusion Criteria:\n\n* Diagnosed type 1 or 2 diabetes and at least one comorbidity (eg, obesity, HIV, heart failure, polycystic ovary syndrome, obstructive sleep apnea, and prediabetes with and without hypertension)\n* Being able to fill in the Redcap surveys, and install and use the audio diary app.\n\nExclusion Criteria:\n\n•Those who cannot use (e.g., no mobile phone, incompatible system), read, type, speak, or understand English in Redcap or the audio diary mobile app.","65 Years",{"count":81,"type":22},[57],"The goal of this clinical trial is to evaluate whether an audio diary mobile application (Fabla-diabetesMM) is feasible to use and may support self-management in older adults with type 1 or 2 diabetes and multimorbidity.\n\nThe main questions it aims to answer are:\n\n* Is it feasible to adapt and implement the Fabla-diabetesMM audio diary mobile app among 30 older adults with diabetes and multimorbidity\n* Does the use of the audio diary mobile app affect self-management outcomes",[266,267],"Diabetes Mellitus, Type 2","Diabetes Mellitus, Type 1",[269],"Diabetes self management","2026-08-14",{"date":148,"type":37},{"date":39,"type":22},{"date":41,"type":22},{"name":43,"class":44},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":76,"sex":18,"minAge":52,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100609031","phase-2-baricitinib-curative-repression-of-hiv-1-100609031","NCT07209267","Baricitinib Curative Repression of HIV-1","Inclusion Criteria:\n\n* Documented HIV infection\n* On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.\n* Plasma HIV-1 RNA levels of \\\u003C50 copies\u002FmL for at least 96 weeks (a minimum of two measures), and \\\u003C50 copies\u002FmL for a sample obtained within 90 days before enrollment.\n* CD4+ T-cell count ≥500 cells\u002Fmm3 obtained within 90 days prior to enrollment\n* No known history of CD4+ T-cell count nadir \\\u003C200 cells\u002Fmm3\n* Negative pregnancy test at time of study enrollment\n* Additional laboratory criteria apply.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age or \\> 70 years of age\n* Pregnancy or breastfeeding, as determined by a blood pregnancy test\n* History of AIDS-defining illness, except for recurrent pneumonia.\n* History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.\n* Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.\n* History of use of any immunomodulatory medications within 6 months before enrollment, including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immunomodulatory effect.\n* History of deep venous thrombosis\n* Cardiovascular disease (Coronary artery disease or history of myocardial infarction, Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines, history of stroke)\n* History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma\u002Fleukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months\n* Major surgery within 8 weeks before screening, or will require major surgery during the study\n* Current or recent (\\\u003C4 weeks before screening) clinically serious viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If a rapid plasma reagin (RPR) test was negative in the 3 months before screening, then an RPR is not needed at screening\n* Symptomatic herpes simplex at the time of screening.\n* Symptomatic herpes zoster infection within 12 weeks before screening.\n* History of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).\n* Positive test for hepatitis B virus (HBV)\n* Additional exclusion criteria apply","70 Years",{"count":283,"type":22},35,[83],"This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.",[287,135],"HIV Infection",[289,290],"Baricitinib","Antiretroviral Therapy (ART)",{"date":148,"type":37},{"date":293,"type":22},"2026-10",{"date":295,"type":22},"2028-01",{"name":43,"class":44},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":76,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":319,"locationsCount":98},"100636271","linking-individuals-needing-care-for-substance-use-disorders-to-peer-coaches--across-incarceration-settings-100636271","NCT07563517","Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches & Across INcarceration Settings","LINCS UP & IN","Inclusion Criteria:\n\n* Incarcerated at participating jail\n* Able to speak and understand English\n* Score of 3 or greater - \"moderate level\", \"substantial level\", or \"severe level\" of problems related to drug abuse - on DAST-10.\n* Willing to follow study procedures and complete research follow-up calls\n* Have at least two reliable contact numbers, e.g. participant and one or more relatives or close friends\n\nExclusion Criteria:\n\n* Cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)\n* Prior participation in the study\n* Awaiting transfer to prison or jail outside the state of Georgia",{"count":305,"type":22},550,[57],"The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders.\n\nThe main questions it aims to answer are:\n\n* Does the PRC intervention increase engagement with at least one recovery resource at 30 and 90 days?\n* Does it improve secondary outcomes such as substance use, recovery capital, overdose events, and recidivism?\n\nResearchers will compare Treatment-as-Usual with the PRC telehealth intervention to see if PRC support improves engagement in addiction care.\n\nParticipants will:\n\n* Complete baseline and follow-up assessments\n* Receive either Treatment-as-Usual or a virtual PRC session focused on motivational interviewing and linkage to recovery resources",[309],"Substance Use",[311,312,313],"Support groups","Recovery","Substance use disorders during incarceration","2026-08-13",{"date":148,"type":37},{"date":39,"type":22},{"date":318,"type":22},"2030-03",{"name":43,"class":44},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":98},"100651989","clinical-evaluation-of-a-novel-textile-radiation-protection-device-100651989","NCT07768605","Clinical Evaluation of a Novel Textile Radiation Protection Device","Evaluation of Novel Woven Fabric Radiation Protection Gear for Head and Neck Regions for Interventional Radiology Personnel","Inclusion Criteria:\n\n* Age ≥18 years.\n* Employed or regularly working in the IR department at the study site.\n* Routinely present in fluoroscopy-guided procedures (e.g., IR attending, IR trainee, technologist, IR nurse, anesthesia provider).\n* Scheduled to work in procedure rooms equipped with Texray garments and dosimetry systems during the study period.\n* Willing and able to provide informed consent.\n* Willing to wear Texray PPE and\u002For standard PPE with dosimeters as specified by the study protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Not regularly present in IR suites during fluoroscopy-based procedures.\n* Known pregnancy at the time of enrollment.\n* Presence of a musculoskeletal or dermatologic condition that, in the opinion of the investigator or the participant, would prevent safe use of the Texray garments (e.g., inability to tolerate additional weight or fabric contact).\n* Decline to participate or are unable to provide informed consent.",{"count":328,"type":22},20,[57],"This study will use procedure-specific dosimetry to evaluate whether Texray's novel woven radiation protection fabric (HeadPeace and MindPeace) reduces occupational radiation dose to the head and thyroid of interventional radiology personnel compared with standard radiation protection equipment, and to explore variation in efficacy by role, procedure type, and fluoroscopy room\u002Fequipment characteristics.",[332],"Radiation Exposure",[334],"Radiation","2026-08-12",{"date":148,"type":37},{"date":338,"type":22},"2026-08",{"date":340,"type":22},"2027-07",{"name":43,"class":44},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":364,"leadSponsor":366,"locationsCount":122},"100651953","phase-2-electrophysiologic-mechanisms-of-ketamine-antidepressant-response-100651953","NCT07768618","Electrophysiologic Mechanisms of Ketamine Antidepressant Response","Electrophysiologic Dynamics of Depression and Antidepressant Response in Epilepsy","Ketamine-sEEG","Inclusion Criteria:\n\n* Admitted to the Emory EMU for clinically indicated sEEG monitoring for epilepsy.\n* At least mild depressive symptoms at baseline, defined as MADRS ≥7 or BDI-II ≥14.\n* Electrode coverage that includes midline regions sufficient for enrollment and analyses.\n* Ability to provide informed consent and to complete bedside tasks\u002Fquestionnaires in English.\n* Expected to remain under inpatient monitoring through the planned \\~24-hour post-infusion follow-up unless clinical needs dictate otherwise.\n\nExclusion Criteria:\n\n* Documented IQ \\\u003C70, intellectual disability, severe cognitive impairment, delirium, severe aphasia, or other condition that prevents valid consent or task participation.\n* Current or past schizophrenia-spectrum disorder or other psychotic disorder.\n* Current manic\u002Fhypomanic episode or bipolar-spectrum illness judged by study psychiatrist\u002Finvestigator to increase risk or confound interpretation.\n* Active alcohol or substance abuse\u002Fdependence within the past 3 months.\n* Imminent suicide risk or active suicidal intent requiring urgent intervention as determined by clinical assessment. Passive ideation without imminent intent may be considered on a case-by-case basis with psychiatric approval and enhanced monitoring.\n* Contraindication to subanesthetic ketamine, including uncontrolled hypertension, unstable cardiovascular disease, aneurysm\u002Fvascular malformation or similar condition conferring unacceptable risk, pregnancy, breastfeeding, or other clinically significant medical instability.\n* Clinical team determination that ketamine administration or study timing would interfere with epilepsy care or perioperative management.\n* Sedative or other medication exposure at a level that, in the judgment of the clinical team, precludes safe ketamine administration or reliable behavioral assessment (participant may be deferred rather than permanently excluded if the issue resolves).",{"count":351,"type":22},37,[83],"This study aims to identify electrophysiologic biomarkers associated with antidepressant response to ketamine in adults with epilepsy undergoing clinically indicated stereo-electroencephalography (sEEG) monitoring who have at least mild depressive symptoms.\n\nParticipants will receive a single subanesthetic intravenous ketamine infusion (0.5 mg\u002Fkg over 40 minutes) during their Epilepsy Monitoring Unit admission. Intracranial neural recordings and behavioral assessments will be collected before and approximately 24 hours after infusion to examine changes in neural circuits associated with rumination and anhedonia.",[355,86],"Epilepsy",[357,355,358,359,360,361],"Depression","Ketamine","Stereo-electroencephalography","Antidepressant Response","Electrophysiologic Biomarker",{"date":148,"type":37},{"date":227,"type":22},{"date":365,"type":22},"2031-12",{"name":43,"class":44},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":281,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":389},"100583014","rapid-evacuation-and-access-of-cerebral-hemorrhage-trial-100583014","NCT06870812","Rapid Evacuation and Access of Cerebral Hemorrhage Trial","REACH","Inclusion Criteria:\n\n* Age 18-70 years\n* Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus)\n* ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement\n* Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well.\n* Glasgow Coma Score (GCS) 5 - 14\n* Historical Modified Rankin Score 0 or 1\n\nExclusion Criteria:\n\n* Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (less than 1 year) ICH, as diagnosed with radiographic imaging\n* NIH Stroke Scale (NIHSS) less than or equal to 5\n* Bilateral fixed dilated pupils\n* Extensor motor posturing\n* Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles\n* Primary thalamic ICH or basal ganglia hemorrhage with involvement \\> 25% of thalamus\n* Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar\n* Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction)\n* Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site\n* Uncorrected coagulopathy or known clotting disorder\n* Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction\n* Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH\n* End-stage renal disease\n* Patients with a mechanical heart valve\n* End-stage liver disease\n* History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements\n* Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal\n* Known life expectancy of less than 6 months before ICH\n* No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization\n* Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional\u002Fobservational studies are eligible\n* Inability or unwillingness of the subject or legal guardian\u002Frepresentative to give written informed consent\n* Homelessness or inability to meet follow-up requirements",{"count":375,"type":22},600,[57],"The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful.\n\nThere is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.",[379],"Stroke Hemorrhagic",[381,382,383],"Intracerebral hemorrhage","minimally invasive surgery","Blood clot",{"date":270,"type":37},{"date":386,"type":37},"2025-05-27",{"date":318,"type":22},{"name":43,"class":44},24,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":76,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":122},"100651862","mobile-health-patient-navigation-for-the-improvement-of-screening-and-the-early-detection-of-breast-cancer-in-women-accessing-primary-care-clinics-in-kenya-100651862","NCT07764796","Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya","A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)","Inclusion Criteria:\n\n* AIM 1: All members of BREAKTHROUGH's Stakeholder Advisory Board (SAB) breast cancer working group\n* AIM 1: Participants (patients and health providers) from primary health care clinics in Nairobi County\n* AIM 1: Will include women (patients) aged over 35 years and speak either Kiswahili or English\n* AIM 1: Include women who:\n\n  * Have never undergone MMG screening\n  * Previously undergone MMG screening\n  * Experienced breast abnormalities and have been referred for or undergone diagnostic investigations\n  * Are currently undergoing or have received breast cancer treatment\n* AIM 1: Health care providers and breast screening facility staff (i.e. primary care clinic nurses, MMG clinic staff and technicians) will also be recruited\n* AIM 2: Will engage with a diverse group of local and national interagency stakeholders, Nairobi County health leadership, and health providers across different levels of the health system\n* AIM 3: Women aged 35 years and older who are able to provide informed consent who are attending the outpatient clinics for primary health care\n* AIM 4: Members of SAB breast cancer group, health facilities leadership (all health facility levels)\n\nExclusion Criteria:\n\n* AIM 1: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study\n* AIM 2: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study\n* AIM 3: Women undergoing breast cancer treatment and women aged 70 years and above will be excluded\n* AIM 4: Members of SAB breast cancer group, and health facilities leadership who will be unwilling and unable to consent will be excluded",{"count":398,"type":22},800,[57],"This clinical trial develops and studies how well mobile health (m-Health) patient navigation (PN) strategies work to improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya. Although highly curable, breast cancer kills thousands of women in developing countries yearly. Mammography (MMG) is used for the early detection of breast cancer by creating a picture of the breast using film or a computer. Despite the availability of MMG in all 47 counties in Kenya, screening remains low in eligible women. Early detection of breast cancer may also be improved through access to high quality clinical breast exams (CBE). However, primary care providers in Kenya face barriers to incorporating CBE into practice, including limited patient awareness of breast cancer screening. m-Health uses applications on mobile phones to deliver PN directly to the patients. The PN strategies in this study include digital platforms and tools to help with education, reminders, navigation, and motivation around breast cancer screening. This may improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.",[402],"Breast Carcinoma","2026-08-10",{"date":270,"type":37},{"date":406,"type":37},"2025-07-22",{"date":408,"type":22},"2029-06-30",{"name":43,"class":44},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":122},"100582631","implementation-and-cost-evaluation-of-project-uplift-100582631","NCT06865820","Implementation and Cost Evaluation of Project UPLIFT","Inclusion Criteria:\n\n* Adults 18 years or older\n* Diagnosis of epilepsy (self-reported by patient)\n* Can speak English\n* Has access to a phone or computer\n\nExclusion Criteria:\n\n* Inability to cognitively participate",{"count":417,"type":22},60,[57],"This study tests Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT) which is a Mindfulness-based Cognitive Behavioral Therapy program teaching participants with epilepsy methods that include challenging thoughts, behavioral activation, coping, problem-solving, and mindfulness, for well-being and costs. Project UPLIFT is delivered as weekly sessions over 8 weeks.",[355],"2026-08-05",{"date":423,"type":37},"2026-08-07",{"date":425,"type":37},"2025-03-24",{"date":427,"type":22},"2027-08",{"name":43,"class":44},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":76,"sex":18,"minAge":436,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":453,"locationsCount":45},"100633144","thrive-with-type-1-diabetes-2026-100633144","NCT07522866","Thrive With Type 1 Diabetes 2026","Intervention to Thrive With Type 1 Diabetes 2026","Inclusion Criteria:\n\n* Aged 31 to 75 years\n* Type 1 Diabetes for at least 1 year\n* One or more sleep health dimensions are out of range\n\nExclusion Criteria:\n\n* Non-English speaking\n* Recent night shift work or transmeridian travel\n* Life-limiting illness","31 Years","75 Years",{"count":439,"type":22},48,[57],"This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.",[443],"Type1diabetes",[445,446,447],"Glycemia","A1C","Sleep","2026-08-04",{"date":450,"type":37},"2026-08-06",{"date":39,"type":22},{"date":175,"type":22},{"name":43,"class":44},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":122},"100535675","phase-2-pre-operative-atezolizumab-in-patients-with-resectable-human-papillomavirus-related-oropharyngeal-carcinoma-100535675","NCT06254911","Pre-operative Atezolizumab in Patients With Resectable, Human Papillomavirus Related Oropharyngeal Carcinoma","Window of Opportunity Study of Pre-Operative Atezolizumab (ANTI PD-L1 ANTIBODY) for Patients With Resectable HPV Related Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Inclusion Criteria:\n\n* The subject is \\>= 18 years old on the day of consent\n* Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 5 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 5 months after the last dose of study drug(s).\n* Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.\n* A male participant must agree to use a contraception as detailed in this protocol during the treatment period and for at least during the active treatment plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose\\] after the last dose of study treatment and refrain from donating sperm during this period.\n* The subject has a histologic or cytologic diagnosis of squamous cell carcinoma of the oropharynx, Stage 1 (T1\u002F2 N1) Squamous Cell Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a clinical laboratory improvement act (CLIA) approved laboratory.\n* Patients must not have evidence of extensive or \"matted\u002F fixed\" pathologic adenopathy on preoperative imaging.\n* The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)\u002FCT scan as appropriate, within 28 days before the first dose of therapy\n* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document\n* Criteria related to comparator drug or background therapy, if applicable: No prior radiation above the clavicles. Patients with a history of a curatively treated malignancy must be disease-free for at least two years prior to entry on study except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and\u002For non-melanomatous skin cancer\n* Age \\>= 18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol\n* Histologically or cytologically confirmed p16+ HPV-driven OPSCC\n* Availability of a representative tumor specimen for exploratory biomarker research\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (1500\u002FGL) without granulocyte colony-stimulating factor support obtained within 14 days prior to initiation of study treatment\n* Lymphocyte count \\>= 0.5 x 10\\^9\u002FL (500\u002FGL) obtained within 14 days prior to initiation of study treatment\n* Platelet count \\>= 100 x 10\\^9\u002FL (100,000\u002FGL) without transfusion obtained within 14 days prior to initiation of study treatment\n* Hemoglobin \\>= 90 g\u002FL (9 g\u002FdL) obtained within 14 days prior to initiation of study treatment.\n\n  * Patients may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) =\\\u003C 2.5 x upper limit of normal (ULN), obtained within 14 days prior to initiation of study treatment with the following exceptions:\n\n  * Patients with documented liver metastases: AST and ALT =\\\u003C 5 x ULN\n  * Patients with documented liver or bone metastases: ALP =\\\u003C 5 x ULN\n* Serum bilirubin =\\\u003C 1.5 x ULN obtained within 14 days prior to initiation of study treatment with the following exception:\n\n  * Patients with known Gilbert disease: serum bilirubin =\\\u003C 3 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN obtained within 14 days prior to initiation of study treatment\n* Serum albumin \\>= 25 g\u002FL (2.5 g\u002FdL) obtained within 14 days prior to initiation of study treatment\n* For patients not receiving therapeutic anticoagulation: international normalization ratio (INR) or activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN obtained within 14 days prior to initiation of study treatment\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Negative human immunodeficiency virus (HIV) test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>= 200\u002FuL, and have an undetectable viral load\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening. The HCV RNA test must be performed for patients who have a positive HCV antibody test\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  * Rash must cover \\\u003C 10% of body surface area\n  * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Active tuberculosis\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain\n* Patients requiring pain medication must be on a stable regimen at study entry\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\>1.5 mmol\u002FL, calcium \\>12mg\u002FdL or corrected serum calcium \\>ULN)\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy must have been treated with curative intent and must be disease free for 1 year prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment\n* Glomerular filtration rate \\\u003C 29 mL\u002Fmin\u002F1.73 m\\^2 as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation\n* An ANC \\\u003C 1.5 x 10\\^9\u002FL (1500\u002FGL) with one exception:\n\n  * Patients with benign ethnic neutropenia (BEN): ANC \\\u003C 1.3 x 10\\^9\u002FL (1300GL) BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups",{"count":328,"type":22},[83],"This phase II trial tests how well atezolizumab works in treating patients with human papillomavirus (HPV) related oropharyngeal squamous cell carcinoma that is able to be removed with surgery (resectable). Immunotherapy with atezolizumab, may include changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.",[465],"Oropharynx Cancer, Stage I","2026-08-03",{"date":421,"type":37},{"date":469,"type":37},"2023-10-27",{"date":471,"type":22},"2026-12-16",{"name":43,"class":44},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":185,"minAge":261,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":122},"100625908","phase-3-investigating-the-impact-of-glp-1-ra-therapy-on-osteosarcopenia-in-older-female-adults-with-diabetes-100625908","NCT07428746","Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes","GLOW","Inclusion Criteria:\n\n* Postmenopausal women aged 65 years or older\n* Has type 2 diabetes\n* Body Mass Index (BMI) ≥27 kg\u002Fm² to max 40kg\u002Fm2 (inclusive)\n* Hemoglobin A1c \\>7% within 3 months of the first visit.\n* Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.\n* No osteoporosis confirmed on DEXA scan within 12 months\n* Able to provide informed consent and participate in all study assessments\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D\n* eGFR \\\u003C30 ml\u002Fmin in the last 3 months\n* Patients with a history of treatment with anti-osteoporosis agents\n* Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies\n* Documented presence of prosthesis or devices in the spine or hip\n* Previous fragility fracture\n* Males\n* Moderate to severe gastroesophageal reflux disease based on patient history.\n* Inability to comply with the treatment protocol or to understand the consent form.\n* Aspartate aminotransferase (AST) \\> 3 times normal or alanine aminotransferase (ALT) \\> 3 times the normal\n* Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal or family history of multiple endocrine neoplasia type 2 syndrome.\n* Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease\n* Personal history of severe diabetic retinopathy.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.\n* Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones\n* Concomitant treatment with GLP-1 receptor agonist therapy\n* Long-term intravenous, oral, and intra-articular administration of high-dose corticosteroids within 2 months before screening (more than 7 days in a row)\n* Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage\n* Incarcerated individuals",{"count":328,"type":22},[25],"The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes.\n\nThe main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength.\n\nParticipants will:\n\n* Receive GLP-1 RA therapy as part of their routine clinical care\n* Complete muscle strength assessments (hand grip strength, Timed Up and Go test)\n* Provide blood samples for bone turnover markers\n* Undergo bone mineral density testing",[266],[485,486,487,488,489,490],"GLP-1 Receptor analogs","Semaglutide","DEXA","Osteosarcopenia","Bone Mineral Density","Bone turnover markers","2026-07-30",{"date":466,"type":37},{"date":494,"type":37},"2026-05-07",{"date":496,"type":22},"2028-11",{"name":43,"class":44},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":505,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":516,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":45},"100564069","phase-1-atovaquone-combined-with-radiation-in-children-with-malignant-brain-tumors-100564069","NCT06624371","Atovaquone Combined With Radiation in Children With Malignant Brain Tumors","AflacBT2303","Inclusion Criteria:\n\n-Stratum 1\n\n* Newly diagnosed pHGG\u002FDMG\u002FDIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline glioma with altered H3K27 (DMG, WHO Grade 4). Primary pHGG or DMG spinal tumors are eligible. Diffuse intrinsic pontine glioma (DIPG) defined by MRI does not require histological confirmation.\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Adequate liver function defined as:\n\n  * Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  * AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\> 1,000\u002FmcL\n  * platelets \\> 100,000\u002FmcL\n  * hemoglobin \\> 8g\u002FdL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 5 x (\\\u003C10 x if taking steroids) the institutional upper limit of normal\n  * creatinine within normal institutional limits for age 2 OR\n  * creatinine clearance \\> 60mL\u002Fmin\u002F1.73 m for patients with creatinine levels above institutional normal\n\nStratum 2\n\n* Relapsed, progressive pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of standard radiation therapy without prior atovaquone exposure and before progression. Patients with metastatic disease are allowed for Stratum 2 only.\n\n  --Measurable disease is not necessary for enrollment study.\n* Patients must have previously undergone standard-of-care treatment including surgery, radiation, and\u002For first-line adjuvant chemotherapy before the experimental treatment (atovaquone).\n* Patients must have recovered from the acute treatment-related toxicities (defined as \\\u003C grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study. There is no upper limit to the number of prior therapies that is allowed.\n* Age \\> 2 to 25 years\n* Weight \\> 10kg\n* Karnofsky and Lansky performance score \\> 50%\n* Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.\n* Patients must have normal organ and marrow function as defined above for Stratum 1\n* Adequate liver function is defined as:\n\n  1. Total bilirubin ≤ 2x upper limit of normal (ULN) and\n  2. AST (SGOT) and ALT (SGPT) ≤ 225 U\u002FL (5x the ULN). The ULN for AST and ALT will be 45 U\u002FL.\n\nExclusion Criteria:\n\nStratum 1\n\n* Chronic systemic concurrent illness\n* Concurrent or history of anti-cancer therapy other than RT\n* Patients with metastatic tumor are excluded for Stratum 1 only.\n* Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Symptomatic intratumoral hemorrhage, or asymptomatic intratumoral hemorrhage larger than punctate foci, at any time prior to enrollment.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.\n\nStratum 2\n\n* Concurrent illness\n* Patients must have recovered from all prior therapy as follows:\n\n  1. Patients must have received their last dose of known myelosuppressive anticancer therapy at least three (3) weeks before study enrollment or at least six (6) weeks if prior nitrosourea.\n  2. Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent ≥ 7 days before study enrollment.\n  3. Antibodies: ≥ 21 days must have elapsed from an infusion of the last dose of antibody and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1. Agents with prolonged half-lives: At least three half-lives must have elapsed before enrollment.\n  4. Immunotherapy: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses. etc.) at least 42 days before enrollment.\n  5. Radiation: Patients must have had their last fraction of • Craniospinal irradiation ≥ 3 months before enrollment. • Other substantial bone marrow irradiation ≥ 6 weeks before enrollment • Local or palliative XRT (small port) ≥ 2 weeks.\n  6. Stem Cell Transplant: Patient must be ≥ 12 weeks since autologous bone marrow\u002Fstem cell transplant before enrollment. Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.\n* Patients must fully recover from all acute effects of prior surgical intervention.\n* History of allergic reactions to atovaquone or attributed to compounds of similar chemical or biological composition to atovaquone.\n* Pregnant or breast-feeding women will not be entered into this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment. This should be documented in the electronic medical records as part of the consent discussion.","2 Years","25 Years",{"count":508,"type":22},18,[216],"The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma\u002Fdiffuse midline glioma\u002Fdiffuse intrinsic pontine glioma (pHGG\u002FDMG\u002FDIPG).\n\nThe secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG\u002FDMG\u002FDIPG and medulloblastoma (MB) or pHGG\u002FDMG\u002FDIPG after completion of RT and before progression.",[512,513,514,515],"High-grade Glioma","Medulloblastoma","Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant",[517,518],"Atovaquone","Progression-free survival",{"date":466,"type":37},{"date":521,"type":37},"2025-03-28",{"date":96,"type":22},{"name":43,"class":44},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":261,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":122},"100618796","phase-3-sleep-quality-and-the-efficacy-of-a-multimodal-sleep-pathway-in-hospitalized-orthopedic-trauma-patients-100618796","NCT07336277","Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Hospitalized with an isolated lower extremity orthopedic injury requiring surgical intervention.\n* Expected hospital stay of at least 3 days.\n* No known pre-existing sleep disorders.\n* No current use of sleep aids, such as zolpidem or melatonin, before hospitalization\n\nExclusion Criteria:\n\n* Participants with a history of chronic opioid use prior to hospitalization.\n* Pre-existing diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia).\n* Contraindications to zolpidem or melatonin use (e.g., allergies, interactions with other medications).\n* Cognitive impairment or inability to comply with study procedures.\n* Severe traumatic brain injury or other neurological conditions that may affect sleep or pain perception.\n* Participants receiving mechanical ventilation or sedatives that significantly affect sleep architecture.",{"count":81,"type":22},[25],"The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery.\n\nThe main study questions are:\n\n* Does the multimodal sleep pathway improve sleep quality and duration?\n* Does the pathway reduce the amount of opioids patients use during hospitalization?\n* Does improved sleep reduce pain interference with daily activities?\n\nResearchers will compare the multimodal sleep pathway to standard postoperative care to see if the pathway helps patients sleep better and rely less on opioids.\n\nParticipants will:\n\n* Receive either the multimodal sleep pathway (zolpidem, melatonin, and sleep hygiene education) or standard care\n* Wear a wrist-worn actigraphy device to track sleep during their hospital stay\n* Complete daily questionnaires about sleep quality and pain",[534,535],"Orthopedic Trauma","Sleep Quality",[537,535,538],"Multimodal Sleep Pathway","Opioid consumption","2026-07-29",{"date":491,"type":37},{"date":542,"type":37},"2026-06-02",{"date":340,"type":22},{"name":43,"class":44},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100497386","phase-2-enfortumab-vedotin-plus-pembrolizumab-for-the-treatment-of-locally-advanced-or-metastatic-bladder-cancer-of-variant-histology-100497386","NCT05756569","Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology","Phase II Single-Arm Study of Enfortumab Vedotin (EV) Plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology","Inclusion Criteria:\n\n* Male or Female\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%)\n* Metastatic disease or unresectable locally advanced disease\n* Histologically documented variant histology (nested, microcytic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal). Variant histology tumors and non-urothelial tumors of ureter, urethra, urachus, or renal pelvis are included. Patients with mixed cell type are eligible if the predominant histology (over 50%) is variant or non-urothelial. All histological classifications will follow the 2016 WHO Classifications.\n* Untreated or having received any number of lines of prior therapy\n* Tumor tissue samples must be available for submission prior to initiation of study treatment. If not, agree to undergo biopsy\n* Patients must have measurable disease as defined by RECIST criteria 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter of \\>= 10 mm for non-nodal lesions or short axis of \\>= 15 mm for nodal lesions) on CT scan, MRI\n* Patients must have adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator\n* The effects of study drugs on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Additionally, FCBP and male subjects should use effective contraception for 6 months after the last dose. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male subjects must not donate sperm and female subjects must not donate ova from screening to 6 months after the last dose\n* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer \\>= 4 weeks before the start of study therapy\n* Life expectancy \\> 12 weeks as determined by the Investigator\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation\n\nExclusion Criteria:\n\n* The neuroendocrine histology (small cell and large cell carcinomas) and non-epithelial bladder tumors (e.g. bladder sarcoma, carcinosarcoma, paraganglioma, melanoma, primary lymphoma, and lymphoepithelioma-like carcinoma) are excluded.\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier \\[i.e. ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment\\]\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study\n* Patients with ongoing sensory or motor neuropathy grade \\>= 2\n* Prior treatment or enrollment in a study with EV or PD1\u002FPD-L1 immune checkpoint inhibitor (including maintenance therapy)\n* Known uncontrolled diabetes mellitus with glycated hemoglobin (HbA1c) \\>= 8% or HbA1c 7% to \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained\n* Active central nervous system (CNS) metastases\n* Excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for localized prostate cancer, definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within the past 24 months\n* Currently receiving systemic antimicrobial treatment for active infection or high dose steroids (\\> 10mg of prednisone or equivalent)\n* A FCBP who has a positive urine pregnancy test at baseline or within 72 hours prior to receiving first study dose. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Breastfeeding females\n* History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), known hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive), known active hepatitis C virus (defined as HCV ribonucleic acid \\[mRNA\\] \\[qualitative\\] is detected) or tuberculosis\n* History of active keratitis or corneal ulcerations\n* History of allogenic tissue\u002Fsolid organ transplant\n* Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 6 months prior to first dose of EV\u002Fpembrolizumab\n* Other uncontrolled current illness including, but not limited to, cardiac arrhythmia or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":7,"type":22},[83],"This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.",[556,557,558,559,560,561,562,563,564,565,566],"Bladder Squamous Cell Carcinoma","Locally Advanced Bladder Carcinoma","Malignant Renal Pelvis Neoplasm","Malignant Ureter Neoplasm","Malignant Urethral Neoplasm","Metastatic Bladder Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","Unresectable Bladder Carcinoma","Urachal Adenocarcinoma","Bladder Adenocarcinoma","2026-07-28",{"date":539,"type":37},{"date":570,"type":37},"2023-09-26",{"date":572,"type":22},"2027-12-16",{"name":43,"class":44},4,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":583,"maxAge":212,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":594,"locationsCount":45},"100243479","phase-1-arginine-therapy-for-the-treatment-of-pain-in-children-with-sickle-cell-disease-100243479","NCT02447874","Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease","Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease","R34 pK\u002FPD","Inclusion Criteria:\n\n* Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia\n* 7-21 years of age\n* Weight \\>= 25kg (55lbs)\n* Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.\n\nExclusion Criteria:\n\n* Decision to discharge home from acute care setting.\n* Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)\n* Hemoglobin less than 5 gm\u002FdL\n* Immediate Red cell transfusion anticipated\n* Renal dysfunction: Creatinine \\>1.0 or 2 x baseline\n* Mental status or neurological changes\n* Acute stroke or clinical concern for stroke\n* Pregnancy\n* Allergy to arginine\n* Previous hospitalization \\\u003C 7 days\n* Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days\n* Not an appropriate candidate in the investigator's judgement","7 Years",{"count":585,"type":22},21,[216,83],"The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.",[167],"2026-07-27",{"date":539,"type":37},{"date":592,"type":4},"2015-05",{"date":295,"type":22},{"name":43,"class":44},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":76,"sex":18,"minAge":261,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":608,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":122},"100638705","inspiring-seniors-towards-exercise-promotion---2-100638705","NCT07629739","Inspiring Seniors Towards Exercise Promotion - 2","iSTEP-2","Inclusion Criteria:\n\n* Adults over 65 years old.\n* Ambulatory without pain or the use of assisted walking devices.\n* Able to speak and read English.\n* Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.\n* Living in the community for the duration of the study (9-10 months).\n* Having a reliable means of transportation.\n* Having a safe place at home or at a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.\n* Being low-active (\\\u003C 90 min\u002Fweek of MAT and \\\u003C 2 days\u002Fweek of ST for the last 3 months).\n\nExclusion Criteria:\n\n* Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity\n* Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular\u002Fmetabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.\n* Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.\n* Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.\n* Stroke or neural impairment in the past 6 months, as self-reported on the PAR-Q+.\n* Hip\u002Fknee\u002Fspinal fracture or surgery in the past 6 months, determined by self-report on the ACSM Health Screening Questionnaire.\n* Unable or unwilling to attend intervention classes, as determined by phone screening.\n* Currently participating in any other exercise or fitness-related research study, determined by phone screening.\n* Use of medications for cognitive impairment, as self-reported on the medication survey.\n* Initiation or change in dosage of psychiatric medications (e.g., antidepressants, anxiolytics) within the past 8 weeks; participants must be on a stable dose for at least 2 months before enrollment and intend to maintain this dose throughout the 8-month study period.\n* Self-report regularly drinking \\> 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.\n* Current regular or hazardous use of illicit substances, or misuse of prescription medications, that occurs on a weekly or more frequent basis, or any substance use that, in the judgment of the investigator, would systematically confound weekly affective assessments or compromise safety during unsupervised exercise training, determined by self-report to screening surveys\n* Cannot ambulate without a walker\u002Fcane, assessed in the American College of Sports Medicine (ACSM) Health Screening Questionnaire\n* Having cognitive impairment, determined by the Montreal Cognitive Assessment (MoCA) BLIND \\\u003C 17.\n* Meet the threshold for clinical depression, determined by the Center for Epidemiological Studies Depression Scale Revised (CESD-R).\n* Uncorrected hearing or visual impairments, self-reported on the Health History Questionnaire.\n* Unable to understand the study procedure.\n* One of the household members is participating in this study, as self-reported during phone screening.",{"count":603,"type":22},150,[57],"Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment). Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program. The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.",[607],"Old Age",[609,113,610,611],"Physical Activity","Music","Cognitive decline prevention","2026-07-22",{"date":614,"type":37},"2026-07-23",{"date":616,"type":37},"2026-05-26",{"date":618,"type":22},"2028-08-31",{"name":43,"class":44},""]