[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Florida\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":649},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,196,0,25,[9,48,77,107,130,150,182,204,223,243,263,293,320,346,364,388,409,432,459,488,513,531,558,583,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644726","cross-system-effects-of-acute-intermittent-hypercapnia-based-interventions-in-pd-100644726",false,"NCT07674264","Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD","A Pilot Study of Acute Intermittent Hypercapnia-Based Interventions on Upper Airway and Axial Motor Function in Parkinson's Disease","Inclusion Criteria:\n\n1. adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)\n2. diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4\n3. medically stable with physician clearance\n4. ability to ambulate at least 10 feet with\u002Fwithout assistance\n5. ability to follow directions\n6. willing to abstain from blood donation for the duration of the study\n\nExclusion Criteria:\n\n1. additional neurologic conditions\n2. severe illness or infection, including respiratory\u002Fcardiovascular\u002Flung disease, or uncontrolled hypertension\n3. inspiratory stridor\n4. pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded\\*\n5. cigarette smoking or vaping within 5 years\n6. history of head\u002Fneck\u002Flung cancer with the exception of basal cell carcinoma\n7. is currently participating in another research study that could influence the results from this study\n8. has deep brain stimulation electrodes implanted or has a history of deep brain stimulation\n9. faints or becomes lightheaded at the sight of blood\n\n   * If a female of childbearing potential indicates there is a chance she could be pregnant, she will be provided a pregnancy test and allowed to continue in the study if negative. This is because the fetal risks associated with intermittent hypoxia are unknown.","ALL","40 Years","75 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"NA","Parkinsonism impairs upper airway and axial motor control, leading to disordered breathing, reduced speech volume, and ineffective cough. Symptoms are poorly addressed by current therapies. This randomized pilot trial tests whether a single session of acute intermittent hypercapnic hypoxia (AIHH) or hypercapnic normoxia (AIHN) improves upper airway and axial motor function in Parkinsonism, and explores biomarker correlates of intervention responsiveness.",[28,29],"Parkinson Disease","Parkinsonism",[31,32,33,34],"Axial function","Upper airway","Breathing","Acute Intermittent Hypercapnic Hypoxia","RECRUITING","2026-08-19",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":39},"2026-08-12",{"date":43,"type":22},"2028-12-31",{"name":45,"class":46},"University of Florida","OTHER",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100641826","charge-pilot-trial-of-self-directed-use-of-resources-for-physical-activity-100641826","NCT07654868","Self-directed Use of Resources for Physical Activity","CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity","CHARGE","Inclusion Criteria:\n\n* Age 18-75\n* Reports a desire to increase physical activity level\n* Not meeting minimum aerobic PA as indicated by L-CAT endorsement indicating level of activity below moderate (moderate defined as \\>= 5x\u002Fweek activity or higher)\n* Reports willingness to use LLMs to help with exercise goals.\n* Access to internet through phone data plan or home Wi-Fi.\n\nExclusion Criteria:\n\n* Conditions warranting more extensive supervision of physical activity, including:\n\n  * Any history of MI or stroke, arrhythmias, or heart failure\n  * Uncontrolled hypertension\n  * Type 1 or 2 diabetes\n  * COPD or asthma\n  * Recent orthopedic surgery or fracture\n  * Advanced Parkinson's\n  * Pregnant or planning to become pregnant in next 9 months\n  * Active cancer undergoing treatment\n  * Recent major surgery (\\\u003C12 weeks)\n  * Use of assistive devices for ambulation\n  * History of eating disorder diagnosis\n* Dementia diagnosis\n* Unable to read on own.\n* Hospitalization for mental health reasons in past year\n* Has used LLM to support physical activity goals in prior 3 months.\n* Currently enrolled in a structured program to promote physical activity or weight loss.","18 Years",{"count":58,"type":22},39,[25],"This is a pilot RCT examining physical activity outcomes at 3 months across 3 conditions: use of large language model (LLM) fully self-directed; use of LLM with guidance; and use of online tools to help with sleep.",[62],"Physical Activity",[64,65,66,67,68,69],"exercise","large language model","generative AI","artificial intelligence","physical activity","chatbot","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":73,"type":22},"2026-09-01",{"date":75,"type":22},"2026-12-15",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":17,"minAge":56,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100616474","phase-2-methylphenidate-and-response-to-alcohol-cues-100616474","NCT07306078","Methylphenidate and Response to Alcohol Cues","Attentional Ability and Resilience to Alcohol Use Disorder: Neurocognitive Mechanisms: Protocol Two","Inclusion Criteria:\n\n* Adults ages 18-25 years\n* Meets DSM-5 criteria for Alcohol Use Disorder -OR- score on the Alcohol Use Disorders Identification Test (AUDIT) of \\>=8\n* Fluent in English\n* Normal or corrected to normal vision\n\nExclusion Criteria:\n\n* Meets DSM-5 criteria for psychotic disorders, neurological disorders, or substance use disorders other than Alcohol Use Disorder.\n* Participant routinely uses psychoactive drugs or medications except for non-dependent marijuana or nicotine use (due to common use of these substances in individuals with Alcohol Use Disorder).\n* Participant has contraindications for taking methylphenidate.\n* Participant has contraindications for being in an MRI machine\n* Self-reported history of high blood pressure over 140\u002F90 or consistent readings of 140\u002F90 or above upon arrival for a session.\n* History of seizure disorder\n* Liver disease\n* Participant is currently pregnant or trying to become pregnant",true,"25 Years",{"count":87,"type":22},50,[89],"PHASE2","The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on neural and craving responses to alcohol cues through fMRI and behavioral testing. Participants will be involved in one remote and two in-person sessions.",[92],"Alcohol Use Disorder",[94,95,96,97,98],"fMRI","methylphenidate","ritalin","attention","alcohol",{"date":100,"type":39},"2026-08-20",{"date":102,"type":22},"2026-10",{"date":104,"type":22},"2028-08",{"name":45,"class":46},1,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":106},"100599090","effects-of-photobiomodulation-on-inflammation-and-chronic-pain-in-knee-osteoarthritis-epic-ko-100599090","NCT07079969","Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis (EPIC-KO)","Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis","EPIC-KO","Inclusion Criteria:\n\n* Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months\n* Average knee-pain intensity ≥ 30\u002F100 on both the Daily Symptom Diary (DSD) run-in and CATI\n* Age ≥ 50 years\n* Ability to give informed consent, attend visits, and complete ≥ 4 of 7 DSD entries pre-randomization\n* Capacity to perform all study tasks (Timed Up-and-Go, knee OA assessments, blood draw, questionnaires, etc)\n\nExclusion Criteria:\n\nSystemic and Rheumatic Disease\n\n* Active systemic rheumatic condition (e.g., rheumatoid arthritis, systemic lupus erythematosus)\n* Fibromyalgia with pain outside the knee that is equal to or worse than knee pain\n\nMusculoskeletal History\n\n* Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)\n* Knee surgery within the past 6 weeks\n* Intra-articular injection to the index knee within the past 14 days\n\nMedication Use\n\n* Daily opioid therapy\n* Hypersensitivity to PBM\n* Migraine triggered by light\n* Open wounds, skin infections, eczema, burns, or other dermatologic conditions at or near the treatment application site.\n* New prescription or OTC analgesic, non-pharmacologic pain therapy, chemotherapy, or radiation therapy initiated ≤ 30 days before screening\n\nCardiovascular Safety\n\n* Uncontrolled hypertension (SBP \\> 150 mmHg or DBP \\> 95 mmHg)\n* Unstable or activity-limiting cardiovascular or peripheral arterial disease\n\nNeurological and Psychiatric Conditions\n\n* Diagnosed neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)\n* History or evidence of stroke or moderate-severe traumatic brain injury\n* Serious psychiatric illness requiring hospitalization within the past 12 months\n* Active suicidal ideation\n* Current substance-use disorder or past hospitalization for substance-use treatment\n\nDermatologic Conditions\n\n* Compromised skin integrity at or near the treatment site (e.g., open wounds, active rash, dermatitis, burns, ulcers, eczema, infection) interfering with topical treatment or PBM\n\nOther Metabolic Conditions\n\n* Uncontrolled diabetes\n* Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)\n\nOther Pain Conditions\n\n* Chronic pain at another body site more severe than knee pain\n\nGeneral Health and Cognition\n\n* Pregnancy or lactation\n* Cognitive impairment that precludes informed consent or task participation","50 Years","99 Years",{"count":118,"type":22},30,[25],"This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.",[122],"Chronic Knee Pain","2026-08-18",{"date":100,"type":39},{"date":126,"type":22},"2026-09",{"date":128,"type":22},"2027-09",{"name":45,"class":46},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":84,"sex":17,"minAge":56,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":106},"100652541","phase-1-a-double-blinded-study-on-rapid-and-sustained-pain-relief-topical-cannabidiol-for-plantar-fasciitis-100652541","NCT07776405","A Double-Blinded Study on Rapid and Sustained Pain Relief Topical Cannabidiol for Plantar Fasciitis","Topical Cannabidiol for Plantar Fasciitis: A Double-Blinded Study on Rapid and Sustained Pain Relief","Inclusion Criteria:\n\n* Patients aged 18-85\n* Clinical diagnosis of plantar fasciitis by a qualified provider\n* Symptomatic for at least four weeks with plantar heel pain consistent with plantar fascia involvement\n* Baseline average pain score that meets eligibility threshold as defined in the protocol (?)\n* Willing to apply assigned cream once daily and attend needed visits (?)\n\nExclusion Criteria:\n\n* Special populations and consent limitations. Pregnancy, breastfeeding, prisoners, inability to provide informed consent, or inability to complete study procedures\n* Contraindications to topical products or CBD. History of allergy or sensitivity to cannabinoids, excipients, or topical creams used in the study\n* Confounding dermatologic conditions at the application site. Open wounds, active infection, dermatitis, ulceration, or recent burns on the heel or midfoot\n* Recent or planned procedures that alter outcomes. Corticosteroid injection, platelet rich plasma, surgery, immobilization, or shockwave therapy within the protocol washout window\n* Concurrent therapies that confound pain outcomes. Routine use of systemic opioids, regular use of nonsteroidal anti-inflammatory drugs beyond rescue parameters, new analgesic starts during the study, or use of other topical analgesics on the study area","85 Years",{"count":87,"type":22},[140],"PHASE1","This prospective, double-blinded, placebo-controlled study evaluates the efficacy of a 6000 mg transdermal CBD cream in adults with plantar fasciitis. Fifty participants will apply either CBD or placebo once daily for one month.",[143],"Plantar Fasciitis","2026-08-17",{"date":100,"type":39},{"date":73,"type":22},{"date":148,"type":22},"2027-03-31",{"name":45,"class":46},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":106},"100651962","multiparametric-lung-mri-with-diffusion-weighted-imaging-in-lung-rads-4-lesion-characterization-100651962","NCT07768046","Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization","Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization: A Single-Center Prospective Diagnostic Accuracy Study","Inclusion Criteria:\n\n1. Age 50 to 80 years, inclusive.\n2. At least a 20 pack-year cigarette smoking history, and currently smoking or quit within the past 15 years (2021 USPSTF lung cancer screening eligibility).\n3. Underwent a standard-of-care lung cancer screening low-dose chest CT (LDCT) at the University of Florida that was assigned Lung-RADS category 4 (4A, 4B, or 4X) per ACR Lung-RADS v2022.\n4. Able to provide written informed consent independently.\n\nExclusion Criteria:\n\n1. Part-solid or cystic nodule with a solid component measuring less than 8 mm.\n2. Endobronchial nodule.\n3. MRI-incompatible or potentially MRI-incompatible implanted device.\n4. Claustrophobia that would prevent the participant from tolerating the MRI examination.\n5. Metallic device in the chest wall or spine that may interfere with adequate image acquisition in the field of view (assessed case by case).\n6. History of prior lung resection for a benign condition that may create susceptibility artifact in the field of view.\n7. Home oxygen supplementation.\n8. Active or treated lower respiratory tract infection within the prior 4 weeks.\n9. Lack of capacity to consent.","80 Years",{"count":118,"type":22},"OBSERVATIONAL","This study evaluates whether multiparametric chest magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI), performed without any contrast material, can distinguish malignant from benign lung lesions that were assigned Lung-RADS category 4 on a standard-of-care lung cancer screening low-dose CT.\n\nParticipants who have a Lung-RADS 4 lesion on screening CT undergo one non-contrast research MRI of the chest at 3.0 Tesla. The MRI is added to standard care; no standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants then continue routine clinical management, and the final nature of the lesion is established from pathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up.\n\nThe primary measure is the sensitivity and specificity of multiparametric MRI against that final diagnosis. Secondary measures include whether DWI alone performs as well as the full MRI protocol, how MRI compares with PET\u002FCT in participants who had PET\u002FCT as part of their care, and quantitative MRI thresholds (apparent diffusion coefficient, lesion-to-spinal-cord signal intensity ratio, native T1 and T2).\n\nThis is an exploratory pilot and feasibility study. No formal power calculation was performed; the sample size is intended to support feasibility assessment, protocol optimization, and preliminary estimates of diagnostic performance.",[162,163,164,165],"Solitary Pulmonary Nodule","Multiple Pulmonary Nodules","Lung Neoplasms","Lung Cancer Screening",[167,168,169,170,171,172,173,174,175],"Lung-RADS 4","diffusion-weighted imaging","apparent diffusion coefficient","multiparametric MRI","lung cancer screening","low-dose CT","pulmonary nodule","diagnostic accuracy","non-contrast MRI",{"date":36,"type":39},{"date":178,"type":22},"2027-01",{"date":180,"type":22},"2032-01",{"name":45,"class":46},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":189,"minAge":56,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":106},"100631940","phase-2-optimized-neuroplasticity-enhanced-depression-one-d-transcranial-magnetic-stimulation-tms-treatment-for-female-athletes-with-co-morbid-depression-and-concussion-100631940","NCT07507214","Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion","Inclusion Criteria:\n\n* Female athletes, both recreational and professional\n* ages 18-65 years old\n* Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present\n* Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater\n* Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding individuals\n* History of seizures or epilepsy\n* Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)\n* Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)\n* History of bipolar disorder\n* Pacemakers or implanted defibrillators\n* Allergy or other contraindications to d-cycloserine\n* Other contraindications as determined by PI\n* Unable to provide informed consent due to language or other barriers\n* Incarceration\n* Biological male gender","FEMALE","65 Years",{"count":192,"type":22},35,[89,194],"PHASE3","Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits:\n\nPrevious studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.",[197,198],"Concussion","Depression",{"date":123,"type":39},{"date":73,"type":22},{"date":202,"type":22},"2028-06-01",{"name":45,"class":46},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":84,"sex":17,"minAge":56,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":106},"100460545","pain-processing-in-inflammatory-and-non-inflammatory-chronic-pain-syndromes-100460545","NCT05277025","Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes","Inclusion Criteria:\n\n* Ages 18-70\n* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM\n* Fulfills the 2010 ACR-EULAR classification criteria for RA\n* Healthy volunteers: No significant pain\u002Ffatigue\u002Fdepression\u002Fanxiety.\n\nExclusion Criteria:\n\n* Diabetes\n* Cancer\n* Advanced liver, kidney or cardiovascular disease\n* Neuropathic pain","70 Years",{"count":212,"type":22},150,"Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.",[215,216],"Fibromyalgia","Rheumatoid Arthritis",{"date":36,"type":39},{"date":219,"type":39},"2022-03-22",{"date":221,"type":22},"2027-07-28",{"name":45,"class":46},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":84,"sex":17,"minAge":56,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":106},"100447784","dysfunctional-myelopoiesis-and-myeloid-derived-suppressor-cells-in-sepsis-100447784","NCT05110937","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology Subtitle: Pathological Myeloid Activation After Sepsis and Trauma","Sepsis participant:\n\nInclusion Criteria:\n\n1. age ≥18 years\n2. meets criteria for sepsis\u002Fseptic shock by Sepsis-3 consensus criteria.\n\nExclusion Criteria:\n\n1. have disease states that predispose to significant immune system dysfunction\n2. have comorbidity burden or goals of care that preclude recovery after sepsis. These criteria include:\n\n   a. irreversible shock (death \\\u003C12 hours) b. uncontrollable surgical source of sepsis c. patients deemed to be futile care or have advanced directives limiting resuscitative efforts d. alternative diagnoses causing shock state (e.g., hemorrhage, myocardial infarction or pulmonary embolus) e. known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3 g. severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to the intensive care unit.\n3. known pregnancy\n4. enrollment \\>96 hours after suspected sepsis onset\n5. pre-hospitalization bedridden performance status (WHO\u002FZubrod score ≥4)\n6. subsequent clinical adjudication diagnosis not consistent with sepsis\u002Fseptic shock by Sepsis-3 criteria.\n7. Burn injury greater than 20% total body surface area (tBSA)\n\nTrauma Participant:\n\nInclusion Criteria\n\n1. All adults age ≥ 18 years\n2. Blunt trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \\> 15 and one of the following: i. \\> 4 units of PRBC or \\>3 units of whole blood or \\>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \\> 2 spine iii. Shock on arrival (Systolic blood pressure (SBP) \\\u003C 90)\n\nOR\n\nc. ISS \\> 15 and two of the following: i. Age \\> 55 ii. AIS \\> 2 chest iii. +ETOH (ethyl alcohol) on arrival iv. Any red blood cell transfusion in first 24 hours\n\nExclusion Criteria\n\n1. Patients not expected to survive greater than 48 hours.\n2. Prisoners.\n3. Pregnancy.\n4. Previous bone marrow transplantation.\n5. Patients with End Stage Renal Disease.\n6. Patients with any pre-existing hematological disease.\n7. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.\n8. Known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3\n9. Burn injury greater than 20% tBSA","100 Years",{"count":232,"type":22},450,"Adverse outcomes in surgical sepsis patients are secondary to dysregulated emergency myelopoiesis, and expansion of myeloid-derived suppressor cells. Here we propose to determine the underlying mechanisms behind the increased expansion of these leukocyte populations and the underlying mechanisms that drive inflammation and immune suppression.",[235,236],"Sepsis","Trauma Injury",{"date":36,"type":39},{"date":239,"type":39},"2022-01-04",{"date":241,"type":22},"2029-04-01",{"name":45,"class":46},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":250,"maxAge":230,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":106},"100500125","distal-femur-fx-orifopen-reduction-and-internal-fixation-vs-dfr-distal-femur-replacement-total-knee-arthroplasty-100500125","NCT05792189","Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)","Evaluation of the Management of Periprosthetic Distal Femur Fractures and Native Knee Distal Femur Fractures, Comparing Open Reduction Internal Fixation With Distal Femur Replacement, a Prospective Cohort Study","Inclusion Criteria:\n\n* English speaking patients\n* 55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA\u002FOA 33C or 338\u002F3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention\n\nExclusion Criteria:\n\n* Patients with an active total knee prosthetic infection\n* Patients unable to undergo surgical intervention\n* Patient with an open fracture\n* Non-English-speaking patients\n* Oncologic\u002Fpathologic fracture\n* Poly-trauma patient (or other associated major orthopaedic injuries)","55 Years",{"count":252,"type":22},100,[25],"Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)",[256],"Distal Femur Fracture",{"date":258,"type":39},"2026-08-14",{"date":260,"type":39},"2023-04-12",{"date":241,"type":22},{"name":45,"class":46},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":269,"minAge":270,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":281,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":106},"100651973","evaluating-vm100-nutritional-supplement-for-improving-quality-of-life-in-duchenne-muscular-dystrophy-patients-100651973","NCT07766980","Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients","Inclusion Criteria:\n\n* Diagnosis of DMD confirmed by genetic report\n* Age 8 years or older.\n* Stable glucocorticoid and\u002For other medication regimen for at least 3 months before enrollment and throughout study participation.\n\nExclusion Criteria:\n\n* Unstable medical conditions or significant concomitant illness.\n* Secondary condition affecting muscle function or metabolism (e.g., myasthenia gravis, endocrine disorders, mitochondrial disease).\n* Participation in another investigational clinical trial within the previous 3 months.","MALE","6 Years",{"count":272,"type":22},20,[25],"This pilot study will investigate the potential efficacy of VM100, a nutritional supplement specifically formulated for patients with DMD, on quality of life and physical symptoms. Twenty patients (aged 8 an over) will be enrolled to undergo a 10-week placebo-controlled intervention with VM100. Outcomes will include validated questionnaires and qualitative interview to assess impact on mental, cognitive and mood related measures, as well as endurance and fatigue).",[276,277,278,279,280],"Duchenne Muscular Dystrophy","Duchenne Disease","Muscular Dystrophy in Children","DMD","Muscular Dystrophy",[279,282,283,284,285],"Nutritional supplement","Quality of life","Cognitive function","Fatigue","2026-08-11",{"date":144,"type":39},{"date":289,"type":39},"2026-07-27",{"date":291,"type":22},"2028-12",{"name":45,"class":46},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":116,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":106},"100459619","novel-rna-lipid-particle-rna-lp-vaccine-for-anti-pd-1-antibody-therapy-sensitization-100459619","NCT05264974","Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* ECOG performance ≤ 2\n* Lab values within the specified ranges:\n\n  * Hemoglobin ≥ 8G\u002FDL\n  * Platelets ≥ 100 thou\u002Fcumm\n  * Absolute Neutrophil Count (ANC) ≥ 1000 thou\u002Fcumm\n  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN\n  * Creatinine clearance (CrCl) ≥ 15 ml\u002Fmin (based on modified Cockcroft and Gault formula)\n* Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles\n* Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included)\n* Written informed consent obtained from the subject.\n* Participants of childbearing potential must have a negative serum pregnancy test at screening\n* Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.\n\nAdditional eligibility criteria for subjects with melanoma:\n\n* Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:\n\n  * Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;\n  * Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;\n  * Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who:\n\n  * Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or\n  * Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.\n* Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.\n* Patients must:\n\n  * Have no contraindication to continued immune checkpoint therapy;\n  * Not have rapidly progressive disease requiring urgent alternative therapy; and\n  * Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.\n\nAdditional eligibility criteria for subjects with soft tissue sarcoma:\n\n* Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist\n* Evidence of progression or resistance to therapy as defined by the treating physician.\n* Must have measurable disease per RECIST 1.1\n* Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin\n* Evidence of unresectable stage II disease; stage III or stage IV disease\n* Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.\n\nExclusion Criteria:\n\n* Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed\n* Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy\n* Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.\n* If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.\n* Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study\n* Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.\n* Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)\n* Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety\n* Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.\n* Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells\u002Ful, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.\n* Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.\n* Symptomatic congestive heart failure (NYHA Class 3 or 4)\n* Subjects with unstable angina pectoris\n* Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment\n* Subjects who are post-splenectomy or otherwise asplenic\n* Personal history of anaphylactic reaction to previous vaccination\n* Known hypersensitivity to the active substance or to any of the excipients\n* Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment\n* Participants who are confirmed to be pregnant or breastfeeding\n* Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with sarcoma originating from bone or cartilage\n* Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.",{"count":300,"type":22},18,[140],"The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.",[304,305],"Melanoma","Soft Tissue Sarcoma",[307,308,309,310,311],"melanoma","immunotherapy","vaccines","RNA-NP","soft tissue sarcoma","2026-08-07",{"date":314,"type":39},"2026-08-10",{"date":316,"type":39},"2026-03-17",{"date":318,"type":22},"2026-12",{"name":45,"class":46},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":84,"sex":189,"minAge":85,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":335,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":106},"100619937","improving-cervical-cancer-prevention-among-women-living-with-chronic-conditions-100619937","NCT07351110","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.","PINPOINT","Inclusion Criteria:\n\nThe following eligibility criteria will be used to determine inclusion into the study:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible\n2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.\n3. Assigned sex at birth is female\n4. Have Obesity or Type 2 Diabetes\n5. Not currently pregnant (self-report)\n6. Have not given birth in the prior 12 weeks\n7. No previous history of cervical cancer\n8. No previous history of a hysterectomy\n9. Have not undergone cancer screening in the past 3 years or more\n10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).\n11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.\n12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).\n\nExclusion Criteria:\n\n* Previous history of cervical cancer\n* Total hysterectomy\n* Pregnant",{"count":272,"type":22},[25],"Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.",[332,333,334],"Diabetes","Cervical Cancer (Early Detection)","Obesity & Overweight",[336,337,338],"cervical cancer screening","self-collection","self-sampling","2026-08-06",{"date":314,"type":39},{"date":342,"type":22},"2026-08-30",{"date":344,"type":22},"2028-03-31",{"name":45,"class":46},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":84,"sex":189,"minAge":85,"maxAge":190,"enrollmentInfo":352,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":106},"100469266","project-continuity-promoting-evidence-based-cancer-screening-among-underserved-women-100469266","NCT05390567","Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women","Inclusion Criteria:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.\n2. Assigned sex at birth is female\n3. No previous history of cervical cancer\n4. No previous history of a hysterectomy\n5. Not currently pregnant (self-report)\n6. Not currently menstruating\\*\n7. Have not used any vaginal products (e.g., oil-based lubricants, antifungal, and douches) in prior 2 days\\*. Use of vaginal contraceptives, condoms and water-based lubricants are allowed.\n8. Have not given birth in the prior 12 weeks\\*\n9. Self-report they have not undergone cancer screening in the past 4 years or more OR report being past due according to provider recommended screening schedule.\n10. Self-report of using the MOC in the past, no current usual source of care OR usual source of care is a non-UFH provider and\u002For cervical cancer screening is not accessible through that provider\n11. Reside in census tracts where the Mobile Outreach Clinic travels.\n12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.\n\nExclusion Criteria:\n\n* For patients who are excluded for criterion 6, 7, and 8, the outreach team (community clinical navigator and CHW) will ask the participant if they can be re-contacted for potential future study eligibility assessment. If the participant agrees, the navigator or CHW will collect contact information to re-contact the participant at a later (pre-determined) date up to 20 weeks later for eligibility screening.",{"count":353,"type":22},800,"Project CONTINUITY (Connecting You to Care in the Community) was developed to increase adherence to cervical cancer screening regimens from initial screening to needed follow-up care by (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method (Pap\u002FHPV co-testing vs. HPV self-test collection), community clinical navigators and community health workers (CHWs), customized messages and support for patient portal access for test results and (2) implementing strategies to address social determinants of health (SDoH) that may influence an individual's ability to adhere to the screening regimen, with an initial focus on removing transportation barriers through the use of a mobile outreach clinics (MOC).",[356],"Cervical Cancer Screening Methods","2026-08-05",{"date":339,"type":39},{"date":360,"type":39},"2024-06-07",{"date":362,"type":22},"2027-12-01",{"name":45,"class":46},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":372,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":47},"100555654","phase-1-adoptive-t-cell-therapy-dc-vaccines-and-hematopoietic-stem-cells-combined-with-immune-checkpoint-blockade-in-patients-with-medulloblastoma-100555654","NCT06514898","Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma","MATCHPOINT - Medulloblastoma Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade","MATCHPOINT","Inclusion Criteria:\n\n1. Children and young adults ages 4-30 years with suspected recurrence\u002Fprogression of Group 3 or 4 (non-SHH\u002Fnon-WNT) MB since completion of definitive focal +\u002F- craniospinal irradiation who are a candidate for surgical resection or biopsy. Of the 6 evaluable subjects, a minimum of 3 slots must be reserved for patients with confirmed Group 4 MB. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence\u002Fprogression.\n2. Patients must currently be prescribed and approved to receive pembrolizumab therapy (patients who have progressed on anti-PD-1 targeting therapy but are otherwise eligible may be enrolled to receive combination with immunotherapy. Patients who have been previously treated with anti-PD-1 targeting therapy alone or in combination with other agents and discontinued for reasons other than toxicity may be enrolled).\n3. Must be a candidate for surgery\u002Fbiopsy Or tumor tissue obtained clinically, has been previously stored in a qualified site in a manner suitable for tumor RNA extraction and amplification and sample is made available to the PI.\n4. Karnofsky or Lansky Performance Status (KPS) ≥ 60% (KPS for \\> 16 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for \\\u003C 16 years of age)\n5. Adequate bone marrow and organ function as defined below:\n\n   * ANC ≥ 1,000\u002FmcL (unsupported)\n   * Platelets ≥ 100,000\u002FmcL (unsupported for at least 3 days)\n   * Hemoglobin ≥ 9 g\u002FdL (may be supported)\n   * Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL\u002Fmin for patients with serum creatinine \\> 1.5 x IULN\n   * Serum total bilirubin ≤ 1.5 x IULN for age OR Direct bilirubin ≤ IULN for patients with total bilirubin \\> 1.5 x IULN for age\n   * AST (SGOT) and ALT (SGPT) ≤ 3 x IULN for age\n   * Cardiac shortening fraction ≥27% or LVEF ≥50% by echocardiogram\n   * Adequate pulmonary function defined as baseline pulse oximetry of ≥92% on room air\n6. For females of childbearing potential, negative serum pregnancy test at enrollment\n7. For women of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.\n\n   or For males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n8. Signed informed consent by patient and\u002For legally authorized representative\n\nExclusion Criteria:\n\nthis study:\n\n1. Prior discontinuation of PD-1 inhibitor treatment due to toxicity.\n2. Corticosteroids equivalent to ≥ 4mg dexamethasone daily.\n3. Known HIV, Hepatitis B, or Hepatitis C seropositive.\n4. Known active infection or immunosuppressive disease.\n5. Known autoimmune disease requiring medical management with immunosuppressant.\n6. Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.\n7. Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).\n8. Known severe, active co-morbidity, defined as follows:\n\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization.\n   * Transmural myocardial infarction within the last 6 months.\n   * Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment.\n   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy.\n   * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n   * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n   * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.","4 Years","30 Years",{"count":375,"type":22},12,[140],"This is a pilot study in a small number of children and young adults with suspected recurrent\u002Fprogressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.",[379,380],"Recurrent Group 3 Medulloblastoma","Recurrent Group 4 (Non-SHH\u002FNon-WNT) Medulloblastoma","2026-08-04",{"date":312,"type":39},{"date":384,"type":39},"2025-05-05",{"date":386,"type":22},"2028-12-01",{"name":45,"class":46},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":395,"maxAge":210,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":106},"100446194","the-path-study-cognitive-and-inflammation-targeted-gut-brain-interventions-in-alcohol-probiotics-alcohol-transcutaneous-vagus-nerve-stimulation-and-hiv-study-100446194","NCT05090267","The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study","Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study","Inclusion Criteria:\n\n* Age 35-70 years\n* English or Spanish speaking\n* Alcohol users\n* Cognitive impairment\n* Current CD4\\>350\n\nExclusion Criteria:\n\n* Diagnosed major psychiatric illness\n* Consumption of over 300 drinks in the past 30 days\n* Recent opioid use\n* Lifetime history of medically-assisted alcohol detoxification\n* Inpatient or intensive treatment for addictive behaviors in the past 12 months\n* MRI contraindications\n* Current antibiotic treatment\n* Current probiotic use\n* Physical impairment precluding motor response or lying still.","35 Years",{"count":397,"type":22},80,[25],"This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.",[401,402],"Cognition","Gut Microbiome",{"date":339,"type":39},{"date":405,"type":39},"2022-06-01",{"date":407,"type":22},"2026-12-30",{"name":45,"class":46},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":116,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100526719","dental-child-interaction-training-100526719","NCT06138405","Dental-Child Interaction Training","Implementing Evidence-based Behavioral Skills in Pediatric Oral Healthcare Providers","DCIT","Inclusion Criteria:\n\nDental Providers\n\n* Licensed dentist, licensed or certified dental hygienist, or dental assistant\n* Provides (or willing to consider providing) dental treatment for children between 2 years and 10 years old -\\>= 18 years old\n* Fluent in spoken and written English\n* Willing to be videotaped\n\nParent\u002FCaregivers\n\n* Understands spoken and written English\n* Willing to be videotaped\n* Provide signed and dated informed consent form\n* Willing to comply with all study procedures and be available for the duration of the study\n\nChild Dental Patients\n\n* Child between 2 years, 0 months, and 0 days, and 10 years, 11 months, 30 days old\n* Receiving preventive, restorative, emergency or any other dental treatment\n* Accompanied by a parent\u002Fcaregiver\n* Understands spoken and written English\n* Willing to be videotaped\n* Parent\u002Fguardian provides signed and dated informed consent form\n* Provide assent (if 7+ years old and who do not have an obvious cognitive impairment or are \"mentally immature\")\n* Willing to comply with all study procedures and be available for the duration of the study\n* In good general health as evidenced by medical history\n\nExclusion Criteria:\n\n* Cognitive impairment or developmental delay\n* Major medical problem in child\n* Autism or other developmental\u002Fneurodevelopmental disorders\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.",{"count":418,"type":22},5808,[25],"The goal of this behavioral, interventional clinical trial is to provide a specialized workshop training for dental providers (e.g., dentists, hygienists, assistants) to improve interactions with young children (2-10 years old) and parents\u002Fcaregivers. The training is derived from a well-established behavior management program for preschoolers, Parent-Child Interaction Therapy (PCIT).\n\nThe main questions it aims to answer are:\n\n* Change in behavior of dental providers\n* Acceptability of training by dental providers\n\nAll participants will receive the same behavior training; however, one group will receive the training on a delayed schedule. Researchers will compare the immediate intervention and control group to see if the training was effective in the dental providers usage of skills.",[422,423],"Behavior and Behavior Mechanisms","Child Behavior","2026-08-03",{"date":357,"type":39},{"date":427,"type":39},"2026-04-03",{"date":429,"type":22},"2029-08-31",{"name":45,"class":46},4,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":438,"targetDuration":440,"studyType":159,"phases":4,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":106},"100650327","respiratory-limb-muscle-properties-and-physical-performance-in-adult-lung-transplant-recipients-100650327","NCT07747337","Respiratory, Limb Muscle Properties, and Physical Performance in Adult Lung Transplant Recipients","Inclusion Criteria:\n\n* 18 years or older.\n* Hospitalized as potential candidates for single- or bilateral-lung transplant surgery.\n* Hemodynamically stable for out-of-bed mobilization\n\nExclusion Criteria:\n\n* Baseline cognitive impairment\n* History of previous solid organ transplantation or thoracic surgery\n* Existing phrenic nerve lesion\n* Lower limb amputation or fracture\n* External fixators or open wounds of the lower extremities\n* Diagnosed neuromuscular disorder.\n* Morbid obesity (body mass index \\>45 kg\u002Fm²).\n* Any other medical condition that, in the opinion of the investigators, would make participation unsuitable.",{"count":439,"type":22},36,"3 Months","The goal of this observational study is to evaluate respiratory and limb muscle properties in adults awaiting lung transplantation and determine how these measures relate to physical performance, symptoms, and recovery after transplantation. Respiratory and limb muscle weakness may contribute to impaired mobility, frailty, and delayed postoperative recovery, but their specific role in lung transplant candidates is not well understood. Participants will undergo muscle ultrasound imaging at weekly basis, respiratory and limb strength testing, physical performance assessments, and symptom questionnaires once before and after transplantation. Researchers will also collect information from medical records regarding intensive care unit stay, hospital length of stay, rehabilitation participation, and postoperative recovery outcomes.",[443,444],"Lung Transplantation","End Stage Lung Disease",[446,447,448,449,450,451],"lung transplant candidates","diaphragm ultrasound","limb muscles ultrasound","respiratory muscles","quadriceps muscles","rehabilitation","2026-07-30",{"date":357,"type":39},{"date":455,"type":39},"2026-02-05",{"date":457,"type":22},"2027-07",{"name":45,"class":46},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":190,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":47},"100602581","phase-1-living-independence-through-functional-training-100602581","NCT07125378","Living Independence Through Functional Training","Living Independence Through Functional Training (LIFT): Feasibility of Hybrid Task-Oriented Resistance Exercise Following Home Health Discharge","LIFT","Inclusion Criteria:\n\n* between the ages of 65 and 90 years\n* community-dwelling\n* live within a 50-mile radius of the study site with wireless connectivity in the area\n* mobility limitations as indicated by self-reported of using a mobility aid or having unsteady gait or walking slower than before\n* cognitive decline as indicated by a score \\\u003C 12 on Mini MoCA Version 2.1\n* a care partner or adult family member living in the home or nearby\n* willing to wear an activity tracker during the study period\n\nExclusion Criteria:\n\n* plan to receive skilled rehabilitation services\n* plan to move away outside the study area in two months\n* reside in an assisted living or long-term care facility or plan to relocate to such a facility in the next three months\n* severe vision or hearing loss that impedes activity performance or communication\n* unable to stand or walk even with a mobility aid\n* unable to follow a one-step command or carry on a conversation over the phone\n* unable to commit to the six-week exercise program\n* contradictions to resistance exercise, such as the end-stage heart failure\n* a terminal disease or on hospice care\n* a neurological condition affecting motor skills\n* not able to provide consent.","90 Years",{"count":469,"type":22},15,[140,89],"The purpose of the research is to evaluate the feasibility and benefits of a six-week hybrid task-oriented resistance exercise program for older adults who have been recently discharged from home health care.",[473,474],"Mobility Limitation","Cognitive Impairment",[476,477,478,479,480,401],"Home-based intervention","Exercise","Older adults","Activities of daily living","Mobility",{"date":482,"type":39},"2026-07-31",{"date":484,"type":39},"2026-01-06",{"date":486,"type":22},"2026-12-31",{"name":45,"class":46},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":84,"sex":17,"minAge":190,"maxAge":495,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":106},"100554648","neural-control-of-gait--navigation-in-adrd-100554648","NCT06501820","Neural Control of Gait & Navigation in ADRD","Neural Control of Gait & Navigation in ADRD, Aim 3 Clinical Trial","Inclusion Criteria:\n\n* Community dwelling men and women 18-35 years old or 65-89 years old\n* Ability to walk unassisted for ten minutes\n* Willingness to undergo all testing procedures\n* English speaking Additional Inclusion Criteria for those with SCD\n* Subjective report of cognitive complaints with scores \\>16 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline (Saykin et al., 2013). This scale consists of 20 items that are rated on 5 point Likert scale, where 1= \"Normal: No change compared to 5 years ago\", 3= \"Mild Problem: Some change compared to 5 years ago) and 5=\"Severe Problem: Much worse compared to 5 years ago\".)\n* No evidence of dementia or mild cognitive impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education and sex using the NACC Uniform Data Set (UDS) norms (Weintraub et al., 2018)\\[119\\]\n* No psychometric evidence of cognitive impairment based on performance on the Neuropsychological Battery from the NACC Unified Data Set, version 3\\[119\\]. The battery includes measures of attention, recent memory, language, visuospatial, and executive function. Norms are available for over 3600 older adults \\[119\\]. Scores on these measures cannot be lower than 1.0 SD (16th %ile) below normative values based on age, education, and gender.\n* Reading at \\> 8th grade level based on the reading subtest of the Wide Range Achievement Test- IV.\n* Global Clinic Dementia Rating (CDR) score must be 0 \\[156\\]\n* Family history of dementia\u002Fprobable Alzheimer's disease in first degree relative (parents, children, siblings)\n* Normal functional behavior in terms of daily activities, based on the Functional Activities Scale\\[122\\]\n* In line with recommendations of SCD task force (Molienueva et al., 2017)\\[116\\] an informant must be available for two reasons: a) to provide information about the participant's complaints using the informant version of the CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire\\[120\\] .\n\nExclusion Criteria:\n\n* Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.)\n* Severe visual impairment or corrected visual acuity less than 20\u002F40, which would preclude completion of the assessments\n* Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal\n* tDCS ineligibility for Aim 3 (history of epilepsy, medications that alter cortical excitability, etc.)\n* History of stroke\n* Any history of clinically diagnosed traumatic brain injury resulting in \\> 1 minute loss of consciousness\n* Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer)\n* Report of lower extremity pain due to osteoarthritis that significantly limits mobility\n* Diagnosis or treatment for rheumatoid arthritis\n* Known neuromuscular disorder or overt neurological disease (e.g. Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)\n* Unable to communicate because of severe hearing loss or speech disorder\n* Planned surgical procedure or hospitalization in the next 12 months (joint replacement, coronary artery bypass graft, etc.)\n* Severe pulmonary disease, requiring the use of supplemental oxygen\n* Terminal illness, as determined by a physician\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Is planning to move out of the area during the follow up period\n* Use of walker or wheel chair\n* Failure to provide informed consent","89 Years",{"count":497,"type":22},60,[25],"Brain network segregation, or independent functioning, declines with age and is associated with slower walking speed. Here, the investigators will determine the extent to which brain vestibular network segregation can be altered with bilateral vestibular cortical transcranial direct current stimulation (tDCS) in older adults with subjective cognitive decline. Participants will be randomly assigned to an active or sham stimulation condition. They will receive three, 20-minute sessions of tDCS while they are walking and performing cognitive tasks. MRI of the brain will be acquired before and after these three sessions.",[501],"Aging",[503,504,505,506],"aging","subjective cognitive decline","vestibular","mobility",{"date":482,"type":39},{"date":509,"type":39},"2025-11-13",{"date":511,"type":22},"2030-05-01",{"name":45,"class":46},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":84,"sex":17,"minAge":190,"maxAge":495,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":106},"100623359","high-frequency-stimulation-to-improve-cognition-mobility-and-affect-in-individuals-with-and-without-subjective-cognitive-decline-100623359","NCT07395609","High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline","Inclusion Criteria\n\n* Community dwelling men and women 65-89 years old\n* Ability to walk unassisted for 10 min\n* English speaking Additional Inclusion Criteria for SCD\n* No evidence of dementia or MCI based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms\n* Global Clinic Dementia Rating (CDR) score must be 0 or 0.531\n* Subjective report of cognitive complaints with scores \\>20 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline6; this scale consists of 20 items that are rated on a 5-point Likert scale, where 1= \"Normal: No change compared to 5 years ago\", 3= \"Mild Problem: Some change compared to 5 years ago) and 5=\"Severe Problem: Much worse compared to 5 years ago\"\n* Family history of dementia\u002Fprobable AD in first degree relative (parents, children, siblings)\n* Normal functional behavior in terms of daily activities, based on the Functional Activities Scale In line with recommendations of the SCD task force an informant must be available for two reasons: a) to provide information about the participant's cognition using the informant version of the CDR and CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire (informant data will be collected via a phone call and linked by code with the participant data).\n\nExclusion criteria\n\n* If participants score less than 21 on the Telephone Interview for Cognitive Status (TICS)\n* Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.)\n* Severe visual impairment or corrected visual acuity less than 20\u002F40 (as per self-report), which would preclude completion of assessments\n* Inability to undergo MRI brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, certain non-removable body jewelry, or shrapnel containing ferromagnetic metal\n* History of severe stroke\n* Epilepsy or family history of epilepsy, past seizure history, as well as history of migraines\n* Current use of psychotropic medications\n* Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer)\n* Report of lower extremity pain due to osteoarthritis that significantly limits mobility\n* Diagnosis or treatment for rheumatoid arthritis\n* Known neuromuscular disorder or overt neurological disease (e.g., Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)\n* Unable to communicate because of severe hearing loss or speech disorder\n* Planned surgical procedure or hospitalization in the next 4 months (joint replacement, coronary artery bypass graft, etc.)\n* Severe pulmonary disease, requiring the use of supplemental oxygen\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Use of walker or wheelchair",{"count":497,"type":22},[25],"The goal is to determine whether three months of at least three times \u002F week of sensory flicker stimulation improves cognition, mobility, and affect in healthy older adults and older adults with and without Subjective Cognitive Decline (SCD). Investigators will also determine whether the intervention slows cortical thinning and declines in brain functional network segregation and changes in blood biomarkers of Alzheimer's Disease (AD).",[523,524],"Subjective Cognitive Decline (SCD)","Healthy Subjects","2026-07-29",{"date":424,"type":39},{"date":424,"type":22},{"date":529,"type":22},"2028-10-31",{"name":45,"class":46},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":538,"maxAge":495,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":546,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":106},"100564948","circadian-adaptive-dbs-in-essential-tremor-100564948","NCT06635811","Circadian Adaptive DBS in Essential Tremor","Circadian Adaptive Deep Brain Stimulation in Essential Tremor","Inclusion Criteria:\n\n* Diagnosis of Essential Tremor confirmed by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society\n* Patients implanted with unilateral or bilateral VIM DBS leads attached to the Medtronic Percept DBS device for the treatment of Essential Tremor\n* Patients with clinical benefit of DBS as defined by a 30% improvement on the TRS or TETRAS at least 3 months after DBS implantation\n* DBS programmed in a monopolar configuration allowing chronic brain sensing (C+1- or C+2- in ring mode or any direction)\n* Be between 21 and 89 years old\n* Ability to give informed consent for the study\n\nExclusion Criteria:\n\n* Inability to comply with the study protocol\n* Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing the study\n* Current active suicidal ideation (Yes to #2-5 on C-SSRS)\n* Any personality or mood symptoms that study personnel believe will interfere with study requirements","21 Years",{"count":7,"type":22},[25],"Deep brain stimulation (DBS) of the thalamus is an effective treatment for medically refractory essential tremor (ET). DBS involves delivering continuous stimulation to the brain through electrodes permanently implanted in the thalamus. Despite proven effectiveness, the long-term benefit of DBS can wane over time (habituation) and side effects, including paresthesia and dysarthria, often limit the amplitude of the stimulation, resulting in suboptimal control of tremor. In clinical practice, many groups advise patients to switch their devices off at night to avoid habituation and reduce side effects. However, manually turning off the device at night can result in uncontrolled tremor when the patient moves at night.\n\nThis study aims to develop an algorithm that automatically turns off stimulation when a patient is asleep, based on circadian brain signals. Turning off stimulation could potentially improve the therapy by limiting adverse effects, increasing efficacy, reducing the risk of habituation, and prolonging battery life. This study will evaluate the feasibility, safety, and tolerability of circadian adaptive DBS.",[543,544,545],"Essential Tremor","Essential Tremor (ET)","Essential Tremor, Movement Disorders",[547,548,549,550,551],"Deep Brain Stimulation","DBS","Adaptive DBS","Adaptive Deep Brain Stimulation","Circadian",{"date":452,"type":39},{"date":554,"type":39},"2025-05-01",{"date":556,"type":22},"2029-10",{"name":45,"class":46},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":106},"100482404","transdiagnostic-intervention-to-reduce-internalized-health-related-stigma-100482404","NCT05561595","Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma","HEARTS","Inclusion Criteria:\n\n* Age 18 years or older\n* Currently residing in the United States\n* At least one of the following stigmatized health conditions:\n* Obesity (or high body weight that negatively affects health)\n* Skin disease (including but not limited to psoriasis, eczema, or vitiligo)\n* Cancer (including but not limited to lung, breast, cervical, colorectal, gynecologic, prostate, or head and neck; including individuals in remission)\n* HIV\n* Type 1 or type 2 diabetes\n* Chronic pain\n* Reported internalization of health-related stigma, as determined by a pre-specified cutoff score on internalized stigma measure and confirmed by interview\n\nParticipants must have availability to attend weekly virtual group meetings for 12 weeks, followed by every-other-week and monthly meetings through 26 weeks, in the evening on a specified weekday. Participants must be willing to actively participate and share information about themselves in the group meetings.\n\nParticipants must be able to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires.\n\nParticipation requires an electronic device (computer, tablet, or phone) with video capabilities and internet, wi-fi, or cellular data in order to attend group sessions and complete study questionnaires. Individuals who do not have such devices or internet access will still be eligible to participate. In such cases, screening procedures will be conducted by phone, and randomized participants will be provided with web cameras or internet-enabled devices (and\u002For provided with pre-paid cellular data) to facilitate participation.\n\nExclusion Criteria:\n\n* Current or recent (e.g., past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention (exceptions may be made if therapy or support is not focused on health conditions and is unlikely to affect internalized health-related stigma; e.g., family or marriage counseling, religious study groups, etc.)\n* Psychiatric hospitalization in the past 6 months\n* Recent (e.g., past 3 months, approximately) change in medications taken for psychiatric reasons\n* Current, active suicidal thoughts or suicide attempt within the past year\n* Current or past thought disorder or psychosis, or unmanaged bipolar disorder\n* Current alcohol\u002Fsubstance use disorder that requires immediate treatment\n* Health-related stigma due primarily to mental illness or substance use, or due to health conditions not specified in inclusion criteria.\n* No reported internalization of health-related stigma and\u002For score below pre-specified cutoff on internalized stigma measure\n* Unwilling or unable to complete study procedures\n\nParticipants with severe progression of disease (e.g., end-of-life) or who are undergoing acute, intensive treatment (such as chemotherapy or radiation therapy) will not be eligible to participate due to expected impacts on HRQOL and greater needs for psychological support than the intervention is intended to provide. Such participants may be eligible after completion of acute treatment or if severe symptoms remit and\u002For prognosis improves.",{"count":566,"type":22},195,[25],"Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life.",[570,571,572,573,332,574],"Obesity","Skin Disease","Cancer","HIV","Chronic Pain","2026-07-23",{"date":577,"type":39},"2026-07-24",{"date":579,"type":39},"2024-10-03",{"date":581,"type":22},"2027-06-30",{"name":45,"class":46},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":210,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":594,"conditions":595,"keywords":603,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":611,"leadSponsor":613,"locationsCount":47},"100609792","early-phase-1-kava-aging-and-mobility-study-100609792","NCT07219186","Kava Aging and Mobility Study","Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study","Inclusion Criteria:\n\n* Age \\> 70 years\n* 8 ≤ Insomnia severity index (ISI) ≤21\n* 4m walking speed \\\u003C1 m\u002Fsec and \\>0.44 m\u002Fsec\n* Mild to moderate physical impairment (Short Physical Performance Battery score \\\u003C 10)\n* Sedentary lifestyle (\\\u003C 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire\n* Willingness and ability to give informed consent\n* Willingness to be randomized to the intervention groups\n* Availability for participation through duration of study Exclusion Criteria (General)\n* Failure to provide informed consent\n* History or clinical manifestation of diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)\n* Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal)\n* Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed\n* Self-reported inability to walk one block\n* Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental Status Exam score \\\u003C 24\n* Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)\n* Terminal illness with life expectancy less than 12 months, as determined by a physician\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Severe pulmonary disease, pneumonitis or interstitial lung disease\n* Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)\n* Current use of antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept)\n* Refuses to reduce alcohol use to 3 or fewer alcoholic drinks per week during the study\n* Planning to permanently leave the area in the next year\n* Blood pressure readings \\>180\u002F100 at screening\n* Participating in another clinical trial or has received an investigational product within 30 days prior to screening\u002Fenrollment.\n\nExclusion Criteria (AB-free kava-related)\n\n* Regular use of any medications that contain acetaminophen\n* Current use of any forms of kava and not willing to stop for a 2-week washout period - dietary supplements or beverages\n* Current use of antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)\n* Diagnosed with liver dysfunction or with previous liver diseases during the past five years\n* Levels of ALT, AST, ALP or total bilirubin over 3xlimit of normal (ULN) range at prescreen\n\nTemporary Exclusion Criteria\n\n* Acute infection (urinary, respiratory, other) or hospitalization within 1 month\n* Myocardial infarction, CABG, or valve replacement within past 6 months\n* Pulmonary embolism or deep venous thrombosis within past 6 months\n* Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months\n* Receiving physical therapy for gait, balance, or other lower extremity training",{"count":591,"type":22},40,[593],"EARLY_PHASE1","The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. The main questions it aims to answer are:\n\n* Does AB-free kava improve physical function and\u002For mobility?\n* Does AB-free kava effect sleep, stress, or cellular signaling? Researchers will compare AB-free kava to a placebo (a look-alike substance that contains no drug) to see if AB-free kava works to improve mobility and physical functioning.",[596,597,598,599,600,601,602],"Old Adults","Sleep Quality","Kava","Mobility Impairment","Physical Activity and Stress","Physical Impairment","Sedentary Lifestyle in Patients Over 70",[604,605,606,607],"AB-free Kava","Old adults","Sleep Difficulties","Mobility Limitations","2026-07-21",{"date":575,"type":39},{"date":178,"type":22},{"date":612,"type":22},"2027-05",{"name":45,"class":46},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":230,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":106},"100596191","the-florida-ascent-study-100596191","NCT07042243","The Florida ASCENT Study","The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)","Patient Eligibility Inclusion Criteria:\n\n1. ≥18 years old.\n2. Pathologically confirmed diagnosis, with a focus on, but not limited to, colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancers.\n3. Self-reported ability to read and speak English.\n4. Able to provide informed consent.\n\nPatient Eligibility Exclusion Criteria:\n\n1. ≤18 years old.\n2. Does not have a pathologically confirmed diagnosis of cancer.\n3. Currently receiving active cancer treatment (e.g., active chemotherapy, radiation therapy or stem cell transplant); patients on stable maintenance therapy are eligible (e.g., endocrine therapy, targeted therapy, or select immunotherapy).\n\n3\\) Does not live within the state of Florida. 3) Does not self-reported ability to read and speak English or Spanish. 4) Not able to provide informed consent.\n\nProvider Eligibility Inclusion Criteria\n\n1. ≥18 years old.\n2. Currently works as a physician, physician assistant, patient navigator and\u002For health system\u002Fadministrative leader in UF and UM affiliated clinics.\n3. Self-reported ability to read and speak English or Spanish.\n4. Able to provide informed consent.\n\nProvider Eligibility Exclusion Criteria\n\n1. ≤ 18 years old.\n2. Does not currently works as a physician, physician assistant, patient navigator and\u002For health system\u002Fadministrative leader in UF and UM affiliated clinics.\n3. Does not self-report having the ability to read and speak English.\n4. Not able to provide informed consent.",{"count":252,"type":22},[25],"The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer.\n\nThe main hypotheses it aims to test are:\n\n* At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care.\n* At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness.\n\nResearchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality.\n\nPhase 1\n\nPatient Participants will:\n\n* Complete the ASCENT Questionnaire, which is comprised of the following:\n\n  * U.S. Food Security Survey Module (U.S. FSSM)\n  * Patient-Reported Outcomes Measurement Information System (PROMIS-29)\n  * General Self-Efficacy Scale (GSE)\n* Complete the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool a total of 4 times.\n* Be assessed using the Veggie Meter instrument\n* Participate in two semi-structured interviews\n\nProvider Participants will:\n\n•Participate in one semi-structured interview\n\nPhase 2\n\nPatient Participants will:\n\n* Participate in ASCENT patient navigator screenings and consultations\n* Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®",[572,625,626,627,628,629,630,631,632,633,634,304,635,636],"Food Deprivation","Food Habits","Food Selection","Colorectal Cancer","Prostate Cancer","Lung Cancer","Breast Cancer","Gynecologic Cancer","Hematologic Cancer","Skin Cancer","Nutrition Poor","Nutritional Deficiency",[638,572,639,640,641,642],"Food Insecurity","Food Access","Community-Informed Research","Nutritional Needs","Mixed-Methods",{"date":575,"type":39},{"date":645,"type":39},"2025-12-05",{"date":647,"type":22},"2027-08",{"name":45,"class":46},""]