[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VA Greater Los Angeles Healthcare System\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":138},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,76,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100595345","evidence-based-quality-improvement-to-reduce-va-primary-care-burnout-100595345",false,"NCT07031245","Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout","Reducing Burnout Among VA PCPs Using Evidence-Based Quality Improvement","Site Inclusion Criteria:\n\n* 5 primary care clinics (2 VA Medical Centers \\[VAMCs\\] and 3 community-based outpatient clinics \\[CBOCs\\]) in 2 VA healthcare systems in 1 VA Veterans Integrated Service Network\n\nProvider and Staff Inclusion Criteria:\n\n* Primary care providers, registered nurses, clinical associates (e.g., licensed vocational or practical nurses), or administrative associates (e.g., clerks) on regular Patient-Aligned Care Team (PACT) teamlets at a study site.\n\nSite Exclusion Criteria:\n\n* All other VAMCs and CBOCs.\n\nProvider and Staff Exclusion Criteria:\n\n* Other primary care professionals at a study site.\n* Members of special types of PACT teamlets at a study site.",true,"ALL",{"count":19,"type":20},203,"ESTIMATED","INTERVENTIONAL",[23],"NA","Burnout is highly prevalent among VA primary care providers and staff, impairing productivity and retention, as well as safety, quality, and patient experience. In this pilot trial, the investigators will facilitate the development of burnout reduction interventions using an evidence-based quality improvement (EBQI) approach, and then evaluate the feasibility, acceptability and effectiveness of a pilot EBQI-facilitated burnout reduction intervention in a modified stepped wedge design in one VA region.",[26,27],"Burnout","Burnout Syndrome",[29,30,31,32,33,34],"primary care","VA","burnout","EBQI","evidence-based","quality improvement","RECRUITING","2025-09-17",{"date":38,"type":39},"2025-09-23","ACTUAL",{"date":41,"type":20},"2025-10-01",{"date":43,"type":20},"2028-09-30",{"name":45,"class":46},"VA Greater Los Angeles Healthcare System","FED",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100587738","integrating-metabolic-and-vascular-sensors-to-monitor-cardiometabolic-disorders-after-nutrition-interventions-100587738","NCT06932289","Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions","Inclusion Criteria:\n\n* United States Veterans\n* Male or female, age 18-55 years at the time of signing informed consent.\n* at least 2 of the following: waist circumference \\> 40\" for men and 35\" for women, FBS \\>100 mg\u002Fdl, triglycerides \\> 150 but \\\u003C 500 mg\u002FdL, HDL \\\u003C 40 mg\u002FdL, Pre- hypertension or hypertension (BP\\>120\u002F80 mmHg but \\\u003C150\u002F90 mmHg)\n\nExclusion Criteria:\n\n* History of diabetes require medications\n* History of alcohol intake ≥ 20g\u002Fday\n* History of cirrhosis\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \\\u003C30 mL\u002Fmin\u002F1.73 m2\n* History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.\n* Any unstable medical conditions or terminal diagnosis.\n* Any participant who is unwilling to sign an informed consent form will not be admitted into the study.","18 Years","55 Years",{"count":57,"type":20},54,[23],"It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.",[61],"NAFLD (Nonalcoholic Fatty Liver Disease)",[63,64,65],"NAFLD","metabolic responses","mixed meal challenge","NOT_YET_RECRUITING","2025-04-09",{"date":69,"type":39},"2025-04-17",{"date":71,"type":20},"2025-05-01",{"date":73,"type":20},"2029-05-01",{"name":45,"class":46},1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":54,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":75},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.","MALE",{"count":85,"type":20},15,[87],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[90,91,92,93,94,95,96,97,98,99,100],"Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","Metastatic Prostate Cancer","Male Urogenital Diseases","Prostatic Diseases","Urogenital Diseases, Male","Genital Diseases, Male","Neoplasms","Neoplasms by Site","Urogenital Neoplasms","Genital Neoplasms, Male",[102,103,104,105,106],"Prostate cancer","PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":109,"type":39},"2024-11-27",{"date":111,"type":20},"2024-12-15",{"date":113,"type":20},"2027-11-01",{"name":45,"class":46},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":83,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":75},"100374248","early-phase-1-responsive-neurostimulation-for-post-traumatic-stress-disorder-100374248","NCT04152993","Responsive Neurostimulation for Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Male aged 25-60 years.\n2. Able to give informed consent in accordance with institutional policies and participate in the 4-year follow-up, involving assessments and stimulator adjustments.\n3. Patients must be stable on their current psychotropic medication for a period of 2 months before implantation and agree to not increase dosages or add any new medications for the first 6 months of the study, unless medically necessary.\n4. Chart diagnosis of chronic and treatment-refractory PTSD as the principal psychiatric diagnosis and cause of distress and social\u002Foccupational impairment.\n5. Confirmation of PTSD as the primary psychiatric diagnosis by the study psychiatrist via clinical interview and CAPS.\n6. Minimum 5-year total illness duration, with no 6-month period of clinical remission during the 2 years prior to entry in the study.\n7. Stage 2 level of treatment resistance as per Sippel et al.136: Clinical record documented failure to respond to adequate (minimum 3 month, with adherence) trials of at least 3 of the following evidence-based treatments including at least one pharmacologic agent below, and at least one trauma-focused individual cognitive-behavior psychotherapy among the following: Pharmacologic: sertraline, paroxetine, fluoxetine or venlafaxine, at maximally tolerated FDA recommended doses. Psychotherapy: Prolonged Exposure Therapy (PE); Cognitive Processing Therapy (CPT); Eye movement Desensitization and Reprocessing (EMDR); or other form of evidence-based cognitive behavior therapy for PTSD\n8. Patients who are unable to complete trauma-focused psychotherapy may be included if they began treatment, and the cause of treatment cessation was that the risks of further treatment, including intense psychological suffering, outweighed the potential benefits of continuing the treatment.\n9. All evidence-based psychotherapy for PTSD has been completed a minimum of 3 months prior to enrolment.\n10. Minimum baseline past month CAPS-5 Score of 47, with full PTSD diagnostic criteria met, and scores of ≥ 3 on at least one item from the intrusive (CAPS-5 items 1-5) and hyperarousal (CAPS-5 Items 15-20) clusters; and this severity maintained for at least one month during the baseline period based on two separate measures.\n11. Clinically significant impairment in occupational functioning due to PTSD, manifested by one or more of the following: a) Total federal (service connected ≥ 70%), or State (SSI) disability compensation for at least the past 2 years for PTSD; b) global assessment of functioning score ≤ 45; c) no period of full time gainful employment ≥ 3 months in the past 5 years. Or clinically significant impairment in social functioning due to PTSD, manifested by one or more of the following: (i) little or no social activity outside the household other than as necessary for medical appointments, practical matters such as grocery shopping, or to interact with other veterans; (ii) reliable description by a spouse or significant other, living with the patient, of repeated avoidance\u002Frefusal to participate in customary social engagements with friends, family or for recreational activities due to PTSD; (iii) two or more verbal or physical interpersonal altercations within the past year requiring another person's intervention to prevent further escalation, or involving law enforcement.\n12. Presence in the veteran's life of a spouse, family member or friend who can confirm the symptoms and impairment from PTSD and lack of symptomatic remission in the past 2 years; participate with the study psychiatrist in answering questions about symptoms and functioning at scheduled follow-up visits; and report unexpected adverse neurological or psychiatric events to study investigators and, if advised by study investigators, assist the patient in accessing necessary services to address obtain care.\n13. Willingness to have unexpected neurological or psychiatric symptom shared with the study psychiatrists and other study clinicians.\n14. Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded).\n\nExclusion Criteria:\n\n1. Suicide attempt in the last 2 years and\u002For presence of a suicide plan (an answer of \"Yes\" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview);\n2. Unstable psychosis or bipolar disorder; significant acute or ongoing risk for violence;\n3. Patients primarily diagnosed with DSM-IV-TR Axis I disorder other than PTSD as determined by the MINI;\n4. Within the 3 months prior to enrolment, subject has started a new psychotherapy program;\n5. Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response;\n6. Current significant neurological conditions, including epilepsy, stroke, movement disorder; history of serious head injury with loss of consciousness if associated with neurological or neuropsychological deficit that could interfere with study participation or outcome assessment; or if associated with structural MRI abnormality.\n7. Uncontrolled medical condition including cardiovascular problems and diabetes;\n8. Uncontrolled chronic pain;\n9. Baseline Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 28;\n10. Use of warfarin;\n11. Significant abnormality on preoperative structural brain MRI;\n12. ECT in the past 6 months;\n13. Contraindications to MRIs or the need for recurrent body MRIs;\n14. Immunosuppression;\n15. High risk for surgery;\n16. Current pursuit of new or increased disability compensation for PTSD;\n17. Intracranial implants (aneurysm clip, shunt, cochlear implant, electrodes);\n18. Patient has had past cranial neurosurgery;\n19. Use of other investigational drugs within 30 days of baseline.\n20. Patients suffering from a neurovascular condition or other intracranial process.\n21. Patients suffering from a condition associated with a significant cognitive impairment.","25 Years","60 Years",{"count":124,"type":20},6,[126],"EARLY_PHASE1","Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation. Fear cells and extinction cells in the basolateral amygdala (BLA) alter their firing rate based on the nature of the stimulus and the influence from the medial prefrontal cortex (mPFC) and the ventral hippocampus (vHPC). Together, the BLA, mPFC, and the vHPC form an anxiety-processing network where the BLA links stimulus to emotion, the vHPC provides memory context, and the mPFC coordinates extinction or consolidation. Local field potential (LFP) recordings from the BLA have revealed specific signals that correspond to an enhanced fear state. Previous studies have shown that neuromodulation of the BLA can promote extinction in a rodent model and in a treatment-refractory PTSD patient. This action is likely carried by disrupting fear signals within the BLA; however, continuous neurostimulation may also disrupt normal function of the amygdala. The present application proposes to investigate the use of Responsive Neurostimulation (RNS, Neuropace) in six (6) veterans suffering from severe treatment-resistant PTSD. This dual-activity device will allow us to chronically record LFPs from the BLA under specific conditions such as fear conditioning, exposure to trauma reminders, and emotional memory encoding and retrieval. In addition, the neural activity will be captured during real-life symptoms of flashback and nightmares. These recordings will provide the specific electrophysiological biomarkers of hypervigilance and re-experiencing. The device will then be programmed to detect and treat these biomarkers with a pre-determined electrical pulse. The patients will be followed prospectively using psychological scales but also with functional neuroimaging and electroencephalograms. These modalities will be used to determine the extent of circuit engagement as a result of the therapy. By approaching PTSD from a fear processing mechanism perspective, our project will serve as a proof of concept for other circuit-based therapies in psychiatry. This proposal is a multi-departmental effort involving 11 investigators across 7 departments and requires a close collaboration between clinical and basic scientists. As a result, the findings underlying chronic recordings will bridge the basic science results from fear conditioning research to clinical neural processes in PTSD patients.",[129],"Post-Traumatic Stress Disorder","2024-05-24",{"date":132,"type":39},"2024-05-28",{"date":134,"type":39},"2021-03-22",{"date":136,"type":20},"2026-07-31",{"name":45,"class":46},""]