[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of California, San Diego\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":714},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,168,0,25,[9,57,98,143,166,205,233,260,288,310,343,371,395,422,448,471,497,528,555,575,595,619,641,665,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100553144","phase-1-transplantation-of-human-ips-cell-derived-dopaminergic-progenitors-ct1-dap001-for-parkinsons-disease-phase-iii-100553144",false,"NCT06482268","Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I\u002FII)","An Investigator-initiated Clinical Trial of Safety and Efficacy of Transplantation of Human Induced Pluripotent Stem Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I\u002FII)","CT1-DAP001","Inclusion Criteria:\n\n1. The subject has a diagnosis of PD (clinically established or clinically probable) in accordance with the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015).\n2. The subject has an inadequate response to drug treatments.\n3. The subject is ≥ 40 years and ≤ 75 years of age at the time of informed consent.\n4. The subject has had PD for at least 5 years.\n5. The subject has both ON and OFF (as demonstrated by the MDS-UPDRS Part III and a symptom diary).\n6. The subject does not have a debilitating dyskinesia score greater than or equal to 3 on the MDS-UPDRS.\n7. The subject is in stage 2 or higher on the Hoehn and Yahr scale at OFF time.\n8. The subject is in stage 3 or lower on the Hoehn and Yahr scale at ON time.\n9. The subject has an L-dopa response of 30% or more without influence of antiparkinsonian drugs.\n10. The subject has the following organ functions as determined by laboratory tests at Screening visit:\n\n    1. Neutrophil count ≥ 2,000\u002FμL\n    2. Platelet count ≥ 5.0 × 104\u002FμL\n    3. AST, ALT ≤ 3.0 × upper limit of normal\n    4. Total bilirubin ≤ 1.5 × upper limit of normal\n    5. eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (As part of Creatinine testing, an estimated glomerular filtration rate (mL\u002Fmin\u002F1.73 m2)will be calculated based on the CKD-EPI 2021 equation)\n11. The subject is willing to avoid pregnancy using abstinence, highly effective means of birth control, surgical sterility, or menopause.\n12. The subject is willing to comply with the protocol-required assessments.\n13. The subject provides written informed consent to participate in the study. If the subject cannot sign due to physical constraints, verbal consent may be provided with signature of a Legally Authorized Representative.\n\nExclusion Criteria:\n\n1. The subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease.\n2. Atypical parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism).\n3. The subject has clinical indication or diagnosis of abnormal immune function.\n4. The subject has been diagnosed with a major neurocognitive disorder such as dementia, or is high risk for this.\n5. The subject has bleeding tendency or abnormal coagulation function as evidenced by platelets \\\u003C50 or PT\u002FPTT \\> 1.5x normal.\n6. The subject is HBs antigen-positive, or HBs antibody- or HBc antibody-positive with evidence of HBV-DNA.\n7. The subject is anti-HIV antibody positive.\n8. The subject is anti-HTLV-1 antibody-positive.\n9. The subject has active infection such as hepatitis C or syphilis (STS\u002FTPHA).\n10. The subject has hypersensitivity or contraindication to tacrolimus, concomitant drugs (e.g., levodopa, carbidopa, MRI contrast), and\u002For their components.\n11. Contraindications to general anesthesia as evaluated by subject matter experts.\n12. The subject has a serious allergy to a component (e.g., gentamicin, component of bovine origin, or component of porcine origin) used in the preparation of the study product.\n13. The subject has any of the following conditions\u002Fdiseases concurrently:\n\n    1. Active malignancy\n    2. Epilepsy\n    3. Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia)\n    4. Diabetes mellitus with poorly controlled blood glucose (glycosylated hemoglobin \\> 9.0%, or fasting plasma glucose (FPG) ≥ 200 mg\u002FdL (11.1 mmol\u002FL).\n    5. Other serious concurrent diseases (e.g., cerebrovascular disorder, heart disease, chronic respiratory disease, inadequately controlled hypertension) as determined by the investigator.\n14. The subject has a history of any of the following:\n\n    1. Prior malignancy \\\u003C 5 years prior to Screening. Patients who had prior malignancies within 5 years and in complete remission with expected survival of more than 5 years are not excluded\n    2. Epilepsy\n    3. Cerebral hemorrhage or stroke\n    4. Psychiatric disease (e.g., uncontrolled anxiety or depression, bipolar disorder, schizophrenia)\n    5. Congenital long QT syndrome\n    6. Pallidotomy, thalamotomy, or Deep Brain Stimulation\n15. The subject is pregnant or lactating or does not agree to avoid pregnancy throughout the study.\n16. The subject has undergone transplantation of human iPSC-derived dopaminergic progenitors.\n17. The subject, in the opinion of the investigator or sub investigator, is not appropriate to conduct the study safely.","ALL","40 Years","75 Years",{"count":22,"type":23},7,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease",[29],"PD - Parkinson's Disease",[31,32,33,34,35,36,37,38,39,40,41,42,43],"Parkinson's Disease","Ataxia","Dopaminergic","Dyskinesia","PD","Neurodegenerative Disease","Brain Disease","CNS","Movement Disorder","Central Nervous System Disease","FDOPA","MRI","Corpus striatum","RECRUITING","2026-08-13",{"date":47,"type":48},"2026-08-17","ACTUAL",{"date":50,"type":48},"2024-06-01",{"date":52,"type":23},"2028-05",{"name":54,"class":55},"University of California, San Diego","OTHER",1,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":18,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":24,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100651117","developing-a-recovery-oriented-suicide-prevention-program-for-young-people-at-clinical-high-risk-for-psychosis-100651117","NCT07756567","Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis","Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis","Young Person Inclusion Criteria:\n\n* symptoms of clinical high risk for psychosis in the last two years\n* lifetime active suicide ideation and\u002For lifetime suicide behavior\n* has a caregiver willing to participate\n\nYoung Person Exclusion Criterion:\n\n* not able to read and write in English\n\nCaregiver Inclusion Criteria:\n\n* has a familial relationship with the young person participant\n* has at least 4 hours of face-to-face contact with the patient participant every week, even if they do not live together\n\nCaregiver Exclusion Criteria: None\n\n\\*\\*\\*\n\nAdministrator\u002FClinician Inclusion Criteria:\n\n* employed at the University of California, San Diego or University of California, Los Angeles early psychosis program\n\nAdministrator\u002FClinician Exclusion Criteria: None","12 Years","30 Years",{"count":67,"type":23},108,[69],"NA","Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them. This study will develop and evaluate a recovery-oriented suicide prevention group program for young people at clinical high risk for psychosis.\n\nThe program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person.\n\nThe study will first gather feedback from participants, caregivers, clinicians, and community advisors to refine the program. Researchers will then compare the program plus standard care with standard care alone to determine whether it improves personal recovery and increases participants' ability to remember and use suicide prevention strategies. Researchers will also collect feedback from participants and program staff to better understand how the program can be integrated into early psychosis services.",[72,73,74,75],"Clinical High Risk for Psychosis (CHR)","Suicidal Ideation","Psychosis","Suicidal Behavior",[77,78,79,80,81,82,83,84,85,86,87],"clinical high risk for psychosis","psychosis","early intervention","peer support","suicidal ideation","suicide","suicidal behavior","recovery","group intervention","implementation science","Hybrid Effectiveness-Implementation Trial","NOT_YET_RECRUITING","2026-08-10",{"date":91,"type":48},"2026-08-12",{"date":93,"type":23},"2026-08",{"date":95,"type":23},"2028-12",{"name":54,"class":55},2,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":106,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":122,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":56},"100610142","postpartum-education-via-artificial-intelligence-for-recovery-and-loneliness-a-randomized-controlled-trial-100610142","NCT07223736","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness (PEARL): A Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\n1. Has the capacity to provide informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Postpartum persons, aged \\>18 years old\n4. Primiparous\n5. Vaginal or cesarean delivery\n6. English Speaking\n7. Internet access and proficiency of internet access\n8. Access to a smartphone\n9. Postpartum 2-6 weeks\n\nExclusion Criteria:\n\n1. Multiparous\n2. Major neonatal anomaly\n3. Delivery \\\u003C 34 weeks gestational age\n4. Intrauterine fetal demise (IUFD)\n5. Enrollment in any interfering studies\n6. Unanticipated NICU admission\n7. Discharge home without live baby\n8. Surrogates\u002Fgestational carrier\n9. Birthing individuals with baby placed for adoption\n10. Currently pregnant\n11. Psychiatric history requiring psychiatric hospitalization prior to delivery\n12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and\u002For treatment team","FEMALE","18 Years",{"count":109,"type":23},130,[69],"The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth.\n\nThe main questions this study aims to answer are:\n\n* Does using the chatbot improve postpartum pelvic floor health knowledge?\n* Does using the chatbot help reduce feelings of loneliness during the postpartum period?\n* Does using the chatbot impact pelvic floor symptoms?\n\nResearchers will compare standard postpartum care to standard care plus the chatbot.\n\nParticipants will:\n\nBe assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot.\n\nIf in the chatbot group, participants will receive education and support via the chatbot over a 4-week period.\n\nBoth groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress.\n\nThe chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.",[113,114,115,116,117,118,119,120,121],"Pelvic Floor Disorder","Loneliness","Postpartum","Mental Health","Depression","Peritraumatic Distress","Women","Artificial Intelligence (AI)","Chatbot",[123,124,125,126,127,128,129,130,131,132,133,134],"loneliness","postpartum","pelvic floor disorder","mental health","depression","peritraumatic distress","artificial intelligence","AI","chatbot","LLM","women","large language model","2026-08-04",{"date":137,"type":48},"2026-08-05",{"date":139,"type":48},"2026-01-08",{"date":141,"type":23},"2026-11-01",{"name":54,"class":55},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":24,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":56},"100470003","blood-pressure-effects-on-cognition-and-brain-blood-flow-in-pd-100470003","NCT05400174","Blood Pressure Effects on Cognition and Brain Blood Flow in PD","Effects of Blood Pressure on Cognition and Cerebral Blood Flow in Parkinson Disease","Inclusion Criteria:\n\n1. Diagnosis of idiopathic Parkinson Disease using the Movement Disorders Society (MDS) Clinical Diagnostic Criteria\n2. Age at least 50 years old\n3. Hoehn \\& Yahr (H\\&Y) stages I-III (early to moderate-stage PD; able to walk without assistance\n4. Proficiency in the English language (native English speaker level)\n\nExclusion Criteria:\n\n1. Any involuntary movements (i.e., tremor or dyskinesia) \\> 3 cm in amplitude (ok if movements are treated with medication), since the motion artifact could interfere with blood pressure monitor data collection\n2. Dementia (including PD dementia)\n3. History of deep brain stimulation (DBS) surgery\n4. Any current unstable, active medical problem, e.g. decompensated heart failure, liver failure, pneumonia, etc.\n5. Moderate or severe carotid artery stenosis (according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria\n6. History of cerebral infarction or hemorrhage\n7. Uncontrolled diabetes or any other systemic disease causing autonomic failure\n8. Syncope (fainting) within the past week\n9. Illiteracy (unable to read)\n10. Taking antihypertensive medications or alpha-adrenergic blocking medications, since these can cause hypotension (see \\* below)\n11. Impairment of hearing or vision that is not corrected by devices (e.g., hearing aids or glasses)\n12. Currently pregnant (will be confirmed by women of child-bearing potential with a urine pregnancy test)\n13. Any other condition, which, in the opinion of the investigator, could place the participant at increased risk.\n\n    * Please note that persons may not participate if they are taking any of the following:\n\n      * medications to treat high blood pressure (called \"antihypertensives\") such as clonidine (Catapres), hydralazine, verapamil, diltiazem (Cartia), or medications ending in \"-olol\", \"-artan\", or \"-pril\")\n      * diuretics (also called \"water pills\") such as furosemide (Lasix), bumetanide (Bumex), hydrochlorothiazide (HCTZ; Microzide), or spironolactone (Aldactone)\n      * medications for enlarged prostate such as prazosin (Minipress), terazosin, doxazosin (Cardura), alfuzosin (Uroxatral), or tamsulosin (Flomax)\n\nIf persons are taking these medications and would like to participate in the study, they will be advised to discuss whether they may discontinue these medications for 48 hours before the study visit with their prescribing doctor.","50 Years",{"count":152,"type":23},60,[69],"Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide. Besides causing symptoms that impair movement, PD also causes non-motor symptoms, such as problems thinking and orthostatic hypotension (OH), i.e., low blood pressure (BP) when standing. About one-third of people with PD have OH, which can cause sudden, temporary symptoms while upright, including lightheadedness, dizziness, and fainting. People with PD and OH can also experience problems thinking that happen only while upright and not while sitting - this can occur without other symptoms, such as feeling dizzy or faint. However, the level of low BP that can affect thinking remains unknown, and no guidelines exist for treating OH when it happens without symptoms. This is significant because OH could be a treatable risk factor for thinking problems in PD, but OH is often not treated if people do not report obvious symptoms.\n\nThis project's goal is to determine how BP affects brain function in PD. The proposed experiments will measure BP and brain blood flow continuously in real-time using innovative wearable technology. Persons with PD with OH and without OH will undergo repeated cognitive tests while supine (lying down) and while upright. I will study the associations between BP, thinking abilities, and brain blood flow, and will compare groups with and without OH. These findings could be important because if a certain level of BP correlates with thinking abilities, then treating OH in PD may prevent thinking problems, which would improve health-related quality of life and reduce disability and healthcare costs.",[156,157,158],"Parkinson Disease","Orthostatic Hypotension","Dysautonomia",{"date":160,"type":48},"2026-08-07",{"date":162,"type":48},"2021-12-14",{"date":164,"type":23},"2027-01-15",{"name":54,"class":55},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":176,"briefSummary":177,"conditions":178,"keywords":184,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":56},"100644735","personalized-ventilator-settings-for-patients-on-ecmo-100644735","NCT07673250","Personalized Ventilator Settings for Patients on ECMO","Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)","PEEPECMO","1. History of Lung or Cardiac Transplantation, or definite bridge to transplantation\n2. Patient is not committed to full support\n3. Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade)\n4. Inability to get informed consent from the patient or legally authorized representative (LAR)\n5. Patients with contraindications to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.\n\n   a. Contraindications include recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement, or severe coagulopathy.\n6. Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician.\n7. Patients who are pregnant or prisoners.\n8. Has been on V-V ECMO \\> 72 hours.",{"count":175,"type":23},62,[69],"While mechanical ventilation can be used to sustain life in those with lung injury, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality as seen in Acute Respiratory Distress Syndrome (ARDS).\n\nUsing extracorporeal membrane oxygenation (ECMO), the highest level of life support also known as the heart-lung machine, investigators may minimize injury from mechanical ventilation to allow the lungs to heal; however, the optimal ventilator strategies while on ECMO are unknown. This study will evaluate personalized ventilator strategy compared to standard of care ventilation.",[179,180,181,182,183],"Acute Respiratory Distress Syndrome (ARDS)","Extracorporeal Membrane Oxygenation","Respiratory Failure Patients Treated With ECMO","Respiratory Failure, ICU","Ventilator Induced Lung Injury",[185,186,187,188,189,190,191,192,193,194,195,196],"Respiratory failure","ARDS","Acute Respiratory Distress Syndrome","ECMO","Pneumonia","Lung injury","Influenza","COVID","Viruses","Personalized ventilator settings","Positive end expiratory pressure","PEEP","2026-08-03",{"date":199,"type":48},"2026-08-06",{"date":201,"type":23},"2026-09-01",{"date":203,"type":23},"2031-06-30",{"name":54,"class":55},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":106,"minAge":213,"maxAge":20,"enrollmentInfo":214,"targetDuration":4,"studyType":24,"phases":216,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":56},"100568258","sleep-and-light-intervention-sali-for-menopausal-mood-dysfunction-100568258","NCT06678880","Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction","Chronobiological Basis of Depression During the Menopause Transition","SALI","Inclusion Criteria:\n\n* Women aged 45-75 years old\n* Experiencing significant down, sad or hopeless feelings that are affecting their daily life\n* These mood changes started or got worse during the menopause transition\n* Irregular or no menstrual cycle for at least 6 months\n* Non-smoking\n* Located in San Diego County\n\nExclusion Criteria:\n\n* Untreated sleep apnea\n* Migraine headaches that are triggered or worsened by bright light\n* Currently suicidal or psychotic\n* History of bipolar disorder\n* A medical condition or job where fatigue or changes in sleep schedule could be unsafe\n* Planning to start, stop, or change medications in the next 4 months","45 Years",{"count":215,"type":23},120,[69],"\\*\\*Participants must live in San Diego County\\*\\*\n\nThe purpose of this study is to learn more about an experimental Sleep \\& Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.",[117,219,220],"Depression During the Menopausal Transition","Menopausal Depression",[222,127,223,224,225,226],"Menopause","sleep and light intervention","melatonin","circadian rhythm","Chronobiology",{"date":137,"type":48},{"date":229,"type":48},"2025-03-11",{"date":231,"type":23},"2029-02-28",{"name":54,"class":55},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":241,"minAge":107,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":24,"phases":244,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":56},"100620934","phase-2-strategic-endocrine-therapy-and-targeted-radiotherapy-for-prostate-cancer-100620934","NCT07364071","Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer","Strategic ENdocrine and Targeted Radiation therapY","SENTRY","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n2. High-risk localized prostate cancer, defined as ≥1 of the following (per National Comprehensive Cancer Network or D'Amico criteria):\n\n   1. Prostate specific antigen ≥ 20 ng\u002FmL\n   2. Gleason score 8-10\n   3. Clinical stage T3a or higher; imaging can be used to determine T stage if there is macroscopic (gross) extraprostatic extension or invasion of the seminal vesicles or other non-prostate organs\n3. No evidence of distant metastasis, confirmed by:\n\n   a. Prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT) or equivalent staging imaging\n4. Planning to receive definitive external beam radiotherapy and hormone therapy as standard of care (on label or medically accepted) treatment\n5. Eastern Cooperative Oncology Group performance status 0-1.\n6. Age ≥ 18 years.\n7. Willingness to use adequate contraception if sexually active and of reproductive potential\n8. Ability to understand and willingness to sign informed consent.\n9. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging.\n2. Clear evidence of regional nodal disease on conventional imaging.\n3. Prior prostatectomy.\n4. Prior systemic therapy for prostate cancer, including:\n\n   1. Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.)\n   2. Androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).\n   3. Chemotherapy for prostate cancer.\n5. Prior pelvic radiotherapy.\n6. Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.","MALE",{"count":243,"type":23},150,[245],"PHASE2","The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation therapy (ADT) in patients with prostate cancer. The investigators want to find out if these drugs work the same way if they are given for 6 months or for the usual 18 months in patients who receive also definitive external beam radiotherapy. The investigators will also learn about the safety of the treatments. The main questions the study aims to answer are:\n\nDo patients who get radiation therapy plus 6 months of androgen deprivation therapy need other hormone therapy or develop castration resistance at a higher rate within 5 years, compared to patients who get radiation therapy plus 18 months of androgen deprivation therapy?\n\nParticipants will:\n\nBe treated with definitive external beam radiation therapy and receive androgen deprivation therapy for 6 months or 18 months.\n\nHave visits once every 3 months for checkups and tests for at least 5 years. The visits at 3 months, 1 year, and 5 years need to be done in person; all the other visits can be done in person or remotely (telehealth).\n\nKeep a diary of the missed doses of the androgen deprivation therapy.",[248],"Prostate Adenocarcinoma",[250,251,252],"Radiotherapy","Androgen deprivation therapy","Prostate cancer","2026-07-31",{"date":135,"type":48},{"date":256,"type":48},"2026-07-20",{"date":258,"type":23},"2034-04",{"name":54,"class":55},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":267,"sex":18,"minAge":107,"maxAge":213,"enrollmentInfo":268,"targetDuration":4,"studyType":24,"phases":270,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":56},"100540470","effects-of-hypoxic-breathwork-100540470","NCT06317259","Effects of Hypoxic Breathwork","Impacts of Rhythmic and Hypoxic Breathwork on EEG, Mood, Sleep, and Physiology","Inclusion Criteria:\n\n* Persons, aged 18-45\n* Availability for the duration of the study\n* In good general health as revealed by self-report\n* Stated willingness and capability to adhere to the breathwork regimen\n* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Current or past regular breathwork practice\n2. Current use of psychoactive medications (e.g., anti-depressants or anxiolytics)\n3. Pregnancy\n4. Bedtime past 11:30pm or regularly getting less than 6 hours of sleep per night.\n5. Feverish illness within 10 days\n6. Regular smoker or tobacco user ( \\> 1 cigarette, gum or pouch per month)\n7. Presence of blood pressure above 140 systolic and\u002For 90 diastolic, seizure disorder, asthma, or serious cardiac fibrillation disorders.",true,{"count":269,"type":23},75,[69],"This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., \"breathwork\"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality.",[273,274,275],"Hypoxic Breathwork With Music and Affirmative Messaging","Hypoxic Breathwork Only","Music and Affirmative Messaging",[277,278,279,280,281],"Breathwork","Intermittent hypoxia","EEG","Mitochondria","Relaxing",{"date":135,"type":48},{"date":284,"type":48},"2024-06-17",{"date":286,"type":23},"2028-01",{"name":54,"class":55},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":24,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":308,"locationsCount":309},"100564077","phase-2-neoadjuvant-nivolumab--relatlimab-opdualag-versus-nivolumab-for-resectable-high-risk-basal-cell-carcinoma-100564077","NCT06624475","Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma","Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma","NEON","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document.\n2. Participants must have histologically or cytologically confirmed basal cell carcinoma.\n3. Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk\u002Fextremities.\n4. Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or anticipated to require skin grafting or free flap reconstruction per investigator assessment.\n5. Participants must have treatment naive BCC.\n6. Aged 18 years or older.\n7. Eastern Cooperative Oncology Group Performance Status 0 or 1\n8. Demonstrates adequate organ function as defined below:\n\n   Adequate bone marrow function\n   1. Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n   2. Platelets ≥ 100,000\u002Fmicroliter\n\n      Adequate hepatic function\n   3. Total bilirubin \\>1.5 x institutional upper limit of normal (except participants with Glibert Syndrome who must have a total bilirubin level of \\\u003C3.0xULN)\n   4. Aspartate aminotransferase (AST or SGOT) ≤ 3 x institutional upper limit of normal\n   5. Alanine transaminase (ALT or SGPT) ≤ 3 x institutional upper limit of normal\n\n      Adequate renal function\n   6. Creatinine clearance Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin (using the Cockcroft Gault formula)\n9. Human immunodeficiency virus (HIV) infected individuals on effective anti retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must not have had an AIDS defining opportunistic infection within the last year or a current CD4 count \\\u003C 350 cells\u002Fmicroliter.\n10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n11. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n12. Concurrent malignancy (present during screening) requiring treatment or history o f prior malignancy active within 2 years prior to randomization (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.\n13. The effects of Opdualag on the on the developing human fetus are unknown. Therefore, the following criteria apply to participants in each study arm:\n\nCohort 1 Opdualag:\n\nA woman of child bearing potential (WOCBP) is eligible to enroll if using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, during the intervention period and for the duration of treatment with Opdualag plus 5 half lives of study treatment for a total of 5 months post treatment completion and agrees not to donate eggs (ova, oocytes) for the purpose of re production for the same time period.\n\nCohort 2 nivolumab:\n\ni. Women who are not of childbearing potential are exempt from contraceptive requirements.\n\nii. Women participants must have documented proof that they are not of childbearing potential.\n\niii. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24 hour window. iv. Additional requirements for pregnancy testing during and after study intervention are located in the Schedule of Assessments.\n\nv. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. vi. WOCBP must agree to follow instructions for method(s) of contraception and as described below and included in the Informed Consent Form.\n\nvii. WOCBP are permitted to use hormonal contraception methods viii. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n1. Is not a WOCBP. OR\n2. Is a WOCB P and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, during the intervention period and for at least 5 months and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period.\n\nExclusion Criteria:\n\n1. Is currently receiving any other investigational agents.\n2. Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.\n3. Hypersensitivity to Opdualag, nivolumab, or any of their excipients.\n4. Presence of untreated (symptomatic) central nervous system metastases.\n5. Presence of leptomeningeal metastatic disease.\n6. Treatment with any live \u002F attenuated vaccine within 30 days of first study treatment.\n7. Radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤1 or at baseline) from radiation related toxicities prior to first study treatment.\n8. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n9. Participants with an active, known, or suspected autoimmune disease. Note: Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n10. Prior allogeneic tissue\u002Fsolid organ transplant.\n11. Severe uncontrolled cardiac disease within 6 months of screening, including but not limited to poorly controlled hypertension , unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or clinically significant uncontrolled cardiac arrhythmias.\n12. Any prior history of myocarditis and\u002For current diagnosis of myocarditis, regardless of etiology.\n13. Troponin T (TnT) or I (TnI) \\> 2 x institutional upper limit of normal (ULN).\n\n    1. Participants with TnT or TnI levels between \\> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. I f TnT or TnI levels are between \\> 1× to 2× ULN within 24 hours, the participant must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2× ULN, the participant must be evaluated by a cardiologist.\n    2. After cardiologist evaluation, the participant may be considered for randomization if the Investigator assesses a favorable benefit\u002Frisk.\n14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient an inappropriate candidate for the study.\n15. Pregnant women are excluded from this study because Opdualag are immune checkpoint inhibitors with the potential for teratogenic o r abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Opdualag, breastfeeding should be discontinued if the mother is treated prior to initiating study treatment.",{"count":297,"type":23},30,[245],"This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)",[301],"Basal Cell Carcinoma","2026-07-25",{"date":304,"type":48},"2026-07-28",{"date":306,"type":48},"2025-08-21",{"date":52,"type":23},{"name":54,"class":55},3,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":106,"minAge":107,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":56},"100648914","phase-2-neu-direction-testing-the-efficacy-of-adding-her-inhibition-to-standard-of-care-in-metastatic-mlh1-low-endocrine-resistant-erher2--breast-cancer-100648914","NCT07729046","Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+\u002FHER2- Breast Cancer","Neu Direction: A Single Center Phase II Randomized Clinical Trial to Assess the Efficacy of Adding HER Inhibition to Standard of Care in Patients With Metastatic MLH1-low Endocrine-resistant ER+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n1. Female over the age of 18 at the time of study enrollment\n2. Not pregnant, planning to become pregnant or breast feeding\n3. Metastatic ER+\u002FHER2- breast cancer that has progressed on 1st line therapy including endocrine therapy +\u002F- CDK4\u002F6 inhibitors\n4. At least one metastatic lesion visible on imaging (including FDG-PET)\n5. At least one metastatic lesion must be biopsied and confirmed ER+ and HER2- by immunohistochemistry within 6 months of study screening (HER2 equivocal disease will be confirmed HER2- by FISH)\n6. Tumors must be MLH1-low defined by \\\u003C50% tumor cells positive for nuclear MLH1 expression on immunohistochemistry\n7. Standard of care next line endocrine therapy can include any endocrine therapy\n8. Performance status ECOG \\> 3\n9. Life expectancy \\> 1 year\n10. Ability to get serial imaging studies\n\nExclusion Criteria:\n\n1. History of concurrent use of other HER2-targeted therapy\n2. Concurrent use of other targeted systemic therapy\n3. History of other cancers other than non-melanoma skin cancer\n4. Actionable mutations on tumor genomic sequencing will be ineligible, and those participants encouraged to proceed with the relevant targeted therapy\n5. Participants where there is not at least one imaging apparent lesion that has not been treated with prior targeted therapy (for example palliative radiation or cryoablation)\n6. Contraindications to Neratinib use including allergy or hypersensitivity\n7. Baseline grade 3+ diarrhea",{"count":243,"type":23},[245],"The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2\u002F3\u002F4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+\u002FHER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:\n\n1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?\n2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.\n\nParticipants will:\n\n1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily\n2. Visit the clinic every 3 months for checkups, tests and imaging studies",[321,322,323],"Metastatic Invasive Breast Cancer","Resistant Breast Cancer","ER+, HER2-, Metastatic Breast Cancer",[325,326,327,328,329,330,331,332,333,334],"endocrine-resistant","DNA mismatch repair","MLH1","dMMR","metastatic breast cancer","ER+ breast cancer","endocrine-resistance","HER2 negative","HER2-","neratinib","2026-07-22",{"date":337,"type":48},"2026-07-27",{"date":339,"type":23},"2027-07",{"date":341,"type":23},"2035-06",{"name":54,"class":55},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":370,"locationsCount":56},"100578686","phase-1-psilocybin-assisted-therapy-for-physician-well-being-and-burnout-100578686","NCT06814522","Psilocybin-Assisted Therapy for Physician Well-Being and Burnout","Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]","PAT-B","Inclusion Criteria:\n\n1. UCSD faculty physician, aged 21-70. Volunteer faculty are not included\n2. Meets criteria for physician burnout\n3. Experiencing symptoms of burnout for \\>6 months\n4. Able to complete all required study visits\n5. Not previously diagnosed with a serious mental illness (including schizophrenia, bipolar disorder, and severe depression), or substance use disorder as confirmed in clinical interview\n6. Not currently taking any psychotropic medications or nonpsychotropic medication that may be associated with serotonin syndrome, such as serotonin reuptake inhibitors (SSRI or SNRI), dextromethorphan, linezolid, tramadol, meperidine\n\nExclusion Criteria:\n\n1. Previous inpatient psychiatric hospitalization(s)\n2. Previously diagnosed with a psychotic disorder (schizophrenia, schizoaffective disorder, or other psychotic spectrum disorder), bipolar spectrum disorder, personality disorder (borderline personality disorder, antisocial personality disorder, or other severe personality disorders), any severe psychiatric disorder.\n3. Exhibiting elevated suicide risk\n4. First degree family history of psychosis or bipolar disorder\n5. Prior exposure to psilocybin or other psychedelic compounds in the previous 10 years\n6. Currently pregnant, nursing, planning pregnancy, engaging in sexual intercourse without effective contraceptive method in last three months\n7. Those who plan to donate sperm within three months following the study.\n8. Known cardiovascular disease including history of stroke, myocardial infarction, uncontrolled hypertension, valvular heart disease, tachycardia, elongated QT interval, or clinically significant arrythmia.\n9. History of seizure disorder\n10. Use of recreational illicit drugs\n11. Clinically concerning results from vital signs, ECG, physical examination, or laboratory tests during screening\n12. Any other clinically significant illnesses deemed to pose risk for the participant","21 Years","70 Years",{"count":354,"type":23},10,[26,245],"Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms.",[358,359],"Burnout","Burnout, Healthcare Workers",[361,362,363],"burnout","physician","doctor","2026-07-17",{"date":366,"type":48},"2026-07-21",{"date":368,"type":48},"2025-01-13",{"date":339,"type":23},{"name":54,"class":55},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":379,"phases":4,"briefSummary":380,"conditions":381,"keywords":386,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":56},"100646323","identifying-biomarkers-related-to-opioid-use-and-pain-response-following-traumatic-injury-and-surgery-100646323","NCT07693270","Identifying Biomarkers Related to Opioid Use and Pain Response Following Traumatic Injury and Surgery","Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Patients admitted for traumatic injury at Hillcrest or Jacobs Medical Center or patients who will undergo the orthopedic (e.g., joint, spine), abdominal, breast, vascular (e.g., amputation), or thoracic surgery.\n\nExclusion Criteria:\n\n* Patients with a prior history of opioid use disorder or dependence\n* Pregnant women\n* Prisoners\n* Patients with an inability to independently provide informed consent to participate in the study due to lack of capacity. This lack of capacity can be from either a chronic\u002Fcontinuous condition (i.e. dementia), or can be temporary (i.e. clear signs of intoxication at the time of the visit (not alert or oriented, slurring words \\[and confirmed not to be baseline\\], unsteady gait \\[and confirmed not to be baseline\\], or appears impaired based on clinical judgement by PI\u002FCo-I)).",{"count":378,"type":23},100,"OBSERVATIONAL","The mechanisms leading to opioid tolerance or dependence are not well understood and there are currently no biomarkers for predicting who is at risk for development of OUD. The purpose of this project is to support the feasibility of detecting a miRNA bio-behavioral signature of opioid misuse risk that will demonstrate improved predictive precision compared to current tools such as polygenic risk scores (PRS). Specifically, the study will address key goals of the Wellcome Leap program to develop scalable measures assessing individual addiction susceptibility and quantifying addiction risk and progression during prescription drug use. The study will utilize behavioral, genomics, and bioinformatics pipelines to characterize opioid-induced miRNA expression dynamics among trauma and surgical patients prescribed opioids at discharge. Based on results from this study, the research will develop a high-throughput screening assay to predict risk for opioid use disorder (OUD). The hypothesis is that miRNAs will serve as powerful bio-signatures for predicting long-term clinical outcomes in patients treated with opioids for pain management following trauma injury and\u002For surgery.",[382,383,384,385],"Opioid Use Disorder","Opioid Consumption","Persistent Opioid Use","Persistent Postsurgical Pain",[387,129,388],"opioid use disorder","persistent postsurgical pain","2026-07-15",{"date":364,"type":48},{"date":389,"type":48},{"date":393,"type":23},"2027-06",{"name":54,"class":55},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":56},"100647828","effect-of-anti-inflammatory-diet-in-systemic-lupus-erythematous-100647828","NCT07713940","Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous","Inclusion Criteria:\n\n* patients who meet the 2019 EULAR\u002FACR Classification Criteria for SLE\n* patients who are on Cellcept or Myfortic for at least 3 months prior to screening\n* patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.\n\nExclusion Criteria:\n\n* pregnant or lactating patients,\n* patients with food allergy\n* patients on antibiotics within 4 weeks of the screening\n* patients that change the SLE therapy during the length of the study (12 weeks).",{"count":402,"type":23},36,[69],"To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus",[406],"Systemic Lupus Erthematosus (SLE)",[408,409,410,411,412,413,414],"lupus","diet","anti-inflammatory diet","mediterranean diet","cellcept","mycophenalate","microbiome","2026-07-14",{"date":256,"type":48},{"date":418,"type":23},"2026-07-01",{"date":420,"type":23},"2029-07-01",{"name":54,"class":55},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":24,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":56},"100646272","phase-2-nicotinamide-riboside-supplementation-in-chronic-kidney-disease-100646272","NCT07693543","Nicotinamide Riboside Supplementation in Chronic Kidney Disease","Pilot Randomized Crossover Trial of Nicotinamide Riboside in Chronic Kidney Disease (NR-CKD Trial)","NR-CKD","Inclusion Criteria:\n\n* Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI equation.\n* Urine albumin-to-creatinine ratio (uACR) \\\u003C300 mg\u002Fg.\n* Able to provide informed consent.\n* Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.\n* Willing and able to comply with study procedures, visits, and study product administration.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Expectation to start dialysis within 6 months.\n* Unable to walk unassisted from room to room.\n* Institutionalization or inability to consent.\n* End-stage liver disease with cirrhosis.\n* HIV.\n* Oxygen-dependent COPD.\n* Baseline systolic blood pressure \\>170 mmHg or diastolic blood pressure \\>100 mmHg.\n* Current participation in another interventional trial.\n* Use of immunosuppressive medications, including steroids or calcineurin inhibitors.\n* Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.\n* Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.",{"count":297,"type":23},[245],"This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism.\n\nThe main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function.\n\nParticipants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period.\n\nStudy visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.",[434],"Chronic Kidney Disease",[436,437,438,439,440],"Nicotinamide riboside","Chronic kidney disease","Microvascular function","Physical function","Cell-free mitochondrial DNA","2026-07-13",{"date":389,"type":48},{"date":444,"type":23},"2026-10-01",{"date":446,"type":23},"2028-09-30",{"name":54,"class":55},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":379,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":56},"100598748","neuroimaging-and-biomarkers-of-neurotoxicity-after-chimeric-antigen-receptor-t-cell-therapy-100598748","NCT07075523","Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy","Comprehensive Neuroimaging and Molecular Biomarkers of Neurotoxicity Following CAR T-Cell Therapy","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Age ≥ 18 years\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Patients recommended to undergo commercial chimeric antigen receptor T-cell therapy\n\nExclusion Criteria:\n\n* Contraindication for magnetic resonance imaging",{"count":402,"type":23},"The goal of this study is to understand why some people receiving chimeric antigen receptor (CAR) T-cell therapy for cancer experience neurotoxicity. The main question it aims to answer is:\n\nCan a novel tool be developed to identify early the patients who will develop immune effector cell-associated neurotoxicity syndrome (ICANS, also called neurotoxicity) after chimeric antigen receptor (CAR) T-cell therapy?\n\nParticipants already scheduled for chimeric antigen receptor (CAR) T-cell therapy as part of the medical care for their cancer will be evaluated with advanced neuroimaging techniques. In addition, neurocognitive assessments using questionnaires and measurement of biomarkers in blood (liquid biomarkers) will be performed to provide a comprehensive characterization of neurotoxicity following chimeric antigen receptor T-cell therapy.\n\nAssessments will be performed in the acute phase (2 to 14 days after chimeric antigen receptor (CAR) T-cell therapy) and after approximately 3 months.",[458],"CAR T-Cell Therapy",[460,461,462,463],"CAR T-cell therapy","RBANS","ICANS","Magnetic resonance imaging","2026-07-10",{"date":441,"type":48},{"date":467,"type":48},"2025-09-19",{"date":469,"type":23},"2027-12",{"name":54,"class":55},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":20,"enrollmentInfo":479,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":56},"100584032","phase-1-time-restricted-eating-in-patients-with-microalbuminuria-100584032","NCT06884059","Time Restricted Eating in Patients With Microalbuminuria","Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)","TREK","Inclusion Criteria:\n\n1. Age: 18-75 years old\n2. Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.\n3. uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg.\n4. Willingness to use smartphone for research procedures (Apple iOS or Android OS)\n5. Baseline eating period ≥12 hours\u002Fday and sufficient logging on the mCC app.\n6. Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.\n7. Post-menopausal and individuals on hormone replacement therapy will be included.\n8. Estimated Glomerular Filtration Rate (EGFR) \\> 45\n9. If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period\n10. Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.\n\nExclusion Criteria:\n\n1. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \\> 9 %.\n2. Estimated Glomerular Filtration Rate (EGFR) \\\u003C 45\n3. Systolic BP greater than 160 mmHg and\u002For Diastolic BP greater than 110 mmHg (with or without treatment\u002Fmedication)\n4. LDL cholesterol greater than 200 mg\u002FdL\n5. Triglycerides greater than 500 mg\u002FdL\n6. Active tobacco or illicit drug use\n7. Pregnant or breastfeeding individuals.\n8. Currently enrolled in a weight-loss or weight-management program,\n9. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),\n10. On recently prescribed medication that is meant for weight loss, or has known effect on appetite suppression ( patient on stable dose for 3 months can be enrolled ).\n11. History of eating disorder(s).\n12. History of surgical intervention for weight management (e) active eating disorder.\n13. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \\\u003C50mL\u002Fmin\u002F1.73m2\n14. Treatment for active inflammatory and\u002For rheumatologic disease and cancer.\n15. A major adverse cardiovascular event within the past 6 months such as acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke\u002Ftransient ischemic attack (TIA).\n16. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation\u002Fatrial flutter are not exclusion criteria) 18. Liver cirrhosis and\u002For significant alterations in liver function\n17. History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion), Shift workers with variable (e.g., nocturnal) hours.\n18. Caregivers for dependents requiring frequent nocturnal care\u002Fsleep interruptions.\n19. More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.\n20. History of major adverse cardiovascular events within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke\u002Ftransient ischemic attack (TIA)).\n21. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).\n22. History of adrenal disease.\n23. History of malignancy undergoing active treatment, except non-melanoma skin cancer.\n24. Known history of type I diabetes.\n25. History of stage 4 or 5 chronic kidney disease or requiring dialysis.\n26. History of HIV\u002FAIDS.\n27. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).",{"count":7,"type":23},[26],"This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.",[483,484,485],"Type 2 Diabetes Mellitus (T2DM)","Time Restricted Eating","Microalbuminuria",[485,484,487,488,489,490],"Urine Albumin-to-Creatinine Ratio","Type 2 Diabetes","uACR","Fasting",{"date":415,"type":48},{"date":493,"type":23},"2026-07",{"date":495,"type":23},"2028-02",{"name":54,"class":55},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":24,"phases":507,"briefSummary":509,"conditions":510,"keywords":515,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":56},"100582636","phase-4-ldl-c-optimization-using-inclisiran-in-patients-in-which-drug-drug-interactions-limit-ldl-lowering-100582636","NCT06865885","LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering","Study of Optimal LDL-C Value Enhancement With Inclisiran in Patients With Multiple Comorbidities in Which There Are Drug-Drug Interactions Limiting LDL-C Lowering","SOLVE-LDL-C","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to injections.\n* Age \\>18 and \\\u003C85 years and able to provide self-consent.\n* Taking five or more prescription drugs at the time of enrollment, of any type.\n* Meets at least one of the following criteria:\n\n  * Elevated 10-year ASCVD risk score ≥7.5% (based on the ACC\u002FAHA ASCVD Risk Estimator Plus tool).\n  * Evidence of subclinical atherosclerosis including:\n\nCalcification in any vascular bed, including coronary arteries and aorta. Calcification of cardiac valves. Breast calcification. Carotid plaque that is not hemodynamically significant.\n\no Type II diabetes on a stable medical regimen with HbA1c \\\u003C8.5%. Per American Diabetes Association guidelines, patients with Type II diabetes aged 40-75 years should be on a moderate-intensity statin.\n\nPatients with documented partial or complete statin intolerance are eligible for enrollment.\n\n* On maximally tolerated statin therapy (which can be no statin for patients with documented intolerance) and have suboptimal LDL levels:\n\n  * For patients with Type II diabetes: LDL \\>70 mg\u002FdL or non-HDL \\>120 mg\u002FdL.\n  * For other patients: LDL \\>90 mg\u002FdL or non-HDL \\>120 mg\u002FdL.\n* Willing to adhere to the randomized study regimen, including subcutaneous injection of inclisiran.\n* Agreement to adhere to lifestyle considerations (see Section 5.3) throughout the study duration.\n\nExclusion Criteria:\n\n* Prior or current use of inclisiran.\n* Known hypersensitivity or allergy to inclisiran or its components.\n* Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST \\>3x upper limit of normal).\n* History of rhabdomyolysis or severe muscle-related statin intolerance.\n* Uncontrolled diabetes (HbA1c \\>8.5%).\n* Active malignancy requiring systemic therapy.\n* Recent major cardiovascular event (myocardial infarction, stroke, or hospitalization for unstable angina) within the past 3 months.\n* History of organ transplant other than solid-organ transplant.\n* Pregnancy or breastfeeding.\n* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures.","85 Years",{"count":378,"type":23},[508],"PHASE4","Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk.\n\nThere is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.",[511,512,513,514],"Drug Interactions","Primary Prevention","Cardiometabolic Syndrome","LDL-Cholersterol Lowering",[516,517,518,519,520,521],"Statin intolerance","drug drug interaction","inclisiran","LDL-Cholesterol","polypharmacy","multiple comorbidities",{"date":441,"type":48},{"date":524,"type":48},"2025-04-02",{"date":526,"type":23},"2027-03-31",{"name":54,"class":55},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":24,"phases":537,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":56},"100571570","thulium-fiber-laser-tfl-vs-thulio-pulsed-thuliumyag-p-tmyag-100571570","NCT06721975","Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)","Prospective Single-center Study Comparing Thulium Fiber Laser to Pulsed Thulium:YAG Laser in the Ureteroscopic Treatment of Nephrolithiasis","Inclusion Criteria:\n\n* Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required\n* Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines\n* Must be able to give consent\n* Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study\n* Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology\n\nExclusion Criteria:\n\n* Concomitant stones in the ureter\n* Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture\n* Prior radiotherapy to the abdomen or pelvis\n* Neurogenic bladder or spinal cord injury\n* Pregnancy\n* Untreated UTI",{"count":536,"type":23},50,[69],"This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.",[540,541],"Kidney Stones","Nephrolithiasis",[543,544,545,546],"laser lithotripsy","laser","nephrolithiasis","kidney stone","2026-07-07",{"date":549,"type":48},"2026-07-09",{"date":551,"type":48},"2024-08-01",{"date":553,"type":23},"2026-12-31",{"name":54,"class":55},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":24,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":574,"locationsCount":56},"100644628","phase-4-precision-pain-management---a-randomized-clinical-trial-assessing-the-efficacy-of-suzetrigine-on-postoperative-analgesia-among-surgical-patients-at-higher-risk-for-persistent-postoperative-opioid-use-pou-100644628","NCT07672015","Precision Pain Management - A Randomized Clinical Trial Assessing the Efficacy of Suzetrigine on Postoperative Analgesia Among Surgical Patients at Higher Risk for Persistent Postoperative Opioid Use (POU)","Inclusion Criteria:\n\n* Patients who are identified as high-risk for POU as calculated by our SurgNet-POU predictive deep learning model. The probability threshold will be set at \\~\\> 0.25. Potential participants will be screened prior to surgery by incorporating their electronic health record data in to the model.\n* Patients undergoing major orthopedic surgery (hip arthroplasty, knee arthroplasty, shoulder arthroplasty, joint arthroscopy, foot\u002Fankle surgery, upper extremity fracture surgery, spine surgery), breast surgery (mastectomy, breast reconstruction), gynecological surgery (hysterectomy, myomectomy), or abdominal surgery.\n* Adult patients of at least 18 years of age\n* Has the capacity to consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Incarceration\n* Patients with a previous history of opioid use disorder.\n* Patients on fentanyl transdermal patch, methadone, and\u002For buprenorphine.",{"count":378,"type":23},[508],"The purpose of the study is to investigate the efficacy of suzetrigine for treatment of acute postoperative pain among surgical patients identified as high risk for persistent postoperative opioid use (POU). Using a validated artificial intelligence predictive model (termed SurgNet-POU) developed by the PI, electronic health record (EHR) data will be queried from all prospective surgical patients undergoing orthopedic surgery and inputted into the model to predict risk of POU (defined as requiring opioids ≥ 3 months after surgery). Those identified as high risk by the SurgNet-POU will be eligible candidates for this study. Suzetrigine (Vertex Pharmaceuticals) is an FDA-approved non-opioid oral analgesic that acts as a selective Nav1.8 sodium channel blocker. It has been shown to have efficacy in post-surgical pain and has compared favorably to placebo and similar to some opioids, without the risk of addiction or other adverse events related to opioids. Consented participants will be randomized to one of two arms: (1) standard care (termed standard care) defined as usual prescribing outpatient opioid analgesic protocols per surgical team; versus (2) standard care combined with 14-day regimen of suzetrigine. Those randomized to the suzetrigine arm will receive 100mg suzetrigine PO \\~ 1-2 hours prior to surgery and take 50mg po twice a day for 14 days postoperatively. The primary outcome will be total opioid consumption over 14 days postoperatively. Secondary outcomes include average, highest and lowest pain scores at 7, 14, 30, and 90 days after surgery; and opioid consumption at 7, 30, and 90 days after surgery.",[565],"Opioid Consumption, Postoperative",[567,129,568],"persistent postoperative opioid use","postoperative pain","2026-07-02",{"date":571,"type":48},"2026-07-06",{"date":569,"type":48},{"date":393,"type":23},{"name":54,"class":55},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":582,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":379,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":56},"100361033","characteristics-and-inflammatory-markers-in-children-with-eosinophilic-esophagitis-eoe-100361033","NCT03980886","Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)","EoE","Inclusion Criteria:\n\n* Have a known EoE diagnosis\n* Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)\n* Present with food impaction\n* Present with esophageal stricture\n* Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings\n\nExclusion Criteria:\n\n* None","1 Year","65 Years",{"count":585,"type":23},1500,"Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers",[588],"Eosinophilic Esophagitis",{"date":547,"type":48},{"date":591,"type":48},"2019-02-11",{"date":593,"type":23},"2028-12-17",{"name":54,"class":55},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":601,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":618,"locationsCount":56},"100529969","enhancing-team-effectiveness-for-a-collaborative-school-based-intervention-for-adhd-100529969","NCT06180681","Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD","Inclusion Criteria:\n\n1. Youth ages of 7-11 years (2-5th grade) who are attending a participating school\n2. Child referred by a school mental health provider (SMHP) with apparent ADHD-related problems,\n3. ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory\n4. ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)\n5. Caretaker and teacher consent to participate in treatment and child provides assent.\n\nExclusion Criteria:\n\n1. No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder\n2. Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)\n3. Parent\u002Fprimary caregiver or child does not read or speak English or Spanish. Note: Participants will need to be able to read\u002Fspeak English or Spanish because all measures are in English or Spanish, and the intervention will be conducted in English or Spanish. Parents will be given the option of having a research staff member assist them in completing the assessment measures.\n4. Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.","7 Years","11 Years",{"count":604,"type":23},144,[69],"The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD, the Collaborative Life Skills Program (CLS), to enhance its implementation and optimize its effectiveness. The investigators will tailor three empirically-supported team development interventions, Team Charters, Team Communication Training (Student Handoff Protocols), and Team Performance Monitoring, and integrate them into a team-enhanced CLS implementation protocol (CLS-T). Team Charters are a written document developed collaboratively by the team at the outset of their work together outlining expectations, goals, roles and responsibilities, and relevant policies and procedures for team collaborative operations. Research shows that Team Charters strengthen affective emergent states, such as trust and cohesion among team members, as well as cognitive emergent states, such as shared mental models. They also strengthen team processes, such as goal specification, communication, and coordination to optimize team effectiveness. Handoff protocols are widely used interventions for ensuring continuity in patient care and minimizing errors in medical settings. They have also been found to improve affective (e.g., trust, cohesion) and cognitive (e.g., shared mental models, situation awareness) emergent states among team members, enhancing team communication and coordination. Finally, Team Performance Monitoring provides feedback to teams that can motivate performance, provide opportunities for adaptation in the event of challenges, and prompt communication among team members. The investigators will conduct a Hybrid Type III cluster randomized trial in 24 schools in two large urban school districts, to evaluate whether CLS-T implementation results in improved implementation outcomes and child outcomes in comparison to standard CLS implementation.",[608,609,610,611],"Team-effectiveness Research","School-based Interventions","Attention Deficit\u002F Hyperactivity Disorder","Implementation Science","2026-06-29",{"date":614,"type":48},"2026-06-30",{"date":616,"type":48},"2024-01-01",{"date":286,"type":23},{"name":54,"class":55},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":24,"phases":628,"briefSummary":629,"conditions":630,"keywords":632,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":640,"locationsCount":56},"100573601","phase-2-tricalm-hydrogel-in-the-treatment-of-immunotherapy-related-pruritus-100573601","NCT06748404","TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","A Phase 2 Randomized Study of TriCalm Hydrogel® in the Treatment of Immunotherapy-Related Pruritus","Inclusion Criteria:\n\n1. Patients aged 18 years or older.\n2. Patients receiving ICIs for hematologic or oncologic malignancies at the Moores Cancer Center Infusion Center at UC San Diego. ICIs include CTLA-4 inhibitors (ipilimumab), PD-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab, avelumab, durvalumab).\n3. Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.\n4. Preexisting use of oral antihistamines and\u002For GABA analogs more than 7 days prior to study entry are allowed.\n\nExclusion Criteria:\n\n1. Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).\n2. Initiation of any new oral or topical antipruritic medications and\u002For systemic corticosteroids within 7 days prior to study entry.\n3. Presence of open wounds on the skin.\n4. Presence of pruritus on the face.",{"count":627,"type":23},28,[245],"This is a phase 2, randomized, open-label, single-center study that will assess the efficacy of TriCalm Hydrogel®, a topical gel containing strontium, for treating pruritus related to immune checkpoint inhibitors (ICIs).",[631],"Immunotherapy-related Pruritus",[633,634],"Immunotherapy","Pruritus","2026-06-25",{"date":614,"type":48},{"date":638,"type":48},"2025-03-05",{"date":95,"type":23},{"name":54,"class":55},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":24,"phases":650,"briefSummary":651,"conditions":652,"keywords":656,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":664,"locationsCount":56},"100579490","time-restricted-eating-and-healthy-eating-in-patients-with-metabolic-liver-disease-or-cancer-100579490","NCT06824974","Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer","Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma","TRE+HE","Inclusion Criteria:\n\n1. Overweight or obese (BMI 27-45 kg\u002Fm2)\n2. Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD\u002FNAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)\n3. English or Spanish speaking over the age of 18.\n4. ECOG Performance Status ≤ 2.\n5. Usual nightly fasting \\\u003C12 hours\n6. Willing to comply with all study procedures\n7. Life expectancy of \\> 12 months\n\nExclusion Criteria:\n\n1. Advanced HCC, progression, and\u002For associated comorbidities\n2. Metastatic disease, tumor in vein, or ascites\n3. Advanced Cirrhosis (hypoalbuminemia\u002FChild-Pugh B+C).\n4. Poorly controlled or refractory (grade 3-4) hepatic encephalopathy\n5. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM\n6. Participation in another conflicting study that requires modification of diet or food timing.\n7. Patients on GLP-1 receptor agonists\n8. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)\n9. Medications that markedly impact metabolic study biomarkers.\n10. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)\n11. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.\n12. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy\n13. Active alcohol abuse or less than 6 months of sobriety\n14. Participation in a trial of an investigational agent within the prior 30 days\n15. Pregnancy or lactating, positive hCG urine test.",{"count":536,"type":23},[69],"This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and\u002For hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are:\n\nIs a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?",[653,654,655],"Liver Cancer, Adult","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Obesity and Overweight",[657,658],"Time-restricted eating","healthy diet","2026-06-22",{"date":635,"type":48},{"date":662,"type":48},"2025-08-01",{"date":95,"type":23},{"name":54,"class":55},{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":24,"phases":674,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":56},"100531903","phase-1-intra-tumoral-mitazalimab-cd40-antibody-with-irreversible-electroporation-ire-in-locally-advanced-pancreas-cancer-100531903","NCT06205849","Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer","Phase 1 Clinical Trial of Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Histologically\u002Fcytologically-confirmed pancreatic ductal adenocarcinoma (PDAC)\n* Persons, aged \\> 18 years of age, as PDAC is extremely rare in pediatric populations.\n* Locally advanced disease that is not amenable to surgical resection. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology\\[53\\]. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT:\n\n  * Occlusion of the superior mesenteric vein (SMV) and\u002For portal vein (PV) that is not amenable to resection and venous reconstruction\n  * Interface between tumor and hepatic artery that is not amenable to resection and reconstruction\n  * Interface between the tumor and superior mesenteric artery (SMA) measuring \\> 180º of the circumference of the vessel wall\n  * Interface between the tumor and celiac axis measuring \\> 180º of the circumference of the vessel wall that is not amenable to resection\n* ECOG Performance Status of 0-2\n* Have adequate organ function per criteria below:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5x109\u002FL\n  * Platelets ≥ 100x109\u002FL\n  * Hemoglobin ≥9 g\u002FdL\n  * Serum creatinine ≤1.5 x ULN OR creatinine clearance ≥40 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n  * Serum total bilirubin ≤ 1.5 X ULN\n  * AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN\n* A minimum of 4 months of one of the chemotherapy regimens preferred by the NCCN for good performance status patients (currently modified FOLFIRINOX, gemcitabine + albumin-bound paclitaxel, or NALIRIFOX)\n* High quality imaging triphasic CT scan contrast-enhanced dynamic MRI of abdomen and either contrast-enhanced or non-contrast CT of chest and pelvis that demonstrate no evidence of metastatic disease within 30 days of enrollment\n* FDG-PET imaging (skullbase-midthigh) at any timepoint between diagnosis and study intervention to determine whether tumor is PET-avid and evaluate for extra-pancreatic metastatic disease, as suggested by NCCN guidelines for high-risk patients.\n* Tumor amenable to \"in situ\" (complete) ablation with maximum primary tumor dimension \\\u003C 4.0 cm\n* For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method until the study intervention and for an additional 1 month after the study intervention.\n* For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner for 1 month after study intervention.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Known allergic reactions to components of the mitazalimab solution (L-Histidine, trehalose, or polysorbate 20)\n* Fever \\> 38 degrees C within 14 days of study intervention\n* Treatment with another investigational drug or other intervention within 30 days of enrollment\n* Prior treatment with a CD40 antibody\n* History of severe auto-immune disease\n* The presence of metal fiducials or embolization coils within the tumor.\n* Prior receipt of radiation therapy to the pancreas\n* The presence of implanted metallic cardiac stimulation devices within the chest\n* Uncontrolled cardiac arrhythmias that prevent synchronization of pulse delivery with the refractory period of the cardiac cycle\n* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \\> 10 mg\u002Fday prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (≤ 10 mg\u002Fday of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted.\n* Any medical condition that precludes major abdominal surgery under general anesthesia\n* Presence of distant metastatic disease (including positive peritoneal cytology) on staging laparoscopy and\u002For exploratory laparotomy at any timepoint.",{"count":673,"type":23},18,[26],"This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.",[677],"Pancreatic Cancer",[679,680,681,682,683],"Irreversible electroporation (IRE)","NanoKnife","immunotherapy","CD40","Locally advanced pancreatic cancer",{"date":635,"type":48},{"date":686,"type":48},"2024-07-17",{"date":688,"type":23},"2030-08",{"name":54,"class":55},{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":267,"sex":106,"minAge":107,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":24,"phases":700,"briefSummary":701,"conditions":702,"keywords":704,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":711,"leadSponsor":713,"locationsCount":56},"100521337","an-mhealth-intervention-to-improve-hiv-prevention-service-engagement-among-people-who-use-drugs-100521337","NCT06068283","An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs","LOTUS","Inclusion Criteria:\n\n* 18 years of age or older\n* Report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Meet current CDC eligibility criteria for PrEP\n* Report low levels of HIV prevention service engagement in the past 6 months\n* Not currently, or planning on becoming, pregnant during the study\n* Owns a smartphone with internet web-browsing capabilities\n\nExclusion Criteria:\n\n* 17 years of age or younger\n* Does not report weekly or daily use of opioids and\u002For stimulants in the past 6 months\n* Does not meet current CDC eligibility criteria for PrEP\n* Report high levels of HIV prevention service engagement in the past 6 months\n* Currently, or planning on becoming, pregnant during the study\n* Does not own a smartphone with internet web-browsing capabilities",{"count":699,"type":23},40,[69],"The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV\u002FSTI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.",[703],"HIV Infections",[119,705,706,707],"Drug Use","mHealth","HIV Prevention",{"date":709,"type":48},"2026-06-26",{"date":418,"type":23},{"date":712,"type":23},"2027-07-30",{"name":54,"class":55},""]