[{"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:":644},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,170,0,25,[9,43,75,102,127,148,170,198,235,258,282,308,335,362,394,419,439,467,485,504,534,553,572,598,627],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053673",false,"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","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","OBSERVATIONAL","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.",[24],"CAR T-Cell Therapy",[26,27,28,29],"CAR T-cell therapy","RBANS","ICANS","Magnetic resonance imaging","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-09-19",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"University of California, San Diego","OTHER",1,{"id":44,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100053765","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":52,"type":20},100,"INTERVENTIONAL",[55],"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.",[58,59,60,61],"Drug Interactions","Primary Prevention","Cardiometabolic Syndrome","LDL-Cholersterol Lowering",[63,64,65,66,67,68],"Statin intolerance","drug drug interaction","inclisiran","LDL-Cholesterol","polypharmacy","multiple comorbidities",{"date":33,"type":34},{"date":71,"type":34},"2025-04-02",{"date":73,"type":20},"2027-03-31",{"name":40,"class":41},{"id":76,"slug":4,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":53,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":42},"100053734","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":84,"type":20},150,[86],"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.",[89],"Prostate Adenocarcinoma",[91,92,93],"Radiotherapy","Androgen deprivation therapy","Prostate cancer","NOT_YET_RECRUITING","2026-07-09",{"date":33,"type":34},{"date":98,"type":20},"2026-08",{"date":100,"type":20},"2034-04",{"name":40,"class":41},{"id":103,"slug":4,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":53,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":42},"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":110,"type":20},144,[112],"NA","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.",[115,116,117,118],"Team-effectiveness Research","School-based Interventions","Attention Deficit\u002F Hyperactivity Disorder","Implementation Science","2026-06-29",{"date":121,"type":34},"2026-06-30",{"date":123,"type":34},"2024-01-01",{"date":125,"type":20},"2028-01",{"name":40,"class":41},{"id":128,"slug":4,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":53,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":42},"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":52,"type":20},[55],"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.",[136],"Opioid Consumption, Postoperative",[138,139,140],"persistent postoperative opioid use","artificial intelligence","postoperative pain","2026-06-26",{"date":121,"type":34},{"date":144,"type":20},"2026-06",{"date":146,"type":20},"2027-06",{"name":40,"class":41},{"id":149,"slug":4,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":53,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":42},"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":155,"type":20},28,[86],"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).",[159],"Immunotherapy-related Pruritus",[161,162],"Immunotherapy","Pruritus","2026-06-25",{"date":121,"type":34},{"date":166,"type":34},"2025-03-05",{"date":168,"type":20},"2028-12",{"name":40,"class":41},{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":53,"phases":181,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":42},"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":180,"type":20},10,[182,86],"PHASE1","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.",[185,186],"Burnout","Burnout, Healthcare Workers",[188,189,190],"burnout","physician","doctor","2026-06-23",{"date":141,"type":34},{"date":194,"type":34},"2025-01-13",{"date":196,"type":20},"2027-07",{"name":40,"class":41},{"id":199,"slug":4,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":53,"phases":207,"briefSummary":208,"conditions":209,"keywords":215,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":42},"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":206,"type":20},62,[112],"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.",[210,211,212,213,214],"Acute Respiratory Distress Syndrome (ARDS)","Extracorporeal Membrane Oxygenation","Respiratory Failure Patients Treated With ECMO","Respiratory Failure, ICU","Ventilator Induced Lung Injury",[216,217,218,219,220,221,222,223,224,225,226,227],"Respiratory failure","ARDS","Acute Respiratory Distress Syndrome","ECMO","Pneumonia","Lung injury","Influenza","COVID","Viruses","Personalized ventilator settings","Positive end expiratory pressure","PEEP","2026-06-22",{"date":119,"type":34},{"date":231,"type":20},"2026-09-01",{"date":233,"type":20},"2031-06-30",{"name":40,"class":41},{"id":236,"slug":4,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":53,"phases":244,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":42},"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":243,"type":20},50,[112],"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?",[247,248,249],"Liver Cancer, Adult","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Obesity and Overweight",[251,252],"Time-restricted eating","healthy diet",{"date":163,"type":34},{"date":255,"type":34},"2025-08-01",{"date":168,"type":20},{"name":40,"class":41},{"id":259,"slug":4,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":53,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":42},"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":265,"type":20},18,[182],"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.",[269],"Pancreatic Cancer",[271,272,273,274,275],"Irreversible electroporation (IRE)","NanoKnife","immunotherapy","CD40","Locally advanced pancreatic cancer",{"date":163,"type":34},{"date":278,"type":34},"2024-07-17",{"date":280,"type":20},"2030-08",{"name":40,"class":41},{"id":283,"slug":4,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":289,"sex":290,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":53,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":42},"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",true,"FEMALE",{"count":292,"type":20},40,[112],"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.",[296],"HIV Infections",[298,299,300,301],"Women","Drug Use","mHealth","HIV Prevention",{"date":141,"type":34},{"date":304,"type":20},"2026-07-01",{"date":306,"type":20},"2027-07-30",{"name":40,"class":41},{"id":309,"slug":4,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":289,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":53,"phases":316,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":334,"locationsCount":4},"100644161","NCT07666867","Virtual Reality for Enhancing Self Compassion and Reducing Burnout Among Healthcare Providers","VR-CF-CBT","Inclusion Criteria:\n\n* have at least one year of experience working in a healthcare setting\n\nExclusion Criteria:\n\n* participating in other behavioral interventions that could confound study results\n* auditory or visual impairments that would interfere with VR usage\n* Participants who experience clinically significant VR-related discomfort\u002Fmotion sickness as assessed by the Simulator Sickness Questionnaire (SSQ)",{"count":315,"type":20},52,[112],"Healthcare providers in high-demand clinical settings are at high risk for burnout and secondary traumatic stress due to repeated exposure to patient trauma, which can compromise well-being and quality of care. Compassion-focused cognitive behavioral therapy (CF-CBT) can reduce stress and enhance self-compassion, but traditional delivery is time- and resource-intensive. This project evaluates the feasibility, acceptability, and potential effectiveness of virtual reality (VR)-enhanced CF-CBT specifically adapted for healthcare providers experiencing vicarious trauma. Grounded in Neff's self-compassion framework (emphasizing self-kindness, common humanity, and mindfulness) the VR intervention provides 8 immersive environments where participants can practice compassion-focused skills, engage in procedural learning, and regulate emotional responses in real time.\n\nThe study will be conducted at UC San Diego Health using a two-arm randomized design comparing VR-enhanced CF-CBT with self-guided compassion-focused CBT\u002Fmindfulness exercises delivered without VR. Participants will complete 8 brief VR interventional sessions (approximately 6-10 minutes each) over 4-6 weeks. Outcomes include self-compassion, burnout, and secondary traumatic stress, measured using validated instruments. Feasibility and acceptability will be evaluated through recruitment, retention, session completion, engagement, and participant feedback.\n\nFindings will provide preliminary evidence for VR-enhanced compassion-focused interventions as a scalable and accessible approach to supporting healthcare providers' emotional well-being in demanding clinical environments, and will inform future cultural adaptation and implementation in low-resource and conflict-affected healthcare settings such as those in post-war zones.",[186,185,319,320,321],"Burnout, Psychological","Self Compassion","Empathy Training of Healthcare Professional Students",[323,324,325,326,327],"Self-Compassion","Empathy","CBT","Virtual Reality","Healthcare Provider Burnout","2026-06-18",{"date":330,"type":34},"2026-06-24",{"date":304,"type":20},{"date":333,"type":20},"2027-02-01",{"name":40,"class":41},{"id":336,"slug":4,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":342,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":53,"phases":345,"briefSummary":346,"conditions":347,"keywords":350,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"100641562","NCT07658391","Optimizing CBSST With Executive Function Training for Schizophrenia (R33)","Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia","ECBSST R33","Inclusion Criteria:\n\n1. Voluntary informed consent to participate;\n2. Age 60 years or older;\n3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;\n4. Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;\n5. Be willing and able to speak English;\n6. Be able to read and converse (with corrected vision or hearing if needed).\n\nExclusion Criteria:\n\n1. Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;\n2. Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;\n3. Received electroconvulsive therapy within six months of the baseline assessment.","60 Years",{"count":344,"type":20},106,[112],"This randomized controlled clinical trial will test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). E-CBSST will be delivered to adults with late-life schizophrenia to determine if it increases Cognitive Behavioral Social Skills Training skills learning more than a supportive contact control condition and leads to improved functioning.",[348,349],"Schizophrenia","Schizoaffective Disorder",[348,351,352,353,354],"serious mental illness","randomized clinical trial","executive function training","Cognitive Behavioral Social Skills Training",{"date":191,"type":34},{"date":357,"type":20},"2026-10-01",{"date":359,"type":20},"2029-06",{"name":40,"class":41},2,{"id":363,"slug":4,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":289,"sex":290,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":53,"phases":370,"briefSummary":371,"conditions":372,"keywords":378,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100579121","NCT06820177","Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes","Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Able to understand and sign informed consent\n* Speaks English or Spanish language,\n* Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation\n\nExclusion Criteria:\n\n* History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonary embolism)\n* History of coagulopathy\n* Anticoagulant use in the preceding five days\n* Severe renal impairment\n* Chorioamnionitis or sepsis\n* Suspected placenta accreta spectrum\n* Prophylactic uterotonics other than oxytocin given (or planned to be given) at the start of the D\\&E\n* Known allergic reaction or hypersensitivity to TXA",{"count":369,"type":20},276,[55],"Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.",[373,374,375,376,377],"Abortion","Dilation and Evacuation","Hemorrhage","Prophylactic Tranexamic Acid Use","Blood Loss",[379,380,381,382,383,384],"abortion","dilation and evacuation","TXA","hemorrhage","Tranexamic acid","D&E","2026-06-12",{"date":387,"type":34},"2026-06-15",{"date":389,"type":34},"2025-04-22",{"date":391,"type":20},"2027-05",{"name":40,"class":41},3,{"id":395,"slug":4,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":53,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100486131","NCT05610085","A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures","A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures","NEOLEV3","Inclusion Criteria:\n\n* at risk for seizures or suspected to be having seizures;\n* all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;\n* Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);\n* weight \\> 2200g.\n* Parental ability to comprehend and provide written informed consent\n\nExclusion Criteria:\n\n* Cumulative seizure burden of 8 minutes\u002F hour or more in phases 1 and 2, Cumulative seizure burden of 20 minutes\u002Fhour or more in phase 3;\n* Renal failure defined as anuria in the first 24 hours of life;\n* Subjects in whom death seems imminent;\n* Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.","1 Month",{"count":403,"type":20},133,[86],"The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg\u002Fkg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 20 minute seizure burden\u002Fhour. This will make the final results of study more generalizable.\n\nIf seizures are confirmed, enrolled subjects will receive 60mg\u002Fkg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site.\n\nFunding Source- FDA OOPD",[407,408,409,410],"Neonatal Seizure","Neonatal Encephalopathy","Hypoxic-Ischemic Encephalopathy","Seizure Newborn","2026-06-11",{"date":387,"type":34},{"date":414,"type":34},"2023-03-24",{"date":416,"type":20},"2027-12-31",{"name":40,"class":41},5,{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":178,"enrollmentInfo":425,"targetDuration":4,"studyType":53,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":42},"100464016","NCT05322213","THC Effects on Glucose in Type 2 Diabetes","The Effects of THC on Glucose Metabolism and Endothelial Function in Subjects With Type 2 Diabetes","Inclusion Criteria:\n\n* Males and Females 21-70 years old at the time of screening.\n* Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study.\n* Male subjects must be willing to use clinically acceptable method of contraception during the entire study.\n* Have a clinical diagnosis of Type 2 Diabetes on a stable medication regimen for at least 3 months.\n* BMI \\> 25 kg\u002Fm2).\n* HbA1c \\\u003C 10%).\n* Negative urine toxicology result at screening visit.\n* Able to provide written informed consent approved by an Institutional Review Board (IRB).\n\nExclusion Criteria:\n\n* History or presence of any clinically significant illness, as detected by history, physical examination, and\u002For laboratory tests, that might put the participant at increased risk of adverse events (e.g., history of psychotic disorder, clinically significant mood and\u002For anxiety disorder, liver, or renal disease).\n* No prior history of myocardial infarction, stroke or heart failure.\n* Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion.\n* Hemoglobin \\\u003C 9g\u002FdL.\n* Liver enzymes ≥ 2 times upper normal limit and\u002For clinical signs\u002Fsymptoms consistent with liver disease, including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, or edema.\n* History of clinically significant adverse events associated with cannabis intoxication (e.g., severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension).\n* History of seizures, head trauma, or other history of CNS insult that could predispose the participant to seizures.\n* Use of any THC containing products within 30 days prior to the screening visit.\n* Current use of tobacco products.\n* Individuals who are pregnant or lactating\u002Fbreastfeeding.\n* Current use of insulin to treat Type 2 Diabetes.\n* Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits.\n* Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.",{"count":426,"type":20},30,[182],"This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.",[430],"Type 2 Diabetes",[432],"THC",{"date":387,"type":34},{"date":435,"type":34},"2024-08-22",{"date":437,"type":20},"2028-06",{"name":40,"class":41},{"id":440,"slug":4,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":289,"sex":16,"minAge":446,"maxAge":342,"enrollmentInfo":447,"targetDuration":4,"studyType":53,"phases":448,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":42},"100642223","NCT07642869","Multivitamin and Mineral Supplementation and Healthy Aging","The Impacts of Multivitamin and Mineral Supplementation on Cellular Metabolism and Healthy Aging","MiMIC","Inclusion Criteria:\n\n1. IPAQ-SF categorical score of low or moderate physical activity (indicating sedentary lifestyle).\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Between 40-60 years of age\n4. BMI ≥18.5 and ≤32 kg\u002Fm2\n5. Weight stable for the prior 6 weeks\n\nExclusion Criteria:\n\n1. Is pregnant or nursing.\n2. Current smoker.\n3. Diabetes (FPG \\> 180 mg\u002FdL or A1c\\>8)\n4. Heart or cardiovascular condition, including coronary artery disease, congestive heart failure, diagnosed abnormality of heart rhythm, atrial fibrillation and\u002For a history of myocardial infarction\n5. Cancer or history of cancer within the past 5 years\n6. Sensory or physical impairment that would prevent participation\n7. Parkinson's disease, multiple sclerosis or other neurological condition, including a previous stroke, that may be causing impaired muscle function or mobility\n8. Consistent use of any multivitamin and mineral supplement use, or any supplement that may interfere with measurements or biological outcomes (including but not limited to: NAD+ supplements, MitoQ)\n9. Individuals with drug interactions as determined by the study physician","40 Years",{"count":84,"type":20},[112],"The goal of this study is to determine the impact of MVM supplementation on clinical and biochemical markers associated with healthy aging, with a particular focus on mitochondrial function and metabolism. Specifically, changes in mitochondrial respiration using isolated blood cells will be measured. This method has been used to compare with various other age-related markers of health such as physical function, gait speed, and resting metabolic rate. It is hypothesize that MVM supplementation will impact the function of blood cells. MVM supplementation impacts other markers of health, including serum nutrient levels, metabolomic profiles, physical function, and skeletal muscle composition and quality will be explored. These comprehensive assessments will provide insights into the potential benefits of MVM supplementation for healthy aging and address critical gaps in our understanding of its immediate effects. Further, this study will aid in the understanding of how multivitamin supplements can support heathy aging in mid-life adults, a key time to start including wellness programs in people's lives.\n\nThe study cohort will consist of 150 sedentary men and women aged 40-60-years of age. A double-blind, three-arm, placebo-controlled randomized clinical trial will be conducted. Participants will receive a daily oral tablet containing one of two possible formulations of vitamins and minerals or a placebo. The three groups will be MVM \"GOLD\" blend formula, the US Restage MVM \"US CORE\", and the placebo group.",[451,452],"Healthy Aging","Multivitamin and Mineral Supplementation",[454,455,456,457,458,459],"Multivitamin and mineral supplements","Supplements","Cellular metabolism","healthy aging","mitochondria","Respirometry","2026-06-10",{"date":387,"type":34},{"date":463,"type":34},"2025-09-05",{"date":465,"type":20},"2026-12",{"name":40,"class":41},{"id":468,"slug":4,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":53,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":482,"leadSponsor":484,"locationsCount":42},"100633289","NCT07524751","Culturally Adapted Pain Management for Indigenous Peoples","Culturally Adapted Pain Management for Indigenous Peoples in the Pacific Northwest (CAP-I)","CAP-I","Inclusion Criteria:\n\n* at least 18 years of age\n* identify as AI\u002FAN (or by another preferred name, such Native American, Native, and\u002For Indigenous)\n* have at least one diagnosis consistent with chronic pain and\u002For meet criteria for chronic pain diagnosis at enrollment (i.e., experience pain for \\> 50% in the past 3 months that interferes with daily functioning)\n* possess the ability to speak and understand English\n* have access to a mode of communication for contact, such as a telephone, for study purposes\n\nExclusion Criteria:\n\n* significant cognitive impairment\n* current uncontrolled serious psychological issues (e.g., schizophrenia, bipolar disorder)\n* active medical treatment for malignant conditions (e.g., cancer)\n* active suicidality with intent\n* active alcohol and\u002For substance abuse",{"count":426,"type":20},[112],"The proposed study involves a randomized feasibility pilot trial of a culturally adapted psychological intervention for chronic pain for American Indian\u002FAlaska Native (AI\u002FAN) individuals receiving care for pain at the Portland Area Indian Health Service - Yakama Service Unit. The study will provide information on whether or not it is feasible to conduct a future fully-powered randomized controlled trial.",[478],"Chronic Pain","2026-06-09",{"date":411,"type":34},{"date":387,"type":20},{"date":483,"type":20},"2028-11-30",{"name":40,"class":41},{"id":486,"slug":4,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":53,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":42},"100561140","NCT06586281","Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy","Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy","Inclusion Criteria:\n\n1. Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.\n2. Must have:\n\n1 or more swollen joint(s) and\u002For one or more active sites of enthesitis\n\n3\\. AND\u002FOR\n\n1 or more psoriatic plaques\n\n4\\. No changes in the regular medication regimen within the last three months, and no use of systemic and\u002For chronic steroids within 8 weeks leading up to the study.\n\n5\\. Overweight or obese by BMI ≥ 25.0 kg\u002Fm2 or ≥ 23.0 for Asian participants\n\n6\\. Patients are starting Guselkumab therapy for PsA as indicated by primary rheumatologist\n\n7\\. Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB\u002Fm, which is consistent with NAFLD after exclusion of secondary causes of liver disease.\n\nExclusion Criteria:\n\n1. Patients with prior exposure to IL12\u002F23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.\n2. Evidence of other causes of chronic liver disease\n\n   * Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).\n   * Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Abin serum (anti-HCV Ab).\n   * Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.\n   * Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.\n   * Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.\n   * Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.\n   * Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y\u002FH63D.\n   * Drug-induced liver disease as defined on the basis of typical exposure and history.\n   * Bile duct obstruction as shown by imaging studies.\n   * History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone or tetracycline in the previous 6 months.\n   * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices\n   * Presence of regular and\u002For excessive use of alcohol (defined as \\>30g\u002Fday for males and \\>15g\u002Fday for females) for a period longer than 2 years at any times in the last 10 years\n   * Serum creatinine \\> 2.0 mg\u002FdL\n   * The subject is a pregnant or nursing female or is planning to become pregnant\n   * Life expectancy less than 5 years\n3. History of known HIV infection",{"count":492,"type":20},20,[112],"While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.",[496],"Psoriatic Arthritis","2026-06-08",{"date":460,"type":34},{"date":500,"type":34},"2025-06-01",{"date":502,"type":20},"2027-12-01",{"name":40,"class":41},{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":53,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":42},"100576846","NCT06790602","Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","A Single-arm, Open-label, Phase II Trial of Cemiplimab Plus Gemcitabine as Second-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Harboring SWItch\u002FSucrose Non-Fermentable (SWI\u002FSNF) Alterations.","SWITCH","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Ability to understand the nature of this study, comply with study and follow-up procedures, and give written informed consent.\n3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Primary tumor can be intact or post-resection with newly developed metastatic disease.\n4. Stage IV disease (measurable disease by Immunotherapeutics Response Evaluation Criteria in Solid Tumors is required).\n5. Alterations in SWI\u002FSNF complex chromatin remodeling genes (ARID1A, ARID1B, PBRM1, SMARCA4 and SMARCB1, etc.) detected by next generation sequencing performed prior to enrollment on an ultrasound-guided core biopsy of the primary tumor.\n6. One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy).\n7. Last dose of chemotherapy administered \\> 14 days prior to the initiation of study therapy.\n8. Last dose of radiation therapy or administered \\> 28 days prior to the initiation of study therapy.\n9. Eastern Cooperative Oncology Group performance score of 0-1.\n10. Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells per microliter; Platelet count ≥ 100,000 cells per microliter; Hemoglobin ≥ 9.0 grams per deciliter.\n11. Adequate hepatic function: Total bilirubin ≤ 1.5 times upper limit of normal (NOTE high bilirubin levels due to Gilbert's syndrome are allowed); Aspartate transaminase ≤ 3.0 times upper limit of normal (≤5.0 times upper limit of normal if liver metastases are present); Alanine transaminase ≤ 3.0 times upper limit of normal (≤5.0 times upper limit of normal if liver metastases are present).\n12. Adequate renal function: Serum creatinine ≤ 1.5 times upper limit of normal.\n13. Calculated corrected QT Interval (QTcF) average of the triplicate electrocardiograms \\\u003C470 milliseconds.\n14. Participants not of child-bearing potential, or participants of child-bearing potential who agree to use adequate contraceptive measures during the study and for at least 6 months after the last cemiplimab dose; who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to initiation of study therapy.\n15. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation and for at least 6 months after the last cemiplimab dose.\n\nExclusion Criteria:\n\n1. Two or more lines of systemic or previous investigational therapy for metastatic pancreatic ductal adenocarcinoma.\n2. History of any autoimmune disease requiring treatment within the past 12 months prior to enrollment.\n3. History of transplanted organ\u002Fbone marrow.\n4. History of interstitial lung disease.\n5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n6. History of previous malignancy (except in-situ cancer or basal or squamous cell skin cancer) within past 3 years prior to enrollment.\n7. History of immune checkpoint inhibitor therapy, ever.\n8. Known bleeding disorders (e.g., van Willebrand's disease or hemophilia).\n9. Current use of warfarin or other vitamin K antagonists. NOTE: if therapeutic anticoagulation is necessary, low molecular weight heparin or oral factor Xa inhibitors are the anticoagulants of choice.\n10. Current use of a strong cytochrome P450 3A inhibitor (for example, antifungal medications, grapefruit juice, amiodarone, etc.).\n11. Presence of known central nervous system or brain metastases.\n12. History of other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.\n13. Life expectancy of \\\u003C3 months.\n14. Known active, not-controlled human immunodeficiency virus, hepatitis B or hepatitis C infection or diagnosis of immunodeficiency.\n15. Receipt of a live vaccine within 4 weeks of start of study medication.\n16. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment.\n17. Major surgery within 4 weeks of the start of study treatment. Major surgeries are defined as those surgeries that require general anesthesia. Insertion of a vascular access device, biliary drainage tube, gastrointestinal stent are NOT considered major surgery.\n18. Pregnancy or lactation.\n19. Known allergic reactions to components of the study intervention, cemiplimab and\u002For gemcitabine.",{"count":512,"type":20},43,[86],"This is a Phase 2 trial evaluating the combination of cemiplimab with the standard of care chemotherapy agent gemcitabine for the treatment of patients with metastatic pancreatic ductal adenocarcinoma with SWItch\u002FSucrose Non-Fermentable (SWI\u002FSNF) alterations who have already been treated with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine\u002Fnab-paclitaxel chemotherapy.",[516],"Pancreatic Ductal Adenocarcinoma (mPDAC)",[518,519,520,521,522,523,524,525,526],"cemiplimab","gemcitabine","immune checkpoint inhibitors","pancreatic ductal adenocarcinoma","SWI\u002FSNF","combination therapy","PDAC","Phase 2","metastatic","2026-06-04",{"date":497,"type":34},{"date":530,"type":34},"2026-05-06",{"date":532,"type":20},"2029-12",{"name":40,"class":41},{"id":535,"slug":4,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":53,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":42},"100642896","NCT07633418","IO Vancomycin Administration in TKA","Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty","IO Vanco","Inclusion Criteria:\n\n1. Is a patient over the age of 18 receiving treatment at UC San Diego\n2. Is undergoing primary unilateral total knee arthroplasty\n3. Is able to provide consent\n4. Is candidate for IO administration of Vancomycin\n\nExclusion Criteria:\n\n1. Has had a previous surgery on the knee of interest (with the exception of arthroscopy)\n2. Has a BMI \\>35\n3. Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)\n4. Has diabetes with A1c \\>7.5% (unless with controlled fructosamine)\n5. Is immunocompromised\u002Fimmunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)\n6. Has a history of active infection\n7. Inability to provide consent\n8. Prisoner\n9. Pregnant women",{"count":426,"type":20},[55],"This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.",[545],"Total Knee Arthroplasty","2026-06-02",{"date":497,"type":34},{"date":549,"type":20},"2026-06-01",{"date":551,"type":20},"2029-04-29",{"name":40,"class":41},{"id":554,"slug":4,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":16,"minAge":559,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":42},"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":562,"type":20},1500,"Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers",[565],"Eosinophilic Esophagitis",{"date":527,"type":34},{"date":568,"type":34},"2019-02-11",{"date":570,"type":20},"2028-12-17",{"name":40,"class":41},{"id":573,"slug":4,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":289,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":53,"phases":581,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":597},"100520340","NCT06055296","Multisite Implementation of COMPRENDO","Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials","COMPRENDO","Non-Stakeholder\u002FStakeholder Parent Eligibility criteria: A parent\u002Flegal guardian who has a Hispanic child aged 0 to 17y with a new diagnosis of cancer, has a child who is eligible for a therapeutic cancer clinical trial, will participate in an informed consent discussion for the therapeutic clinical trial, understands written and spoken English or Spanish, and has signed the consent form for the proposed COMPRENDO study. Participants will not be eligible if their child has second malignancy\u002Frelapse, was diagnosed at an outside institution, has potential transfer of care, was previously on a clinical trial\n\nStakeholder Clinician\u002FNavigator\u002FAdministrator Clinicians, navigators and administrators who work at each site, are involved in treating pediatric patients and who are involved in the informed consent conference for clinical trials.",{"count":580,"type":20},450,[112],"COMPRENDO (ChildhOod Malignancy Peer Research NavigatiOn) is a multi-site randomized clinical trial (RCT) that uses a Hybrid Type 1 design, to test the effects of a clinical intervention on patient-level outcomes, while exploring multilevel implementation factors that can inform real-world setting implementation. This study will test the impact of COMPRENDO, a peer-navigation intervention, vs. usual care on accrual to childhood cancer therapeutic clinical trials and parental informed consent outcomes. COMPRENDO will be delivered by trained peer navigators in 4 visits. A mixed methods (surveys, individual interviews) implementation evaluation will examine implementation factors that can inform the use of peer navigation in clinical practice, integrating data from clinicians, navigators, administrators, and parents pre and post the RCT.",[584],"Pediatric Cancer",[586,587,588,589],"Research Literacy","Cancer Disparities","Minority Clinical Trial Accrual","Patient Navigation",{"date":591,"type":34},"2026-06-03",{"date":593,"type":34},"2024-01-11",{"date":595,"type":20},"2028-06-30",{"name":40,"class":41},4,{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":11,"sex":16,"minAge":446,"maxAge":604,"enrollmentInfo":605,"targetDuration":4,"studyType":53,"phases":607,"briefSummary":608,"conditions":609,"keywords":613,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":42},"100457508","NCT05237505","The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)","CRESCENDO-SLP","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* Persons aged 40-79.\n* For women, only postmenopausal women will be included\n* Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events\u002Fhr and ≤80 events\u002Fhr) and\u002For diagnosed with COPD with FEV1\u002FFVC ratio \\\u003C0.7 and will be on stable medications as assessed by a board-certified pulmonologist.\n\nExclusion Criteria:\n\n* Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation\n* Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants\u002Fear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.\n* Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).\n* Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).\n* Exhibit Cheyne-Stokes respiration or central sleep apnea (\\> 25 % of events central)\n* Take potentially confounding medications or hormones that affect breathing.\n* Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.\n* We will also exclude participants with pulmonary disease apart from COPD.\n* We will exclude participants with active cancer treatment.\n* We will exclude azotemia (estimated glomerular fraction rate \\\u003C 30ml\u002Fmin) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).\n* people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol consumption (\\>3 oz\u002Fday) and other environmental pollution effects (indoor and outdoor).\n* Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.\n* Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.\n* Individuals with OSA (AHI range 15-80\u002Fhr) will be screened for pathological sleepiness and will be excluded if ESS \\>18\u002F24, history of motor vehicle accident or near miss accident, or high-risk occupation.\n* COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.\n* Individuals who are currently incarcerated.","79 Years",{"count":606,"type":20},240,[86],"Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear.\n\nThe combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues.\n\nThe purpose of this study is to examine vascular mechanisms in individuals with COPD\u002FOSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.",[610,611,612],"Obstructive Sleep Apnea","Chronic Obstructive Pulmonary Disease","Overlap Syndrome",[614,615,616,617,618,619,620],"OSA","obstructive sleep apnea","COPD","chronic obstructive pulmonary disease","PAP therapy","oxygen","cardiovascular health",{"date":591,"type":34},{"date":623,"type":34},"2024-02-13",{"date":625,"type":20},"2028-08-31",{"name":40,"class":41},{"id":628,"slug":4,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":289,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":53,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":42},"100614683","NCT07282782","Vancomycin in TKAs","A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty","Inclusion Criteria:\n\n* Any patient over the age of 18 years of age receiving treatment at UC San Diego Health\n* Undergoing primary unilateral TKA\n* Ability to provide consent\n\nExclusion Criteria:\n\n* previous surgery on the knee (with the exception of arthroscopy)\n* BMI \\> 35\n* contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)\n* diabetics with A1c\\>7.5% (unless controlled fructosamine)\n* immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)\n* no history of active infections\n* no history of chronic kidney disease",{"count":426,"type":20},[55],"Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would\u002Ftissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.",[545],"2026-05-31",{"date":591,"type":34},{"date":640,"type":34},"2024-06-10",{"date":642,"type":20},"2028-12-31",{"name":40,"class":41},""]