[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of California, San Francisco\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":676},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,342,0,25,[9,49,79,106,135,158,190,217,239,264,295,316,338,368,390,417,441,472,503,529,555,581,603,627,650],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053615",false,"NCT07288437","Deep Brain Stimulation for Spinocerebellar Ataxia","Adaptive Deep Brain Stimulation Targeting the Dentate Nucleus to Treat Spinocerebellar Ataxia","Inclusion Criteria:\n\n1. A diagnosis of SCA6 by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society.\n2. A positive genetic test for SCA6.\n3. A total scale ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale.\n4. Ability to walk with or without support (score \\\u003C 8 on the 'gait' subsection of the SARA rating scale).\n5. Age ≥ 21 years and \\\u003C 89 years.\n6. Ability to give informed consent for the study.\n7. Be able to understand the study protocol.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to comply with the study protocol.\n2. History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants.\n3. Severe cognitive impairment or dementia, defined as a score \\\u003C 21 on the Montreal Cognitive Assessment (MoCA).\n4. Evidence of ataxia due to other etiologies, including but not limited to:\n\n   1. Genetic\u002Finherited disorders other than SCA6.\n   2. Acquired causes: tramautic brain injury, multiple sclerosis, paraneplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia).\n   3. Toxic\u002Fmetabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies.\n   4. Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations.\n   5. Suspected multiple system atrophy-cerebellar type (MSA-C).\n5. The presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team.\n6. Coagulopathy, uncontrolled epilepsy, or other medical condition considered to place the patient at elevated risk for surgical complications. Presence of a concomitant medical condition that, in the investigator's opinion, may interfere with the study participation or gait\u002Fbalance, for example, severe arthritis.\n7. Presence of a concominant medical condition that, in the investigator's opinion, may interfere with the study participation or gait\u002Fbalance, for example, severe arthritis.\n8. Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation.\n9. Pregnancy or lactation.\n10. Active suicidal ideation, defined as fined as a \"Yes\" response to questions #2-5 on the Columbia Suicide Severity Rating Scale, C-SSRS.\n11. Refractory Epilepsy.","ALL","21 Years","89 Years",{"count":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to test the safety of placing Deep Brain Stimulators (DBS) in the cerebellum and using electrical stimulation of that part of the brain to treat symptoms related to the participants spinocerebellar ataxia. Five adults diagnosed with spinocerebellar ataxia type 6 (SCA6) with inadequate cerebellar symptom relief will be implanted with a Medtronic Percept Primary Cell Neurostimulator. The device will be implanted into the dentate nucleus, which is a structure located within the cerebellum that is responsible for controlling movement and balance.\n\nSpecifically, the investigators will be using adaptive deep brain stimulation (aDBS), which analyzes brain signals and automatically adjusts the strength, timing, and pattern of stimulation according to the patient's needs at any given moment. This study will evaluate the feasibility, safety, and tolerability of aDBS in SCA6 patients.",[27,28],"Spinocerebellar Ataxia (SCA)","Spinocerebellar Ataxia Type 6",[30,31,32,28,33,34,35],"adaptive deep brain stimulation","aDBS","Spinocerebellar Ataxia","SCA6","DBS","deep brain stimulation","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2026-04-27",{"date":44,"type":21},"2031-03",{"name":46,"class":47},"University of California, San Francisco","OTHER",2,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100053401","NCT07296770","An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service","TPS-Select","Patients may take part in this study if they:\n\n* Are 18 years or older\n* Are having a planned (elective) surgery at UCSF\n* Are identified as higher risk for chronic pain after surgery by a computer model\n* Agree to join the study and sign consent\n\nPatients cannot take part if they:\n\n* Have too much missing information in their medical record (more than 75%)\n* Have a surgery scheduled less than 1 month away\n* Have serious memory or thinking problems that make participation difficult\n* Are in another clinical study that would interfere with this one\n* Do not live in California\n* Choose not to participate or sign consent\n* Have severe depression with suicidal thoughts that requires urgent care\n* Are pregnant or breastfeeding\n\nA patient who has already joined may be removed from the study if they:\n\n* Cannot complete most of the scheduled follow-up phone calls or pre-surgery recommendations (up to 6 months after discharge)\n* Pass away between the surgery booking date and 6 months after leaving the hospital\n* Become pregnant in the 6 months after discharge\n\nPatients may remain enrolled but their data may not be used in the main study results if they experience:\n\n* A long-lasting infection after surgery\n* Hardware problems related to their surgery (for example, issues with implanted devices)\n* A major injury or life event that affects their pain levels, such as a significant fall or an emergency surgery\n* Difficulty completing the planned follow-up phone calls up to 6 months after discharge","18 Years",{"count":57,"type":21},126,[59],"PHASE3","The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.",[62,63,64],"Postsurgical Pain Management","Postsurgical Pain, Chronic","Opioid Use After Surgery",[66,67,68,69],"Pain","Transitional Pain Service","Postsurgical Pain","Postoperative Opioid Use","NOT_YET_RECRUITING","2026-07-09",{"date":39,"type":40},{"date":74,"type":21},"2026-10-01",{"date":76,"type":21},"2028-07-01",{"name":46,"class":47},1,{"id":80,"slug":4,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100053894","NCT06003725","Cultural Adaptation of Drug Treatment for DJJ Youth","The Cultural Adaptation of an Alcohol and Other Drug Use Treatment for Black Justice Involved Youth","CAST","For Focus Groups and Interviews:\n\nBlack JIY Participants:\n\nInclusion Criteria:\n\n• 1) Between the ages of 13-17; 2) identify as Black or African American; and 3) on community probation.\n\nExclusion Criteria:\n\n• Will be excluded if they do not have parental consent to participate.\n\nFor Focus Groups and Interviews:\n\nAdult Participants\n\nInclusion Criteria:\n\n* A guardian of JIY\n* An advocate (someone who supports change and reform in the justice community) for Black JIY.\n\nExclusion Criteria:\n\n• Will be excluded if they do not provide consent to participate.\n\nFor pilot feasibility study:\n\nBlack JIY Participants:\n\nInclusion Criteria:\n\n* Between the ages of 13 and 17\n* Identify as Black or African American\n* Be on community probation\n* Meet criteria for alcohol, cannabis, or other drug misuse as defined by the DSM 5\n* Be experiencing at least 1 problem related to AOD;\n* The frequency of AOD must be weekly use over a 3-month period\n\nExclusion Criteria:\n\n* Will be excluded if they do not have parental consent to participate\n* Parole violation",true,"13 Years","17 Years",{"count":90,"type":21},55,[24],"This project aims to improve the understanding of the impact of Ethnic and Racial Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus groups with parents and guardians of Black JIY and community members who support change and reform in the justice community for Black JIY will be conducted.",[94],"Substance Use",[96,97,98,99],"Substance use","substance misuse","adolescent","cultural adaptation",{"date":39,"type":40},{"date":102,"type":40},"2024-05-15",{"date":104,"type":21},"2027-08-30",{"name":46,"class":47},{"id":107,"slug":4,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":113,"minAge":55,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100053652","NCT06883344","Automated Insulin for Management of Intrapartum Glycemia","Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial","AIMING","Inclusion Criteria:\n\n* Currently pregnant at ≥ 34 weeks\n* Known diagnosis of type 1 diabetes ≥ 1 year\n* Use of commercially available AID system since at least 28 weeks gestation\n* Singleton pregnancy\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Planned cesarean delivery\n* Use of medications known to interfere with glucose metabolism\n* Intrauterine fetal demise\n* Physical or psychological disease likely to interfere with the conduct of the study and\u002For the ability to participate in own healthcare","FEMALE","55 Years",{"count":116,"type":21},150,[24],"The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor\u002Fdelivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are\n\n* What are the neonatal glycemic outcomes with use of AID systems during labor\u002Fdelivery?\n* Do patients report higher birth satisfaction with use of AID systems during labor\u002Fdelivery?\n* Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor\u002Fdelivery?\n\nResearchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor\u002Fdelivery) by randomly assigning participants to one or the other.",[120,121,122],"Type 1 Diabetes (T1D)","Pregnancy","Pre-Gestational Diabetes",[121,124,125,126,127],"Intrapartum glycemic management","Neonatal hypoglycemia","Perinatal care","Diabetes in pregnancy",{"date":39,"type":40},{"date":130,"type":40},"2025-12-05",{"date":132,"type":21},"2028-12-31",{"name":46,"class":47},3,{"id":136,"slug":4,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":141,"targetDuration":143,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100513364","NCT05964504","Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)","Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Histologically confirmed invasive lobular carcinoma. Mixed lobular\u002Fductal cancer is allowed.\n2. Age \\>=18 years\n3. Any receptor subtype.\n4. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Stage I-III breast cancer.\n2. Lack of lobular histology on tumor biopsy.\n3. Other active cancer (prior treated cancer with no current evidence of disease is allowed).",{"count":142,"type":21},12,"10 Years","OBSERVATIONAL","This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.",[147,148],"Metastatic Breast Cancer","Lobular Breast Carcinoma","2026-06-30",{"date":151,"type":40},"2026-07-02",{"date":153,"type":40},"2023-12-20",{"date":155,"type":21},"2036-02-28",{"name":46,"class":47},4,{"id":159,"slug":4,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":114,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":170,"conditions":171,"keywords":179,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":78},"100466892","NCT05359653","Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","ReVIVE","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any assessment being performed.\n* Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \\\u003C 15 years\n* Male or female patients aged 18-55 years (inclusive)\n* Use of appropriate contraception during period of trial (women). Before entry women must be:\n\n  * Post-menopausal for at least 1 year OR\n  * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR\n  * Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR\n  * Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.\n\nExclusion Criteria:\n\n* Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI\n* New lesion in most recent MRI (within 3 months)\n* Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.\n* Treatment with corticosteroids within 30 days prior to screening.\n* Expanded Disability Status Scale (EDSS) ≥ 4.5\n* History of significant cardiac conduction block.\n* History of cancer.\n* Suicidal ideation or behavior in 6 months prior to baseline.\n* Pregnancy, breastfeeding or planning to become pregnant.\n* Involved with other study protocols simultaneously without prior approval.\n* Concomitant use of any other putative remyelinating therapy as determined by the investigator.\n* Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.\n* Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.\n* Serum creatinine \\> 1.5 mg\u002FdL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \\> 2 times the upper limit of normal. (Reported within 72 hours)\n* History of drug or alcohol abuse within the past year.\n* Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid \\[MMA\\] and homocysteine) or untreated hypothyroidism.\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.\n* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study\n* Inability to participate in MRI, including extreme claustrophobia.\n* Any dental braces or permanent or undetachable metals in the jaw or face.",{"count":166,"type":21},74,[168,169],"PHASE1","PHASE2","The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.\n\nNo reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.\n\nThis study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis.\n\nIn addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.",[172,173,174,175,176,177,178],"Multiple Sclerosis (MS)","Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Primary Progressive","Multiple Sclerosis, Chronic Progressive","Multiple Sclerosis Relapse","Multiple Sclerosis Brain Lesion","Multiple Sclerosis Benign",[180,181,182,183],"multiple sclerosis","mri","brain","spinal cord",{"date":151,"type":40},{"date":186,"type":40},"2023-08-01",{"date":188,"type":21},"2027-06-01",{"name":46,"class":47},{"id":191,"slug":4,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":78},"100645251","NCT07682311","Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator","Auto aDBS","Inclusion Criteria:\n\n1. Age 25-75.\n2. Diagnosis of idiopathic PD.\n3. Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment.\n4. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)).\n5. Signed informed consent.\n6. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.\n7. Patient has been on cDBS for at least two months and still experiences significant residual motor fluctuation while on cDBS. Consequently, patient is undergoing aDBS treatment currently or was recommended aDBS as part of clinical care to manage their residual motor fluctuation.\n8. Has available cDBS Timeline LFP and stimulation data lasting at least 1 day.\n9. To be enrolled in the clinical trial phase of the study, patient will need to consent to reverting back to their baseline cDBS settings for all required cDBS testings.\n\nExclusion Criteria:\n\n1. Patient meets criteria for a psychogenic movement disorder.\n2. Significant untreated depression (BDI-II score \\>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).\n3. Any personality or mood symptoms that study personnel believe will interfere with study requirements.","25 Years","75 Years",{"count":199,"type":21},40,[24],"Parkinson's disease (PD) affects \\~1% of people over 60 years old, is highly disabling and represents a large economic burden. While dopaminergic medications effectively treat motor symptoms early in the disease, most patients develop complications, including motor fluctuations and dyskinesias, which can be partially managed by deep brain stimulation (DBS). This surgical therapy consists of delivering continuous electrical stimulation through electrodes permanently implanted in basal ganglia nuclei, with a pulse generator and battery unit implanted in the chest. However, conventional DBS therapy is delivered with constant stimulation parameters, referred to as constant deep brain stimulation (cDBS), that are unresponsive to patient activities or to variations in the severity of symptoms during daily life. This leaves many patients under- or over-stimulated during parts of the day.\n\nTo address the shortcomings of cDBS, adaptive DBS (aDBS) uses real-time detection of neural signals to automatically adjust stimulation amplitude or other parameters in response to patients' dynamic clinical needs. aDBS was approved by the U.S. Food and Drugs Administration (FDA) for clinical treatment of PD in the Percept PC and RC (Medtronic) device in February 2025.\n\nFully leveraging this therapy in the real world is limited by technical challenges, in particular the fact that: while the investigators developed a consistent pipeline for implementing aDBS, there were several critical control parameters that strongly influenced algorithm performance and required prolonged trial-and-error based testing, to achieve successful control. In this new study, the investigators seek to significantly extend this work and address the major barriers to widespread, easy adoption of aDBS by groups without specialized knowledge of neurophysiology or feedback control. Here the investigators aim to test an automated, data-driven pipeline for the recommendation of the adaptive control parameters.",[203],"PD - Parkinson's Disease",[34,205,31,30,206,207,208,209],"adaptive","Medtronic Percept","Parkinson's Disease","PD","Percept","2026-06-26",{"date":151,"type":40},{"date":213,"type":21},"2026-06",{"date":215,"type":21},"2032-05",{"name":46,"class":47},{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":78},"100645317","NCT07682441","CBITS-RTM Pilot Study","Preventing Substance Use Among Incarcerated Youth Through Addressing Posttraumatic Stress","Inclusion Criteria:\n\n* Youth must 1) be currently incarcerated in a partnering juvenile detention center, 2) be between 13-18 years of age, and 3) have a minimum of 3 months remaining on their sentence (i.e., sufficient time required to complete CBITS-RTM). Youth will complete a screening with a study team member involving the 2-item Abbreviated PTSD Checklist-Civilian version, with scores ≥4 considered a positive screen\n* Clinicians are eligible if they are behavioral health staff working with youth at the detention school..\n\nExclusion Criteria:\n\n* Observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.",{"count":224,"type":21},28,[24],"This pilot study, conducted in partnership with juvenile detention centers, evaluates an adapted CBITS-RTM intervention delivered in a detention school setting.",[228,94],"PTSD - Post Traumatic Stress Disorder",[230,231,232],"Incarcerated youth","Juvenile detention school","CBITS-RTM",{"date":151,"type":40},{"date":235,"type":21},"2026-09-01",{"date":237,"type":21},"2027-12-31",{"name":46,"class":47},{"id":240,"slug":4,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":48},"100645279","NCT07682454","Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin","Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin","Inclusion Criteria:\n\n1. Participants must have radiographically documented, previously untreated LIRADS V liver lesions or biopsy-confirmed hepatocellular carcinoma (HCC), as determined by the ZSFG Liver Tumor Board.\n2. Lesions must be determined to be suitable for conventional trans-arterial chemoembolization (cTACE) based on multidisciplinary tumor board review.\n3. No prior locoregional therapy (e.g., TACE, Y-90) to the index lesion(s).\n4. Age ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky \\>70%)\n6. Demonstrates adequate organ function as defined below:\n\n   1. Absolute neutrophil count \\>=1,500\u002Fmicroliter (mcL).\n   2. Platelets ≥100,000\u002Fmicroliter (mcL).\n   3. Total bilirubin ≤ 3.0 milligrams per deciliter (mg\u002FdL), unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   4. Aspartate aminotransferase (AST) \u002F serum glutamic-oxaloacetic transaminase (SGOT) ≤3 X institutional upper limit of normal.\n   5. Alanine aminotransferase (ALT) \u002F serum glutamic-oxaloacetic transaminase (SGPT) ≤3 X institutional upper limit of normal\n   6. Creatinine ≤ 1.5 x within institutional upper limit of normal or\n   7. Creatinine clearance Glomerular filtration rate (GFR) \\>= 60 milliliters per minute (mL\u002Fmin)\u002F1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 milliliters per minute (mL\u002Fmin)\u002F1.73 m2.\n7. Liver function: Child-Pugh score must be no higher than B5.\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n10. The female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after study intervention.\n\nExclusion Criteria:\n\n1. Multifocal disease (i.e., presence of more than one HCC lesion).\n2. Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.\n3. Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).\n4. Is currently receiving any other therapeutic\u002Finvestigational agents.\n5. Has participated in a study of an investigational product and received study treatment or used an investigational device within 3 weeks of the first use of an investigational product.\n6. Co-morbid disease or concurrent illness (e.g., cardiovascular disease, portal vein thrombosis).\n7. Hypersensitivity to nitroglycerine or any of its excipients.\n8. Concomitant medications (contraindicated):\n\n   1. Concurrent use of prescription phosphodiesterase inhibitors (e.g., sildenafil)\n   2. Concurrent use of nitrate-containing medications.\n   3. Concurrent use of vasoactive chemotherapeutic agents, such as bevacizumab (Avastin).\n9. Recent anti-cancer therapies:\n\n   1. Systemic anticancer therapies within 3 weeks of the procedure.\n   2. Radiation therapy within 2 weeks.\n   3. Antibody-based therapy within 4 weeks.\n   4. Use of investigational agents or devices within 3 weeks of the index procedure.\n10. Unresolved toxicities from prior cancer therapy, unless ≤ Grade 1 (excluding alopecia).\n11. Currently receiving any other therapeutic or investigational agents during the study period.",{"count":246,"type":21},50,[169],"This is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin.",[250,251],"Hepatocellular Carcinoma (HCC)","Liver Cancer, Adult",[253,254,255,256,257],"Parenchymal Blood Volume Imaging","Transarterial Chemoembolization","Intra-Arterial Nitroglycerin","Tumor Perfusion","TACE",{"date":151,"type":40},{"date":260,"type":21},"2026-08-01",{"date":262,"type":21},"2030-02-01",{"name":46,"class":47},{"id":265,"slug":4,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":86,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":281,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":294,"locationsCount":78},"100610448","NCT07227714","Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes","A Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia","Inclusion Criteria:\n\n* The catchment area of the proposed VC site is predominantly rural.\n* The proposed VC site is located within 20-100 km of the base hospital.\n* There are no major primary eye care services within 10 km of the proposed site.\n* Care at sites randomized to establish VCs immediately is accessible to anyone.\n\nExclusion Criteria:\n\n* Sites located in non-rural or urban catchment areas.\n* Sites outside the 20-100 km distance range from the base hospital.\n* Sites with existing major primary eye care services within a 10 km radius.",{"count":271,"type":21},150000,[24],"This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are:\n\n1. Do vision centers improve effective refractive error coverage?\n2. Do vision centers increase eye care center utilization?\n3. Do vision centers improve population visual acuity?\n\nResearchers will compare outcomes in communities randomized to immediate versus delayed establishment of a vision center. Outcomes will be assessed through population-based surveys at baseline and after two years as well as through hospital records collected throughout the study period.",[275,276,277,278,279,280],"Cataract Surgery","Eye Care","Glasses","Primary Eye Care","Vision Center","Eyecare Visits",[282,283,284,285,286,287,288,289],"vision center","primary eye care","cataract surgery","glasses","glassess ownership","spectacle ownership","cluster-randomized trial","eyecare visits",{"date":149,"type":40},{"date":260,"type":21},{"date":293,"type":21},"2028-12-01",{"name":46,"class":47},{"id":296,"slug":4,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100582279","NCT06861244","Embryonal Tumor With Multilayered Rosettes","PNOC031: Protocol for Embryonal Tumor With Multilayered Rosettes (ETMR)","PNOC031","The eligibility criteria listed below are interpreted literally and cannot be waived.\n\nInclusion Criteria:\n\n1. Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.\n2. For enrollment, a confirmation of a minimum of 10-20 unstained formalin-fixed paraffin-embedded (FFPE) slides or 1 block (15-20 mg) with tumor content of 40% or greater is required. Anything less must be discussed and approved by the study chairs prior to enrollment.\n3. Prior Therapy:\n\n   1. Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.\n   2. Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment.\n4. Participants must not have received prior radiation for treatment of tumor.\n5. Participants of any age are eligible.\n6. Participants should begin induction chemotherapy within 28 days of the most recent definitive surgical procedure. Participants beginning therapy beyond 28 days from surgery, will need to discuss with study chairs.\n7. Cohort specific eligibility\n\n   1. Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease.\n   2. Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease.\n   3. Cohort 3A: Metastatic or residual disease, and early radiotherapy.\n   4. Cohort 3B: Metastatic or residual disease, and high dose chemotherapy.\n   5. Radiotherapy Age Criteria (at the time of planned radiation): \\>12 months of age for participants with infratentorial tumor OR \\>15 months of age for participants with supratentorial tumor. For participants being treated on radiotherapy-containing arms, the legal parent\u002Fguardian or patient and the physician must be willing to allow the use of radiotherapy for treatment.\n8. Performance Score: Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants \\\u003C=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n9. Organ Function Requirements:\n\n   1. Peripheral absolute neutrophil count (ANC) \\> 75,000\u002Fmm3\n   2. Platelet count \\> 75,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment).\n10. Adequate Renal Function defined as:\n\n    a. Serum creatinine \\\u003C 1.5 x upper limit normal (ULN) based on age and gender.\n11. Adequate Liver Function defined as:\n\n    1. Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \\\u003C 3 x ULN or direct bilirubin \\\u003C 1.5 x ULN,\n    2. alanine aminotransferase (ALT) \\\u003C 3 x ULN,\n    3. aspartate aminotransferase (AST) \\\u003C 3 x ULN,\n12. Adequate Neurologic Function defined as:\n\n    a. Participants with seizure disorder may be enrolled if well controlled. Participants on enzyme inducing anticonvulsants may be excluded pending interaction(s) with study drugs.\n13. As chemotherapeutic agents used in this trial are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n14. Participants must be enrolled on PNOC COMP prior to enrollment on PNOC031 if PNOC COMP is open to accrual at the enrolling institution.\n15. A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n\nExclusion Criteria\n\n1. Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention\n2. Participants who are receiving any other tumor directed investigational agents.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.\n4. Uncontrolled intercurrent illness.\n5. Women of childbearing potential must not be pregnant or breast-feeding.",{"count":303,"type":21},70,[169],"This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR).",[298,307],"Embryonal Tumor With Multilayered Rosettes, Nos",{"date":309,"type":40},"2026-06-29",{"date":311,"type":40},"2025-03-06",{"date":313,"type":21},"2032-03-31",{"name":46,"class":47},8,{"id":317,"slug":4,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":78},"100583120","NCT06872190","Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department","Inclusion criteria:\n\n* All University of California, San Francisco ED providers (residents, attendings, advanced practice providers) who have used either CDSv1 or CDSv2 will be eligible to participate in surveys and interviews regarding feasibility and acceptability.\n* English-speaking patients ≥18 years of age presenting to the UCSF ED with opioid use disorder who receive medication treatment (as a result of CDSv1 or CDSv2) will be eligible to participate.\n\nExclusion criteria:\n\n\\- Participants will be excluded if:\n\n* they have a medical or psychiatric condition requiring hospitalization at the index ED visit,\n* are actively suicidal, are cognitively impaired,\n* present from an extended care facility, or\n* require opioids for a pain condition.",{"count":322,"type":21},300,[24],"The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision support (CDS) tool (CDSv1) to facilitate emergency department (ED)-initiated, social risk-informed opioid use disorder (OUD) medication treatment and ultimately improve treatment adherence and follow up. The investigators will evaluate the feasibility and acceptability of the social care-enhanced CDS tool, CDSv2, (compared to CDSv1) at a single study site (UCSF) as an intervention to increase medication treatment adherence and follow up for adult ED patients experiencing opioid use disorder using a mixed-methods, before-after approach.",[326,327],"Opioid Use Disorder","Social Determinants of Health (SDOH)",[329,330,331],"social risk-informed care","clinical decision support","opioid use disorder",{"date":309,"type":40},{"date":334,"type":40},"2025-04-20",{"date":336,"type":21},"2027-07",{"name":46,"class":47},{"id":339,"slug":4,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":356,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":78},"100645320","NCT07680842","Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy","Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy","Inclusion Criteria\n\n* Male or female between 21 and 65 years of age at screening\n* Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.\n* Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.\n* Be willing to undergo a brain MRI.\n* Be able and willing to wear a headband during the treatment duration.\n* Be able to complete scheduled visits and daily seizure logs.\n\nExclusion Criteria\n\n* Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.\n* Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Has any unstable medical or psychiatric disease.\n* Any contraindications for completing a brain MRI scan.\n* Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.","65 Years",{"count":199,"type":21},[24],"The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.",[349,350,351,352,353,354,355],"Drug-Resistant Epilepsy","Epilepsy","Epilepsy (Treatment Refractory)","Epilepsy Comorbidities","Epilepsy, Drug Resistant","Epilepsy, Generalized","Epilepsy, Focal",[357,349,350,358,359,360,361],"Seizures","Transcranial Ultrasound Stimulation","Focused ultrasound Stimulation","Electroencephalography (EEG)","Low Intensity Focused ultrasound (LIFU)","2026-06-25",{"date":151,"type":40},{"date":365,"type":40},"2025-07-09",{"date":188,"type":21},{"name":46,"class":47},{"id":369,"slug":4,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":374,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":387,"leadSponsor":389,"locationsCount":78},"100601418","NCT07110233","Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma","Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Participants must have histologically or imaging-confirmed confirmed HCC.\n2. Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.\n3. No prior therapy to target tumor(s).\n4. Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.\n5. Age ≥22 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1.\n7. Demonstrated adequate organ function as defined below:\n\n   1. Total bilirubin ≤3.0 mg\u002FdL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   2. aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal.\n   3. alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal.\n   4. Creatinine Glomerular filtration rate (GFR) \\> 30 ml\u002Fmin.\n8. Child-Pugh score ≤ B7\n9. Albumin-bilirubin (ALBI) score 1-2\n10. Participants who have received systemic therapy for HCC will be excluded from the trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n13. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n1. Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.\n2. History of severe allergy to iodinated contrast agents despite appropriate premedication.\n3. Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.\n4. Symptomatic heart failure or severe valvular insufficiency.\n5. Symptomatic pulmonary hypertension or lung disease.\n6. Symptomatic ascites.\n7. Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000.\n8. Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland.\n9. Pregnant women are excluded from this study because TheraSphere emits radiation with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere.\n10. Lung-shunt fraction (LSF) resulting in anticipated lung dose of \\>30 Gray (Gy).\n11. History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted.\n12. Tumor perfused by extrahepatic collateral arteries.\n13. Prior partial hepatectomy.\n14. Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.\n15. History of or current extrahepatic cancer.\n16. Pulmonary insufficiency (defined by an arterial oxygen pressure (Pa,O2) of \\\u003C 60 mmHg, or oxygen saturation (Sa,O2) of \\\u003C 90%).","22 Years",{"count":376,"type":21},64,[24],"This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.",[380,381,382,383],"Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Hepatocellular Cancer","Hepatocellular Carcinoma Non-resectable","2026-06-23",{"date":210,"type":40},{"date":74,"type":21},{"date":388,"type":21},"2029-03-31",{"name":46,"class":47},{"id":391,"slug":4,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100440030","NCT05009992","Combination Therapy for the Treatment of Diffuse Midline Gliomas","A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression","PNOC022","--COHORTS 1, 2, AND 3 CLOSED---\n\nINCLUSION CRITERIA:\n\nCOHORT 1A AND 1B:\n\n* New diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 1B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma Histone 3 lysine 27 - mutant (H3K27M); World Health Organization (WHO) grade III and IV H3 wildtype gliomas.\n* Must be within 6 weeks of diagnosis to begin standard of care radiation therapy on study.\n\nCOHORT 2A AND 2B:\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In Cohort 2B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.\n* Participants must be within 4-14 weeks of completion of radiation. Radiation should have started within 6 weeks of diagnosis.\n\nCOHORT 3A AND 3B:\n\n* Diagnosis of recurrent DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors, who have complete standard-of-care radiation therapy. In cohort 3B, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG including diffuse midline glioma H3K27M mutant; WHO grade III and IV H3 wildtype gliomas.\n* Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nCOHORT 4A AND 4B:\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 4B\\^1, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG diffuse midline glioma H3K27-altered.\n* Not currently eligible for any other clinical trials that include administration of ONC201.\n\nCohort 4A\\^1 and 4B\\^1 (participants with newly diagnosed DMG prior to radiation): Must be able to begin standard of care radiation therapy on study within 6 weeks of diagnosis.\n\nCohort 4A\\^2 and 4B\\^2 (participants with newly diagnosed DMG who have completed radiation): Participants must be within 4-14 weeks of completion of radiation and not have received additional therapy beyond completion of radiation therapy. Radiation should have started within 6 weeks of diagnosis.\n\nCohort 4A\\^3 and 4B\\^3 (participants with DMG at progression): Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nCOHORT 5\n\n* Diagnosis of DMG with imaging and\u002For pathology consistent with a DMG, including spinal cord tumors. In cohort 5\\^1, previous tumor tissue confirmation of DMG is mandatory and pathology must be consistent with a DMG diffuse midline glioma H3K27-altered.\n* Not currently eligible for any other clinical trials that include administration of ONC201.\n* Multifocal and leptomeningeal disease will be eligible for Cohort 5.\n* Participant's tumor must demonstrate one of the following molecular alterations considered targetable by an approved agent:\n\n  * BRAFV600E\n  * PDGFRA (DNA point mutation or amplification with \\>=5 copy numbers)\n  * FGFR1 (DNA point mutation, gene fusions, or amplification with \\>=5 copy numbers)\n  * NF1\n\nCohort 5\\^1 (participants pre-radiation): Must be able to begin standard of care radiation therapy on study within 6 weeks of diagnosis.\n\nCohort 5\\^2 (participants post-radiation): Participants must be within 4-14 weeks of completion of radiation and not have received additional therapy beyond completion of radiation therapy. Radiation should have started within 6 weeks of diagnosis.\n\nCohort 5\\^3 (participants with progression): Participants must have evidence of progression and not have received any treatment for this progression and have not previously received re-irradiation.\n\nAll Cohorts (except Cohort 6):\n\n* Age 2 to 39 years\n* Participants must have recovered from all acute side effects of prior therapy and be beyond the window for expected ongoing acute toxicities. Any number of prior therapies are allowed.\n* Prior ONC201 exposure is allowed, except in participants who have participated in Chimerix trials investigating ONC201 in the upfront setting. Participants who participated in trials investigating ONC201 in the upfront setting will not be eligible at any time, with the exception if participants received ONC201 as part of PNOC022 or other expanded access programs such as German sources of ONC201.\n* Participant body weight must be above the minimum necessary for the participant to receive ONC201 (at least 10 kilograms (kg))\n* From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies (21 days for bevacizumab when used for tumor-directed therapy, guidance on use for pseudo-progression is below), or, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n\n  o The use of bevacizumab to control radiation therapy-induced edema is allowed (if used for tumor-directed therapy, please see required time period above).\n  * Dosing limitations are as follows:\n  * \\* Bevacizumab (or equivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period.\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm2 \u002Fdose continuously during radiation therapy for 42 days) or dexamethasone is allowed. Any other agent given throughout radiation therapy must be discussed with the study chairs prior to beginning the agent.\n* Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 3 days prior to baseline magnetic resonance imaging (MRI) scan.\n* The participant must have adequate organ function defined as:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (1.0g\u002Fl) AND\n  * Platelet count \\>= 75,000\u002Fmm\\^3 (100x10\\^9\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n  * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR\n  * A serum creatinine within the normal limits for age\n  * Bilirubin (sum of conjugated + unconjugated) =\\\u003C 1.5 x upper limit of normal (ULN) for age AND\n  * Serum glutamate pyruvate transaminase (SGPT)(alanine aminotransferase (ALT)) =\\\u003C 3 x ULN AND\n  * Serum albumin \\>= 2 g\u002FDl\n  * No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of \\> 92% while breathing room air.\n  * Diarrhea \\\u003C grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0\n  * No history of congestive heart failure or family history of long QT syndrome.\n  * ECG must be obtained to verify the Corrected QT Interval (QTc). If an abnormal reading is obtained, the ECG should be repeated in triplicate. QTC \\\u003C 470 msec.\n  * Participants with history of congestive heart failure, at risk of having or have underlying cardiovascular disease, or with history of exposure to cardiotoxic drugs must have adequate cardiac function as determined by echocardiogram. Shortening fraction of \\>= 27%.\n  * Participants with seizure disorder may be enrolled if seizure disorder is well controlled\n* Females of child-bearing potential and males must agree to use adequate contraception.\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required. Frozen tissue is also acceptable.\n\nCOHORT 6 Inclusion Criteria:\n\n* Diagnosis of newly diagnosed thalamic or pontine located DMG with imaging and\u002For pathology consistent with a DMG, excluding spinal cord tumors, who have completed standard-of-care radiation therapy. If archival tissue is available prior to first biopsy, participants must be willing to provide adequate tissue. A minimum of 10-20 paraffin embedded unstained slides OR 1 block with tumor content of 40% or greater is required.\n* Participants must be within 4-14 weeks of completion of radiation. Radiation should have started within 6 weeks of diagnosis.\n* Age 2-39 years.\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm2 \u002Fdose continuously during radiation therapy for 42 days) is allowed. Any other agent given throughout radiation therapy must be discussed with the study chairs prior to enrollment.\n* Participants must have recovered from all acute side effects of prior therapy and be beyond the window for expected ongoing acute toxicities. Washout requirements from prior therapy include:\n\n  * At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 30 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies (28 days for bevacizumab when used for tumor-directed therapy, guidance on use for pseudo-progression is below), or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n  * At least 4 weeks prior to study enrollment from last immune therapy\n* Corticosteroids: Participants treated with corticosteroids must be on stable or decreasing dose for at least 1 week prior to enrollment, with maximum dexamethasone dose 0.1 mg\u002Fkg\u002Fday dexamethasone equivalent at time of enrollment.\n* The participant must have adequate organ function defined as:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm3 (1.0g\u002Fl) and\n  * Platelet count \\>= 75,000\u002Fmm3 (100x109\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment.\n  * Creatinine clearance or radioisotope GFR \\>= 70mL\u002Fmin\u002F1.73 m2 or\n  * A serum creatinine within the normal limits for age.\n  * Total bilirubin \\\u003C= 3 x upper limit of normal (ULN); in presence of Gilbert's syndrome, total bilirubin \\\u003C\u002F= 6 x ULN or direct bilirubin \\\u003C= 3 x ULN\n  * ALT \\\u003C= 5 x ULN\n  * AST \\\u003C= 5 x ULN.\n  * Serum albumin \\>= 2 g\u002FdL\n  * Diarrhea \\\u003C grade 2 by CTCAE v5.0.\n  * No history of congestive heart failure or family history of long QT syndrome.\n  * Participants with seizure disorder may be enrolled if seizure disorder is well controlled.\n* The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception.\n* Karnofsky \\>\u002F= 70 for Participants \\> 16 years of age and Lansky \\>\u002F= 70 for participants \\\u003C\u002F= 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\nEXCLUSION CRITERIA:\n\nCOHORT 1A AND 1B:\n\n* Prior exposure to radiation therapy.\n* Thalamic and Cerebellar H3K27M DMG.\n\nCOHORT 2A AND 2B:\n\n* For tumors that do not have a pontine or spinal cord epicenter the following specific exclusion criteria apply:\n* Thalamic and Cerebellar H3K27M DMG that has undergone standard radiation without concurrent therapy (other than temozolomide).\n\nCOHORT 1A AND 2A:\n\n• Deemed not appropriate for tissue resection\u002Fbiopsy.\n\nCOHORT 3A AND 3B:\n\n* Prior exposure to re-irradiation for tumor progression.\n* Thalamic and cerebellar H3K27M mutant DMG.\n\nCOHORT 4A AND 4B:\n\nCohort 4A\\^1and 4B\\^1: Prior exposure to radiation therapy Cohort 4A\\^3 and 4B\\^3: Prior exposure to re-irradiation for tumor progression\n\n* Thalamic and cerebellar H3K27M mutant DMG, except those who received ONC201\u002FONC026 from alternative source prior to 2024 or US patients enrolled while the accelerated approval new drug application for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma is under review by US FDA.\n* Cohort 4A\\^1and 4B\\^1: Prior exposure to radiation therapy\n* Cohort 4A\\^3 and 4B\\^3: Prior exposure to re-irradiation for tumor progression\n\nCOHORT 5:\n\n* Thalamic and cerebellar H3K27M mutant DMG, except those who received ONC201\u002FONC026 from alternative source prior to 2024 or US patients enrolled while the accelerated approval new drug application for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma is under review by US FDA.\n* Cohort 5\\^1: Prior exposure to radiation therapy\n* Cohort 5\\^3: Prior exposure to re-irradiation for tumor progression\n\nAll Cohorts (except Cohort 6):\n\n* Diagnosis of a histone H3 wildtype grade II diffuse astrocytoma.\n* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the study chairs.\n* Participants who are currently receiving other anti-cancer agents.\n* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair.\n* Participants with uncontrolled infection or other uncontrolled systemic illness.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study.\n* Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of CSF dissemination, with the exception of Cohort 5.\n* Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.\n* Concomitant use of potent CYP3A4\u002F5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.\n* Concomitant use of potent CYP3A4\u002F5 inducers, which include enzyme inducing antiepileptic drugs (EIAEDs), during the treatment phase of the study and within 2 weeks prior to starting treatment. Concurrent corticosteroids is allowed.\n\nCOHORT 6 Exclusion Criteria:\n\n* • DMGs located outside the thalamus and pons including bilateral thalamic tumors.\n* Unacceptable anesthesia or surgery risk, as determined by the anesthesiologist or the neurosurgeon.\n* Evidence of significant mass effect\n* Evidence of herniation on imaging.\n* Participants with a known history coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of registration.\n* Participants must not require systemic anti-coagulation that cannot be halted for each intraoperative and perioperative biopsy time-period.\n* Participants with active viral infection or who are currently receiving antiviral treatment.\n* Participants with active, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseases.\n* This virus infects cells with a deficit in the RB gene. Therefore, participants with Li-Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its related pathway are excluded.\n* Participants must not have live or live-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted.\n* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the study chairs.\n* Participants with a known disorder that affects their immune system, such as HIV or Hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants who are currently using inhaled, intranasal, ocular, topical or other non-oral or non-IV steroids are not necessarily excluded from the study but need to be discussed with the study chair(s).\n* Participants with uncontrolled infection or other uncontrolled systemic illness.\n* Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in the study.\n* Evidence of disseminated disease, including multi-focal disease, diffuse leptomeningeal disease or CSF dissemination.","2 Years","39 Years",{"count":400,"type":21},360,[169],"This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial.\n\nNovel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).",[404,405,406,407,408,409],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27M-Mutant","Recurrent WHO Grade III Glioma","WHO Grade III Glioma",{"date":210,"type":40},{"date":412,"type":40},"2021-10-20",{"date":414,"type":21},"2029-06-30",{"name":46,"class":47},32,{"id":418,"slug":4,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":86,"sex":113,"minAge":55,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":48},"100644466","NCT07671989","Period Pills for Menstrual Regulation: A New Reproductive Health Option","Period Pills","Inclusion Criteria:\n\n* Be 18 years old or older\n* Read and speak English\n* Know the date of their last menstrual period within 2 days\n* Have a period that is late by up to 21 days\n* Must have had regular periods in the last 4 months\n* Does not want to be pregnant\n* Does not want to verify pregnancy status\n* Understand that if they are pregnant, the pills will end their pregnancy\n* Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)\n\nExclusion Criteria:\n\n* Under 18 years old\n* Does not read and speak English\n* Does not know the date of their last menstrual period within 2 days\n* Has not had regular periods in the last 4 months\n* Wants to be pregnant\n* Wants to verify pregnancy status\n* Does not display understanding that if they are pregnant, the pills will end their pregnancy\n* Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)",{"count":424,"type":21},100,[426],"PHASE4","The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.",[429,430],"Menstrual Regulation","Menstrual Health Intervention",[432,433,434],"late period","missed period","mestruation","2026-06-22",{"date":210,"type":40},{"date":435,"type":40},{"date":439,"type":21},"2027-05-31",{"name":46,"class":47},{"id":442,"slug":4,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":455,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":471,"locationsCount":78},"100644762","NCT07673237","Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring","RESPOND-ILD","Inclusion Criteria:\n\n* age 18 or older\n* English or Spanish speaking\n* have a UCSF diagnosis of one of the major ILD subtypes seen in the ILD Clinic (Idiopathic Pulmonary Fibrosis, Chronic Hypersensitivity Pneumonitis, Connective-tissue disease related ILD, Sarcoidosis, Familial Fibrosis). Languages are limited to those for which both device instructional materials and user support are available (written and video). The ILD diagnosis will be based on multidisciplinary conference review, which is the diagnostic gold standard. We have restricted the ILD subtypes to those for which there is efficacy data for RPM or comparable clinical trajectories, and subtypes that account for \\>10% of the ILD diagnoses seen at UCSF.\n\nExclusion Criteria:\n\n* Patients who are unable provide informed consent for any reason or are acutely ill.",{"count":448,"type":21},200,[24],"The purpose of this interventional study is to identify which combination of remote monitoring devices (e.g. home spirometry, pulse oximetry, scale, ePROs) is the most feasible (as defined by adherence, retention, and data completeness) and acceptable when used for the detection of clinically significant Interstitial Lung Disease events.",[452,453,454],"Fibrotic Interstitial Lung Disease","IPF and PPF","Lung Fibrosis Interstitial",[456,457,458,459,460,461,462,463,464,465,466],"Interstitial lung disease","pulmonary fibrosis","idiopathic pulmonary fibrosis","progressive pulmonary fibrosis","Remote patient monitoring","Digital health","Telemonitoring","Home monitoring","Pragmatic study design","Real-world monitoring","Decentralized clinical trial",{"date":309,"type":40},{"date":260,"type":21},{"date":470,"type":21},"2028-08-01",{"name":46,"class":47},{"id":473,"slug":4,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":489,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":78},"100641543","NCT07661498","Indomethacin for Biliary ERCP Patients","Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age at the time of ERCP.\n2. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy.\n3. Ability to receive rectal medication.\n4. Ability and willingness to comply with all study procedures and follow-up requirements.\n5. Written informed consent (and assent when applicable) was obtained from the subject or the subject's legal representative, and the subject's ability to comply with the requirements of the study was confirmed.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components.\n3. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use.\n4. Significant renal impairment (e.g., baseline serum creatinine above institutional upper limit of normal or estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n5. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment.\n6. Known chronic pancreatitis\n7. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.",{"count":479,"type":21},860,[426],"This study is a randomized clinical trial evaluating the efficacy of rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients undergoing biliary ERCP who have a history of prior biliary sphincterotomy. While rectal indomethacin has demonstrated benefits in preventing post-ERCP pancreatitis in high-risk patients, its utility in this specific patient subgroup remains unclear. This trial aims to determine whether prophylactic administration of indomethacin offers a measurable benefit over no intervention in this lower-risk population.\n\nEligible patients will be identified prior to their scheduled biliary ERCP and screened for inclusion criteria. Following informed consent, participants will be randomized to receive either rectal indomethacin or no indomethacin prior to the procedure.",[483,484,485,486,487,488],"Pancreatitis Biliary","Pancreatitis Acute Biliary","Pancreatitis","Post-ERCP Pancreatitis","Post-ERCP Acute Pancreatitis","Post-ERCP Adverse Events",[490,491,492,493,494,495],"ERCP","pancreatitis","post-ERCP pancreatitis","PEP","pancreatitis acute biliary","post-ERCP adverse events","2026-06-16",{"date":435,"type":40},{"date":499,"type":21},"2026-07",{"date":501,"type":21},"2031-07",{"name":46,"class":47},{"id":504,"slug":4,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":511,"conditions":512,"keywords":516,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":78},"100520384","NCT06055868","People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity","People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study","Inclusion Criteria:\n\n* Participants must be 18-years old or older.\n* Participants must be individuals living with HIV\n* Ability to speak and understand English\n* Identify as one or more racial\u002Fethnic minority groups or sexual and gender minority groups\n* All genders and members of all races and ethnic groups are eligible for this study.\n\nExclusion Criteria:\n\n* Younger than 18-years old.\n* Not living with HIV.\n* Not able to speak and understand English.\n* Not classified as one or more racial\u002Fethnic minority groups or sexual and gender minority groups.",{"count":510,"type":21},144,"This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial\u002Fethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) \u002FOropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC\u002FOPSCC prevention.",[513,514,515],"HIV Infections","Oral Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[517,518,519,520,521],"Health Equity","Focus Group","Sexual and Gender Minority","People living with HIV","HPV, human papillomavirus",{"date":523,"type":40},"2026-06-18",{"date":525,"type":40},"2025-02-13",{"date":527,"type":21},"2029-11-30",{"name":46,"class":47},{"id":530,"slug":4,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":545,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":78},"100492635","NCT05694715","Combination Therapy in Cancers With Mutations in DNA Repair Genes","Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes","Inclusion Criteria:\n\n1. Individuals 18 years of age or older.\n2. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted; and willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Solid tumors where topoisomerase I inhibitors have shown efficacy, including gastrointestinal tumors (e.g., colon, pancreatic, gastric cancer and cholangiocarcinoma), breast cancer, and ovarian cancer (prostate cancer is excluded), with one or more of the following DNA repair defects:\n\n   a. BRCA1, BRCA2, ATM, and\u002For PALB2 (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab). This testing must occur prior to study enrollment.\n4. Presence of at least one lesion with measurable disease as defined by RECIST 1.1 criteria for response assessment\n5. Advanced solid tumor malignancy without curative options\n6. At least 5 half-lives or 3 weeks (whichever is shorter) must have passed since last anticancer therapy\n7. The washout period for investigational agents without published half-lives should be 3 weeks since last therapy, and all treatment related toxicities must have recovered to less than grade 2.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1 (Karnofsky \\> 60%; Appendix 1).\n9. Adequate organ function:\n\n   1. Absolute neutrophil count (ANC) \\>= 1.5 X 109\u002FL (no growth factors allowed within 14 days of enrollment)\n   2. Hemoglobin (Hgb) ≥10 g\u002FdL (no transfusion allowed within 7 days of enrollment)\n   3. Platelets (plt) \\>= 100 x 109\u002FL\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 x Upper Limit Normal (ULN), or AST and ALT \\\u003C5 x ULN in patients with known liver metastases or known primary liver tumor(s)\n   5. Serum total bilirubin \\\u003C= 1.5 x ULN\n   6. Creatinine \\\u003C1.5 x ULN, or Estimated Glomerular filtration rate (GFR) \\>= 50ml\u002Fmin by Cockcroft-Gault (http:\u002F\u002Fwww.mdcalc.com\u002Fcreatinine-clearance-cockcroft-gault-equation\u002F)\n10. Must have recovered to less than Grade 2 (CTCAE v5.0) in terms of toxicity from prior treatments (excluding neuropathy which can be ≤ Grade 2, alopecia, nail changes\u002Fnail loss or other chronic minor grade 2 AEs).\n11. Must be able to take oral medications.\n12. Based on its mechanism of action and pre-clinical findings, irinotecan can cause fetal harm when administered to a pregnant woman. Additionally, the effects of niraparib on the developing fetus are unknown. Therefore:\n\n    a. Females of childbearing potential and their male partners are advised to practice a highly effective method of contraception during treatment with niraparib and\u002For irinotecan and for 180 days following the last dose for females and 90 days following the last dose for males. A woman is considered to be of childbearing potential unless one of the following applies:\n\n    i. Is considered to be permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n    ii. Is postmenopausal, defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 milli-international units per millilitre (mIU\u002FmL) or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.\n\n    b. A male participant of reproductive potential is eligible to participate if he agrees to the following starting with the first dose of study treatment through at least 90 days (a spermatogenesis cycle) after the last dose of study treatment:\n\n    i. refrain from donating sperm.\n\n    ii. Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak).\n\n    c. Highly effective contraception is considered to be a method with a \\\u003C 1% per year failure rate. Recommendations for highly effective contraception while taking niraparib include:\n\n    i. Ongoing use of injectable or implantable progesterone.\n\n    ii. Placement of an intrauterine device or intrauterine system.\n\n    iii. Bilateral tubal occlusion.\n\n    iv. Complete (as opposed to periodic) abstinence\n\n    . v. Male sterilization, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n15. 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.\n\nExclusion Criteria:\n\n1. Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study at clinician's discretion and not otherwise stated below.\n2. Prior allergic reaction to PARP inhibitor or irinotecan or their excipients. Prior PARP inhibitor or irinotecan (or topoisomerase 1 inhibitors) use is allowed.\n3. Individuals with known toxicity to irinotecan (e.g., grade 3 or 4 neutropenia) or suspected sensitivity.\n4. Individuals with homozygous or compound heterozygous UGT1A1 polymorphisms (e.g., alleles \\*28\u002F\\*28, \\*6\u002F\\*6, or \\*6\u002F\\*28) predicted to be associated with medium-to-high risk of irinotecan-related toxicity\n5. Individuals receiving any other investigational agents concurrently with the study drugs within 3 weeks or 5 half-lives, whichever is shorter, of the first dose of therapy preceding the study.\n6. Participants with unstable brain metastases are excluded. Patients with a history of brain metastases (\\>1cm) are permitted to enroll if they have been treated and have been stable for a minimum of one month on imaging. Patients may not currently receive steroids for their brain metastases. Patients with small, asymptomatic brain metastases (\\\u003C1cm) may enroll.\n7. Individuals with a second primary malignancy\n8. Individuals with a prior history of posterior reversible encephalopathy syndrome (PRES)\n9. Individuals with systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg that has not been adequately treated or controlled\n10. History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.\n11. Known or suspected diagnosis of Myelodysplastic syndromes (MDS) or Acute myeloid leukemia (AML).\n12. Known Gilbert's disease\n13. Individuals who are pregnant and\u002For breast feeding, or expecting to conceive children while receiving study treatment and\u002For for up to 180 days after the last dose of study treatment.\n14. Inability to comply with study procedures or unwilling to use adequate highly effective contraception",{"count":536,"type":21},24,[168],"The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA), partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators. There is significant interest in this combination, and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial.",[540,541,542,543,544],"Metastatic Solid Tumor","BRCA1 Mutation","BRCA2 Mutation","ATM Gene Mutation","PALB2 Gene Mutation",[546,547,548],"DNA Repair Gene Mutations","Small Molecule Inhibitor","Poly (ADP-ribose) polymerase inhibitor therapy (PARPi)",{"date":523,"type":40},{"date":551,"type":40},"2023-05-23",{"date":553,"type":21},"2028-01-31",{"name":46,"class":47},{"id":556,"slug":4,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":16,"minAge":561,"maxAge":196,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":569,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":579,"locationsCount":580},"100399771","NCT04485559","Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)","PNOC021: A Phase I Trial Evaluating the Combination of Trametinib and Everolimus in Pediatric and Young Adult Patients With Recurrent Low-Grade Gliomas and High Grade Gliomas","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high grade glioma (HGG) (WHO grade III-VI)\n\n  * Participants with LGG who have had surgery alone are not eligible.\n  * Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected\n  * Participants with spinal cord primaries or disseminated disease are eligible\n* For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required\n\n  * If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs\n* Participants must have evaluable disease\n* Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent \\>= 7 days prior to study registration. For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration\n\n    * Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)\n  * Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration\n  * Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\\> 24 Gy) or total body irradiation \\> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression\n  * Bone marrow transplant: Participants must be: \\>= 6 months since allogeneic bone marrow transplant prior to registration; \\>= 3 months since autologous bone marrow\u002Fstem cell prior to registration\n  * Corticosteroids: Participants who are receiving steroids must be on a stable or decreasing dose for at least 1 week prior to registration\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (unsupported)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>= 8 m\u002FdL (may be supported)\n* International normalized ratio (INR) =\\\u003C 1.5\n* Creatinine clearance or radioisotope growth factor receptor (rGFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fgender as follows:\n\n  * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Bilirubin (sum of conjugated + unconjugated) =\\\u003C 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum albumin \\>= 2 g\u002FdL\n* Sodium, potassium, calcium and magnesium within 1.5 x institutional lower limit of normal (LLN) or ULN\n* Participants must have cholesterol level \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400 mg\u002FdL before starting therapy. In case one or both of these are exceeded, the participant can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400mg\u002Fdl before start of therapy\n* Participants with seizure disorder may be enrolled if well controlled. Participants must be on non-enzyme inducing anticonvulsants which are not excluded on study therapy\n* Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration\n* Corrected QT (QTc) interval =\\\u003C 450 msecs\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* Pulse oximeter (Ox) \\> 93% on room air\n* Hypertension\n\n  * Participants 3-17 years of age must have a blood pressure that is =\\\u003C 95th percentile for age, height, and gender at the time of registration\n  * Participants who are \\>= 18 years of age must have a blood pressure that is \\\u003C 140\u002F90 mm of Hg at the time of registration\n* Participants must agree to use adequate contraception: The effects of trametinib and everolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and males of child fathering potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of trametinib and everolimus administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* A legal parent\u002Fguardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate per institutional guidelines\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agent for treatment of their tumor\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib\n* Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)\n* Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents after enrollment and prior to start of therapy they will not be eligible to initiate study therapy):\n\n  * Known strong inducers or inhibitors of CYP3A4\u002F5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges\n  * Substrates of CYP3A4\u002F5 with a narrow therapeutic index\n  * Herbal preparations\u002Fmedications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Participants should stop using all herbal medications at least 7 days prior to enrollment\n  * As part of the enrollment\u002Finformed consent procedures, the participant and\u002For legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Women of childbearing potential who are pregnant or breast-feeding\n\n  * Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of enrollment AND within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised\n* Participants with known hepatitis B or C are not eligible\n* Participants with any clinically significant unrelated systemic illness (serious infectious or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the opinion of the investigator would interfere with the study procedures or results\n* Participants with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above are excluded","1 Year",{"count":246,"type":21},[168],"This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.",[566,567,568],"Recurrent World Health Organization (WHO) Grade II Glioma","Low-grade Glioma","High Grade Glioma",[570,571,572,573],"Mitogen-activated protein kinase (MAPK)","phosphatidylinositol 3-kinase (PI3K)","MAPK","PI3K",{"date":575,"type":40},"2026-06-17",{"date":577,"type":40},"2020-12-09",{"date":237,"type":21},{"name":46,"class":47},17,{"id":582,"slug":4,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":588,"conditions":589,"keywords":595,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":602,"locationsCount":78},"100642337","NCT07659652","Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Inclusion Criteria:\n\n1. Be male or female 18 years of age or older.\n2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and\u002For leptomeninges.\n3. Have the intention to start or continue anticancer therapy.\n4. Be able to provide informed consent.\n5. Be able to speak and read English.\n\nExclusion Criteria:\n\nParticipants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.",{"count":448,"type":21},"Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.",[590,591,592,593,594],"Breast Cancer, Quality of Life","Breast Cancer, Metastatic","Breast Cancer, Metastatic Breast Cancer","Leptomeningeal Metastasis of Breast Cancer","Brain Metastases From Breast Cancer",[596],"Quality of Life","2026-06-15",{"date":435,"type":40},{"date":597,"type":21},{"date":601,"type":21},"2035-12-31",{"name":46,"class":47},{"id":604,"slug":4,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":618,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":626,"locationsCount":78},"100568531","NCT06682442","Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed (from primary lesion and\u002For lymph nodes) nasopharyngeal carcinoma.\n* Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\\> 0 copies\u002FmL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.\n* Stage III-IVA disease (American Joint Committee on Cancer \\[AJCC\\], 8th edition \\[ed.\\]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:\n\n  * History\u002Fphysical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);\n  * Evaluation of tumor extent with either one of the following:\n\n    * MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or\n    * MRI of the nasopharynx and PET\u002FCT (with contrast) of the neck\n  * Imaging to rule out distant metastasis:\n\n    * CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET\u002FCT scan (non-contrast PET\u002FCT is acceptable); and\n    * Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET\u002FCT scan can substitute for the bone scan)\n* Started or planning to start platinum-based induction systemic therapy.\n* Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.\n* Use of adjuvant (post-chemoradiation) immunotherapy is permitted.\n* Age \\>=18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection: must be on suppressive therapy, if indicated.\n* For individuals with a history of hepatitis C virus (HCV) infection: must be currently on treatment, or must have been treated and cured.\n* Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 60 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted\n* Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields\n* Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment\n* Severe, active comorbidity, defined as any of the following:\n\n  * Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential complications of the therapy\n  * Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude safe administration of study treatment\n  * Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the opinion of the treating investigator\n  * Active, untreated infection and\u002For acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n* Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test\n\n  \\* A female participant is considered to NOT be of child-bearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria:\n  * Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)\n  * Has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries)\n* Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study endpoints",{"count":609,"type":21},66,[24],"This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy \\[IMRT\\]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.",[613,614,615,616,617],"Nasopharyngeal Carcinoma","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Nasopharyngeal Cancer","Nasopharyngeal Cancer Stage",[619,620,621],"HHV-4 Positive","EBV Positive","human herpesvirus 4 (HHV-4) positive",{"date":575,"type":40},{"date":624,"type":40},"2025-03-18",{"date":313,"type":21},{"name":46,"class":47},{"id":628,"slug":4,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":11,"sex":16,"minAge":634,"maxAge":196,"enrollmentInfo":635,"targetDuration":4,"studyType":22,"phases":637,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":649},"100601419","NCT07110246","Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas","A Phase 2 De-escalation Study of Dabrafenib and Trametinib for Patients With BRAF V600 Mutant Low-Grade Gliomas","PNOC037","Inclusion Criteria:\n\n* Participants must have histologically confirmed LGG World Health Organization (WHO) Grade I or II with BRAF V600 mutation confirmed by immunohistochemistry or sequencing\n* Participants must have measurable tumor.\n\n  \\* For participants with measurable disease, this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) with a minimum size of no less than double the slice thickness. Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy. Participants without measurable disease may be considered for enrollment and followed for survival and progression purposes but will not be included as part of a measurable disease cohort.\n* Cohort 1:\n\n  * Participants must have no prior therapy, except for surgical intervention (i.e. biopsy or resection)\n  * Participants may currently be taking dabrafenib and trametinib as frontline therapy, with a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking a dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol\n* Cohort 2:\n\n  \\* Participants must have a history of recurrent or progressive disease following prior therapy (e.g., carboplatin and vincristine, vinblastine, bevacizumab, mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor, radiation therapy etc). Participants who previously completed a course of therapy with dabrafenib and trametinib, who did not progress on this therapy, and who are beyond 6 months from completion of therapy are eligible for retreatment.\n\n  \\*\\* Participants may currently be taking dabrafenib and trametinib as therapy for disease recurrence, for a maximum duration of 21 months and participants must not yet have met criteria for confirmed best response as defined in this protocol. For participants entering the trial currently taking dabrafenib and trametinib, they must be taking dose that is within 20% of the standard dosing for both drugs based on age and weight. Participants who are already on dabrafenib and trametinib when enrolling on trial and whose dosing deviates more than 20% from the protocol nomogram need to be discussed with the study chairs. Eligibility for these participants will be based on ability to wean within the parameters of the protocol\n* Participants must have received their last dose of chemotherapy 3 weeks prior to enrollment (6 weeks for nitrosoureas) and recovered from acute adverse events due to agents administered\n* Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent except dabrafenib and trametinib. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants must be discussed with study chairs\n* Radiation:\n\n  * No prior radiation is allowed for participants in Cohort 1\n  * Participants in Cohort 2 must have:\n\n    * Had their last fraction of local irradiation to primary tumor ≥ 12 weeks prior to registration\n    * Had their last fraction of craniospinal irradiation ≥ 12 weeks prior to registration\n    * At least 14 days after local palliative radiation (small-port)\n* Age: ≥ 12 months and \\\u003C 25 years old\n* Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3\n* Platelet count ≥ 100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* A serum creatinine ≤ 1.5 upper limit of normal (ULN) based on age and gender\n* Total bilirubin ≤ 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 3 x ULN\n* Aspartate aminotransferase (AST) ≤ 3 x ULN\n* Participants with seizure disorder may be enrolled if well controlled\n* Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function)\n* Correct QT (QTc) interval \\\u003C 480 msecs\n* Patient must agree to adequate contraception. (The effects of dabrafenib and trametinib on the developing human fetus are unknown. For this reason and because agents as well as other therapeutic agents used on this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method birth control, or abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of the study medication administration. Should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately)\n* A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate\n* Participants must enroll on Pediatric Neuro-Oncology Consortium (PNOC) comprehensive follow up protocol (PNOC COMP) if PNOC COMP is open to accrual at the enrolling institution\n* Pathology reports, next generation sequencing reports, or both, confirming BRAF V600E mutation status must be submitted at the time of enrollment\n\nExclusion Criteria:\n\n* Participant's tumor has any of the following additional previously known or expected activating molecular alterations:\n\n  * Isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutation\n  * Histone H3 mutation (p.K28M, p.G35R, p.G35V)\n  * Neurofibromatosis Type 1 (NF-1) loss of function alteration\n* Participants who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and trametinib\n* Medications that are affected by the induction of CYP3A4 and CYP2C9 should be avoided or used cautiously. Dabrafenib has been shown to induce CYP3A4 and CYP2C9. In addition, dabrafenib is an in vitro inducer of CYP2B6, CYP2C8, CYP2C19, Uridine 5'-diphospho (UDP)-glucuronosyltransferase. Co-administration of dabrafenib and medications which are affected by the induction of these enzymes (including warfarin) and transporters may result in loss of efficacy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the participant and\u002For legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection\n* Women of childbearing potential must not be pregnant or breast-feeding\n* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised","12 Months",{"count":636,"type":21},96,[169],"This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.",[640,567,641,642],"BRAF V600 Mutation","Low Grade Glioma of Brain","Recurrent Low Grade Glioma","2026-06-12",{"date":496,"type":40},{"date":646,"type":40},"2025-11-07",{"date":313,"type":21},{"name":46,"class":47},7,{"id":651,"slug":4,"hasResults":11,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":86,"sex":16,"minAge":55,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":22,"phases":659,"briefSummary":660,"conditions":661,"keywords":663,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":78},"100517646","NCT06020248","Melanin and Dermal Uptake of Thirdhand Cigarette Smoke","THS05","Inclusion Criteria:\n\n* Adult nonsmoker\n* Aged 18-50\n* Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument\n* Healthy on the basis of medical history\n* Systolic blood pressure \\\u003C150\n* Diastolic blood pressure \\\u003C100\n* C-reactive protein \\\u003C3.1 mg\u002Fml\n* Liver function (AST and ALT) in normal ranges\n* kidney function (BUN) in normal ranges\n* LDL\\\u003C131\n* Blood glucose \\\u003C110\n* Not exposed to tobacco SHS.\n\nExclusion Criteria:\n\n* Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18 instrument.\n* Positive SARS-CoV-2 antibody test\n* Age 18 \\\u003C or \\> 50\n* Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.\n* Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications\n* Systolic blood pressure greater than or equal to 150\n* Diastolic blood pressure greater than or equal to 100\n* Blood glucose greater than or equal to 110\n* LDL greater than or equal to130\n* Pregnancy or breastfeeding (by urine hCG and\u002For history)\n* Alcohol or illicit drug dependence within the past 5 years\n* BMI \\> 35 and \\\u003C 18\n* Current illicit drug use (by history or urine test)\n* More than 1 pack year smoking history\n* Ever a daily marijuana smoker\n* Smoked anything within the last 3 months\n* Unable to hold allergy or other OTC medicines\n* Occupational exposure to smoke, dusts OR fumes\n* Concurrent participation in another clinical trial\n* Unable to communicate in English\n* No social security number","50 Years",{"count":658,"type":21},60,[24],"This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and longer retention of nicotine in the skin and body.",[662],"Healthy",[664,665,666,667,668,669],"Thirdhand tobacco smoke","Dermal","Exposure","Tobacco Smoke Pollution","Melanin","Nicotine",{"date":496,"type":40},{"date":672,"type":40},"2023-09-01",{"date":674,"type":21},"2026-11",{"name":46,"class":47},""]