[{"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:":673},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,334,0,25,[9,45,80,103,130,155,180,211,235,256,273,297,319,342,369,390,418,449,470,532,551,576,603,624,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100634008","intervention-for-hearing-health-among-native-americans-100634008",false,"NCT07534098","Intervention for Hearing Health Among Native Americans","IHHANA","Inclusion Criteria:\n\n* Indigenous or Native American community member\n* Age 18 years and older\n* May work in a noisy environment\n* Willing to give informed consent to participate in the study\n* People without hearing loss and with hearing loss as well\n\nExclusion Criteria:\n\n* Younger than the age of 18\n* Non Native American community member\n* Unwillingness to provide informed consent to participate in the study",true,"ALL","18 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of the study is to understand the cultural impact on hearing loss among Native American populations who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to address hearing health inequities among Native Americans. The goal is to establish a sustainable culturally based Talking Circle (TC) hearing loss prevention program to disseminate messages, thus promote hearing health and improve access to preventive tools within the larger tribal community with high occupational and recreational noise exposure.\n\nTC Participants will:\n\n* Complete a set of questionnaires (3 total) throughout the study.\n* Complete an audiometer hearing test with headphones, and watch one video computer related to hearing and how to protect hearing at the tribal wellness center.\n* In 6-months into the trial, participants will be asked to complete the same set of questionnaires from the beginning of the study.\n* In 12-months after the baseline surveys and hearing test, participants will be asked to complete the same set of questionnaires that were done at the beginning of the study and complete another hearing test by the computer.\n\nThe intervention will include facilitator training for local implementation and a delayed-intervention control to assess knowledge gains and protective behavior changes. Through use of the TC, the participants in the training program can use the support and insight from each other to be trained to establish self-sustaining hearing loss prevention program in the tribal community.",[28],"Noise-Induced Hearing Loss",[30,31],"Native American","hearing health","NOT_YET_RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":22},"2027-04-01",{"date":40,"type":22},"2030-04-30",{"name":42,"class":43},"University of California, San Francisco","OTHER",2,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100591026","phase-4-effect-of-magnesium-on-neuromonitoring-100591026","NCT06975072","Effect of Magnesium on Neuromonitoring","Pharmacokinetics and Impact of Magnesium Sulfate on Neuromonitoring in Spinal Surgery","MgNm","Inclusion Criteria:\n\nAdult patients (\\>18 years of age) undergoing open thoracolumbar fusion with planned neuromonitoring\n\nExclusion Criteria:\n\n1. Patients with a history of significant cardiac disease (LVEF \\\u003C35%, 2nd\u002F3rd-degree block without a pacemaker, or significant arrhythmia)\n2. Patients with kidney disease (GFR \\\u003C30), or hepatic dysfunction (history of cirrhosis)\n3. Allergy or sensitivity to magnesium\n4. Patient with neuromuscular disease such as myasthenia graves",{"count":54,"type":22},40,[56],"PHASE4","Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.",[59,60,61,62,63,64],"Spine","Pain","Spine Surgery","Spine Surgery With Neuromonitoring","Spine Surgery With Motor Evoked Potential Monitoring","Spine Fusion",[66,67,68,69,70,71],"spine","spine surgery","spine fusion","magnesium","neuromonitoring","motor evoked potential monitoring","RECRUITING",{"date":35,"type":36},{"date":75,"type":36},"2025-07-01",{"date":77,"type":22},"2026-12-30",{"name":42,"class":43},1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":79},"100652370","biomarkers-of-cervical-spondylotic-myelopathy-100652370","NCT07772297","Biomarkers of Cervical Spondylotic Myelopathy","Investigating -Omic Features and Prognostic Indicators of Cervical Spondylotic Myelopathy","Healthy Inclusion Criteria:\n\n* Age \\>18\n* No neck pain\n* No radiculopathy or myelopathy symptoms\n* No trauma in the past 6 months\n* Does not meet exclusion criteria.\n\nCSM Inclusion Criteria:\n\n* Age \\>18\n* Diagnosis of\u002Fencompassed by\u002Frelated to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament.\n\nHealthy Exclusion Criteria:\n\n* Age \\\u003C18.\n* Malignancy\n* Trauma in the past 6 months\n* Infectious etiology\n* Prior cervical spine surgery.\n* Symptoms of cervical radiculopathy, myelopathy or neck pain.\n\nCSM Exclusion Criteria:\n\n* Age \\\u003C18.\n* Malignancy\n* Trauma in the past 6 months\n* Infectious etiology.\n* Prior cervical spine surgery.\n* MRI or CT imaging demonstrating an alternative cause for cervical myelopathy that is not degenerative stenosis (i.e. transverse myelitis, tumor compressing cord, pathologic fracture).",{"count":88,"type":22},50,"OBSERVATIONAL","Investigators believe that patients with cervical spondylotic myelopathy (CSM) have measurable changes in certain molecules in their blood compared with people without CSM. Investigators expect that these changes may be related to how severe a patient's condition is based on imaging and clinical exams. Investigators will also study how these molecules change before and after surgery to see whether they are related to how well patients recover. By combining these blood markers with clinical and imaging information, investigators hope to develop a tool that may help predict patient outcomes.",[92],"Cervical Spondylotic Myelopathy",[92,66,94],"Biomarkers","2026-08-18",{"date":97,"type":36},"2026-08-20",{"date":99,"type":22},"2026-09",{"date":101,"type":22},"2030-09",{"name":42,"class":43},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":111,"minAge":19,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":79},"100621955","cheer-oral-health-in-pregnancy-study-100621955","NCT07377344","CHEER Oral Health in Pregnancy Study","Closing Health Equity Through Empowering Oral Health for Maternal Wellness","CHEER","Inclusion Criteria:\n\n1. Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)\n2. Less than 20 weeks pregnancy at time of enrollment\n3. Has dental insurance (Medi-Cal or private coverage)\n4. Willing and able to provide informed consent\n5. Planning to receive ongoing prenatal care at study-affiliated clinics\n6. Access to a mobile phone for receiving text messages\n\nExclusion Criteria:\n\n1. Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures\n2. Current immunosuppressive therapy\u002Fuse of anti-inflammatory medications\n3. Receipt of active periodontal treatment within the past 6 months\n4. Complete edentulism (no natural teeth)\n5. Unable to read and write English\n6. Less than 9th grade education\n7. Enrollment in another oral interventional study","FEMALE",{"count":113,"type":22},160,[25],"Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study:\n\nAim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.\n\nAim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.",[117,118,119,120,121,122,123],"Gingivitis","Dental Health","Pregnancy","Pregnancy Outcomes","Randomized Controlled Trial","Periodontal Disease","Gum Disease",{"date":97,"type":36},{"date":126,"type":22},"2026-09-30",{"date":128,"type":22},"2028-12-31",{"name":42,"class":43},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":79},"100609538","phase-1-dopamine-and-sensorimotor-function-in-stuttering-100609538","NCT07215884","Dopamine and Sensorimotor Function in Stuttering","Inclusion Criteria:\n\n* native speakers of American English\n* for adults who stutter, presence of stuttering will be confirmed, with onset before age 6 years\n* Normal hearing\n* Ages of 18 to 65 years\n* healthy adults without hearing-language difficulties\n\nExclusion Criteria:\n\n* self-reported speech-language-hearing difficulties other than stuttering\n* self-reported neurological or psychological problems\n* other medications (drugs that affect dopaminergic system and\u002For benzodiazepines)","65 Years",{"count":7,"type":22},[139],"PHASE1","This study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency. This study aims to understand sensorimotor pathways of stuttering and possible interventions.",[142],"Stuttering, Adult",[144,145,146,147,148],"Stuttering","Aripiprazole","Adults with Stuttering","Speech Fluency","Auditory Feedback",{"date":33,"type":36},{"date":151,"type":36},"2025-09-30",{"date":153,"type":22},"2027-08-30",{"name":42,"class":43},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":79},"100561203","wearable-activity-tracking-to-curb-hospitalizations-100561203","NCT06587100","Wearable Activity Tracking to Curb Hospitalizations","Wearable Activity Tracking to Curb Hospitalizations (WATCH)","WATCH","Inclusion Criteria:\n\n* Age \\>= 18.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 or Karnofsky Performance Scale (KPS) ≤ 50%.\n* Able to understand study procedures and to comply with them for the entire length of the study.\n* Ability of individual or legal guardian\u002Frepresentative to understand a written informed consent document, and the willingness to sign it.\n* Diagnosis of invasive malignancy.\n* Able to ambulate independently (without the assistance of a cane or walker).\n* Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).\n* Not a previous participant on this protocol for subsequent courses.\n\nExclusion Criteria:\n\n* Participants bound to a wheelchair.\n* Participants unable to ambulate independently (needing assistance of cane or walker).",{"count":164,"type":22},260,"This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.",[167,168,169],"Hematopoietic Neoplasm","Malignant Solid Neoplasm","Lymphatic System Neoplasm",[171,172,173],"Activity tracking","Hospitalization prevention","Artificial Intelligence (AI) modelling",{"date":97,"type":36},{"date":176,"type":36},"2025-04-07",{"date":178,"type":22},"2027-12-31",{"name":42,"class":43},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":79},"100652434","relaxation-intervention-to-improve-newborn-growth-and-maternal-well-being-100652434","NCT07774793","Relaxation Intervention to Improve Newborn Growth and Maternal Well-being","Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being","RING-MW","Inclusion Criteria:\n\n* Newborn low birth weight (LBW) (birth weight \\\u003C 2500 grams)\n* Newborn birth weight \\>= 1800 g\n* Newborn admitted to Neonatal Intensive Care Unit (NICU)\n* Newborn in stable condition without WHO danger signs\n* Newborn age \\\u003C24 hours old\n* Breastfeeding initiated\n* Residence in the catchment area\n\nExclusion Criteria:\n\n* Twins and other multiples\n* Newborn respiratory support or WHO danger signs\n* Newborn with major congenital anomaly or expected surgery\n* Contraindications to or unable to breastfeed\n* Mother with hearing impairment\n* Unable to speak Luganda","0 Days",{"count":190,"type":22},100,[25],"The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:\n\n* Does listening to a relaxation audiorecording during breastfeeding improve infant growth?\n* Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety?\n\nResearchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being.\n\nParticipants will:\n\n* Listen to an audiorecording twice daily while breastfeeding for 12 weeks\n* Have study visits at 1, 2, 4 and 12 weeks for checkups and tests\n* Let us know what they think of the audiorecording",[194,195,196,197],"Well-Being, Psychological","Breastfeeding","Low Birth Weight","Undernutrition",[199,200,201,202,203],"relaxation","audiorecording","breastfeeding","well-being","maternal-child health","2026-08-17",{"date":33,"type":36},{"date":207,"type":22},"2026-08",{"date":209,"type":22},"2027-05",{"name":42,"class":43},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":17,"sex":18,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":227,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":79},"100641380","music-therapy-for-oral-mucositis-pain-in-pediatric-patients-100641380","NCT07653360","Music Therapy for Oral Mucositis Pain in Pediatric Patients","Effect of Music Therapy on Oral Mucositis Pain in Pediatric Patients","Inclusion Criteria:\n\nPhase 1\n\n* Child ages 6-18 years old\n* Child has received music therapy and experienced oral mucositis\n* Parent\u002Fguardian 18 years and older\n* Able to communicate in English\n\nExclusion Criteria:\n\nPhase 1\n\n* Diagnosis of a developmental disorder that would prevent engagement in the active music-making or passive music-listening intervention or completion of study measures.\n* Significant pre-existing hearing loss or impairment that would interfere with participation in the interventions.","6 Years","64 Years",{"count":88,"type":22},[25],"This mixed-methods pilot study will examine the effect of music therapy on oral mucositis pain in pediatric oncology patients. Oral mucositis, characterized by painful ulcerative lesions in the mouth, is a common side effect of high-dose chemotherapy and hematopoietic stem cell or bone marrow transplantation. Despite its high prevalence and impact on quality of life, effective pain management strategies for pediatric oral mucositis remain limited and often rely heavily on medications that may cause significant side effects or provide insufficient relief. Music therapy may offer a promising non-pharmacologic adjunct for reducing pain, yet no studies to date have specifically evaluated its use for oral mucositis pain in pediatric patients.",[224,225,226],"Oral Mucosa Discomfort","Pediatric Cancer","Mucositis Oral",[228],"Music Therapy",{"date":95,"type":36},{"date":231,"type":22},"2026-09-01",{"date":233,"type":22},"2027-07-31",{"name":42,"class":43},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":79},"100630722","phase-4-pilot-exploration-of-platelet-characterization-of-platelet-rich-plasma-created-by-two-different-systems-100630722","NCT07491367","Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems","PRP-PEPC","Inclusion Criteria:\n\n* Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis\n* Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee\n* Will be able to attend and perform physical therapy\n\nExclusion Criteria:\n\n* Received injection therapy for knee osteoarthritis in the past 6 months\n* Have severe arthritis diagnosed in ≥1 major joint by radiology criteria\n* History of septic arthritis\n* Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)\n* Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee\n* Received a platelet-rich plasma injection elsewhere in the body within the past 3 months\n* Have a platelet disorder or bleeding disorder\n* Have a rheumatologic disease, autoimmune disorder, immunocompromised status, or active history of cancer\n* Are taking chemotherapy, require regular prednisone, or require regular anti-inflammatory use\n* Are pregnant, breastfeeding, or unwilling to practice birth control during the study\n* If both knees have osteoarthritis and the other knee has KL score equal to or greater than 2.\n* Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training",{"count":243,"type":22},20,[56],"The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.",[247,248,249,250],"Knee Osteoarthristis","Cartilage Damage","Platelet Rich Plasma","Platelet Rich Plasma Injection",{"date":95,"type":36},{"date":231,"type":22},{"date":254,"type":22},"2028-09",{"name":42,"class":43},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":272,"locationsCount":79},"100610352","evaluating-biomarkers-of-cognitive-dysfunction-in-patients-with-cancer-100610352","NCT07226466","Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer","Inclusion Criteria:\n\n1. \\>= 18 years old\n2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.\n3. Diagnosis of primary solid tumor and secondary involvement of the brain\n4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \\> 1 cm in max diameter.\n5. Candidate for standard of care \u002F usual care (SOC) focused brain radiotherapy.\n6. No prior brain radiotherapy, including whole brain radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.\n8. Estimated life expectancy post-treatment of \\> 2 years.\n\nExclusion Criteria:\n\n1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).\n2. Diagnosis of memory disorder pre-treatment.\n3. Leptomeningeal disease or disease involving either hippocampus.",{"count":54,"type":22},"This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.",[265,266,267,268],"Brain Tumor Adult","Brain Metastases From Solid Tumors","Brain Tumor, Primary","Brain Tumor",{"date":95,"type":36},{"date":231,"type":22},{"date":128,"type":22},{"name":42,"class":43},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100610351","phase-2-target-validation-and-efficacy-of-metformin-in-patients-with-posterior-fossa-group-a-pfa-ependymoma-100610351","NCT07226453","Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma","A Target Validation and Efficacy Study of Metformin in Patients With Recurrent or Progressive Posterior Fossa Group A (PFA) Ependymoma","PNOC041","Inclusion Criteria:\n\n1. Participants must have recurrent or progressive posterior fossa A (PFA) ependymoma following surgery AND radiation treatment (RT).\n2. Participants must have a diagnosis of PFA ependymoma. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria.\n3. Participants must have adequate tumor tissue available from initial diagnosis or from pre- trial enrollment. Formalin-fixed paraffin-embedded (FFPE) material (1 full block) should be provided. If FFPE material is not available, 10 unstained slides with an accompanying hematoxylin and eosin (H\\&E) report should be provided.\n\n   Target Validation (TV) Phase:\n\n   o Participants are candidates to undergo elective surgery for removal of all or a portion of their recurrent\u002Fprogressive tumor.\n\n   Efficacy Phase:\n   * Participant must have measurable disease; this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) The size threshold is met if both in-plane diameters are ≥10 mm or both in-plane diameters are at least two times the MRI slice thickness, plus the interslice gap with a minimum size of no less than double the slice thickness on MRI.\n   * Participants with an isolated local progression of the tumor following RT (or stereotactic radiosurgery, SRS) must be \\> 6 months from completion of RT to the lesion to rule out pseudo progression or must have tissue confirmation of progression prior to enrollment.\n   * Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy as outlined above.\n4. Prior Therapy: Participants must not be receiving metformin for other medical indications or previous exposure to metformin following their diagnosis of PFA ependymoma. However, participants treated on the TV phase, but did not continue onto maintenance therapy will be allowed to enroll on the efficacy phase with future recurrences or progression of their disease.\n5. Age: 1 -39 years at the time of enrollment.\n6. 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.\n7. Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.\n8. Organ Function Requirements\n\n   1. Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3.\n   2. Platelet count \\>=100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n   3. Serum creatinine \\\u003C 1.5 Upper Limit normal (ULN) based on age and gender\n   4. Total bilirubin \\\u003C= 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin \\\u003C 3 x ULN or direct bilirubin \\\u003C 1.5 x ULN\n   5. alanine aminotransferase (ALT) \\\u003C= 3 x ULN.\n   6. aspartate aminotransferase (AST) \\\u003C=3 x ULN.\n9. Participants with seizure disorder may be enrolled if well controlled and are on stable dose of anti-seizure medication for \\> 72 hours prior to enrollment. Participants who have neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.\n10. Participants must enroll on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution.\n11. A legal parent\u002Fguardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n\nExclusion Criteria:\n\n1. Participants with a history of diabetes mellitus or those meeting criteria for pre-diabetes are excluded. Pre-diabetes is defined per American Diabetes Association criteria as any of the following: fasting plasma glucose (FPG) 100-125 mg\u002FdL (5.6-6.9 mmol\u002FL); 2-hour plasma glucose (OGTT) 140-199 mg\u002FdL (7.8-11.0 mmol\u002FL); or hemoglobin A1c (HbA1c) 5.7%-6.4% (39-47 mmol\u002Fmol).\n2. Participants without any measurable disease.\n3. Participants who have had chemotherapy or have received radiotherapy to the non-target lesion within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n4. Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. 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 should also be discussed with study chairs.\n5. Participants with rapidly progressive symptoms that require urgent surgery that in the investigators assessment cannot be safely deferred for 6 weeks are excluded from target validation phase of the study\n6. Participants who are receiving any other investigational agents.\n7. Concurrent radiation therapy in any form is not permitted while on the study drug\n8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.\n10. Women of childbearing potential must not be pregnant or breast-feeding.\n11. 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.","1 Year","39 Years",{"count":284,"type":22},30,[286],"PHASE2","This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.",[289],"Posterior Fossa Ependymal Tumor",{"date":33,"type":36},{"date":292,"type":36},"2026-05-05",{"date":294,"type":22},"2030-03-31",{"name":42,"class":43},10,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":304,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":79},"100417429","phase-4-secondhand-tobacco-smoke-and-cardiovascular-disease-100417429","NCT04715568","Secondhand Tobacco Smoke and Cardiovascular Disease","Occult Cardiovascular Disease With Chronic Exposure to Secondhand Tobacco Smoke","Inclusion Criteria:\n\n* Must be able to understand and provide informed consent.\n* Adults \\>= 40 years of age.\n* Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies.\n* Must have never smoked or have a remote history of light smoking defined as follows:\n\n  * Lifetime smoking history equivalent to \\\u003C 1 pack-year and\n  * No smoking history for \\>= 20 years at the time of enrollment.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* Subject is pregnant, breast-feeding, or plans to become pregnant.\n* Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).\n* Known intolerance to ACE inhibitor or ARB.\n* History of angioedema.\n* Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy).\n* Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting.\n* Known unilateral or bilateral renal artery stenosis higher than 70%.\n* Renal insufficiency (Creatinine Clearance \\\u003C30 mL\u002Fmin by Cockcroft-Gault calculation).\n* Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month.\n* Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)\u002FdL or higher at V1.\n* Current use of a potassium sparing diuretic.\n* History of clinically overt cardiovascular disease including: stable or unstable angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary artery disease (as defined by history of abnormal stress test; cardiac catheterization showing \\>70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); poorly controlled resting hypertension (SBP\\>160\u002F DBP\\>95); congestive heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) \\\u003C55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (\\>mild) valvular heart disease; congenital heart disease; cardiac arrhythmias including frequent premature atrial or ventricular contractions (\\>5 per minute).\n* History of clinically overt pulmonary disease that may interfere with study procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial lung disease, and pulmonary hypertension.\n* Neuromuscular disorders or physical disability to perform exercise testing using an ergometer.\n* Significant history of recreational drug use other than marijuana as defined by: recreational drug use within the last 30 years of recruitment (or) recreational drug use at a frequency of more than once a month before 30 years.\n* Marijuana use more than once a week.\n* Other uncontrolled chronic illnesses which in the judgment of the study physician would interfere with completing study procedures.\n* Failure to keep screening appointments or other indicators of non-adherence.\n* Concomitant participation in another interventional study.\n* Subjects with BMI \\\u003C15 or \\>40 kg\u002Fm2.\n* MRI Scan Participation Exclusion Criteria - The participants will be excluded from the MRI portion of the study if they have a metallic object embedded or implanted in their body that is incompatible with Magnetic Resonance (MR) scanning, including MR incompatible pacemaker or defibrillator.","40 Years",{"count":190,"type":22},[56],"This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.",[309,310],"Cardiovascular Diseases","Hypertension",[312],"Second Hand Tobacco Smoke",{"date":33,"type":36},{"date":315,"type":36},"2021-03-30",{"date":317,"type":22},"2026-12-31",{"name":42,"class":43},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":44},"100408402","phase-2-binimetinib-and-imatinib-for-unresectable-stage-iii-iv-kit-mutant-melanoma-100408402","NCT04598009","Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma","A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Have histologically or cytologically confirmed melanoma\n* Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy\n* Have measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria\n* Have documentation of KIT-mutant melanoma by Clinical Laboratory Improvement Act (CLIA)-certified testing platform\n* Participants have progressed on prior standard-of-care therapy, or would be ineligible for or unable to tolerate standard-of-care therapy, in the opinion of the treating Investigator\n* For participants who have received prior ICI, the following is permitted:\n\n  * Prior adjuvant or neoadjuvant ICI, if last dose administered at least 4 weeks prior to study drug start\n  * Prior ICI for the treatment of unresectable\u002Fmetastatic disease, if last dose administered at least 4 weeks prior to study drug start\n* Absolute neutrophil count \\>= 1,500\u002Fmicroliter (mcL)\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin below normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 x institutional upper limit of normal\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin calculated using the Cockcroft-Gault formula\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy, with undetectable viral load within 3 months of study drug start, are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* 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* Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS)-specific treatment is not required prior to study start\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* Imatinib and\u002For binimetinib may have teratogenic effects. Women of child-bearing potential (WOCBP) must agree to:\n\n  * Use highly effective contraception to avoid pregnancy from screening through 30 days after the last dose of study drugs;\n  * Refrain from donating ova during the study through 30 days after the end of systemic exposure to study drugs;\n  * Inform her treating physician immediately should she become pregnant or suspect she is pregnant while she is participating in this study\n* Sexually active men enrolled on this protocol must agree to:\n\n  * Use a condom for the duration of study participation and through 90 days after the end of systemic exposure to study drugs;\n  * Refrain from donating sperm during the study through 90 days after the end of systemic exposure to study drugs;\n  * If the male participant has a partner that is a WOCBP, that partner should also use highly effective contraception for the duration of the study and through 90 days after the end of the male participant's systemic exposure to study drug\n  * Inform his treating physician immediately should his partner become pregnant while he is participating in this study\n\nHighly effective (i.e., failure rate \\\u003C1% per year when used consistently and correctly) methods of contraception include:\n\n* Complete abstinence from heterosexual intercourse\n* Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n* Intra-uterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomized male partner (provided the vasectomized male has received medical assessment of surgical success, and that the male is a female participant's sole sexual partner)\n\n  * Ability to understand a written informed consent document, and the willingness to sign it\n  * The participant is deemed by the Investigator to have the initiative and means to be compliant with scheduled visits, treatment plan, and study procedures\n\nExclusion Criteria:\n\n* Has received systemic anti-cancer therapies within 3 weeks of study drug start, radiation within 2 weeks, antibody therapy within 4 weeks\n* Has not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline. Note: Stable chronic conditions (grade =\\\u003C 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll\n* Is currently receiving any other investigational agents or has received an investigational agent within 14 days or within 5 half-lives of investigational agent (whichever is shorter), prior to start of study drugs\n* Inability to swallow and retain study drugs\n* Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drugs (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, complete small bowel resection), or recent (=\\\u003C 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs\n* Hypersensitivity to binimetinib or any of its excipients\n* Hypersensitivity to imatinib or any of its excipients\n* Concurrent neuromuscular disorder that is associated with elevated creatinine-kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity of hypercoagulability syndromes); history of retinal degenerative disease\n* Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty of stenting) \\\u003C 6 months prior to screening;\n  * Congestive heart failure requiring treatment (New York Heart Association grade \\>= 2);\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO);\n  * Uncontrolled hypertension defined as persistent systolic blood pressure \\>= 150 mmHg or diastolic blood pressure \\>= 100 mmHg despite current therapy;\n  * History of presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Triplicate average baseline corrected QT (QTc) interval \\>= 480 msec\n* Use of a prohibited medication (including herbal medications, supplements, or foods) that cannot be safely discontinued prior to the start of study treatment\n* Patients on warfarin who cannot be safely transitioned to an alternative systemic anticoagulant\n* History of thromboembolic or cerebrovascular events =\\\u003C 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks prior to study drug start. Note: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled\n* Pregnant women are excluded from this study because binimetinib and imatinib are small molecule inhibitors 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 binimetinib and\u002For imatinib, breastfeeding should be discontinued prior to study drug start\n* Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study",{"count":7,"type":22},[286],"This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.",[330,331],"Melanoma Stage III","Melanoma Stage IV",[333,334,335],"KIT-Mutant","Unresectable Melanoma","Melanoma",{"date":95,"type":36},{"date":338,"type":36},"2021-03-03",{"date":340,"type":22},"2028-05-31",{"name":42,"class":43},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":281,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":357,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":368},"100399771","phase-1-trametinib-and-everolimus-for-treatment-of-pediatric-and-young-adult-patients-with-recurrent-gliomas-pnoc021-100399771","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* Participants must also enroll in a separate observational study to examine the effects of cancer therapies on them, if it is open to accrual at their site of enrollment\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 that have received prior therapy with a MEK inhibitor in combination with an mTOR inhibitor\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","25 Years",{"count":88,"type":22},[139],"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.",[354,355,356],"Recurrent World Health Organization (WHO) Grade II Glioma","Low-grade Glioma","High-Grade Glioma (HGG)",[358,359,360,361],"Mitogen-activated protein kinase (MAPK)","phosphatidylinositol 3-kinase (PI3K)","MAPK","PI3K","2026-08-14",{"date":95,"type":36},{"date":365,"type":36},"2020-12-09",{"date":178,"type":22},{"name":42,"class":43},17,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":79},"100639794","phase-4-short-term-effects-of-methamphetamine-on-residual-latent-hiv-disease-study-100639794","NCT07584369","Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study","Short-term Effects of Methamphetamine on Residual Latent HIV Disease (EMRLHD) Study","EMRLHD","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Any gender, age ≥ 18 years \\\u003C 65 years\n* Laboratory confirmed documentation of HIV-1 infection.\n* Continuous therapy with a Department of Health and Human Services (DHHS) recommended\u002Falternative combination ART for least 12 months (at least 3 agents) at study entry with no regimen changes in the preceding 12 weeks\n* Maintenance of undetectable plasma HIV-1 RNA ( \\\u003C40copies\u002Fml) below the limit of quantification for at least 12 months. Episodes of single HIV plasma RNA 50-500 copies\u002Fml will not exclude participation if subsequent HIV plasma RNA is below the limit of assay detection\n* No plans to modify ART during the study period (approximately 4-5 months)\n* Participant and partner(s) are willing to use two forms of contraception throughout the study period as well as up to 60 days after the last day of study completion\n* Ability and availability to participate in the full duration of the study (approximately 4-5 months) and maintain the inclusion\u002Fexclusion criteria\n* No current or prior history of methamphetamine (MA) use disorder by DSM-5 diagnostic criteria. Participants may have a prior history of taking prescription medications containing amphetamines- type stimulants such as Adderall® or Dexedrine® or Ritalin for the treatment of conditions such as attention deficit hyperactivity disorder as long as the participant has not taken these medications in the last 12 months or plans to take these medications during the entire study period\n\nExclusion Criteria:\n\n* History of methamphetamine (\"meth\") use disorder by DSM-5 diagnostic criteria using the 11-symptom checklist.\n* Evidence of MA use other than due to the administered oral methamphetamine study drug, based on urine, hair, or serum MA measurements collected at baseline and follow-up study visits.\n* Current use of prescription medications containing amphetamine-type stimulants (e. g.,Adderall®, Dexedrine®, Ritalin, etc.) within the past 1 year.\n* Sensitivity or allergy to amphetamine-type stimulants.\n* Current use of any other \"psychoactive\" drug within the last 1 month. These include cocaine, ecstasy, lysergic acid diethylamide (LSD), mushrooms, or other recreational drugs - but cannabis, nicotine or caffeine use is ok.\n* Use of illicit opioids (heroin, fentanyl)- but ok if use of prescription opioid agonists with known prescribed doses, such as methadone, hydrocodone (Norco®), buprenorphine\u002Fnaloxone (Suboxone®), oxycodone (Oxycontin®), hydromorphone (Dilaudid®) within the past 3 months by self-report and\u002For urine qualitative screening.\n* Current moderate to severe use of alcohol use disorder (DSM-5 criteria) as this might put patient at risk of withdrawal during the study.\n* Recent use within the last month of the following medications given potential interactions with oral methamphetamine: acebrophylline, iobenguane, isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine, asunaprevir, bupropion, topical cocaine, fluoxetine, iohexol, linezolid, paroxetine, potassium citrate, quinidine, sodium bicarbonate, sodium citrate, sodium lactate, tipranavir, and tromethamine.\n* Recent hospitalization in the last 90 days.\n* Recent infection in the last 90 days requiring prolonged (e.g., \\>3 weeks) of systemic intravenous antibiotics.\n* Known anemia (HIV+ males Hct\\\u003C 34; females Hct\\\u003C 32) or contraindication to donating blood.\n* Screening hemoglobin below 12.5 g\u002FdL\n* Poorly controlled hypertension or systolic blood pressure \\> 140 on repeat measurement in the last 3 months, on more than one occasion.\n* Significant myocardial disease (e.g., current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.\n* History of cardiac arrhythmia that needs to be medically treated.\n* History of psychotic symptoms (e.g., hallucinations, delusional thinking) in the prior 3 months.\n* History of seizures, abnormal electroencephalogram or brain damage with significant persisting neurological deficit in the past 3 months or currently on anti- seizure medications\n* Significant respiratory disease requiring oxygen.\n* Exposure to any immunomodulatory drug (including maraviroc) in the 12 weeks prior to study\n* Prior or current use of experimental agents used with the intent to perturb the HIV-1 viral reservoir in the 12 weeks prior to study.\n* Participants of reproductive potential or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at screening. All participants of childbearing potential must agree to use a double-barrier method of contraception throughout the study period and up to 90 days after the last dose of MA.\n* Pregnancy. A serum pregnancy test will be performed. If this test is positive, the participant will not be allowed to enter the study since body changes occurring during pregnancy will alter the study results.\n* Recent vaccination within the last 2 weeks prior to study baseline visit.\\* \\*Note: Routine or standard of care vaccinations (such as SARS-CoV-2, influenza, pneumococcal, and meningococcal vaccinations) are allowed, but must be administered greater than 14 days prior to baseline study visit. For SARS-CoV-2 vaccination, the last dose must be administered at least 14 days prior to baseline study visit.",{"count":243,"type":22},[56],"The most commonly used illicit stimulant in people with HIV (PWH) is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized populations who are most likely to benefit from an HIV cure but possess poorer immune responses. For this study, N = \\~20 PWH virally-suppressed on antiretroviral therapy (ART) with no prior history of MA use disorder will be administered oral methamphetamine to determine the effects of short-term MA exposure on residual virus production, gene expression, and inflammation. Measures of MA exposure in urine and serum will then be associated with residual virus production, gene expression, cell surface immune marker protein expression, and systemic markers of inflammation. Thus, the proposed work will leverage a unique clinical trial design to generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in PWH who use MA.",[381,382],"HIV -1 Infection","Methamphetamine Use","2026-08-13",{"date":204,"type":36},{"date":386,"type":22},"2026-10",{"date":388,"type":22},"2030-05",{"name":42,"class":43},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":17,"sex":18,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":407,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":79},"100543669","phase-4-azithromycin-for-child-survival-in-niger-ii-100543669","NCT06358872","Azithromycin for Child Survival in Niger II","Azithromycine Pour la Vie Des Enfants au Niger II","AVENIR II","Inclusion Criteria:\n\nCSI-level for mortality and AMR monitoring:\n\n* Located in a region participating in the program\n* Designated as rural by local study team\n* Selected for participation in monitoring activities\n* Safe and accessible for study teams\n* Verbal approval from community leaders\n\nIndividual level for mortality monitoring:\n\n* Residing in the catchment area of an eligible CSI\n* Selected for participation in monitoring activities\n* Female\n* Age between 12 and 55 years old\n* Verbal approval from participant\n\nIndividual-level for AMR monitoring:\n\n* Residing in the catchment area of an eligible CSI\n* Selected for participation in monitoring activities\n* Age between 1 and 59 months old\n* Verbal approval from a caregiver or guardian\n\nExclusion Criteria:\n\nAt the community-level:\n\n* Designated as urban by local study team\n* Inaccessible or unsafe for study team\n\nAt the individual-level:\n\n* Known allergy to macrolides","1 Month","59 Months",{"count":401,"type":22},3300000,[56],"Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.",[405,406],"Mortality","Antimicrobial Resistance",[408,409,410,406,411],"Mass Treatment","Azithromycin","Childhood Mortality Rate","Implementation and Cost Analysis",{"date":204,"type":36},{"date":414,"type":36},"2024-04-29",{"date":416,"type":22},"2028-04-29",{"name":42,"class":43},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":427,"conditions":428,"keywords":431,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":79},"100080584","brain-development-research-program-100080584","NCT00305305","Brain Development Research Program","Disorders of Cerebral Development: A Phenotypic and Genetic Analysis","Inclusion Criteria:\n\n* Clinical diagnosis of agenesis or dysgenesis of the corpus callosum, polymicrogyria, or Dandy-Walker malformation\n* Should be confirmed by an MRI (Magnetic Resonance Imaging) of the brain\n\nExclusion Criteria:\n\n* Fully formed but hypoplastic corpus callosum",{"count":426,"type":22},2000,"Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are studying the genetic causes of disorders of cognition and epilepsy, in particular disorders of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of the investigators' research is to use a better understanding of the underlying genetic causes as a foundation to develop better treatments for these groups of patients.",[429,430],"Brain Disorders","Aicardi Syndrome",[432,433,434,435,436,437,438,439,440,441,442],"Agenesis Corpus Callosum","Polymicrogyria","Dandy-Walker","Brain Malformation","Autism","Epilepsy","Mental Retardation","MRI","Agenesis of the Corpus Callosum (complete or partial)","Confirmed by a brain MRI.","Aicardi Syndrome.",{"date":204,"type":36},{"date":445,"type":36},"2003-08",{"date":447,"type":22},"2027-01",{"name":42,"class":43},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":79},"100652114","validation-of-biomarkers-for-long-covid-in-the-liinc-viral-immunopathogenesis-and-persistence-repeat-donor-cohort-viper-100652114","NCT07770022","Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER)","VIPER","Inclusion Criteria:\n\n* Willing and able to provide written informed consent, and\n* Age \\>\u002F= 18 years, and\n* Either:\n\nHistory of a SARS-CoV-2 infection resulting in Long COVID symptoms, confirmed by the investigator, or\n\nExposure to SARS-CoV-2 without establishment of Long COVID.\n\n* Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC).\n* Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols.\n\nExclusion Criteria:\n\n* Self-reported or documented chronic anemia with hemoglobin \\\u003C 9 g\u002FdL. Anemia during a preceding acute illness will not be exclusionary.\n* Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.\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.",{"count":457,"type":22},150,"The purpose of this study is to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection.\n\nParticipants will provide health information and biological samples, such as blood, saliva, stool, and, for some participants, tissue biopsies. These samples will be used to study the biological processes involved in Long COVID and to support the development of new diagnostic tests that may improve future research, clinical trials, and patient care.",[460],"Long Covid",[462],"Long COVID","2026-08-12",{"date":95,"type":36},{"date":466,"type":36},"2026-05-18",{"date":468,"type":22},"2031-05-15",{"name":42,"class":43},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":44},"100379539","radiation-therapy-for-the-treatment-of-metastatic-gastrointestinal-cancers-100379539","NCT04221893","Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers","Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)","Inclusion Criteria:\n\n1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).\n2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.\n3. Patients must have at least one metastasis which is progressing as per RECIST criteria.\n4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:\n\n   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea\n   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise\n5. Evaluation by a radiation oncologist within 28 days of study registration.\n6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.\n7. Age \\>= 18 years.\n8. Life expectancy exceeding 6 months.\n9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \\>= 50.\n10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.\n\n    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.\n2. Administration of radiation therapy within 4 weeks prior to study enrollment.\n3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.\n4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.",{"count":478,"type":22},28,[25],"This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.",[482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525],"Stage IV Esophageal Adenocarcinoma","Stage IV Esophageal Squamous Cell Carcinoma","Stage IV Gastric Cancer","Stage IV Adenocarcinoma of the Gastroesophageal Junction","Stage IVA Esophageal Adenocarcinoma","Stage IVA Esophageal Squamous Cell Carcinoma","Stage IVA Gastric Cancer","Stage IVA Adenocarcinoma of the Gastroesophageal Junction","Stage IVB Esophageal Adenocarcinoma","Stage IVB Esophageal Squamous Cell Carcinoma","Stage IVB Gastric Cancer","Stage IVB Gastroesophageal Junction Adenocarcinoma","Metastatic Anal Canal Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IV Gastric Cancer AJCC v8","Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Stage IV Anal Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8",{"date":362,"type":36},{"date":528,"type":36},"2020-08-07",{"date":530,"type":22},"2028-04-30",{"name":42,"class":43},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":548,"leadSponsor":550,"locationsCount":79},"100641901","preoperative-outreach-to-improve-surgical-attendance-100641901","NCT07644819","Preoperative Outreach to Improve Surgical Attendance","Reducing No-Shows in High-Risk Urology Patients Through Enhanced Preoperative Outreach","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Identified as high risk for no-show by the study predictive model\n* Scheduled to undergo a urologic procedure at UCSF\u002FUCSF affiliated sites\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Not scheduled for a urologic procedure",{"count":540,"type":22},68,[25],"This study aims to evaluate the impact of reminder call intervention on no-shows for urologic procedures in patients identified to be high risk for no-showing. Patients scheduled to undergo a urologic procedure will be randomized into two groups: the intervention group, who receives a series of reminder calls and text messages about appointment details and patient questions prior to the procedure date; and the control group, who receives standard care only. Secondary outcomes include rates of patient re-scheduling and healthcare utilization.",[544],"Urology","2026-08-11",{"date":383,"type":36},{"date":207,"type":22},{"date":549,"type":22},"2026-12",{"name":42,"class":43},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":17,"sex":18,"minAge":558,"maxAge":349,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":79},"100610093","sauna-for-offline-connections-and-interactive-authentic-living-100610093","NCT07223099","Sauna for Offline Connections and Interactive, Authentic Living","SOCIAL","Inclusion Criteria:\n\n* Aged 19-25\n* English-speaking\n* Able to provide written informed consent\n* Graduated from high school or high school equivalent\n* Elevated level of loneliness\n* Able and willing to receive study text messages\n* Able to attend weekly in-person sauna visits in San Francisco, CA\n\nExclusion Criteria:\n\n* Self-reported heat intolerance\n* Pregnancy, active lactation, or intention to become pregnant during the study period\n* Regular use of any nicotine products, including cigarettes, vapes, chewing tobacco, or other forms of nicotine (if use is not regular, must be willing to refrain for 24 hours before and 24 hours after sauna visits)\n* Current social heat practices 2 or more times per month (e.g., visiting sauna or hot tub facilities with others present)\n* Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after sauna visits\n* Unwilling to refrain from heavy exercise on the day of sauna visits\n* Any medical condition that, in the opinion of investigators, may increase the risk of sauna use or introduce excessive variance into physiological or behavioral responses to sauna visits\n* Use of any medication that might impact thermoregulatory capacity or that, in the opinion of investigators, would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to sauna visits","19 Years",{"count":560,"type":22},15,[25],"This pilot trial will test an intervention (sauna visits) targeting reductions in loneliness in adults aged 19-25 years.\n\nParticipants will:\n\n* Visit a sauna in San Francisco once per week for 2 hours by themselves or with a friend, for 8 weeks total\n* Complete online surveys throughout their participation\n\nThe main question this pilot trial aims to answer are:\n\n* To what extent do participants find the study design acceptable?\n* To what extent do participants complete the weekly sauna visits?\n* To what extent do participants complete the weekly online surveys?",[564],"Loneliness",[564,566,567,568,569],"Sauna","Gen Z","Young adult","Emerging adult",{"date":383,"type":36},{"date":572,"type":36},"2026-04-20",{"date":574,"type":22},"2027-03-30",{"name":42,"class":43},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":17,"sex":18,"minAge":584,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":595,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":79},"100601549","evaluating-the-impact-of-connect-in-a-multilingual-population-100601549","NCT07111936","Evaluating the Impact of CONNECT in a Multilingual Population","Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population","CONNECT-ML","Inclusion Criteria:\n\n* Age 50-80 years old.\n* Current smokers defined at smoking at least one cigarette in past 7 days AND eligible for lung cancer screening (LCS) based on smoking history (\\>=20 pack year history)\n* California (CA) residents\n* Able to understand and comply with study procedures for the entire length of the study.\n* Ability of individual or legal guardian\u002Frepresentative to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* Non-smokers.\n* Individuals with a diagnosis of lung cancer.\n* Individuals receiving hospice care.\n* Individuals whose providers do not think that they should participate (e.g., psychiatric illness or significant cognitive impairment that would impede the individuals ability to participate).\n* Hearing and\u002For vision disabilities that would prevent participants from adequately receiving treatment components such as video or telephone counseling.","50 Years","80 Years",{"count":587,"type":22},439,[25],"This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.",[591,592,593,594],"Smoking Cessation","Smoking Cessation Counseling Ability and Practice","Smoking Cessation Counselling","Lung Cancer Screening",[596],"Multilingual",{"date":383,"type":36},{"date":599,"type":36},"2025-08-07",{"date":601,"type":22},"2028-03-31",{"name":42,"class":43},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":79},"100548984","phase-1-levothyroxine-supplementation-for-heart-transplant-recipients-100548984","NCT06428097","Levothyroxine Supplementation for Heart Transplant Recipients","Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial","Levo","Inclusion Criteria:\n\n1. Participants must be listed for heart transplantation\n2. Age ≥18 years\n3. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy\n2. Patients with a known allergy or intolerance to levothyroxine\n3. Patients participating in another study evaluating an investigational drug within the past 30 days.",{"count":612,"type":22},97,[139],"This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.",[616,617],"Heart Transplant Failure","Heart Transplant Infection",{"date":383,"type":36},{"date":620,"type":36},"2024-03-29",{"date":622,"type":22},"2027-03-01",{"name":42,"class":43},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":17,"sex":632,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":643,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":79},"100651615","gwan-enjoy-life-a-peer-supported-mental-health-mentoring-intervention-to-improve-engagement-in-care-among-sexual-minority-men-living-with-hiv-in-jamaica-100651615","NCT07762612","\"Gwan Enjoy Life:\" A Peer-Supported Mental Health Mentoring Intervention to Improve Engagement in Care Among Sexual Minority Men Living With HIV in Jamaica","\"Gwan Enjoy Life:\" Protocol for a Randomized Controlled Trial to Test a Peer-Supported Mental Health Intervention to Improve Engagement in Care for High-Priority Sexual Minority Men Living With HIV","GwanEnjoyLife","Inclusion Criteria:\n\n* Self-identified as a cisgender man who have sex with men\n* Age 18 and older,\n* Living in one of the 14 parishes\n* Able to offer informed consent\n* Living with HIV (currently engaged, marginally engaged, and not engaged in care)\n* Provide consent to clinic staff to review medical records.\n\nExclusion Criteria:\n\n* Self-reported participation in another HIV care engagement study\n* Unable to understand the consent process\n* Planning on relocating out of Jamaica over the next 12 months.","MALE",{"count":634,"type":22},60,[25],"Sexual minority men (SMM) in Jamaica face many challenges that affect their health and well-being. Although they make up a relatively small part of the population, they are much more likely to be living with HIV than the general public. Many also experience discrimination because of their sexual orientation, HIV-related stigma, violence, poverty, unstable housing, limited educational opportunities, and barriers created by laws and social attitudes. These experiences can have a serious impact on mental health, leading to problems such as depression, anxiety, trauma, and thoughts of suicide. Many people also face barriers to getting mental health care because of stigma or a lack of services that are welcoming and appropriate for their needs. These challenges can make it difficult for people living with HIV to stay connected to medical care and take their HIV medications consistently. Missing appointments or stopping treatment can make it harder to keep the virus under control and can lead to poorer health over time. While researchers know that stigma, discrimination, and violence affect health, we still do not fully understand how these experiences work together to influence HIV care among sexual minority men in Jamaica.\n\nTo help address these challenges, we developed the Gwan Enjoy Life program, a culturally relevant program designed specifically for sexual minority men living with HIV in Jamaica. The program combines practical coping skills, emotional support, and strategies for managing the effects of trauma and stress. It is led by trained peer mentors who are also living with HIV, allowing participants to learn from people who understand their experiences. The six-session program gives participants the option of meeting one-on-one with a peer mentor or participating in a small group, depending on what they find most comfortable. The program will be tested in partnership with Jamaica AIDS Support for Life (JASL), one of Jamaica's leading HIV service organizations. Sixty participants from JASL clinics in Kingston and St. Andrew, St. James, and St. Ann will take part in the intervention. Participants will be randomly assigned to either receive the Gwan Enjoy Life program or continue with their usual care, and they will be followed for one year. Researchers will examine whether the program improves mental health, strengthens social support, helps participants stay engaged in HIV care, and improves medication adherence.\n\nThe goal of the intervention is to determine whether the Gwan Enjoy Life intervention is a practical and effective program that can be expanded to reach more people across Jamaica. The findings will help researchers, healthcare providers, and policymakers better understand how stigma, violence, and mental health affect HIV care and will support the development of programs that improve the health and well-being of sexual minority men living with HIV.",[638,639,640,641,642],"Mental Health","HIV","Pyschological Distress","Suicidal Ideation","Engagement in HIV Care",[638,639,644,645,646,647],"Engagement in Care","Jamaica","Sexual Minority Men","Psychological Distress","2026-08-07",{"date":383,"type":36},{"date":651,"type":22},"2026-08-25",{"date":153,"type":22},{"name":42,"class":43},{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":661,"maxAge":349,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":79},"100638768","incorporating-narrative-into-the-treatment-of-youth-with-anorexia-nervosa-virtual-100638768","NCT07579442","Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa (Virtual)","Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa","Inclusion Criteria:\n\n* 16-25 years old\n* have a DSM-5 diagnosis of AN (confirmed by the UCSF Eating Disorders Program clinical team),\n* currently engaged in outpatient eating disorder treatment, ensuring medical stability and capacity for a group-based intervention\n* English fluency to engage in reflective writing and discussions\n* Cognitive ability to meaningfully participate in narrative-based exercises\n\nExclusion Criteria:\n\n* Currently medically unstable or require inpatient hospitalization\n* History of psychosis, schizophrenia spectrum disorder, bipolar disorder, or personality disorder\n* Severe neurocognitive impairment that would prevent engagement with the intervention\n* Active suicidal ideation or non-suicidal self-injury within the past two months\n* Insufficient English proficiency to participate in group discussions and writing exercises","16 Years",{"count":296,"type":22},[25],"The goal of this clinical trial is to evaluate whether a narrative medicine (NM) curriculum can enhance self-expression, reflection, and resilience in adolescents and young adults with anorexia nervosa.\n\nThe main questions it aims to answer are:\n\n* Does participation in an NM curriculum improve self-expression and reflection in individuals with anorexia nervosa?\n* Does engaging in creative writing and group discussion promote resilience and emotional processing in this population?\n\nParticipants will be 16-25 years old, medically stable for outpatient eating disorder therapy, and actively engaged in treatment. Those with active suicidal ideation, recent non-suicidal self-injury, or a co-occurring personality disorder will not be eligible.\n\nParticipants will:\n\n* Attend six weekly workshops focused on themes such as self-definition, kindness, resilience, and possibility\n* Engage in close reading of visual or written texts\n* Complete creative writing exercises in response to prompts\n* Participate in group discussions and sharing\n\nAn optional capstone reading event will provide a supportive space for participants to share their work with peers, loved ones, and providers, fostering connection and community.\n\nThis study aims to explore the role of narrative medicine in eating disorder treatment and assess its potential benefits for psychological well-being and self-expression.",[666],"Anorexia Nervosa",{"date":545,"type":36},{"date":669,"type":22},"2026-08-15",{"date":671,"type":22},"2027-07-01",{"name":42,"class":43},""]