[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Virginia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":664},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,108,0,25,[9,53,83,121,149,174,201,228,248,280,304,325,357,380,401,427,450,473,499,521,549,577,598,621,641],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100555094","phase-3-pre-operative-window-of-et-to-inform-rt-decisions-power-ii-100555094",false,"NCT06507618","Pre-Operative Window of ET to Inform RT Decisions (POWER II)","A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)","POWER II","Inclusion Criteria (summary):\n\n* Diagnosis of ER+, PR +\u002F-, and HER2- non amplified invasive breast cancer and clinically negative nodes\n* ECOG performance status 0-2\n* Females, aged ≥ 65 years\n* Patient is eligible for BCS and opted for BCS\n* Patient is a candidate for radiation therapy\n* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)\n* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS\n* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Bilateral synchronous breast cancer\n* Multicentric disease\n* Prior use of Tamoxifen or aromatase inhibitors\n* History of ipsilateral breast radiation therapy\n* Has a known additional malignancy that is progressing and\u002For requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.\n* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.","FEMALE","65 Years",{"count":21,"type":22},354,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:\n\nIntervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.\n\nBoth arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).",[28],"Breast Cancer Female",[30,31,32,33,34,35,36,37,38,39],"breast cancer","endocrine therapy","radiation","letrozole","anastrozole","exemestane","tamoxifen","survey","questionnaire","geriatric","RECRUITING","2026-06-25",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2024-07-19",{"date":48,"type":22},"2034-03-01",{"name":50,"class":51},"University of Virginia","OTHER",6,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100644213","a-pre-post-pilot-of-a-smartphone-intervention-100644213","NCT07665346","A Pre-post Pilot of a Smartphone Intervention","A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones","Inclusion Criteria:\n\n* age = 18 years\n* 0-5 years post-diagnosis of Stage I, II, or III female breast cancer\n* elevated symptoms of depression and\u002For anxiety as measured by the PHQ-8 (score \\> 9) or GAD-7 (score \\> 7).\n\nExclusion Criteria:\n\n* receiving individual (1 on 1) treatment for depression and\u002For anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)\n* active suicidal ideation during the enrollment\u002Fscreening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone (\"In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?\"). If an individual responds in any way other than \"not at all\" based on the available response options (i.e., either \"several days\", \"more than half the days\", or \"nearly every day\"), or if they mention having suicidal ideation or thoughts of death during the enrollment\u002Fscreening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources\n* do not have an app-compatible phone\n* cannot read and speak English (intervention and measures only available in English).","18 Years",{"count":62,"type":22},44,[64],"NA","Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills.\n\nDigital health interventions delivered through smartphones have strong potential to improve access to care for the large number of breast cancer survivors who need mental and behavioral health support. There is a need to evaluate a range of supportive interventions that target different aspects of mental health, including negative thinking, coping skills, and knowledge. Our research team has previously tested individual digital interventions in relatively small samples, and found that they were effective in reducing mood symptoms among women with breast cancer.\n\nThe ultimate goal of this project is to evaluate how integrating these interventions into a single 8-week long app program affects mood and overall mental health in breast cancer survivors. The digital micro-interventions to be tested in this study are brief interventions that target specific behavioral and cognitive mechanisms of mental health. These include skills such as reducing negative thinking patterns, increasing knowledge of mental health factors, fostering a grateful outlook, promoting the practice of relaxation breathing, savoring positive memories, and acceptance-based mindfulness approaches.",[67,68],"Mental Health Issue","Breast Cancer",[70,71,72],"depression","anxiety","well-being","NOT_YET_RECRUITING","2026-06-18",{"date":76,"type":44},"2026-06-24",{"date":78,"type":22},"2026-07",{"date":80,"type":22},"2026-09",{"name":50,"class":51},1,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":18,"minAge":60,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":104,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":82},"100635054","carrii-native-intervention-optimization-trial-100635054","NCT07547696","CARRII Native Intervention Optimization Trial","CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions","Inclusion Criteria:\n\n* Native American\u002FAmerican Indian\u002FAlaska Native,\n* who are not surgically sterile,\n* who report alcohol consumption at risk levels and risk for pregnancy in the past 90 days due to having sex with a man with inconsistent, ineffective, or no contraception.\n* Participants must have access to the Internet via a mobile device they can access daily\n\nExclusion Criteria:\n\n* cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.",true,"44 Years",{"count":93,"type":22},512,[64],"The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.",[97,98,99,100,101,102,103],"Fetal Alcohol Spectrum Disorders","Pregnancy","Alcohol-Related Disorders","Drinking, Alcohol","Contraception Behavior","Alcohol Exposed Pregnancy","Sexual Behavior",[105,106,107,108,109,110,111,112,113],"Native American","female","adult","contraception","alcohol","digital intervention","mobile health (mHealth)","optimization","risk reduction",{"date":115,"type":44},"2026-06-23",{"date":117,"type":44},"2026-06-02",{"date":119,"type":22},"2028-07-30",{"name":50,"class":51},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":90,"sex":128,"minAge":60,"maxAge":19,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":82},"100571748","early-phase-1-psilocybin-for-prolonged-grief-disorder-100571748","NCT06724289","Psilocybin for Prolonged Grief Disorder","Psilocybin-Assisted Therapy for Prolonged Grief","Inclusion Criteria:\n\n* Ages 18 years old up to and including 65 years of age\n* Negative UDS results for illicit drugs at screening and prior to each drug administration session\n* Consent to all study procedures\n* Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria\n* Score of greater than 25 on the Inventory of Complicated Grief\n* Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session\n* People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective.\n* Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9.\n* Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and\u002For bupropion (\\\u003C 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study\n* Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen\n* Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration\n* Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals\n* Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours\n* Willingness and ability to follow study protocol as directed by research staff\n* Willing and able to attend all sessions in the study and complete follow up assessments\n* Fluent in English\n* Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task.\n\nExclusion Criteria:\n\nGeneral medical exclusion criteria:\n\n* Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.\n* Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report\n* People of childbearing potential that are sexually active who are not practicing an effective means of birth control\n* Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \\> 450 msec), heart valve, or TIA in the past year.\n* History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases\n* Type 1 diabetes\n* BMI \\\u003C18\n* Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs. Bupropion dosage must be \\\u003C 300 mg in order to be included\n* Nicotine dependence that would be incompatible with remaining in study area for the entirety of the visit\n* Prescribed or illicit use of benzodiazepines or opioids within 4 weeks prior to screening\n* Baseline blood pressure greater than 139\u002F79 (after repeat measures) unless stable with medication as determined by PI or PI designate\n* Taking any muscle relaxers, antihistamines, or other medications known to cause lethargy or impair cognitive ability within one day prior to psilocybin session\n* Serious medical comorbidity requiring medical intervention or close supervision\n* History of claustrophobia\n* Any court mandated or legal restrictions that would impair the participant from attending all visits\n* Inability to follow and comply with all study procedures\n* Deemed unable to meaningfully or safely participate in the study\n* Any legal judgement toward subject determined to interfere with study attendance or jeopardize compliance with study protocol determined by PI or designate\n* Individuals who are unable to undergo MRI as determined by MRI pre-screening.\n\nGeneral psychiatric exclusion criteria:\n\n* Score of less than 25 on the Inventory of Complicated Grief\n* Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis\n* Clinically significant suicidal ideation (e.g., with strong intent or means) within past 6 months or lifetime history of suicide attempt based on the MINI, Patient Health Questionnaire-9 or Columbia-Suicide Severity Scale. At any point during the study, a participant may be withdrawn from the study for concerns of suicidality and provided follow-up care by our team or a referral to care if needed.\n* Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I disorder\n* Current or previous history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco, caffeine, and cannabis)\n* Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day\n* Have a first degree relative with schizophrenia or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I disorder","ALL",{"count":130,"type":22},12,[132],"EARLY_PHASE1","The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).",[135],"Prolonged Grief Disorder",[137,138,139,140,141,142],"prolonged grief disorder","psilocybin","psychedlic-assisted treatment","psilocybin-assisted therapy","grief","grief disorder",{"date":115,"type":44},{"date":145,"type":44},"2026-03-24",{"date":147,"type":22},"2027-08",{"name":50,"class":51},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":82},"100552911","phase-1-study-of-egfrbi-armed-fresh-pbmc-in-metastatic-or-unresectable-pancreatic-cancer-100552911","NCT06479239","Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer","Phase I\u002FII Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer","Panc 002","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced pancreatic cancer (LAPC)\u002Funresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy\n2. Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein\u002Fmicrosatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial.\n3. Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n5. Age ≥ 18 years\n6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment\u002Fregistration\n7. Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug.\n8. Adequate organ function within 14 days prior to registration, defined as the following:\n\n   * Absolute neutrophil count \\>= 500\u002Fmm3\n   * Absolute lymphocyte count \\>= 400\u002Fmm3\n   * Platelets \\>= 75,000\u002Fmm3\n   * Hemoglobin \\>= 8 g\u002FdL\n   * Serum creatinine \\\u003C 2.0mg\u002FdL or calculated\u002Fmeasured creatinine clearance \\>= 50 ml\u002Fmin\n   * Bilirubin \\\u003C= 2 mg\u002FdL\n   * Aspartate transferase (AST) and Alanine transaminase (ALT) \\\u003C= 5.0 x upper limit of normal (ULN)\n   * Alpha gal \\\u003C 0.35 IU\u002Fml or \"negative\"\n9. Ability to provide informed consent and provision of written informed consent\n10. Stated willingness to comply with all study procedures and availability for the duration of the study\n11. Adequate cardiac function as defined as:\n\n    * No uncontrolled angina or severe ventricular arrhythmias\n    * No clinically significant pericardial disease\n    * No history of myocardial infarction (MI) in the last year before registration\n    * No Class 3 or higher New York Heart Association Congestive Heart Failure\n\nExclusion Criteria:\n\n1. Known hypersensitivity to cetuximab\n2. Treatment with investigational agent within 3 weeks prior to registration\n3. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration\n4. Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed)\n5. Active infection; prior antibiotic\u002Fantifungal\u002Fantiviral therapies within 2 weeks prior to registration\n6. History of a myocardial infarction within 1 year prior to registration\n7. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n8. Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed)\n9. History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n10. Females must not be currently breast feeding.\n11. The treating investigator feels the patient is not able to be compliant.\n12. History of active Bacillus Tuberculosis (TB).\n13. Has received a live vaccine within 30 days of registration.\n14. Prisoners or patients who are incarcerated.\n15. Patients who are compulsorily detained for treatment of a psychiatric or physical illness.",{"count":158,"type":22},23,[160,161],"PHASE1","PHASE2","The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 twice weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.",[164,165],"Pancreas Cancer","Pancreatic Cancer","2026-06-12",{"date":168,"type":44},"2026-06-16",{"date":170,"type":44},"2024-11-06",{"date":172,"type":22},"2031-06",{"name":50,"class":51},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":82},"100641655","evaluating-a-decision-aid-for-sentinel-lymph-node-biopsy-in-intermediate-risk-melanoma-100641655","NCT07653087","Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma","Mel73","Inclusion Criteria:\n\n1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.\n2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.\n3. Patients with either:\n\n   * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or\n   * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\\\u003C5%, 5-10%, or \\>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.\n4. Willingness and ability to comply with study procedures.\n5. Ability to provide informed consent.\n6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.\n\nExclusion Criteria:\n\n1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.\n2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.\n3. Inability to speak or read English.\n4. Inability or unwillingness to provide informed consent.\n5. Prisoners",{"count":182,"type":22},66,[64],"This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma.\n\nSentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision.\n\nPatients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.",[186,187],"Sentinel Lymph Node Biopsy (SLNB)","Melanoma (Skin Cancer)",[189,190,191,192],"SLNB","Melanoma","Sentinel Lymph Node Biopsy","Decision Aid","2026-06-11",{"date":195,"type":44},"2026-06-17",{"date":197,"type":22},"2026-06",{"date":199,"type":22},"2028-01",{"name":50,"class":51},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":90,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":82},"100540602","text-based-messaging-strategies-for-preventing-subsequent-problematic-alcohol-use-100540602","NCT06318975","Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use","The Effectiveness of Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use Among Technical Trainees in the US Air Force","Inclusion Criteria:\n\n* Must be a United States Air Force Technical Training student in one of the following training groups or wings: 37th Training Wing, 81st Training Wing, 82nd Training Wing, or 59th Training Group.\n* Must be 18 years of Age\n* Must be able to understand English\n* Must be able to receive text messages\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not in the specified Technical Training groups or wings",{"count":209,"type":22},7000,[64],"Binge drinking, and its health\u002Fsocial consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).\n\nBrief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.\n\nOne challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 7000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity.",[213,214,215],"Alcohol Drinking","Binge Drinking","Text Messaging",[217,218,219],"Military Population Health","Brief Alcohol Intervention","BAI","2026-06-10",{"date":222,"type":44},"2026-06-15",{"date":224,"type":44},"2023-12-01",{"date":226,"type":22},"2028-12-31",{"name":50,"class":51},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":245,"leadSponsor":247,"locationsCount":82},"100626919","phase-1-her2-fpbmc-in-patients-with-metastatic-breast-and-prostate-cancer-am006-100626919","NCT07441889","HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)","Phase I\u002FII Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age ≥ 18 years at the time of signing informed consent\n4. Expected survival ≥ 3 months in the judgment of the investigator\n5. ECOG PS 0-1\n6. Adequate Organ Function per the following criteria (within 10 days of study registration):\n\n   * Absolute lymphocyte count ≥ 400\u002Fmm3\n   * Absolute neutrophil count ≥ 1000\u002Fmm3\n   * Platelets ≥ 75,000\u002Fmm3\n   * Hemoglobin ≥ 9g\u002FdL\n   * Serum creatinine \\\u003C 2.0 mg\u002FdL OR measured or calculated creatinine clearance ≥ 50 ml\u002Fmm\n   * Total bilirubin ≤ mg\u002FdL\n   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C 5.0 times normal\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. A diagnosis of either of the following:\n\n   a. Prostate Cancer: i. Histological and\u002For cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels \\\u003C50 ng\u002FdL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide).\n\n   v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.\n\n   b. Breast Cancer i. Histological and\u002For cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria.\n\niii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy.\n\niv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.\n\nExclusion Criteria:\n\n1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation\n2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week\n3. Inadequate cardiac function, as defined as any of the following:\n\n   * Uncontrolled angina or severe ventricular arrhythmias\n   * Clinically significant pericardial disease\n   * History of myocardial infarction (MI) in the last year before registration\n   * Class 3 or higher New York Heart Association Congestive Heart Failure\n4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration\n6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis\n7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus.\n8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)\n9. Has an active infection requiring systemic therapy\n10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy\n11. Has a known history of active TB (Bacillus Tuberculosis)\n12. Has received a live vaccine within 30 days of study registration.\n13. Treatment with any investigational agent within 3 weeks prior to study registration\n14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin\n15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant\n\nAdditional Exclusion Criteria for Patients with Prostate Cancer:\n\n1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions\n2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.\n\nAdditional Exclusion Criteria for Patients with Breast Cancer:\n\n1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.\n2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement \\> 50%.",{"count":158,"type":22},[160,161],"The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.",[68,239],"Prostate Cancer",[241],"FPBMC","2026-06-09",{"date":166,"type":44},{"date":197,"type":22},{"date":246,"type":22},"2032-10",{"name":50,"class":51},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":256,"minAge":60,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":82},"100634119","a-feasibility-study-of-biometric-measurements-via-wearable-smart-watch-technology-for-evaluation-of-vasomotor-symptoms-in-patients-treated-with-androgen-deprivation-therapy-for-prostate-cancer-prostate-007-100634119","NCT07535541","A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (Prostate 007)","A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (BioWEAR)","BioWEAR","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male (biologic sex), aged ≥18 years of age\n4. Diagnosis of prostate cancer\n5. Must be receiving active treatment with ADT at the time of enrollment\n\n   a. ADT is defined as any medical or surgical intervention intended to lower the serum testosterone to \\\u003C50 mg\u002FdL for the purpose of treating prostate cancer\n6. Evidence of castrate level testosterone by either of the following:\n\n   1. A documented serum testosterone level of \\\u003C50 ng\u002FdL at any time point since initiation of ADT or\n   2. A documented decrease in PSA following initiation of ADT and no evidence of PSA progression per PCWG3 criteria (PSA progression defined as a rise in PSA of ≥25% from PSA nadir and absolute increase of ≥1 ng\u002FmL confirmed by a second measurement at least 3 weeks later)\n7. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment\n8. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day\n9. Own a smartphone with Bluetooth 5 compatibility and be willing to use cellular data and\u002For Wi-Fi on their smartphone. Participants must agree to download the Empatica Care app on their smartphone.\n\n   1. iPhone 8 or higher with iOS 16.0 or higher\n   2. Android devices version 12, 12.1, 13, 14, 15, or higher\n10. Ability to read, speak, and understand English\n11. ECOG performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n1. Wrist circumference less than 95 mm or greater than 222 mm\n2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone\n3. Presence of VMS prior to initiation of ADT, regardless of severity or duration\n4. Active febrile illness (temperature \\>38°C) or on active treatment for febrile illness\n5. Inability to press button on smart watch crown\n6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)\n7. Evidence of progression of prostate cancer as defined by PCWG3 criteria","MALE",{"count":258,"type":22},18,[64],"The purpose of this study is to find out if patients with prostate cancer who have vasomotor symptoms, commonly called hot flashes, from their Androgen Deprivation Therapy (ADT) will consistently wear a smartwatch device to track their health data, log hot flashes on their smartwatch, and how these data compare with daily surveys about their hot flashes. Participants will be asked to wear the smartwatch for 4 weeks and to log their hot flashes on their smart watch pressing a button on the watch. Participants will be asked to complete surveys (sent through a text message link) to describe their experiences with hot flashes.",[239,262],"Hot Flashes",[264,265,266,239,267,268,269,270,271,272],"VMS","Hot flashes","ADT","vasomotor symptoms","vasomotor symptom event","Smartwatch","Survey","EMA","androgen deprivation therapy","2026-06-05",{"date":242,"type":44},{"date":276,"type":44},"2026-05-21",{"date":278,"type":22},"2027-05",{"name":50,"class":51},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":128,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":82},"100582901","early-versus-delayed-rehabilitation-after-reverse-total-shoulder-arthroplasty-for-proximal-humerus-fracture-100582901","NCT06869343","Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture","A Randomized Controlled Trial of Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture","Inclusion Criteria:\n\n* aged 50-85 undergo reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures\n\nExclusion Criteria:\n\n* previous rTSA to ipsilateral shoulder\n* undergoing elective rTSA\n* Prisoners\n* unwilling to be randomized\n* unwilling or unable to attend follow up visits","50 Years","85 Years",{"count":290,"type":22},10,[64],"Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.",[294,295,296,297],"Orthopedic Disorder","Humerus Fracture","Shoulder Arthroplasty","Reverse Shoulder Replacement",{"date":242,"type":44},{"date":300,"type":44},"2025-05-19",{"date":302,"type":22},"2026-12-31",{"name":50,"class":51},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":19,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":82},"100460823","simplified-post-op-rehabilitation-for-ankle-and-pilon-fractures-100460823","NCT05280639","Simplified Post Op Rehabilitation for Ankle and Pilon Fractures","Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol","Inclusion Criteria:\n\n* Ages 18-65\n* Surgically treated open or closed fractures of the ankle or tibial plafond\n\nExclusion Criteria:\n\n* Contralateral lower extremity injuries that would limit weight bearing after 6 weeks\n* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)\n* Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment\n* Desire to participate in formal physical therapy program\n* Additional injury that would compromise subjects ability to follow either Home Exercise Program\n* Non ambulatory prior to injury\n* Previous ankle or tibial plafond injury on ipsilateral extremity\n* BMI \\> 50\n* Severe problems maintaining follow up\n* Previous ankle\u002Ftibial plafond fracture\n* Prisoners\n* Neurological impairments that impair balance",{"count":312,"type":22},30,[64],"The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.",[316,317],"Ankle Fractures","Pilon Fracture",{"date":319,"type":44},"2026-06-08",{"date":321,"type":44},"2022-10-03",{"date":323,"type":22},"2027-06-01",{"name":50,"class":51},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":344,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":82},"100603043","interaction-between-inorganic-nitrate-supplementation-and-metformin-in-individuals-with-prediabetes-100603043","NCT07131384","Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes","The Interaction Between Inorganic Nitrate Supplementation and Metformin on Exercise Capacity, Vascular Function, and Insulin Sensitivity in Individuals With Pre-Diabetes","NO3-PreDM","Inclusion Criteria:\n\n* Individuals who can communicate meaningfully with the investigator and can provide written consent.\n* Confirmed prediabetic individuals (ages 18-60 years old) (2-hour glucose of 140-199 mg\u002FdL following OGTT test or HbA1c between 5.7-6.4% tested on two occasions within 6 months).\n* Taking metformin (stable dose for at least a week) or naïve to metformin\n* Sedentary (\\\u003C1 day\u002Fweek of structured exercise)\n* Be able to perform exercise on a cycle ergometer without assistance\n* Stable medication regimen for the last 6 months\n* If female, have a normal menstrual cycle\n\nExclusion Criteria:\n\n* Estimated Glomerular filtration rate (GFR) ≤ 45\n* Body mass index ≥ 40 Kg\u002Fm2\n* HbA1c \\> 6.4%\n* Smokers within the last 5 years\n* Has experienced significant weight loss \\~3 kg in the last three months or is taking any weight loss drugs\n* Current medical condition that prohibits exercising at high intensities\n* Currently on hormone replacement of any kind\n* History of myocardial infarction, cerebrovascular event, acute or unstable disease other than pre-diabetes or obesity\n* Currently taking any of the following medications (calcium channel blockers, statins, ACE or renin inhibitors, angiotensin receptor blockers, organic nitrates (e.g., nitroglycerine) or recent regular use of inorganic nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, PDE-5 inhibitors (e.g.,: Cialis, Viagra), or xanthine oxidase inhibitors (e.g.,: Allopurinol))\n* Oral antibiotic use within the previous four weeks, including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Oral cancer\u002Fsevere oral disease\n* Uncontrolled hypertension (\\>140\u002F90)\n* Had hysterectomy or oophorectomy\n* Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants","60 Years",{"count":335,"type":22},24,[64],"This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.",[339,340,341,342,343],"Males","Females","Sedentary","Metformin","Prediabetes",[345,346,347,348,349],"Prediabetic Individuals","Exercise Capacity","Vascular health","Inorganic nitrate","Insulin Sensitivity",{"date":351,"type":44},"2026-06-03",{"date":353,"type":44},"2026-01-01",{"date":355,"type":22},"2027-06-30",{"name":50,"class":51},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":82},"100471832","phase-2-randomized-double-blinded-placebo-controlled-wsemaglutide-to-prevent-weight-gain-after-liver-transplant-100471832","NCT05424003","Randomized Double Blinded Placebo-Controlled w\u002FSemaglutide to Prevent Weight Gain After Liver Transplant","A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation","Inclusion Criteria:\n\n* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)\n* Liver transplant surgery within 8-24 weeks prior to randomization\n* Fasting glucose \\> 125 mg\u002FdL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \\>5.7%)\n* Ability to provide informed consent\n* Discharged from the hospital following LT surgery\n* Tolerating diet\n* Normal graft function\\* (determined by treating hepatologist\u002Fsurgeon based on clinical status and hepatic panel)\n* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \\*\\* (i.e. calcineurin inhibitors + mycophenolate)\n* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study\n\nExclusion Criteria:\n\n* BMI≤ 27kg\u002Fm2\n* GFR (Glomerular Filtration Rate) ≤ 25 ml\u002Fmin\u002F1.73m2\n* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)\n* History of gastroparesis\n* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2\n* History of pancreatitis\n* History of active malignancy post- LT with the exception of non-melanoma skin cancers\n* History of uncontrolled or unstable diabetic retinopathy or maculopathy\n* Acute cellular rejection\n* Hepatic artery thrombosis\n* Medical non-compliance\n* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening\n* History of hypersensitivity to semaglutide or its excipients\n* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures","75 Years",{"count":366,"type":22},50,[161],"In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a \"sugar pill\") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.",[370],"NAFLD",[372],"Liver Transplant",{"date":374,"type":44},"2026-06-04",{"date":376,"type":44},"2024-02-22",{"date":378,"type":22},"2026-08-01",{"name":50,"class":51},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":128,"minAge":386,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":82},"100638772","phase-1-assessing-the-impact-of-unnecessary-antibiotic-treatment-on-the-development-of-appropriate-adaptive-immune-responses-in-malnourished-bangladeshi-infants-100638772","NCT07615842","Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants","Inclusion Criteria:\n\n* presenting with diarrheal symptoms\n* age under 1 year\n* enrolled in study NCT02764918\n\nExclusion Criteria:\n\n* unwilling to give blood and stool samples","6 Months","48 Months",{"count":389,"type":22},150,[160],"The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40\u002F41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40\u002F41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.",[393],"Antibiotic Resistance Prevention","2026-05-29",{"date":396,"type":44},"2026-06-01",{"date":396,"type":22},{"date":399,"type":22},"2028-06-01",{"name":50,"class":51},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},"100618492","phase-3-steroids-and-enhanced-spectrum-antibiotics-for-the-treatment-of-patients-in-africa-with-refractory-sepsis-100618492","NCT07332325","STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis","STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)","STARS","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female aged ≥18 years living with HIV\n4. Admitted to hospital with 1) clinical concern for infection; 2) ≥2 qSOFA score criteria (Glasgow Coma Scale score \\\u003C15, a respiratory rate ≥22, or a systolic blood pressure ≤90 mmHg or a mean arterial pressure of ≤65 mmHg)\n5. Resident within a pre-defined geographic area to ensure TB clinic follow-up\n6. For females of reproductive potential: use of highly effective contraception through 28 days\n\nExclusion Criteria:\n\n1. Known active TB or receiving anti-TB therapy\n2. Pregnancy or lactation. Women will undergo urine pregnancy screening. Pregnant people will be excluded due to lack of pharmacokinetic data for the expanded antibiotic regimen in pregnancy.\n3. Known allergic reactions to the components of the interventional therapy\n4. Treatment with another investigational drug or other intervention within one month\n5. Known liver disease\n6. Alcohol use \\> 14 standardized drinks per week and\u002For \\> 4 drinks per day for men and \\>7 standardized drinks per week and\u002For \\>3 drinks per day for women, defined as 14 grams of ethanol, as found in example 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof spirits\n7. Positive serum cryptococcal antigen test\n8. Current treatment with a drug known to have significant, non-correctable interaction with anti-TB therapy\n9. Already receiving corticosteroids at the time of presentation to the hospital",{"count":410,"type":22},344,[25],"Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa, particularly among people living with HIV. The prevailing standard of care in the region, ceftriaxone alone, is insufficient as it does not address TB, drug-resistant bacteria, or adrenal insufficiency, which is common in HIV-related sepsis. Therefore, the investigators propose a randomized 2x2 factorial clinical trial to compare 28-day survival from sepsis between study participants who along with a standard of care that includes immediate conventional anti-TB treatment receive 1) hydrocortisone to treat septic shock and 2) rifampin, isoniazid, levofloxacin and linezolid to treat TB and other drug-resistant bacteria in order to deliver important and scalable knowledge that may alter the standard of care for sepsis in HIV endemic settings of sub-Saharan Africa. Improving understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.",[414,415],"Sepsis","Tuberculosis",[414,417,418,419],"HIV","tuberculosis","Africa",{"date":396,"type":44},{"date":422,"type":22},"2026-10",{"date":424,"type":22},"2029-09",{"name":50,"class":51},4,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":82},"100600224","phase-2-safety-immunogenicity-and-efficacy-of-therapeutic-mycobacterium-bovis-bcg-boost-100600224","NCT07094711","Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)","Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG in Patients With Mycobacterium Avium Complex Lung Disease (BOOST)","BOOST","Inclusion Criteria\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female aged ≥18 years\n2. Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician in the medical record. The following data will be extracted from the medical record:\n\n   1. History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from bronchial lavage or biopsy, one culture rather than 2 will meet criteria.\n   2. Respiratory and\u002For constitutional symptoms consistent with MAC lung disease\n   3. Nodular or cavitary opacities on chest radiograph or bronchiectasis with multiple small nodules on high-resolution computed tomography\n3. Provision of signed and dated informed consent form\n4. Stated willingness to comply with all study procedures\n5. Women of childbearing potential (WOCBP) (i.e., fertile following menarche and until becoming postmenopausal unless permanently sterile) agree to practice a highly effective method of birth control from Day 0 to at least 90 days after study intervention. Some examples of acceptable birth controls are:\n\n   1. True abstinence (refraining from heterosexual intercourse during the entire study),\n   2. Copper intrauterine device (IUD),\n   3. Hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \\[combined with barrier method\\]), exclusive homosexual relationship) sole male partner who has undergone surgical sterilization\n\nExclusion Criteria\n\nSelection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Currently receiving antibiotics prescribed for their MAC lung disease\n2. Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0\n3. Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol\n4. Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician\n5. Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years; immunosuppressive therapy such as anti B cell depleting therapies, corticosteroids (\\>20 mg\u002Fday for \\> 14 days), dupilumab, elivaldogene, etrasimod, cytotoxic chemotherapy, miscellaneous oncologic agents, therapeutic immunosuppressant agents, methotrexate, teplizumab, tezepelumab, tildrakizumab, tralokinumab, ustekinumab). Persons with lung and other solid organ transplants\u002Fhematologic stem cell transplants who may be contraindicated to receive a live vaccine. Point of care HIV testing must be negative at baseline.\n6. Prior BCG Vaccination. If unknown Bcgatlas.org shall be consulted for local vaccination administration policies.\n7. Known pregnancy at the time of screening or breastfeeding at the time of enrollment (pregnancy test negative at baseline if applicable)\n8. Cystic fibrosis\n9. Active tuberculosis: Active tuberculosis (respiratory AFB culture growing Mycobacterium tuberculosis complex within the past 4 months).\n10. Known exposure to a case of active pulmonary tuberculosis within 10 weeks of enrollment\n11. Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine\n12. Received live injectable vaccine within 28 days of day 0 study vaccination\n13. Any condition in the opinion of the investigator that may confound the study endpoints Note that colonization or co-infection with other nontuberculous mycobacteria is not exclusionary, as MAC will be the endpoint.",{"count":436,"type":22},48,[161],"The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease.\n\nResearchers will compare responses from patients with MAC lung disease after receiving an injection of BCG or placebo (a look-alike substance that contains no drug)\n\nParticipants in the study:\n\n* Receive a BCG or placebo injection at UVA study center on Day 0\n* Come to UVA study center on Day 60\n* Come to UVA study center at the end of the study\n* Answer surveys and questionnaires about how you are doing\n* Have blood drawn 3 times, on injection day, day 60, and at end of study\n* Give the study team personal and demographic information\n* Discuss any new symptoms with the study team\n* Provide monthly sputum samples per usual care",[440,441],"Mycobacterium Avium-intracellulare Infection","Mycobacterium Infections, Nontuberculous","2026-05-26",{"date":444,"type":44},"2026-05-27",{"date":446,"type":44},"2026-04-27",{"date":448,"type":22},"2028-12-30",{"name":50,"class":51},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":128,"minAge":457,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100585807","phase-3-ketamine-add-on-therapy-for-established-status-epilepticus-treatment-trial-kesett-100585807","NCT06907173","Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)","KESETT","Inclusion Criteria:\n\n* The patient was witnessed to have a convulsive seizure for greater than 5-minute duration\n* The patient received an adequate dose of benzodiazepines. The doses may be divided.\n* The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.\n* Continued or recurring seizures in the Emergency Department.\n* Age 1 years or older\n* Known or estimated weight ≥10 Kg\n\nExclusion Criteria:\n\n* Known pregnancy\n* Prisoner\n* Opt-out identification or otherwise known to be previously enrolled in KESETT\n* Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE\n* Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)\n* Endotracheal intubation prior to enrollment\n* Acute traumatic brain injury clearly precedes seizures\n* Scalp injury or burn preventing EEG placement\n* Known allergy or other known contraindication to KET or LEV\n* Hypoglycemia \\\u003C 50 mg\u002FdL\n* Hyperglycemia \\> 400 mg\u002FdL\n* Cardiac arrest \u002F post-anoxic seizures","1 Year",{"count":459,"type":22},770,[25],"The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.",[463],"Status Epilepticus","2026-05-12",{"date":466,"type":44},"2026-05-14",{"date":468,"type":44},"2026-03-06",{"date":470,"type":22},"2029-12",{"name":50,"class":51},52,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":481,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":487,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":82},"100619389","phase-1-study-of-low-intensity-focused-ultrasound-in-combination-with-immunotherapy-in-newly-diagnosed-unmethylated-glioblastoma-100619389","NCT07343986","Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma","Phase I Clinical Trial of Anti-CD3 × Anti-EGFR Bispecific-armed T Cells (EGFR BATs) and Low-Intensity Focused Ultrasound (LIFU) Blood-brain Barrier Opening in Patients With MGMT Unmethylated Glioblastoma (GBM)","BATs FUS","Inclusion Criteria:\n\n1. Newly diagnosed supratentorial glioblastoma or gliosarcoma IDH wildtype and MGMT unmethylated that express EGFR (score ≥ 1 by IHC)) and confirmed by UVA pathology review.\n2. Age ≥ 18 and ≤ 70 years at the time of signing informed consent.\n3. Karnofsky Performance Status (KPS) ≥ 70.\n4. Be willing and able to provide written informed consent for the trial.\n5. Females of childbearing potential, and males, must be willing to use an effective method of contraception.\n6. Maximal surgical debulking of the tumor was performed where residual contrast enhancement is 2 cm3 or less on immediate post-operative MRI. Intraoperative post-resection MRI is acceptable.\n7. Able to communicate during the LIFU BBB opening procedure.\n8. BBB opening target(s) must lie in non-eloquent area(s).\n9. The brain tumor to be treated must be in the treatment envelope of the NaviFUS system with a minimum distance of 30 mm from the inner skull table.\n10. Females of childbearing potential should have a negative serum pregnancy test. Males who are partners of females of childbearing potential must agree to use an acceptable method of contraception throughout the study and for 1 month following completion of the EGFR BATs infusions.\n11. Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of another malignancy within 2 years of being on-study. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or any type of in situ cancer. Patients must not be on any treatment for another malignancy.\n2. Patients undergoing only biopsy (partial resection or greater is required).\n3. Patients with cerebellar or brainstem tumors.\n4. Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.\n5. Patients with extracranial metastases.\n6. Patients with evidence of acute intracranial hemorrhage.\n7. Known hypersensitivity to cetuximab or another EGFR antibody.\n8. Known sensitivity to gadolinium-based contrast agents.\n9. Known sensitivity to Lumason® ultrasound contrast agent.\n10. Alpha 1,3 Galactose IgE (\"alpha gal\") test result outside of the reference range (indicating likely hypersensitivity to cetuximab).\n11. Patients with claustrophobia.\n12. Clips, shunts, or other non-MRI compatible metallic implanted objects in the skull or the brain.\n13. Evidence of active bleeding or bleeding diathesis.\n14. Unable to discontinue use of anticoagulant therapy as per local standard.\n15. Scalp atrophy or scars in the expected location of the ultrasound transducer.\n16. Cardiac Status: Patients will be ineligible for treatment on this protocol if (before protocol entry):\n\n    * There is a history of a recent (within one year) myocardial infarction or stroke.\n    * There is a current or prior history of angina\u002Fcoronary symptoms requiring medications and\u002For a history of depressed left ventricular function (LVEF \\\u003C 45%).\n    * Patient has a pacemaker.\n17. There is clinical evidence of congestive heart failure requiring medical management.\n18. Has Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies) or known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n19. Has received a live vaccine within 30 days of leukapheresis.\n20. Has received any treatment for GBM besides surgery.\n21. Females must not be pregnant or breastfeeding.\n22. Ongoing immunosuppressive therapy except for corticosteroids\n23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n24. A patient may be excluded if, in the opinion of the treating investigator, the patient is not capable of being compliant.","70 Years",{"count":130,"type":22},[160],"This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.",[486],"Glioblastoma (GBM)",[488,489,490],"Focused Ultrasound","Unmethylated","Immune Therapy","2026-05-05",{"date":493,"type":44},"2026-05-06",{"date":495,"type":44},"2026-03-23",{"date":497,"type":22},"2028-12",{"name":50,"class":51},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":128,"minAge":60,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":82},"100613775","phase-1-phase-ib-study-of-cd33-fpbmc-in-patients-with-mrd-aml-or-mds-100613775","NCT07270978","Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS","Phase Ib Study of Anti-CD3 x Anti-CD33 Bispecific Antibody (CD33Bi) Armed Fresh Peripheral Blood Mononuclear Cells (CD33 FPBMC) in Patients With Measurable Residual Disease (MRD)+ Acute Myeloid Leukemia or Myelodysplastic Syndrome","AML-MDS 001","Inclusion Criteria:\n\n1\\. Adults: ≥18 years of age 2. Diagnosis of either:\n\n1. Newly diagnosed or relapsed\u002Frefractory AML who have received either intensive induction chemotherapy or at least 2 cycles of a non-intensive options such as hypomethylating agent and venetoclax or other targeted agent\n2. Relapsed\u002F refractory (R\u002FR) MDS who have received at least 2 prior cycles of hypomethylating agent and venetoclax or single agent hypomethylating agent for at least 4 cycles\n3. Relapsed\u002Frefractory (R\u002FR) MDS\u002FMPN overlap syndromes like CMML who have received at least 2 prior cycles of azacitidine and venetoclax or single agent hypomethylating agent for at least 4 cycles 3. For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and\u002For decision not to receive associated inhibitor.\n\n   4\\. Patients with R\u002FR MDS or R\u002FR MDS\u002FMPN overlap syndromes must have at least one of the following:\n   1. Bone marrow blasts ≥ 5%\n   2. Appearance of previously absent leukemic blasts in peripheral blood\n   3. Absolute neutrophil count \\\u003C1 x 109\u002FL and 50% below best unsupported on-study value\n   4. Platelet count \\\u003C100 x 109\u002FL and 50% below best unsupported on-study value\n   5. Hemoglobin \\\u003C11g\u002FdL, and ≥2 g\u002FdL reduction from best unsupported on-study value\n   6. Increase of the volume of transfused red blood cells by more than 30% in an 8-week period\n   7. Increase of the number of transfused platelet units by more than 30% in an 8-week period In the case of criteria 4-8 above, no reasonable alternative explanation such as drug toxicity should be identified.\n\n   5\\. Patients with AML must have persistent or recurrent MRD positivity defined by presence of blasts ≥5% AND\u002FOR disease detected by multiparametric flow cytometry (MFC) at a level of ≥0.1%, AND\u002FOR persistent genomic mutations other than those found most with CHIP AND\u002FOR persistent cytogenetic abnormalities related to underlying myeloid neoplasm\n\n   6\\. Residual blasts must be positive for CD33 expression at any level. Note: Patients whose most recent disease-positive evaluation by flow cytometry showed CD33 expression but whose current assessment for MRD is only positive for genomics or cytogenetics may be included.\n\n   7\\. Left Ventricular Ejection Fraction (LVEF) ≥ 45% at rest (MUGA or echocardiogram)\n\n   8\\. Performance status ≤ 2 (ECOG Scale)\n\n   9\\. Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug.\n\n   10\\. Ability to provide informed consent and provision of written informed consent In order to be eligible to participate in the dose expansion portion of this study, an individual must meet all criteria that apply to the R\u002FR MDS or R\u002FR AML population (Newly diagnosed patients and patients with MDS\u002FMPN overlap syndromes are not eligible for the expansion phase of the study).\n\nIn order to be eligible to participate in the dose expansion portion of this study, an individual must meet all criteria that apply to the R\u002FR MDS or R\u002FR AML population (Newly diagnosed patients and patients with MDS\u002FMPN overlap syndromes are not eligible for the expansion phase of the study).\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Prior treatment with anti-CD33 therapy\n3. Patients who are being actively considered for stem cell transplant, unless participation in the study prior to the planned stem cell transplant is considered to be in the best interest of the patient in the opinion of the treating investigator in consultation with the transplant team. This does not exclude patients that may be eligible for stem cell transplant at some future (undetermined) date.\n4. Past hematopoietic stem cell transplant (HSCT) with graft vs host disease requiring systemic immunosuppression other than low dose prednisone (10 mg) (or the equivalent dose of another immunosuppressant) within the 4 weeks before registration\n5. Clinically significant organ dysfunction, defined as any of the following:\n\n   * AST or ALT \\>3x the upper limit of normal (ULN)\n   * Total bilirubin \\>1.5x the ULN, unless due to ongoing hemolysis or Gilbert's syndrome, in which case \\> 3.0 mg\u002FdL\n   * Absolute lymphocyte count (ALC) \\\u003C 300 lymphocytes\u002Fmicroliter\n   * Creatinine clearance \\\u003C30 mL\u002Fmin\n   * Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of clinical improvement despite antimicrobial treatment).\n6. Known human immunodeficiency virus (HIV) with detectable viral load.\n7. Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n   a. Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment is anticipated to interfere with the safety or efficacy assessment of the investigational regimen (according to the treating investigator).\n9. Treatment with any antileukemic agents or chemotherapy (other than hypomethylating agents or venetoclax) agents in the last 7 days or 5 half-lives (whichever is sooner) before study entry. Note: treatment with hydroxyurea may continue through the first cycle of study treatment.\n10. Known allergy to hypomethylating agents\n11. Blasts ≥ 25%",{"count":158,"type":22},[160],"The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they still have detectable disease (\"MRD+\") after some treatment. Participants receive 4 weekly doses of CD33 FPBMC by intravenous infusion followed by 4-6 weeks of standard treatment with a hypomethylating agent (type of treatment such as decitabine or azacitidine) and possibly a drug called venetoclax. This is considered 1 cycle of study treatment and may be repeated up to 4 times during the study.",[511,512,513],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",{"date":515,"type":44},"2026-05-11",{"date":517,"type":44},"2026-03-26",{"date":519,"type":22},"2031-07",{"name":50,"class":51},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":128,"minAge":528,"maxAge":19,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":82},"100615923","phase-3-the-effect-of-exercise-and-tirzepatide-on-weight-and-health-outcomes-exer-med-100615923","NCT07298915","The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)","EXER-MED","Inclusion Criteria:\n\n* Men and women 30-65 years of age, postmenopausal women included\n* 27-29.9 with an additional CVD risk factor or 30-40 kg\u002Fm2\n* For overweight adults only: additional cardiometabolic risk factor (diagnosed dyslipidemia, hypertension)\n* Willingness and adequate health to go on weight loss medication\n* The capability and willingness to provide written informed consent\n* Approval of their primary care provider to go on weight loss medication\n\nExclusion Criteria:\n\n* Including but not limited to serious arrhythmias\n* Cardiomyopathy\n* Congestive heart failure\n* Stroke or transient ischemic attacks\n* Peripheral vascular disease\n* Previous history of myocardial infarction or stroke\n* Previous diagnosis or taking medication for type 1 or 2 diabetes, fasting glucose \\>125 mg\u002FdL or HbA1C ≥6.5%\n* Systolic blood pressure \\>160 mmHg and diastolic blood pressure \\>100 mmHg.\n* Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness\n* Conditions that can be aggravated or are contraindicated by exercise training\n* Plans to be out of town more than 3 weeks in the next 4 months.\n* Currently pregnant or plans to become pregnant\n* Currently in a diet or exercise program\n* Non-compliance during screening or extreme difficulty in obtaining baseline blood samples\n* Enrolled in a different exercise program\n* Previous weight loss surgery\n* Use of weight loss medication within the last year\n* hypo\u002Fhyper thyroid (medicated or unmedicated)","30 Years",{"count":335,"type":22},[25],"This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity.\n\nThe main questions it will answer includes:\n\n* Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone\n* Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life\n\nParticipants will:\n\n* Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician\n* (Exercise group only) Will perform exercise \\~3 times a week at the University of Virginia). Walking on a treadmill and resistance training\n* Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures",[533],"Obesity & Overweight",[535,536,537,538,539,540,541],"Obesity","Overweight","Exercise","aerobic","resistance training","GLP-1","Weight loss","2026-05-02",{"date":493,"type":44},{"date":545,"type":22},"2026-08",{"date":547,"type":22},"2027-06",{"name":50,"class":51},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":90,"sex":128,"minAge":557,"maxAge":287,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":82},"100637018","impact-of-obesity-on-microvascular-insulin-action-and-cardiorespiratory-fitness-in-type-1-diabetes-100637018","NCT07573228","Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes","Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes (","ZQL010","Inclusion Criteria:\n\n* • Male or female ≥21 and ≤50 years old\n\n  * For persons with T1D: Disease duration ≥ 5 years and HbA1c ≤ 8.5% on multiple daily insulin injection or insulin pump\n  * Body mass index: ≥19 and ≤27 kg\u002Fm2 for control and T1D, ≥30 and ≤40 kg\u002Fm2 (27.5 to 37.5 for Asian Americans) for obesity and T1D + obesity. BMI is limited to ≤40 kg\u002Fm2 (37.5 for Asian Americans) for easier vascular access and cardiac imaging.\n  * Stable use of non-insulin medications for over 6 months other than estrogen\u002Fprogesterone containing medications which must be discontinued at least 3 months prior to the study (intrauterine devices may be continued due to limited systemic absorption)\n\nExclusion Criteria:\n\n* • Acute or chronic disease other than T1D or obesity\n\n  * History of microvascular or macrovascular diabetes complications\n  * History of diabetic ketoacidosis in the past 24 months\n  * History of hypoglycemia unawareness\n  * Recently active (\\>20 min of moderate\u002Fhigh intensity exercise, 2 times\u002Fweek)\n  * Subjects who are smokers or who have quit smoking \\\u003C5 years\n  * Subjects with hypertriglyceridemia (\\>400 mg\u002Fdl)\n  * Current use of vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha- or beta-blockers, or diuretics).\n  * Females taking oral contraceptives in the past 3 months\n  * Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy\n  * Pregnant (as evidenced by positive pregnancy test) or nursing women\n  * Musculoskeletal condition preventing participation in exercise testing or exercise training\n  * History of gastroparesis\n  * Pulse oximetry \\\u003C90%","21 Years",{"count":559,"type":22},60,[64],"The purpose of this study is:\n\n* To see if insulin resistance (how sensitive your muscle tissue is to insulin) is associated with lower cardio fitness in people with Type 1 diabetes compared to healthy controls, before and after a High Intensity Interval Training (HIIT) exercise program.\n* To see if being overweight and having Type 1 diabetes is associated with lower cardio fitness compared to overweight healthy controls, before and after a HIIT exercise program.",[563,536],"Type 1 Diabetes",[565,566,567,568],"Type 1 diabetes","Exercise training","healthy controls","overweight","2026-05-01",{"date":571,"type":44},"2026-05-07",{"date":573,"type":44},"2026-02-23",{"date":575,"type":22},"2030-06-30",{"name":50,"class":51},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":128,"minAge":457,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":82},"100627633","phase-2-comparative-efficacy-of-antibiotics-for-small-intestine-bacterial-overgrowth-in-bangladeshi-children-100627633","NCT07451171","Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children","A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth","Inclusion Criteria:\n\n* Positive glucose hydrogen breath test (GHBT)\n* Weight-for-age Z score \\> -1\n* Length-for-age Z score \\> -1\n\nExclusion Criteria:\n\n* Presence of known chronic or congenital illness, including developmental delay\n* Presence of acute gastrointestinal illness in the preceding 14 days\n* Antibiotic use in the preceding 14 days\n* Previous adverse reaction to any of the three study medications or other drugs in the same antibiotic classes\n* Sibling previously enrolled in this study","2 Years",{"count":559,"type":22},[161],"The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.",[589],"Small Intestine Bacterial Overgrowth",[591],"environmental enteric dysfunction",{"date":493,"type":44},{"date":594,"type":44},"2026-04-18",{"date":596,"type":22},"2026-09-01",{"name":50,"class":51},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":128,"minAge":4,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":613,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":82},"100590786","tuberculosis-in-rural-and-malnourished-populations-100590786","NCT06971952","Tuberculosis in Rural and Malnourished Populations","Closing the Tuberculosis Diagnosis Gap in Rural and Malnourished Populations","TB-RAMP","Inclusion Criteria:\n\n* Index person\u002Fpeople diagnosed with drug sensitive pulmonary tuberculosis disease (PWTB) and starting TB treatment within 2 months of enrollment, of any age.\n* Index PWTB are eligible if they reside within the catchment area of Haydom Lutheran Hospital (HLH), and\n* Index PWTB intend to receive TB care at a participating study site.\n* Index PWTB (or their parent or guardian if index PWTB are \\\u003C18 years) and head of household (if different from index PWTB) are able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Inability to provide informed consent, or assent when applicable.\n* Residing or receiving TB care outside of the catchment area of study sites\n* Prior completion of TB screening procedures for all household members.",{"count":607,"type":22},360,[64],"Background: Tuberculosis (TB) remains a large public health threat in Tanzania with an estimated incidence of 195 per 100,000 people in 2022 and 36% of cases going undiagnosed. Nutritional and financial barriers combine to compound the burden of TB in Tanzania and many other high burden countries.\n\nObjectives: In this study, we aim to evaluate the effect and cost-effectiveness of conditional cash transfer added to the current facility-based approach to improve TB screening among household contacts (HHCs) of index people diagnosed with TB disease (PWTB) in rural Tanzania; and characterize the prevalence of undernutrition among HHCs of index PWTB and quantify the effect of undernutrition severity on the progression to active TB disease.\n\nMethods: In this prospective, interventional cohort study we plan to enroll 360 PWTB and their households within 2 months of TB treatment initiation. The duration of the study is 3 years in total: 2-year enrollment period, divided equally between the current standard of care phase and the added conditional cash transfer phase. All participating households will be visited 2 months after enrollment to complete TB screening for all HHCs and perform anthropometric measurements, and then followed a 2-year period to evaluate for incident TB disease among HHCs.\n\nData analysis: The proportion of households completing TB screening procedures for all HHCs during phase 1 will be compared to that during phase 2 using a chi-square test to evaluate the effect of conditional cash transfer on completion of HHC TB screening. A similar approach will be used to compare proportions of HHCs diagnosed with active TB disease based on nutritional status. We will use regression and Bayesian modeling to quantify the effect of demographic, nutritional and socioeconomic predictors on completion of HHC TB screening and the incidence of TB disease among HHCs to prioritize higher risk subgroup for TB prevention effort.\n\nImpact: Successful completion of this proposal will informTB programs in many high burden countries with implementable interventions that can be scaled in rural communities to prioritize TB prevention efforts to the HHCs at the highest risk of developing TB disease",[611,612],"Tuberculosis (TB)","Undernutrition",[415,614,612],"Active case finding",{"date":491,"type":44},{"date":617,"type":44},"2025-09-01",{"date":619,"type":22},"2030-09-01",{"name":50,"class":51},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":90,"sex":128,"minAge":557,"maxAge":333,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":82},"100406701","phase-4-effects-of-exercise-and-glp-1-agonism-on-muscle-microvascular-perfusion-and-insulin-action-in-adults-with-metabolic-syndrome-100406701","NCT04575844","Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome","ZQL008","Inclusion Criteria:\n\n* Male or female ≥21 and ≤60 years old.\n* Body mass index \\>25 and ≤35 kg\u002Fm2 and is weight stable (\\\u003C5 kg weight change in the past 6 months). BMI is limited to ≤35 kg\u002Fm2 for easier vascular access and cardiac imaging.\n* Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria:\n\n  * Increased waist circumference (≥102 cm in men; ≥88 cm in women)\n  * Elevated triglycerides (≥150 mg\u002Fdl)\n  * Reduced HDL-cholesterol (\\\u003C40mg\u002Fdl in men, \\\u003C50 mg\u002Fdl in women)\n  * High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic)\n  * Elevated fasting glucose (≥100 mg\u002Fdl)\n  * Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months.\n  * Ace inhibitor\n  * ARB\n  * HMG CoA reductase inhibitor\n  * Beta blocker\n  * Calcium channel blockers\n  * Alpha-adrenergic antagonist\n  * Statin\n\nExclusion Criteria:\n\n* A diagnosis of any type of diabetes or history of diabetes medication use\n* Recently active (\\>20 min of moderate\u002Fhigh intensity exercise, 2 times\u002Fweek)\n* Subjects who are smokers or who have quit smoking \\\u003C5 years\n* Subjects with hypertriglyceridemia (\\>400 mg\u002Fdl) or hypercholesterolemia (\\>260 mg\u002Fdl)\n* Subjects with BP\\>160\u002F90\n* Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy\n* Pregnant (as evidenced by positive pregnancy test) or nursing women\n* Subjects with contraindications to participation in an exercise training program\n* Allergic to perflutren\n* A prior use of Liraglutide",{"count":629,"type":22},80,[631],"PHASE4","The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.",[634],"Metabolic Syndrome",{"date":493,"type":44},{"date":637,"type":44},"2020-11-01",{"date":639,"type":22},"2027-04-30",{"name":50,"class":51},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":90,"sex":128,"minAge":60,"maxAge":648,"enrollmentInfo":649,"targetDuration":4,"studyType":651,"phases":4,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":82},"100412937","4d-mri-for-precision-medicine-100412937","NCT04657042","4D-MRI for Precision Medicine","Toward Precision Radiotherapy: Physiological Modeling of Respiratory Motion Based on Ultra-quality 4D-MRI","Inclusion Criteria:The inclusion criteria for lung and liver cancer patients are:\n\n* Patient is 21 or older\n* Patient has primary or metastatic tumor(s) in the lungs or the liver\n* Diameter of the tumor(s) is less than 7 cm\n* Patient will receive radiation therapy (ordered by the treating Radiation Oncologist) as part of their treatment regimen\n* Patient will undergo a planning CT scan with tumor motion assessment (planning 4D-CT ordered by the treating Radiation Oncologist) as part of their treatment regimen\n* Patient has signed informed consent and is willing to comply with the 4D-MRI imaging protocol\n\nThe inclusion criteria for healthy volunteers are:\n\n* Subject is 18 or older\n* Subject has signed informed consent and is willing to comply with the 4D-MRI imaging protocol\n\nExclusion Criteria:\n\n* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.\n* Subjects who have difficulty lying flat on their back for extended periods of time\n* Patients with any serious\u002Fpoorly controlled medical or psychological conditions that would complicate protocol compliance\n* Too large to adequately fit in the magnet bore or RF coils\n* Claustrophobia\n* Females who are pregnant or lactating\n* Presence of active or chronic infection","82 Years",{"count":650,"type":22},100,"OBSERVATIONAL","The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!)\n\nThis new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.",[654,655,656],"Healthy Volunteers","Liver Cancer","Lung Cancer","2026-04-30",{"date":493,"type":44},{"date":660,"type":44},"2020-11-05",{"date":662,"type":22},"2030-12-31",{"name":50,"class":51},""]