[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mayo Clinic\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":650},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,559,0,25,[9,42,64,87,106,132,153,172,190,209,229,250,268,289,310,429,452,473,495,522,543,563,584,603,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614738","phase-4-itraconazole-therapy-in-bronchiectasis-with-airway-mold-100614738",false,"NCT07283497","Itraconazole Therapy In Bronchiectasis With Airway Mold","Itraconazole Therapy In Bronchiectasis With Airway Mold: A Single-Arm Pilot Trial Of Feasibility, Safety, And Impact On Respiratory Symptoms And Airway Microbiome Diversity","Inclusion Criteria:\n\n* Age ≥18 years seen at Mycobacterial and Bronchiectasis Clinic (MMBC) in Rochester\n* Diagnosis of bronchiectasis confirmed by MMBC provider and chest CT\n* Within the last 3 months - culture growth of a mold in high quantity ('many') or culture growth of at least two distinct mold species in any quantity\n* Not actively on antimicrobial therapy AND no current plan to initiate antimicrobial therapy at the time of enrollment, as determined by treating provider\n* Ability to produce spontaneous sputum at Visit 1.\n\nExclusion Criteria:\n\n* Known diagnosis of allergic bronchopulmonary aspergillosis or invasive fungal disease\n* Use of the following medications: rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, dofetilide, quinidine, dronedarone, simvastatin, lovastatin, certain immunosuppressants (tacrolimus, cyclosporine, sirolimus, everolimus) and anticoagulants (rivaroxaban, apixaban, edoxaban, warfarin).\n* Abnormal baseline liver function tests (ALT, AST, alkaline phosphatase, or bilirubin \\> upper limit of normal)\n* Prolonged QTc interval on baseline ECG (\\>460 ms in females or \\>450 ms in males)\n* History of congestive heart failure (black box warning), known cardiomyopathy, or arrhythmias\n* Pregnancy or lactation\n* Known hypersensitivity or contraindication to azole antifungal therapy\n* Prior use of systemic antifungals within the past 3 months","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold. Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention. The study will also explore the impact on respiratory symptoms and airway microbiome diversity.",[27,28],"Bronchiectasis","Fungal Infection of Upper Respiratory Tract","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2026-08-17",{"date":37,"type":21},"2030-12-31",{"name":39,"class":40},"Mayo Clinic","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100609979","phase-4-oral-methadone-in-cardiac-surgery-100609979","NCT07221617","Oral Methadone in Cardiac Surgery","Oral Methadone In Cardiac Surgery","OMICS","Inclusion Criteria:\n\n• Undergoing elective cardiac surgery\n\nExclusion Criteria:\n\n* Chronic pain requiring opioid medications as an outpatient\n* Opioid use disorder on medication assistance treatment\n* Prolonged QTc \\>500ms\n* Chronic kidney disease with eGFR \\\u003C 30mL\u002Fmin\n* Documented cirrhosis\n* Intolerance to methadone\n* Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery\n* Pregnancy at the time of surgery\n* Subsequent surgeries after index surgery",{"count":51,"type":21},100,[24],"The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.",[55,56,57],"Pain, Postoperative","Anesthesia","Cardiac Surgery",{"date":32,"type":33},{"date":60,"type":33},"2026-01-13",{"date":62,"type":21},"2026-08-31",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100641521","phase-1-aavrh10-pcca-gene-therapy-for-propionic-acidemia-100641521","NCT07643844","AAVrh10-PCCA Gene Therapy for Propionic Acidemia","Phase 1 Study of Intravenous Administration of a Serotype rh.10 Replication Deficient Adeno-associated Virus Gene Transfer Vector Expressing the Human Propionyl-CoA Carboxylase cDNA (AAVrh10-PCCA) to Individuals With Propionic Acidemia","Inclusion Criteria:\n\n* Age six months to 2 years of age at day of vector infusion. For those \\\u003C1 year of age they must have been ≥37 weeks gestational age at the time of birth and without other conditions\u002Fcomorbidities that in the opinion of the Investigator may interfere with the interpretation of study results.\n* Confirmed diagnosis of propionic acidemia with biallelic PCCA gene mutations based on molecular genetic testing.\n* Study participants must have a diagnosis of neonatal-onset propionic acidemia with a documented episode of decompensation that can include any of the following findings: lethargy, poor feeding, irritability, vomiting, encephalopathy, respiratory failure, seizures, coma, metabolic acidosis, lactic acidosis, ketonuria, hypoglycemia, hyperammonemia, and cytopenias or history of recurrent hospitalizations.\n* Parents or legal guardians of study participants must agree to comply in good faith with the conditions of the study, including attending all of the required baseline and follow-up assessments, and parents or legal guardians must give consent for their child's participation.\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C10 g\u002Fdl\n* Platelet count \\\u003C 100,000 per mm3\n* Liver Enzyme ALT\u002FAST \\>2.5 ULN\n* Direct Bilirubin \\> 1.5\n* Active viral infection (includes HIV or serology positive for hepatitis B or C).\n* Previous liver transplant\n* Subjects with active decompensation as demonstrated by a pH \\\u003C 7.3, bicarbonate \\\u003C 15 mmol\u002FL, NH3 \\> 75 mcmol\u002FL, lactate \\> 2.5 mmol\u002FL, urine ketones\n* Previously received gene therapy or messenger ribonucleic acid (mRNA) treatments for PA.\n* Grade 3 or 4 heart failure according to the Modified Ross Heart Failure Classification for Children or the New York Heart Association Classification.\n* Family does not want to disclose patient's study participation with primary care physician and other medical providers.","6 Months","2 Years",{"count":74,"type":21},9,[76],"PHASE1","Propionic acidemia is a genetic metabolic disorder characterized by metabolic acidosis, ketosis, vomiting, lethargy, cognitive impairment, and risk of death. It results from loss of function of the mitochondrial enzyme propionyl-CoA carboxylase and can be due to disease-causing variants in the PCCA gene, leading to accumulation of propionyl-CoA and its toxic metabolites. The purpose of this trial is to evaluate the safety and potential therapeutic benefit of an AAV-based gene therapy for propionic acidemia in patients with genetically confirmed biallelic variants in PCCA.",[79],"Propionic Acidemia","2026-08-19",{"date":32,"type":33},{"date":83,"type":33},"2026-07-20",{"date":85,"type":21},"2033-12",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100638454","phase-4-the-effect-of-lisinopril-on-polycythemia-100638454","NCT07594535","The Effect Of Lisinopril On Polycythemia","Inclusion Criteria:\n\n* Hemoglobin in Men: \\>16.5 g\u002FdL (10.3 mmol\u002FL).\n* Hemoglobin in Women \\>16.0 g\u002FdL (10.0 mmol\u002FL).\n* BMI 18-40 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Positive JAK2 gene linked to Polycythemia Vera.\n* Current smoker or previous heavy smoker (\\>15 pack years) who quit less than 12 months prior to enrollment.\n* Resting SpO₂ ≤ 94% on room air.\n* Current or recent (within the past 6 months) use of testosterone or androgen supplementation.\n* Any confounding respiratory or renal disease, including diagnosed or suspected sleep apnea, or stage 3 and up of chronic kidney disease.\n* Any confounding hematologic disease that may alter hemoglobin level.\n* Currently treated with ACE inhibitors.\n* Currently treated with potassium-sparing diuretics.\n* Currently on SGLT2 or use within 4 weeks prior to screening.\n* Baseline systolic blood pressure ≤90 mmHg.\n* Baseline systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg.\n* Occupational exposure associated with chronically elevated COHb (auto repair, etc.).\n* History of anaphylaxis or angioedema.\n* Pregnant or breastfeeding.","80 Years",{"count":20,"type":21},[24],"The purpose of this study is to evaluate the effect of the (angiotensin-converting enzyme) ACE inhibitor lisinopril on hemoglobin, hematocrit, and erythropoietin levels in patients with secondary polycythemia due to high-oxygen-affinity hemoglobin variants, oxygen-sensing pathway mutations, or other unexplained and potentially irreversible forms of erythrocytosis. This study aims to determine whether ACE inhibition can effectively reduce excessive erythrocytosis by modulating erythropoietin production.",[98],"Polycythemia",{"date":32,"type":33},{"date":101,"type":33},"2026-07-01",{"date":103,"type":21},"2029-07-01",{"name":39,"class":40},2,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":105},"100566865","phase-2-rilonacept-in-subjects-with-cardiac-sarcoidosis-100566865","NCT06660732","Rilonacept in Subjects With Cardiac Sarcoidosis","A RandomizEd PhAse II TrIal of Rilonacept in Subjects With Cardiac Sarcoidosis (REPAIR-CS)","Inclusion Criteria:\n\n1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements\n2. Age ≥ 18 years and ≤ 80 years\n3. Female subjects must be:\n\n   * postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or\n   * permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, or having a male partner with vasectomy as affirmed by the subject, or\n   * nonpregnant, nonlactating, and having agreed to use an effective method of contraception (i.e., hormonal contraception, intrauterine device \\[IUD\\], or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening Visit 1 until 5 months after study drug administration, if sexually active.\n4. Male subjects must have documented vasectomy or must use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condoms plus hormonal contraceptives or condoms plus IUD with their female partners of childbearing potential from randomization to 3 months after the last dose of study drug administration. Male subjects must agree to refrain from donating sperm during this time period.\n5. Routine adult vaccinations should be up to date and\u002For offered at least 2 weeks prior to randomization according to regional and national guidelines based on medical history or presence of risk factors, in the opinion of the Investigator.\n\n   Cardiac Inclusion Criteria:\n6. Has a diagnosis of cardiac sarcoidosis by the Heart Rhythm Society (HRS) expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis, or the Japanese Circulation Society 2016 Guideline on diagnosis and treatment of cardiac sarcoidosis (Terasaki 2019)\n7. Three or more segments of active FDG uptake on PET scan within 8 weeks of randomization, despite standard therapy\n8. Willing to wear an ambulatory cardiac rhythm monitor at the specified timepoints\n\nExclusion Criteria\n\n1. Unable or unwilling to provide informed consent\n2. Weight \\>380 pounds (172 kilograms)\n3. Women who are pregnant or lactating or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study\n4. Planned to initiate TNF-α antagonist therapy over the course of the study.\n5. Known claustrophobia, or difficulty completing prior PET scan procedure(s)\n6. Left ventricular end-systolic diameter (LVESD) \\> 60 mm on echocardiogram\n7. Other systemic immune disorder(s) or other disorder(s) that require treatment with immunomodulators or immunosuppressants\n8. Has received, or is scheduled to receive after randomization, mechanical circulatory support\n9. Congenital, valvular, and\u002For coronary artery disease that could explain the severity of cardiac dysfunction\n10. Known hypersensitivity to rilonacept (KPL-914) or to any of its excipients\n11. Meets the following TB criteria:\n\n    1. History of active TB prior to screening OR\n    2. History of latent TB that was not adequately treated prior to screening OR\n    3. Signs or symptoms suggestive of active TB (e.g., new cough of \\>14 days in duration or a change in chronic cough, persistent fever, unintentional weight loss, or night sweats) upon review of medical history and\u002For physical examination at screening OR\n    4. Recent close contact with a person with active TB OR\n    5. Positive or indeterminate Interferon Gamma Release Assay (IGRA) test results or results from another positive TB test at screening based on acceptable local clinical practice\n12. Use of the following immunosuppressive or immunomodulatory therapies (see also Section 5.6 \"Prior and Concomitant Therapy\") within the timeframe prior to randomization as defined below for each drug class or category:\n\n    1. INCREASE in dose of existing immunosuppression\u002Fimmunomodulation drug or INITIATION of new immunosuppression\u002Fimmunomodulation drug in the one month prior to or ON or AFTER the date of the eligibility\u002Fbaseline FDG-PET scan until the date of randomization.\n    2. Anakinra within 1 week prior to first dose of study drug; canakinumab within 8 weeks prior to the first dose of study drug; abatacept within 8 weeks prior to first dose of study drug;\n    3. TNF inhibitors within 2-8 weeks of or 5 half-lives (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks) prior to first dose of study drug, whichever is longer.\n    4. Rituximab within 6 months prior to the first dose of study drug unless levels of CD20+ B cells have been assessed and have returned to normal.\n    5. Cyclosporine A (CsA) within 4 weeks prior to the first dose of study drug.\n13. Received any investigational product within 30 days or 5 half-lives (if the half-life is known) of an investigational product (whichever is longer) prior to first dose of study drug\n14. Concurrent enrollment in another clinical study, with the exception of observational studies\n15. Uncontrolled hypertension (systolic blood pressure \\>170 mmHg and diastolic blood pressure \\>110 mmHg\n16. Uncontrolled thyroid disease (serum TSH \\\u003C 0.1 mU\u002FL or \\> 10 mU\u002FL)\n17. Uncontrolled diabetes mellitus (serum glucose \\> 180 mg\u002FdL fasting or HbA1c \\>9%)\n18. Estimated glomerular filtration rate (eGFR) \\\u003C30mL\u002Fmin\n19. Major surgery within 8 weeks prior to screening or planned major surgery within 6 months after first dose of study drug.\n20. Transplanted organs (except corneal transplant performed more than 3 months prior to first dose of study drug).\n21. Severe active, recurrent, or chronic infection (per PI discretion), or any episode of infection requiring hospitalization or treatment with a course of IV antibiotics within 12 weeks before screening. Subjects with a history of severe opportunistic infection (per PI discretion) are also excluded from the study.\n22. High risk of infection (e.g., history of hereditary or acquired immune deficiency disorder), a history of an infected joint prosthesis at any time with that prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections.\n23. Chronic active HBV infection, defined as:\n\n    1. HBV surface antigen positive\n    2. HBV anti-core antibody positive but anti-surface antibody negative\n24. Presence of symptoms indicative of COVID-19 infection (per PI discretion), unless a PCR test for COVID-19 has been reported as negative within the previous 7 days or is acquired prior to randomization.\n25. History of cancer within the last 5 years from screening, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.\n26. Has screening laboratory test results meeting any of the following criteria:\n\n    1. Hemoglobin level \\\u003C 8.0 g\u002FdL\n    2. WBC count \\\u003C 3.0 × 103\u002FµL\n    3. Neutrophil count \\\u003C1.5 × 103\u002FµL\n    4. Platelet count \\\u003C 100 × 103\u002FµL\n    5. Total bilirubin level \\>1.5 × ULN unless the test results are consistent with those for Gilbert's syndrome\n    6. AST or ALT values \\> 2 × ULN\n27. Any condition that, in the opinion of the investigator, could interfere with evaluation of the investigational product or interpretation of subject safety or confound the results of the study",{"count":114,"type":21},60,[116],"PHASE2","The primary objective of this study is to evaluate the effect of rilonacept, added to standard therapy and compared with standard therapy alone, on improvement in myocardial inflammation in subjects with cardiac sarcoidosis after 24 weeks of therapy.",[119],"Cardiac Sarcoidosis",[119,121,122,123,124,125],"Sarcoid Myocarditis","Myocarditis","Inflammation","PET scan","Heart Failure",{"date":30,"type":33},{"date":128,"type":33},"2025-03-05",{"date":130,"type":21},"2027-03",{"name":39,"class":40},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":41},"100539463","validation-of-dna-methylation-markers-for-universal-and-site-specific-guided-cancer-detection-vanguard-study-100539463","NCT06304168","Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study","Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)","Inclusion Criteria:\n\n* Aim 1 Tissue\n\n  * Cases:\n\n    * Patient has a biopsy confirmed diagnosis of target histology\n    * Tissue samples from synchronous or metachronous primary cancers may be used as long as they are clearly of a different target organ.\n    * Tumors from patients with an underlying genetic disorder pre-disposing to cancer may be included as long as they are stratified from those without\n  * Controls:\n\n    * Patient does not have the diagnosis of target histology\n* Aim 2 Blood\n\n  * Cases:\n\n    * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)\n  * Controls:\n\n    * Patient does not have a documented diagnosis of cancer within 1 year following blood collections\n* Aim 3 Urine\n\n  * Cases:\n\n    * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)\n  * Controls:\n\n    * Patient does not have a diagnosis of the target histology\n\nExclusion Criteria:\n\n* Aim 1 Tissue\n\n  * Cases and Controls:\n\n    * Patient has had any transplants prior to tissue collection\n    * Patient has received chemotherapy class drugs within 5 years prior to tissue collection\n  * Cases:\n\n    * Patient has had radiation to the current target lesion prior to tissue collection\n    * Patient has multi-centric\u002Fmulti-focal breast cancer with differing genetic profiles (ER\u002FHER2\u002FPR status differ; if multiple masses are present and not all are tested then exclude patient)\n    * Patient has bilateral breast cancer\u002FDuctal carcinoma in situ (DCIS)\n* Aim 2 Blood\n\n  * Controls:\n\n    * Patient has known cancer prior to current sample acquisition (not including basal cell or squamous cell skin cancers) (if patient has not been seen or if information is not available, the patient is still eligible)\n  * Cases:\n\n    * Patient has known cancer outside of the target cancer 5 years prior to blood collection (not including basal cell or squamous cell skin cancers)\n    * Patient has received chemotherapy class drugs in the 5 years prior to blood collection\n    * Patient has had any prior radiation therapy to the target lesion prior to blood collection\n    * Patient has had an intervention to completely remove current target pathology\n    * The current target pathology is a recurrence\n    * Patient has had a biopsy to the target organ and\u002For lesion within 3 days before blood collection\n* Aim 3 Urine\n\n  * Patient has known cancer outside of the target cancer 5 years prior to urine collection (not including basal cell or squamous cell skin cancers)\n  * Patient has received chemotherapy class drugs in the 5 years prior to urine collection\n  * Patient has had any prior radiation therapy to the target lesion prior to urine collection\n  * Patient has had a biopsy to the target organ and\u002For lesion within 3 days before urine collection\n  * The current target pathology is a recurrence\n  * Patient has chronic indwelling urinary catheter\n  * Patient has had a urinary tract infection within the 14 days prior to sample collection\n  * If patient does not have a primary bladder, ureter or urethral cancer, patient has a history of bladder ureter, or urethral cancer\n  * Cases:\n\n    * Patient has had an intervention to completely remove current target pathology\n    * The current target pathology is a recurrence",true,{"count":141,"type":21},6150,"OBSERVATIONAL","This study explores the potential value of a new blood test approach for early detection of cancer.",[145,146],"Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm",{"date":30,"type":33},{"date":149,"type":33},"2019-05-13",{"date":151,"type":21},"2028-05-15",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":41},"100350376","understanding-mechanisms-of-normal-and-disordered-defecation-100350376","NCT03842007","Understanding Mechanisms of Normal and Disordered Defecation","Inclusion Criteria\n\n* Male and female volunteers aged 18-80 years.\n* Able to provide written informed consent before participating in the study.\n* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.\n* Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: \\\u003C3 bowel motions\u002Fweek, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.\n* Able to provide written informed consent before participating in the study.\n* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.\n\nExclusion Criteria\n\n* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and\u002For pose safety concerns.\n* Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.\n* Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight \\>4500gms (macrosomia), or known 3rd or 4th degree perineal tear.\n* Medications that are likely to alter gastrointestinal motility: e.g., opiates and anticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).\n* Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.\\*\n* Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.\n* Pregnant women, prisoners and institutionalized individuals.",{"count":160,"type":21},160,[162],"NA","Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.",[165],"Constipation",{"date":32,"type":33},{"date":168,"type":33},"2019-01-29",{"date":170,"type":21},"2029-06",{"name":39,"class":40},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":178,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":41},"100623833","exercise-cardiovascular-magnetic-resonance-in-heart-failure-with-preserved-ejection-fraction-100623833","NCT07401771","Exercise Cardiovascular Magnetic Resonance In Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n1. Informed consent obtained\n2. Three groups will be enrolled:\n\n   1. HFpEF (cardiologist-adjudicated diagnosis as verified by PI, EF≥50%)\n   2. Non-cardiac dyspnea (patients have dyspnea but were found on invasive exercise testing not to have HFpEF).\n   3. Healthy volunteers with no history of dyspnea or effort intolerance.\n\nExclusion Criteria:\n\n1. Contraindication for low-field CMR, as indicated in MRI safety screening checklist (Research Document #1)\n2. Patient inability or unwillingness to undergo Ex-CMR\n3. Cardiac implants, mechanical or biological valve, causing artifacts that compromise the quality of data\n4. Hospitalization for heart failure in the preceding 30 days.\n5. Large R-R interval variation, caused by frequent premature ventricular contractions or non-sinus rhythms such as persistent atrial fibrillation, which, in the opinion of the investigators, compromises the quality of data acquisition, image analysis and disrupts the consistency of the cohorts\n6. Myocardial infarction or unstable angina pectoris\n7. Planned coronary, carotid, or peripheral artery revascularization\n8. Other causes of dyspnea as indicated in patients' medical history based upon the opinion of the PI, such as restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, more than moderate chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, severe anemia, or more than moderate mitral or aortic heart valve disease).",{"count":179,"type":21},400,"The purpose of this study is to internally validate low-field Ex-CMR as a noninvasive tool for diagnosing, phenotyping, and risk stratifying HFpEF in patients with exertional dyspnea.",[182],"Heart Failure With Preserved Ejection Fraction","2026-08-18",{"date":30,"type":33},{"date":186,"type":21},"2026-11",{"date":188,"type":21},"2028-03",{"name":39,"class":40},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":41},"100619979","a-study-of-heart-disease-using-ai-enabled-electrocardiography-and-focused-cardiac-ultrasound-100619979","NCT07351656","A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound","Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.","Adolescents and young adults:\n\nInclusion Criteria:\n\n* Enrollment in a high-school, college or a resident in MN during the study period\n* Age 18-29 years\n* Informed consent (and assent for minors)\n\nExclusion Criteria:\n\n* Presence of a pacemaker or defibrillator\n* Inability to obtain a quality ECG tracing\n\nCommunity dwelling adults:\n\nInclusion Criteria:\n\n• Adult patients (\\>30 years of age, with pre-specified subgroups 30-64 and 65+))\n\nExclusion Criteria:\n\n• Inability to provide informed consent to participate in the study\n\nPregnant women:\n\nInclusion Criteria:\n\n* Adult female aged 18 to 49 years\n* Pregnant at the time of enrollment\n* Receiving obstetric care at identified study site(s)\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n• Inability to provide consent",{"count":198,"type":21},19300,[162],"A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.",[202],"Heart Disease",{"date":30,"type":33},{"date":205,"type":33},"2026-03-09",{"date":207,"type":21},"2028-02",{"name":39,"class":40},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":222,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":41},"100584641","effects-of-a-mobile-app-based-mindfulness-intervention-in-persons-with-spinal-cord-injury-and-chronic-pain-100584641","NCT06891989","Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain","Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Traumatic SCI of at least 6 months duration\n* Chronic pain \\[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\\]\n* Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys\n\nExclusion Criteria:\n\n* Lack of daily internet access\n* Inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study\n* Significant visual\u002Fhearing impairment that does not allow use of the MM app's audiovisual presentations\n* Use of any meditation more than once a week in the last 3 months\n* Inability to provide or obtain an email address for registration to the AC intervention and\u002For communication with study staff\n* Inability to provide a phone number for communication with study staff",{"count":217,"type":21},282,[162],"The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.",[221],"Spinal Cord Injuries","NOT_YET_RECRUITING",{"date":30,"type":33},{"date":225,"type":21},"2026-10",{"date":227,"type":21},"2029-12-30",{"name":39,"class":40},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":41},"100573640","navicam-for-detection-of-barretts-esophagus-100573640","NCT06748911","Navicam for Detection of Barrett's Esophagus","Use of a Detachable String Capsule for Evaluation of Barrett's Esophagus","DS-MCE-BE","Inclusion Criteria\n\n* Adults greater than or equal to 22 years of age with or without Barrett's Esophagus\n* All Patients:\n\n  o Have had an endoscopy within 1 year of baseline enrollment\n* Patients with Barrett's Esophagus:\n\n  * Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or\n  * Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines\n\nExclusion Criteria\n\n* Inability to comprehend or read the consent form\n* Have an oropharynx, esophageal, or gastro-esophageal tumor\n* Ongoing symptoms of dysphagia\n* Presence of active clinically significant stricture\n* History of stricture requiring dilation\n* Presence of pacemaker or implanted cardiac defibrillator\n* History of esophageal surgery with the exception of fundoplication\n* Pregnancy\n* History of surgery or obstructive process of the small bowel\n* BMI \\> 38","22 Years",{"count":239,"type":21},57,[162],"Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus",[243],"Barrett's Esophagus",{"date":80,"type":33},{"date":246,"type":33},"2025-02-20",{"date":248,"type":21},"2026-09-30",{"name":39,"class":40},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":41},"100531074","contrast-echocardiography-during-exercise-to-assess-pulmonary-blood-volume-100531074","NCT06195059","Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume","Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise","Inclusion Criteria:\n\n* Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.\n\nExclusion Criteria:\n\n* Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.\n* Prior adverse reaction to echo contrast administration",{"count":258,"type":21},800,"The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.",[125,261],"Pulmonary Vascular Disease",{"date":30,"type":33},{"date":264,"type":33},"2024-07-30",{"date":266,"type":21},"2027-08",{"name":39,"class":40},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":41},"100525463","a-tool-for-improving-the-shared-decision-making-process-in-patients-with-non-small-cell-lung-cancer-100525463","NCT06122064","A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer","Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial","Inclusion Criteria:\n\n* CLINICIANS:\n* All clinicians within identified departments participating are eligible (doctor of medicine \\[MD\\]\u002Fdoctor of osteopathy \\[DO\\], fellows\u002Fresidents, physician assistant \\[PA\\]\u002Fnurse practitioner \\[NP\\])\n* PATIENTS:\n* Adult patients (\\>= 18 years of age)\n* Appointments at Mayo Clinic in Rochester\n* Non-small cell lung cancer (NSCLC) stage \\> 1B\n* Eligible by their oncologist for adjuvant treatment\n\nExclusion Criteria:\n\n* Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)",{"count":51,"type":21},[162],"This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.",[279,280,281,282],"Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8",{"date":30,"type":33},{"date":285,"type":33},"2023-11-20",{"date":287,"type":21},"2029-10-31",{"name":39,"class":40},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":139,"sex":296,"minAge":18,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100482119","phase-2-low-dose-aspirin-for-the-prevention-of-postpartum-related-breast-cancer-100482119","NCT05557877","Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer","Targeted Prevention of Postpartum-Related Breast Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age \\>= 18 years and =\\\u003C 45 years of age\n* PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.\n* PRE-REGISTRATION: Had a live birth =\\\u003C 10 years prior to pre-registration\n* PRE-REGISTRATION: Pre-menopausal according to patient report and\u002For clinical determination\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research\n* REGISTRATION: Age \\>= 18 years and =\\\u003C 45 years of age\n* REGISTRATION: Registration for this study must be completed either =\\\u003C one (1) year after the qualifying pre-registration biopsy is performed for this study or =\\\u003C one (1) year after collection of the archived tissue (for those who did not have a pre-registration biopsy performed after pre-registration for this study)\n* REGISTRATION: Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 90 days prior to registration)\n* REGISTRATION: Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 90 days prior to registration\n* REGISTRATION: Serum creatinine =\\\u003C 2.0 mg\u002Fdl (obtained =\\\u003C 90 days prior to registration)\n* REGISTRATION: Negative pregnancy test done =\\\u003C 15 days prior to registration\n* REGISTRATION: Willing to use contraception while on treatment\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research\n* REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)\n* PRE-REGISTRATION: Received systemic treatment for any other cancer at any time\n* PRE-REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within =\\\u003C 5 days prior to pre-registration and no more than four doses within =\\\u003C 30 days prior to pre-registration)\n* PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer\n* PRE-REGISTRATION: Currently taking anticoagulants\n* PRE-REGISTRATION: Contraindication for aspirin use\n* PRE-REGISTRATION: Known or suspected active breast infection\n* REGISTRATION: Known DCIS or invasive cancer\n* REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\\\u003C 12 months prior to pre-registration)\n* REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) (NOTE: no doses within =\\\u003C 5 days prior to registration and no more than four doses within =\\\u003C 30 days prior to registration)\n* REGISTRATION: Co-morbid illnesses\u002Fconditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Any contraindication to aspirin use including but not limited to:\n\n  * Bleeding disorders (e.g., hemophilia)\n  * Stomach or intestinal bleeding =\\\u003C 6 months prior to registration\n  * Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)\n* REGISTRATION: Currently taking anticoagulants\n* REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy\n* REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days\n* REGISTRATION: Post-menopausal:\n\n  * Prior bilateral surgical oophorectomy or\n  * No menses for \\> 1 year with estradiol levels within postmenopausal range, according to institutional standard\n* REGISTRATION: Known or suspected active breast infection","FEMALE","45 Years",{"count":114,"type":21},[116],"This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.",[302],"Breast Carcinoma",{"date":30,"type":33},{"date":305,"type":33},"2023-03-09",{"date":307,"type":21},"2027-01-30",{"name":39,"class":40},5,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":318,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":41},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests\n\n  * NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n  * NOTE 2: This criteria will not apply to patients who had sequencing and neoantigen prediction previously completed.\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations.\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test 7 days prior to pre-registration for persons of childbearing potential.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained ≤ 28 days prior to pre-registration:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL (Must be ≥ 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 or ≥ 1.5 X 10\\^9\u002FL\n  * Platelet count ≥ 100,000\u002Fmm\\^3 or ≥ 100 X 10\\^9\u002FL (Must be ≥7 days after most recent transfusion)\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN or ≤ 5 x ULN with liver metastases\n  * Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance must be ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained ≤ 14 days prior to registration:\n\n  * Hemoglobin ≥ 9.0 g\u002Fdl\n  * ANC ≥ 1500\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 1.5 x ULN\n  * ALT and AST ≤ 3 x ULN (≤ 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status or NCI CTCAE v5 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease ≥ 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery, willing to provide clinically collected FFPE tissue blocks, or willing to provide available sequencing data available from commercial or research test\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor ≥ 2 cm on pre-surgery evaluation imaging (residual disease ≥ 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II PRE-REGISTRATION PILOT AND COHORT 5:\n\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations\n* Willing to proceed with surgery and provide mandatory tissue specimens or previously collected FFPE tissues for complete exome and transcriptome sequencing or available sequencing data available from commercial or research test\n\n  * NOTE: Patients who had sequencing under Mayo IRB protocol #13-000942, #14-004094, or #21-007742 and neoantigens have been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test done ≤ 7 days prior to pre-registration for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Willing to employ a highly effective method of contraception from the time of preregistration through 6 months after the final vaccine cycle\n* ECOG performance status of 0 or 1\n* Anticipated life expectancy of \\> 6 months\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 5 (ILC) ONLY:\n\n* Histologically confirmed invasive lobular carcinoma or other histology with lobular features\n\n  * Histological confirmation of adenocarcinoma of the breast with invasive lobular histology or other histology with lobular features with any estrogen receptor (ER), progesterone receptor (PR), and HER2 status\n  * Stage II-IV based on the 7th edition of TNM staging system from AJCC\n  * Tumor mutational burden ≥ 10 muts\u002FMb either in tissue or blood\n\nPHASE II AND PILOT COHORT 5 REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive ≥ 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Lab values as per Phase I registration criteria obtained ≤ 14 days prior to registration:\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE v5 grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke ≤ 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in ≤ 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to cycle 1 day 1 (C1D1) neoantigen vaccinations\n  * Radiation ≤ 2 weeks prior to C1D1 neoantigen vaccinations\n  * Major Surgery ≤ 4 weeks prior to C1D1 neoantigen vaccinations\n  * Received live vaccine ≤ 30 days prior to C1D1 neoantigen vaccinations\n  * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications ≤ 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, the patient will be excluded:\n\n  * Tumor tissue cellularity ≥ 30%\n  * Sufficient tissue (fresh frozen or FFPE) for both DNA and RNA sequencing with passing cellularity.\n  * ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30)\n  * \\\u003C 10% of DNA fragments are smaller than 1 kb\n  * Sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and RNAseq according to the Mayo sequencing core (note: kits and technologies change over time, so these are not fixed numbers)\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * CHF with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are ≥ 2 cores with passing cellularity; (3) ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to study treatment\n  * Radiation ≤ 2 weeks prior to study treatment\n  * Major surgery ≤ 4 weeks prior to study treatment\n  * Received live vaccine ≤ 30 days prior to study treatment\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n\nOther inclusion\u002Fexclusion criteria as indicated per protocol not listed here due to limitation in number of characters (text) allowed.","16 Years",{"count":320,"type":21},138,[76,116],"This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,281,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,282,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Invasive Breast Lobular Carcinoma",{"date":30,"type":33},{"date":425,"type":33},"2022-03-31",{"date":427,"type":21},"2028-03-31",{"name":39,"class":40},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":296,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},"100406082","comparison-of-proton-or-intensity-modulated-radiation-therapy-after-surgery-for-endometrial-or-cervical-cancer-100406082","NCT04567771","Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer","A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of cervical or endometrial cancer\n* Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium\n* History and physical prior to registration\n* Documentation of history of:\n\n  * Smoking status\n  * Pelvic infection\n  * Pelvic inflammatory disease\n  * Endometriosis\n* Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site\n* Plan for RT to pelvis with or without para-aortic lymph node irradiation\n* If received high-dose chemotherapy prior to registration, last dose must have been given \\>= 21 days prior to start of RT\n* Complete blood count (CBC) performed within 21 days prior to registration\n* Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)\u002FCT, or PET\u002FMRI for staging before registration; may be pre-operative (op) or post-op\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n* Provide written informed consent\n* Willing to complete quality of life (QOL) questionnaires\n\nExclusion Criteria:\n\n* Receiving external beam boost dose during RT\n* Distant metastases\n* Gross disease at time of RT\n* Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas\n* Patients who exceed the weight\u002Fsize limits of the treatment table\n* Positive or close surgical margins (=\\\u003C 3 mm)\n* Prior RT to the pelvis\n* Planned to receive inguinal node RT\n* Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n* Other major medical illness which requires hospitalization or precludes study therapy at the time of registration\n* Patients unwilling to have rectal balloon placed on a daily basis during RT",{"count":437,"type":21},121,[162],"This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.",[441,442,443,444],"Cervical Carcinoma","Endometrial Carcinoma","Endometriosis","Pelvic Inflammatory Disease",{"date":80,"type":33},{"date":447,"type":33},"2020-12-04",{"date":449,"type":21},"2029-04-01",{"name":39,"class":40},3,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100343329","phase-3-pre-operative-or-post-operative-stereotactic-radiosurgery-in-treating-patients-with-operative-metastatic-brain-tumors-100343329","NCT03750227","Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors","Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological or cytological confirmation of solid tumor malignancy and\u002For clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings\n* Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate\n* Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\\\u003C 10 metastases)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent\n* Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \\* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior open neurosurgery for malignancy\n* Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma\n* History of whole brain radiation therapy (WBRT)\n* Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible\n* Leptomeningeal metastasis\u002Fdisease\n* A brain metastasis that is located =\\\u003C 5 mm of the optic chiasm\n* Any brain metastasis \\> 5 cm in size\n* \\> 10 brain metastases\n* Indication for surgical resection of \\>= 2 brain metastases\n* Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab\n* Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions",{"count":460,"type":21},140,[462],"PHASE3","This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.",[146,465],"Metastatic Malignant Neoplasm in the Brain",{"date":80,"type":33},{"date":468,"type":33},"2018-11-19",{"date":470,"type":21},"2030-11-08",{"name":39,"class":40},4,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":481,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":41},"100639277","a-study-comparing-shoulder-replacement-techniques-for-patients-with-shoulder-arthritis-and-an-intact-rotator-cuff-100639277","NCT07584356","A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff","A Randomized Trial Comparing Anatomic And Reverse Total Shoulder Replacement For Shoulder Arthritis With An Intact Rotator Cuff","SOAR","Inclusion Criteria\n\n* Shoulder arthritis\n* Intact rotator cuff\n* Glenoid retroversion less than 25°\n\nExclusion Criteria\n\n* Rotator cuff insufficiency\n* Fracture deformity\u002Fsequelae\n* Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)\n* Current or previous infection of shoulder\n* Previous acromion fracture (not os acromiale)\n* Brachial plexopathy\n* Axillary neuropathy\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.\n* Medical conditions that would make 2 years follow up unlikely\n* Non-English speaking","60 Years","85 Years",{"count":484,"type":21},108,[162],"The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).",[488],"Shoulder Arthritis",{"date":80,"type":33},{"date":491,"type":33},"2026-05-05",{"date":493,"type":21},"2029-12",{"name":39,"class":40},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":41},"100630449","phase-2-a-study-of-vagal-nerve-stimulation-in-conjunction-with-nrt-for-smoking-cessation-100630449","NCT07487818","A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation","Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation","Inclusion Criteria:\n\n* 18 years of age or older at the time of consent.\n* Currently smoking at least 10 cigarettes\u002Fday\n* Motivated to stop smoking (on a scale of 0 to 10, motivation must be 3 or above);\n* Ability to participate fully in all aspects of the study.\n* Have the ability to provide informed consent.\n* Have no contraindicating comorbid health conditions that would interfere with study participation, as determined by the clinical investigators.\n\nExclusion Criteria:\n\n* Patients with a current moderate\u002Fsevere depression as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9).\n* Patients who are or have used an investigational drug within the past 30 days.\n* Patients who are currently using medication(s) known to interact with varenicline.\n* Patients who have clinically significant acute\u002Fchronic progressive or unstable neurologic, hepatic, renal, cardiovascular, psychological, respiratory, or metabolic disease.\n* Patients with a known allergy to nicotine patches or varenicline.\n* Patients with a personal history of acute pancreatitis, hypoglycemia, acute kidney injury or impairment of renal function, type 1 diabetes or diabetic ketoacidosis, and\u002For severe gastrointestinal disease such as gastroparesis.\n* Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device.\n* Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)\n* Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)\n* Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia\n* Patients who have a metallic device such as a stent, bone plate, or bone screw implanted at or near your neck\n* Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).\n* Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded.\n\n  1. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine devices, surgical sterilization, and abstinence. The study does not include vulnerable populations.\n  2. Specifically, the study does not include fetuses, neonates, pregnant women, children (\\\u003C18 years of age), prisoners, institutionalized individuals, or other vulnerable populations.\n\n  i. All female participants of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during study participation.",{"count":503,"type":21},150,[116,462],"The purpose of this study is to provide preliminary evidence for the efficacy of 12 weeks of vagal nerve stimulation (VNS) and nicotine replacement therapy (NRT) for increasing smoking abstinence rates.",[507],"Smoking Cessation",[509,510,511,512,513,514,515],"nicotine dependence","smoking","vagal nerve stimulator","VNS","varenicline","nicotine replacement therapy","nicotine patches",{"date":80,"type":33},{"date":518,"type":33},"2026-04-15",{"date":520,"type":21},"2027-05-31",{"name":39,"class":40},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":529,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":41},"100584322","radio--ko-radiotherapy-for-knee-osteoarthritis-clinical-trial-100584322","NCT06887829","Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial","The Randomized Clinical Trial of Low-Dose Radiotherapy for Knee Osteoarthritis","Inclusion Criteria:\n\n* • patient's primary care provider is at Mayo Clinic in Rochester, MN\n\n  * age 50-100 years\n  * ICOAP pain scale A1 at least moderate intensity or B6 at least moderate intensity\n  * diagnosed with primary knee OA ICD-10 codes M17.x\n\n    o You have not had recurrent episodes of sudden onset of warmth, redness, or swelling of the affected knee\n  * physical exam findings of medial or lateral joint line tenderness on palpation that is in the same location as the knee pain.\n  * absence of primary knee pain in the pes anserine or hamstring or gastrocnemius, quadriceps, or patellar tendons on exam.\n  * radiographic Kellgren-Lawrence grade 2-3 on 4-view knee x-rays taken within the last year ability to complete surveys electronically by email\n\nExclusion Criteria:\n\n* • Kellgren-Lawrence grade 1 or 4\n\n  * pregnancy or women 54 years and younger with potential for pregnancy (if they or their partner have not had tubal ligation, hysterectomy, or vasectomy)\n  * history of ipsilateral intraarticular knee surgery\n  * use of injected corticosteroids within 3 months or hyaluronans within 6 months or within 1 month if there was no sustained improvement post-injection of either corticosteroid or hyaluronan.\n  * history of trauma to this knee in the last year that clearly caused the pain now present\n  * history of RA, gout, pseudogout, hemarthroses (eg, hemophilic arthropathy) or other inflammatory arthritis involving this knee\n  * history of symptomatic hip OA\n  * history of psychosis, personality disorder, uncontrolled affective disorder\n  * history of fibromyalgia\n  * malignancy requiring active treatment current regular use of opiate analgesics, PRP, or acupuncture for the knees","50 Years","100 Years",{"count":532,"type":21},128,[162],"The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.",[536],"Osteoarthritis, Knee",{"date":80,"type":33},{"date":539,"type":33},"2025-06-04",{"date":541,"type":21},"2027-10-29",{"name":39,"class":40},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":41},"100582585","post-covid-19-syndrome-treatment-with-variable-pulse-transcranial-magnetic-stimulation-100582585","NCT06865222","Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation","Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome","Inclusion Criteria:\n\n* Patients who have had a recent episode of COVID-19 and who present to the Post COVID-19 Clinic at Mayo Clinic Rochester with at least one of the PCC symptoms of interest - anosmia, tinnitus, fatigue. Symptoms consistent with PCC lasting at least 1 month after the positive test date. Subjects must have ongoing symptoms for \\> 4 weeks following the start of an acute covid infection. This is consistent with the CDC definition for post covid conditions. Start date is determined by date of first positive COVID test. There is no limitation of maximum time from acute infection start.\n* At least one of the PCC symptoms of interest:\n\n  * Anosmia: Olfactory Threshold Test scores corresponding to Anosmia or Hyposmia\n  * Tinnitus: \\>0 score on Tinnitus Handicap Inventory (not present prior to SARS-COVID 2 infection)\n  * Fatigue: Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above\n\nExclusion Criteria:\n\n* Implanted electronic devices, including pacemakers, defibrillators, implant medication pumps, or vagus nerve stimulators (VNS)\n* Active alcohol abuse: \\>14 drinks a week or formal diagnosis, illicit drug use or drug abuse\n* Any seizure history within the past 10 years\n* Intracranial implant within 30 cm of magnet (e.g., aneurysm clips, endovascular coil, cerebral shunts, brain stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed\n* Enrolled or plans to enroll in an interventional trial during this study\n* Previous stroke with residual deficits\n* Subjects unable to comprehend or follow verbal commands\n* Subjects unable to comprehend and sign the informed consent\n* Based on PI's or local physician's assessment that subject unable to tolerate the trial procedure due to medical condition\n* Clinical abnormality or clinically unstable medical condition, as indicated by medical history, physical examination, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results\n* Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required for females of childbearing potential\n* Any condition which in the judgment of the investigator would prevent the subject from completion of the study","65 Years",{"count":552,"type":21},40,[162],"The purpose of this study is to test if Variable Pulse TMS (Transcranial Magnetic Stimulation) can result in objective improvements in patients with Post COVID Syndrome (PCS).",[556],"Post COVID-19 Condition",{"date":80,"type":33},{"date":559,"type":33},"2025-07-22",{"date":561,"type":21},"2027-04",{"name":39,"class":40},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":296,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":41},"100527905","phase-2-neurotization-of-the-nipple-areolar-complex-to-restore-sensation-for-patients-with-breast-cancer-undergoing-nipple-sparing-mastectomy-and-reconstruction-100527905","NCT06153836","Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction","Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction","Inclusion Criteria:\n\n* Female patients age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Planned nipple sparing mastectomy (NSM)\n* Ideal NSM candidates would meet the following criteria:\n\n  * Cup size A-C\n  * BMI \\\u003C34\n  * Ptosis grade \\\u003C 2\n  * Clinical stage 0 - T2N0\n  * Final planned implant volume \\\u003C 400cc\n  * Inframammary or lateral mammary incision\n  * Tumor \\> 0.5cm from the nipple areolar complex (NAC)\n  * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM\n  * No prior breast radiation on side of planned NSM\n  * Tumor \\\u003C0.5cm from NAC (including suspicious calcifications or MRI enhancement)\n  * No planned post mastectomy radiation (PMRT)\n  * No nicotine use within 4 weeks of surgical date\n\nExclusion Criteria:\n\n* Planned autologous reconstruction (immediate or delayed)\n* Pregnancy",{"count":571,"type":21},45,[116],"This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.",[575,576,577],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8",{"date":80,"type":33},{"date":580,"type":33},"2023-12-05",{"date":582,"type":21},"2026-11-10",{"name":39,"class":40},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":74},"100470831","collecting-blood-and-stool-samples-to-detect-colorectal-cancer-or-advanced-neoplasia-in-lynch-syndrome-patients-100470831","NCT05410977","Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients","Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study","Inclusion Criteria:\n\n* Patients at least 18 years of age\n* Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\\\u003C55 years old)\n* Colonoscopy\u002Fflexible sigmoidoscopy (flex sig) scheduled +\u002F- 90 days from sample collection\n* Patient has agreed to participate and has signed the study consent form\n\nExclusion Criteria:\n\n* Patient has known cancer (stage I-IV) within 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)\n* Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection\n* Patient has had any abdominal radiation therapy prior to current sample collection\n* Patient had therapy to the target (non-hyperplastic) lesion with intent to completely remove or debulk the lesion prior to sample collection \\[examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision\\]\n* Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \\[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\\]\n* ADDITIONAL STOOL EXCLUSIONS:\n* Bowel prep \\\u003C7 days prior to stool collection\n* Oral or rectal contrast given within 7 days prior to stool collection\n* Presence of ileostomy\n* Enteral feeds or total parenteral nutrition (TPN)\n* Diagnosis of inflammatory bowel disease",{"count":592,"type":21},950,"This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.",[595,596],"Colorectal Carcinoma","Lynch Syndrome",{"date":183,"type":33},{"date":599,"type":33},"2022-03-30",{"date":601,"type":21},"2027-12-31",{"name":39,"class":40},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":139,"sex":296,"minAge":610,"maxAge":481,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":41},"100609735","phase-4-the-effect-of-tirzepatide-on-menopausal-vasomotor-symptoms-and-biological-aging-in-post-menopausal-women-with-obesity-100609735","NCT07218445","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study","Inclusion Criteria\n\n1. Females\n2. Age 46-60 years old.\n3. BMI ≥30 kg\u002Fm2 or BMI ≥27 kg\u002Fm2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).\n4. Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).\n5. Hot flashes must be present for \\>30 days prior to study entry.\n6. Willingness to self-inject drug\n7. Provided informed consent to be part of the study.\n8. Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal\u002Fday relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal\u002Fday. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.\n\nExclusion Criteria\n\n1. Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.\n2. Any current, recent use (past 4 weeks), or planned use of:\n\n   1. Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).\n   2. Vaginal estrogen.\n   3. Androgens.\n   4. Progestogens.\n3. Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and\u002For hypnosis.\n4. Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.\n5. Menopause as a result of cancer treatments.\n6. Impaired renal function (GFR ≤30 ml\u002Fmin\u002F1.73 m²).\n7. Thyroid-stimulating hormone ≥7 with low free T4.\n8. 10-year ASCVD risk \\> 7.5%.\n9. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.\n10. \\>5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).\n11. Other obesity medication was used within the past 3 months.\n12. History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \\> 1 year before screening).\n13. Past or intended endoscopic and\u002For device-based therapy or removal within last six months.\n14. Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time\n15. Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.\n16. Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n17. Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.\n18. Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days.\n19. Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.","46 Years",{"count":552,"type":21},[24],"The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.",[615,616],"Obesity","Menopause Hot Flashes",[618,619,620,621],"Hot flashes","menopause","Tirzepatide","GLP","2026-08-16",{"date":183,"type":33},{"date":625,"type":33},"2026-04-08",{"date":627,"type":21},"2027-09-18",{"name":39,"class":40},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":451},"100652505","feasibility-and-usability-of-a-chest-strap-ambulatory-ecg-monitor-in-active-individuals-in-comparison-with-a-traditional-ambulatory-ecg-patch-monitor-mome-arc-100652505","NCT07772817","Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)","Inclusion Criteria:\n\n* Adult participants (\\>22 years; Frontier X is approved for use in this age group) who participate in \\>4 days a week of \\>150 minutes total per week of moderate to high intensity exercise who were prescribed a ambulatory ECG monitor for clinical purposes for 24 hours or more.\n* Patients must agree to wear the Frontier X monitor for the prescribed duration and use the Frontier X Plus application\n\nExclusion Criteria:\n\n* Current use of Implanted Cardiac Devices\n* Pregnancy\n* Known allergies to any of the materials listed in the \"List of Patient-Contacting Materials\"\n* Presence of skin injuries or broken skin in the area where the chest strap is worn\n* Inability to use a compatible mobile device required for the operation of the study device\n* Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures\n* Medical restrictions on exercise for safety including cardiac, orthopedic or other relevant past medical history",{"count":636,"type":21},15,"The purpose of this research is to compare the standard ambulatory ECG monitor, the MoMe ARC, against Fourth Frontier's \"Frontier X Plus\". This device is an FDA-Cleared chest-strap-based ECG wearable that provides an alternative modality to capture ambulatory ECG rhythm changes.",[639],"Cardiac Arrhythmia",[641,642],"Ambulatory electrocardiographic monitoring","Arrhythmia detection","2026-08-14",{"date":80,"type":33},{"date":646,"type":21},"2026-08",{"date":648,"type":21},"2027-06",{"name":39,"class":40},""]