[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Texas Southwestern Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":622},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,175,0,25,[9,44,70,96,121,142,163,190,217,242,272,303,326,346,377,399,418,441,466,492,516,534,561,582,605],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100627255","early-phase-1-thio-and-cadonilimab-in-resectable-hepatocellular-carcinoma-100627255",false,"NCT07446257","THIO and Cadonilimab in Resectable Hepatocellular Carcinoma","A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria\n\n   a. Availability of tumor tissue samples prior to the first day of study treatment is required for all patients.\n2. HCC that is amenable to R0 resection with curative intent as determined by treating surgical\u002Fmedical oncologists in consultation with the principal investigator. Subject must be a suitable candidate for surgery based on evaluations by the treating surgeon\u002Foncologist.\n3. Measurable disease according to RECIST 1.1\n4. No prior anti-PD (Programmed death)-1\u002FL1 therapies for any indication\n5. Age ≥18\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n7. Child Pugh A\n8. Adequate organ and marrow function as defined below:\n\n   1. ANC (absolute neutrophil count) ≥ 1.5 x 109\u002FL (does not apply to patients with benign ethnic neutropenia)\n   2. Platelets ≥ 75 x 109\u002FL without transfusion\n   3. Hemoglobin ≥ 9 g\u002FdL without transfusion within 2 weeks of screening\n   4. ALT (Alanine Aminotransferase) ≤ 3 2 x ULN (Upper Limit of Normal)\n   5. Bilirubin ≤ 3 x ULN\n   6. Creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula using actual body weight\n9. All etiologies of chronic liver disease including but not limited to Hepatis C Virus (HCV) or Hepatis B Virus (HBV) infection. HCV and HBV infection status does not preclude eligibility as long as patients meet all other eligibility criteria but must be known prior to starting treatment. Patients with HBV must be on anti-viral therapy prior to the first day of investigational drug treatment. Patients with HCV may include active or resolved infection.\n10. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following the last dose of ateganosine or 4 months following the last dose of cadonilimab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n    A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n11. Ability to understand and the willingness to sign a written informed consent.\n12. Willing and able to comply with the requirements and restrictions in this protocol.\n\nExclusion Criteria:\n\n1. Presence of extrahepatic extension of disease\n2. Prior locoregional therapy to target lesions is not allowed. History of curative locoregional therapy is allowed provided the following are met: 1) previously treated tumor is not viable without evidence of residual disease for at least 12 months, and 2) patient has not received local therapy in the past 12 months.\n3. Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology\n4. History of hepatic encephalopathy\n5. Severe ascites requiring paracentesis in the past 3 months\n6. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study\n7. Prior significant bleeding event in the past 3 months that may pose a surgical risk\n8. History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure)\n9. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:\n\n   1. Autoimmune interstitial lung disease (lymphangitic spread of cancer is not disqualifying or stable\u002Fchronic lung disease that is not likely to be autoimmune in nature and progressive),\n   2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,\n   3. Clinically significant cardiovascular disease,\n   4. A condition that may obscure the interpretation of toxicity determination or AEs,\n   5. History of prior bone marrow and\u002For solid-organ transplantation\n10. Hypersensitivity to IV contrast; not suitable for pre-medication\n11. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past year (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), with the following exceptions:\n\n    1. Autoimmune diseases with only dermatologic involvement such as eczema, vitiligo, lichen chronicus, or resolved childhood asthma\u002Fatopy which involves less than 10% of the body surface area and symptoms are well controlled on topical treatments without recent exacerbations requiring other therapies\n    2. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n    3. Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study\n12. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg\u002Fday prednisone equivalents are permitted in the absence of autoimmune disease.\n13. Prior malignancy that required systemic treatment within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer. Patients with a cancer history with a low risk of recurrence or progression may be enrolled as determined by the principal investigator.\n14. Prisoners or subjects who are involuntarily incarcerated\n15. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG (Human chorionic gonadotropin) laboratory test\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n17. Evidence of bleeding diathesis or significant coagulopathy\n18. Current use of full dose anticoagulant use which cannot be temporarily discontinued for surgery\n19. Receipt of live vaccinations within 30 days of first treatment day","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC).",[27],"Resectable Hepatocellular Carcinoma",[29,30],"liver","hepatocellular carcinoma","NOT_YET_RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2031-08-01",{"name":41,"class":42},"University of Texas Southwestern Medical Center","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100553034","cerebral-autoregulation-brain-perfusion-and-neurocognitive-outcomes-after-traumatic-brain-injury-100553034","NCT06480838","Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury","CAPCOG-TBI","Inclusion Criteria:\n\n* Documented\u002FVerified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian\u002Fcyclist, fall, other non-intentional, violence\u002Fassault)\n* A documented moderate to severe TBI defined as: Glasgow Coma Scale (GCS) \\\u003C 13, or loss of consciousness (LOC) \\> 30 minutes, or posttraumatic amnesia (PTA) \\> 24 hours or intracranial neuroimaging abnormalities\n* Between the age 18 - 80 year-old\n* ≤ 1 week postinjury\n* Acute brain CT for clinical care\n* Admitted to the hospital for TBI\n* Visual acuity\u002Fhearing adequate for testing\n* Fluent in English or Spanish\n* Patient or LAR ability to provide informed consent\n\nExclusion Criteria:\n\n* Age greater or less than the range 18-80 years\n* Significant polytrauma that would interfere with follow-up and outcome assessment\n* Major debilitating baseline mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression with active suicidal thoughts at the time of evaluation) that would interfere with follow-up and the validity of outcome assessment.\n* Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.\n* Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g., active substance abuse, alcoholism, HIV\u002FAIDs, end-stage cancers, learning disabilities, developmental disorders)\n* Patients on psychiatric hold\n* Prisoners or patients in custody\n* Pregnancy in female subjects\n* Low likelihood of follow-up (e.g., participants or family indicating low interest, residence in another state or country, homeless or lack of reliable contacts)\n* Current participant in an interventional trial (e.g., drug, device, behavioral)\n* Penetrating TBI\n* Spinal cord injury with ASIA score of C or worse\n* Contraindications to MRI","80 Years",{"count":53,"type":21},130,"OBSERVATIONAL","Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\\\u003C 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.",[57,58,59,60,61],"Traumatic Brain Injury With Loss of Consciousness","Brain Injury Traumatic Severe","Brain Injury Traumatic Moderate","TBI (Traumatic Brain Injury)","TBI","RECRUITING",{"date":34,"type":35},{"date":65,"type":35},"2023-09-01",{"date":67,"type":21},"2029-05-31",{"name":41,"class":42},3,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100530236","ceus-vs-amri-for-hcc-detection-in-patients-with-indeterminate-liver-nodules-100530236","NCT06184152","CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules","Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules","Inclusion Criteria:\n\n* Child A or B cirrhosis from any etiology with at least one ILN on 4-phase CT, contrast- enhanced MRI, or contrast enhanced US but without HCC at baseline.\n* Adults 18 years old and above\n\nExclusion Criteria:\n\n* Patients post liver transplantation\n* Patients with concurrent or prior HCC (LR-5 or biopsy proven)\n* other liver cancer including cholangiocarcinoma\n* Patients with any active extra-hepatic malignancy\n* Patients with significant comorbidity and limited life expectancy, e.g., stage D congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit\n* Patients with contraindication to contrast-enhanced MRI or CEUS, including implanted medical devices that are considered MR unsafe and severe claustrophobia",{"count":78,"type":21},600,[80],"NA","The study will be conducted at the following locations:\n\n1. UT Southwestern Medical Center\n2. Parkland Health and Hospital System\n3. University of Michigan\n\nInvestigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.",[83,84],"HCC","Hepatocellular Carcinoma",[86,87,88],"LR3","LR4","HCC Surveillance",{"date":34,"type":35},{"date":91,"type":35},"2023-11-28",{"date":93,"type":21},"2028-11-28",{"name":41,"class":42},2,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":43},"100259000","genetic-and-metabolic-disease-in-children-100259000","NCT02650622","Genetic and Metabolic Disease in Children","Genetic Regulators of Metabolism and Development in Children","Inclusion criteria of Cohort 1- Newborn:\n\n* Subjects aged 1-2 days\n* Subjects with gestational age 37-42 weeks\n* Subjects with stable clinical status (admitted to normal newborn nursery)\n\nInclusion criteria of Cohort 2 - Older children:\n\n• Subjects aged 0-18 years\n\nInclusion criteria of Cohort 3 - Diseased children:\n\nSubjects (no age limit) with ANY phenotype as below:\n\n* Confirmed metabolic or genetic diseases\n* Suspected metabolic or genetic diseases\n* Episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia, metabolic acidosis)\n* Developmental regression\n* Major congenital malformation\n* Other unexplained symptoms of potential genetic origin\n\nExclusion criteria of Cohort 1 - Newborn:\n\n* Subjects with gestational age \\\u003C37 weeks or \\>42 weeks\n* Subjects with overt signs of metabolic dysfunction, distress or genetic diseases including hypoglycemia, hyperglycemia, sepsis\u002Fshock, hypoxemia, or major congenital malformation\n* Subjects with mothers whose pregnancies were complicated by gestational diabetes, gestational hyperglycemia, gestational hypertension, preeclampsia, or any other major disorders.\n\nExclusion criteria of Cohort 2 - Older children:\n\n* Subjects with confirmed metabolic or genetic diseases\n* Subjects with suspected metabolic or genetic diseases\n* Subjects with episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia, metabolic acidosis)\n* Subjects with developmental regression\n* Subjects with major congenital malformation\n\nExclusion criteria of Cohort 3 - Diseased children No.","1 Day",{"count":105,"type":21},1550,"This is a prospective, non-randomized, non-blinded observational study. The overarching goal is to discover new disease-associated genes in children, while establishing a specific focus on disorders where molecular characterization is most likely to lead to novel therapies. This study will merge detailed phenotypic characterization of patients presenting to the Pediatric Genetics and Metabolism Division in the Department of Pediatrics\u002FChildren's Medical Center at Dallas and collaborating clinics with Next-Generation sequencing techniques to identify disease-producing mutations. The primary objective of the study is to identify novel pathogenic mutations in children with rare Mendelian disorders. A secondary objective of the study is to establish normative ranges of a large number of metabolites from healthy newborns and older children.",[108,109],"Genetic Diseases","Metabolic Diseases",[111,112,113,114],"Metabolism","Genetics","Metabolomics","Genomics",{"date":34,"type":35},{"date":117,"type":35},"2015-06",{"date":119,"type":21},"2030-05",{"name":41,"class":42},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100645371","phase-2-phase-2-study-of-pembrolizumab-and-lenvatinib-in-anal-squamous-cell-cancer-100645371","NCT07680088","Phase 2 Study of Pembrolizumab and Lenvatinib in Anal Squamous Cell Cancer","A Multicenter Single-arm Phase 2 Study of Pembrolizumab and Lenvatinib in Previously Treated Inoperable or Advanced Anal Squamous Cell Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of anal squamous cell carcinoma.\n2. The participants should have inoperable local recurrence or advanced cancer (stage 4; any T, any N, M1).\n3. The participants should have received at least one prior line of cytotoxic chemotherapy regimen in palliative setting or have declined cytotoxic chemotherapy use or have a contraindication to receive chemotherapy. Prior use of PD-1 systemic therapy is allowed\n4. ECOG Performance status: 0, 1 or 2.\n5. Adequate organ and bone marrow function as outlined below:\n\n   * Absolute neutrophil count (ANC): ≥1500\u002FµL\n   * Platelets: ≥100 000\u002FµL\n   * Creatinine; creatinine clearance GFR can also be used in place of creatinine or CrCl): Creatinine ≤1.5 × ULN OR Creatinine Clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n   * Total bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n   * aspartate aminotransferase (serum glutamic oxaloacetic transaminase) - AST (SGOT) and ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase) - ALT (SGPT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): INR ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n6. A participant will be eligible for inclusion in the study if the participant:\n\n   Female Participants\n\n   • Is not a Women Of Child Bearing Potential (WOCBP): OR\n\n   • Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix D during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever date occurs last. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n   * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) during screening (for the purpose of confirming eligibility\u002Fenrollment).\n   * Note: If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. (WOCBP should also have a negative pregnancy test within 24 hours before the first dose of study intervention (cycle1 day 1) as described in schedule of Activities Table).\n\n   Male Participants\n\n   Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of lenvatinib:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below and in Appendix D:\n\n     * Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n     * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n   * Please note that 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed.\n7. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n8. Archival tumor tissue sample or fresh core biopsy of a tumor lesion is available. In a situation where a safe and suitable site for a fresh biopsy is not feasible and an archival tissue is not available; patients may still be eligible to enroll after discussing with UTSW PI.\n9. Have adequately controlled BP with or without antihypertensive medications, defined as BP ≤150\u002F90 mm Hg with no change in antihypertensive medications within 1 week before C1D1.\n10. The subject's urinary protein is \\\u003C 1+ on dipstick or routine urinalysis; if urine protein \\> 2+, a 24-hour urine must be collected and must demonstrate \\\u003C 1000 mg of protein in 24 hours to allow participation in the study.\n11. Has a left ventricle ejection fraction \\> 45% as determined by multi-gated acquisition (MUGA) or 2D echocardiogram (ECHO). If patient is asymptomatic and there is a documented MUGA or 2D ECHO completed in the last 18 months, then this will be adequate to confirm eligibility.\n12. Patients receiving therapeutic anticoagulation should be on a stable anticoagulant regimen within 14 days prior to first dose of study drug.\n13. Subjects must have recovered from prior treatment-related toxicities to grade 1 or baseline (Some exception to criterion are, alopecia or clinically stable chronic toxicities that may be requiring ongoing medical management but are not affecting daily function as per investigator assessment, e.g. hypothyroidism or chemotherapy-induced neuropathy etc.).\n14. Participants who have known history of HBV infection are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to C1D1.\n\n    * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n    * Hepatitis B screening tests are not required unless:\n\n      * Known history of HBV infection\n      * As mandated by local health authority or institution\n15. Participants with known history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n    * Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n    * Hepatitis C screening tests are not required unless:\n\n      * Known history of HCV infection\n      * As mandated by local health authority or institution\n16. Participants with known history of HIV infection must have well-controlled HIV on anti-retroviral therapy (ART), defined as:\n\n    * Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n    * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n    * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n    * Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.\n    * The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)\n17. Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Has received chemotherapy within 2 weeks prior to starting study treatment.\n2. Has received any investigational agents for the treatment of the cancer under study within 3 weeks of start of the study.\n3. Has received prior radiotherapy within 3 weeks of start of study intervention or suffers from radiation-related toxicities requiring corticosteroids.\n4. Had a major surgery within 3 weeks prior to first dose of study interventions or has not adequately recovered from a previous major surgery or has ongoing surgical complications, in the opinion of the investigator, that would limit participation in study. Note: Adequate wound healing after major surgery must be assessed clinically by investigator or qualified designee.\n5. Has an uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection requiring systemic antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.\n6. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided participants are not on steroid treatment for the CNS metastasis at least 14 days prior to first dose of study intervention. An MRI assessment of the brain may be needed during Screening if clinically indicated as per investigator.\n7. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula\n8. Has a left ventricle ejection fraction \\\u003C45% as determined by multi-gated acquisition (MUGA) or 2D echocardiogram (ECHO). Among patients with a prior known history of congestive heart failure with a low ejection fraction, then ejection fraction assessment will be performed during screening to determine eligibility.\n9. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n10. Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. NOTE: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n11. Have prolongation of QTc interval to \\>480 ms.\n12. Has a history of gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator.\n13. Has an active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n14. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n15. Has received chronic systemic steroid therapy (exceeding 10 mg daily dose of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n16. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).\n17. Has a known additional malignancy that is progressing or has required active systemic treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n18. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n19. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lenvatinib or Pembrolizumab used in study.\n20. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. Has a concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\n    Note: Hepatitis B and C screening tests are not required unless:\n    * Known history of HBV and HCV infection\n    * As mandated by local health authority or institution\n22. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":129,"type":21},17,[131],"PHASE2","The goal of this clinical trial is to see the safety and efficacy of pembrolizumab and lenvatinib in patients with anal squamous cell cancer that cannot be removed through surgery or is spread to other organs. Eligible participants should have also received some form of standard therapy previously for their advanced cancer.\n\nParticipants will be required to come for a clinic visit and infusion of pembrolizumab. Lenvatinib will be taken by mouth at home based on direction provided by physicians and research team.",[134],"Anal Squamous Cell Carcinoma","2026-06-25",{"date":34,"type":35},{"date":138,"type":21},"2026-09-30",{"date":140,"type":21},"2030-09-30",{"name":41,"class":42},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":150,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":43},"100617024","phase-2-phase-ii-trial-of-psa-response-based-androgen-deprivation-therapy-and-nodal-coverage-for-prostate-cancer-early-salvage-radiotherapy-ranger-100617024","NCT07313241","Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)","Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy","(RANGER)","Inclusion Criteria:\n\n* Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥0.05ng\u002FmL.\n* Radical prostatectomy ≥4 months prior to enrollment without nodal involvement (pN0 or pNx)\n* Performance status ECOG 0-2\n* No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows:\n\n  * PSA\\>=0.2ng\u002FmL: positron emission tomography (PET) with FDA-approved advanced imaging agent for prostate cancer (e.g. PSMA) required.\n  * PSA \\\u003C0.2 n\u002Fgm: PET with above noted agents OR conventional CT or MRI at investigator discretion.\n* All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior androgen deprivation therapy (ADT) \\> 3 months OR anti-androgen therapy (AAT) of \\> 30 days. For shorter courses of either, at least 30 day \"wash out\" period is required with confirmation of resolved castration of testosterone to \\>50ng\u002FmL.\n* Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥0.05ng\u002FmL and non-castrate testosterone \\>50ng\u002FmL after 14 days of TRT cessation)\n* Prior pelvic radiotherapy\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, in the opinion of the investigator, would limit compliance with study requirements.\n* History of bladder neck or urethral stricture requiring procedural intervention.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to actively interfere with the safety or efficacy assessments of this study in the investigator's view.\n* Active inflammatory bowel disease requiring recurring systemic or steroid\u002Fenema therapy","MALE",{"count":152,"type":21},68,[131],"This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.",[156],"Prostate Cancer",{"date":32,"type":35},{"date":159,"type":35},"2025-11-14",{"date":161,"type":21},"2030-11-14",{"name":41,"class":42},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":150,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":43},"100644944","early-phase-1-response-with-interim-psma-pet-in-metastatic-castration-sensitive-prostate-cancer-for-optimization-of-adaptive-metastasis-directed-radiotherapy-delivery-100644944","NCT07674771","Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery","RIPCORD","Inclusion Criteria:\n\n1. History of pathologically confirmed prostate cancer.\n2. Age \\>=18 years.\n3. Performance status ECOG 0-2.\n4. Staging 68Ga PMSA-11 PET\u002FCT showing 4-20 sites of metastasis from prostate cancer within \\\u003C=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).\n5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.\n6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.\n2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.\n3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.\n4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.\n5. History of allergic reactions to PMSA-11 68Ga imaging agent.\n6. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.",{"count":171,"type":21},30,[24],"The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.",[175,156,176],"Castrate Sensitive Prostate Cancer","Metastasis Castration Resistant Prostate Cancer(mCRPC)",[178,179,180,181,182],"metastatis","poly-metastatic","prostate cancer","castration sensitive","radiotherapy","2026-06-24",{"date":32,"type":35},{"date":186,"type":21},"2026-07-15",{"date":188,"type":21},"2029-06-15",{"name":41,"class":42},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":43},"100570861","early-phase-1-feasibility-study-of-personalized-ultra-fractionated-stereotactic-ablative-radiotherapy-pulsar-for-cancers-of-the-central-lung-100570861","NCT06712745","Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung","Inclusion Criteria:\n\n1. Age ≥ 18 years of age.\n2. Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.\n3. Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.\n4. Tumor entirely within the 2 cm \"central zone\" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.\n5. Zubrod\u002FECOG Performance Status 0-2 within 30 days prior to registration.\n6. Ability to tolerate MRI.\n7. All men, as well as women of child-bearing potential\\* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of consent, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nNote: A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.\n2. Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and\u002For surgery) while on this study, except at disease progression.\n3. Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.\n4. Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.",{"count":171,"type":21},[24],"The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.",[200,201],"Cancer, Lung","Metastasis",[203,204,205,206,207,208,209],"lung","central lumg","cancer","metastasis","PULSAR","non small cell lung cancer","NSCLC",{"date":211,"type":35},"2026-06-29",{"date":213,"type":35},"2025-09-19",{"date":215,"type":21},"2028-12-30",{"name":41,"class":42},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":17,"minAge":225,"maxAge":51,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":43},"100571980","phase-1-mtor-inhibitors-in-older-adults-100571980","NCT06727305","MTOR Inhibitors in Older Adults","Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .","Inclusion Criteria:\n\n1. Community-dwelling adults\n2. Patients should be 65 Years and older\n3. Patients is able to understand and follow trial procedures\n\nExclusion Criteria:\n\n1. Creatinine clearance \\\u003C30 mL\u002Fmin;\n2. History of chronic liver disease;\n3. Uncontrolled Hypertension (i.e., systolic blood pressure \\>160 mm Hg);\n4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;\n5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;\n6. Planned major surgical procedures;\n7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);\n8. Taking medication that increase or decrease sirolimus blood concentrations;\n9. Other investigational therapy received within 1 month prior to screening visit;\n10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.",true,"65 Years",{"count":20,"type":21},[228,131],"PHASE1","Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications",[231],"Aging",[231,233,234],"Geriatic","Disability","2026-06-23",{"date":135,"type":35},{"date":238,"type":35},"2026-05-11",{"date":240,"type":21},"2027-11-13",{"name":41,"class":42},{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":249,"maxAge":51,"enrollmentInfo":250,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":252,"conditions":253,"keywords":259,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":69},"100476869","subclinical-transthyretin-cardiac-amyloidosis-in-v122i-ttr-carriers-100476869","NCT05489549","Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers","Identifying Subclinical Transthyretin Cardiac Amyloidosis in Asymptomatic Carriers of the V122I TTR Allele","(V122I TTR carriers and carriers of other pathogenic TTR alleles (or matched non-carriers))\n\nInclusion Criteria:\n\n* Men and women ages 30-80 who are carriers of pathogenic TTR alleles (or matched non-carriers) without history of HF (this will be assessed by study personnel) and defined as: a) No history of hospitalization within the previous 12 months for management of HF; b) Without an elevated B-type natriuretic peptide level ≥100 pg\u002FmL or NT-proBNP ≥360 pg\u002FmL within the previous 12 months; or c) No clinical diagnosis of HF from a treating clinician\n* Signed informed consent\n\nExclusion Criteria:\n\n* A self-reported history or clinical history of HF\n* Other known causes of cardiomyopathy\n* History of light-chain cardiac amyloidosis\n* Prior type 1 myocardial infarction (non-ST segment elevation myocardial Infarction {NSTEMI} or ST-elevation myocardial infarction {STEMI})\n* Cardiac transplantation\n* Body weight \\>250 lbs\n* Estimated glomerular filtration rate ≤30 mL\u002Fmin\u002F1.73 m2\n* Inability to safely undergo CMRI\n\n(For participants with symptomatic hATTR-CA, we will enroll probands with HF from Aim 1 or patients with suspected symptomatic hATTR-CA from the three study sites.)\n\nInclusion Criteria:\n\n* Men and women ages 30-80 who have symptomatic hATTR-CA as determined by a history of HF (this will be assessed by study personnel) and defined as: a) History of hospitalization within the previous 12 months for management of HF; b) An elevated B-type natriuretic peptide level ≥100 pg\u002FmL or NT-proBNP ≥360 pg\u002FmL within the previous 12 months; or c) A clinical diagnosis of HF from a treating clinician.\n* Have an established or suspected diagnosis of hATTR-CA based on either a) Biopsy confirmed by Congo red (or equivalent) staining with tissue typing with immunohistochemistry or mass spectrometric analysis or immunoelectron microscopy, OR b) positive technetium-99m (99mTc)-pyrophosphate or -bisphosphonate scan, combined with accepted laboratory criteria without abnormal M-protein.\n* TTR gene sequencing that is pending or that is confirming the pathogenic TTR variant\n* Signed informed consent\n\nExclusion Criteria:\n\n* Other known causes of cardiomyopathy\n* History of light-chain cardiac amyloidosis\n* Cardiac transplantation\n* Liver transplantation\n* Previous treatment with a TTR stabilizer (tafamidis, acoramidis) within the prior 14 days or TTR any silencer (inotersen, patisiran, eplontersen)\n* Estimated glomerular filtration rate ≤30 mL\u002Fmin\u002F1.73 m2","30 Years",{"count":251,"type":21},500,"Approximately 1.5 million of the 44 million Blacks in the United States are carriers of the valine-to-isoleucine substitution at position 122 (V122I) in the transthyretin (TTR) protein. Virtually exclusive to Blacks, this is the most common cause of hereditary cardiac amyloidosis (hATTR-CA) worldwide. hATTR-CA leads to worsening heart failure (HF) and premature death. Fortunately, new therapies that stabilize TTR improve morbidity and mortality in hATTR-CA, especially when prescribed early in the disease. However, hATTR-CA is often diagnosed at an advanced stage and conventional diagnostic tools lack diagnostic specificity to detect early disease.\n\nThe overall objectives of this study are to determine the presence of subclinical hATTR-CA and to identify biomarkers that indicate amyloid progression in V122I TTR carriers. The central hypothesis of this proposal is that hATTR-CA has a long latency period that will be detected through subclinical amyloidosis imaging and biomarker phenotyping.\n\nThe central hypothesis will be tested by pursuing 2 specific aims: Aim 1) determine the association of V122I TTR carrier status with CMRI evidence of amyloid infiltration; Sub-aim 1) determine the association of V122I TTR carrier status with cardiac reserve; Aim 2) determine the association between amyloid-specific biomarkers and V122I TTR carrier status; and Sub-aim 2) determine the association of amyloid-specific biomarkers with imaging-based parameters and evaluate their diagnostic utility for identifying subclinical hATTR-CA. In Aim 1, CMRI will be used to compare metrics associated with cardiac amyloid infiltration between a cohort of V122I TTR carriers without HF formed by cascade genetic testing and age-, sex-, and race-matched non-carrier controls. For Sub-Aim 1, a sub-sample of carriers and non-carrier controls enrolled in Aim 1 will undergo novel exercise CMRI to measure and compare cardiac systolic and diastolic reserve. Aim 2 involves measuring and comparing amyloid-specific biomarkers in V122I TTR carriers without HF with samples matched non-carriers (both from Aim 1) and individuals with symptomatic V122I hATTR-CA from our clinical sites. These biomarkers detect and quantify different processes of TTR amyloidogenesis and include circulating TTR, retinol binding protein 4, TTR kinetic stability, and misfolded TTR oligomers. Sub-aim 2 will establish the role of these biomarkers to detect imaging evidence of subclinical hATTR-CA disease.",[254,255,256,257,258],"Amyloidosis, Hereditary","Amyloidosis Cardiac","Amyloidosis, Familial","Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy","Transthyretin Gene Mutation",[260,261,262,263,264],"Amyloidosis","Transthyretin Amyloidosis","V122I TTR","p.Val142Ile TTR","Cardiac magnetic resonance imaging",{"date":266,"type":35},"2026-06-26",{"date":268,"type":35},"2022-11-21",{"date":270,"type":21},"2027-06-30",{"name":41,"class":42},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":289,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":43},"100596878","recovery-through-inspiration-support-and-empowerment-100596878","NCT07051200","Recovery Through Inspiration, Support, and Empowerment","RISE","Inclusion Criteria:\n\n* Chief complaint of suicidal ideation, suicide attempt, depression, and\u002For anxiety\n* discharged from inpatient care or from emergency department\n* men and women ages 18-27\n\nExclusion Criteria:\n\n* primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)","27 Years",{"count":281,"type":21},40,[80],"The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.\n\nThe current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.\n\nThe intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).\n\nParticipants will be assigned to either Cohort A or B for 8 weeks.\n\nCohort A will be the intervention group with PSS and RCOs.\n\n* Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4.\n* Weeks 5 and 7: One-on-one meetings with PSS for education and support.\n* Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.\n\nCohort B will be the SOC group with no PSS or RCOs.\n\n* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4.\n* Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.\n\nData collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.",[285,286,287,288],"Suicidal Ideation","Suicide Attempt","Anxiety","Depression Disorders",[290,291,292,293,294,295],"Peer Support Specialist (PSS)","Recovery Community Organization (RCO)","Mental Health Recovery","Transitional Age Youth (TAY)","UT Southwestern Medical Center","Young Adult","2026-06-22",{"date":135,"type":35},{"date":299,"type":35},"2025-04-01",{"date":301,"type":21},"2027-12-01",{"name":41,"class":42},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":43},"100375766","phase-2-erlotinib-for-hepatocellular-carcinoma-chemoprevention-100375766","NCT04172779","Erlotinib for Hepatocellular Carcinoma Chemoprevention","Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention","ECHO-B","Inclusion Criteria:\n\n* Adults (≥ 18 years-old)\n* Clinically and\u002For histologically diagnosed advanced liver fibrosis or cirrhosis\n* No active hepatic decompensation\n* No prior history of HCC\n* FIB-4 index \\> 3.25\n* PLSec score ≥ 3\n* Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70\n* Both sexes and all racial\u002Fethnic groups will be considered\n\nExclusion Criteria:\n\n* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors\n* Uncontrolled intercurrent, use of CYP3A4 modulators\n* Erlotinib treatment \\\u003C4 weeks or \\\u003C80% of planned regimen at the end of week 4\n* HCC development during the study",{"count":20,"type":21},[131],"This phase II randomized placebo-controlled trial studies low-dose erlotinib treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with advanced liver fibrosis or cirrhosis.",[315,316],"Cirrhosis, Liver","Advanced Liver Fibrosis",[30,318],"chemoprevention","2026-06-20",{"date":183,"type":35},{"date":322,"type":21},"2026-12",{"date":324,"type":21},"2030-08",{"name":41,"class":42},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":345,"locationsCount":43},"100622749","early-phase-1-imaging-acetadote-metabolism-in-glioblastoma-100622749","NCT07387666","Imaging Acetadote Metabolism in Glioblastoma","A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* 1\\. Glioblastoma\n* 2\\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent\n* 3\\. Age ≥18 years\n* 4\\. KPS \\> 70\n* 5\\. Adequate organ and marrow function as defined below:\n* \\- Bilirubin ≤1.5 times upper limit of normal\n* \\- AST and ALT ≤ 3 times ULN\n* \\- Creatinine ≤ 1.5 x ULN and\u002For GFR ≤ 60 mL\u002Fmin\n* -ANC ≥ 1000 cells\u002Ful\n* \\- Platelet ≥ 100,000\u002Ful\n* \\- Hemoglobin ≥ 9 g\u002Fdl\n* 6\\. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n* \\- Has not undergone a hysterectomy or bilateral oophorectomy; or\n* \\- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* 7\\. Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.\n* 2\\. Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).\n* 3\\. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.\n* 4\\. Brain metastases\n* 5\\. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.\n* 6\\. 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, in the opinion of the investigator, would limit compliance with study requirements.\n* 7\\. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",{"count":334,"type":21},10,[24],"This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors.\n\nThe investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.",[338,339],"Glioblastoma","GBM","2026-06-18",{"date":235,"type":35},{"date":340,"type":35},{"date":344,"type":21},"2028-07-01",{"name":41,"class":42},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":354,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":365,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":43},"100641620","phase-2-reducing-inflammation-to-improve-vascular-and-bone-outcomes-with-low-dose-colchicine-in-ckd-100641620","NCT07654231","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)","RESOLVE-CKD","Inclusion Criteria:\n\n* Men and women aged 18-\\\u003C70 years of all race\u002Fethnicity groups\n* CKD stage 3 (estimated glomerular filtration rate (eGFR) \\>30 to 59 ml\u002Fmin\u002F1.73m2)\n* Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg\u002Fg\n* Cardiac artery calcification (CAC) Agatston score ≥30\n* Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Current Colchicine therapy\n* Hepatic disease\n* Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.\n* Immunosuppression\n* Current use of chemotherapy drugs or active cancer\n* Pregnancy\u002Fbreastfeeding\n* Hospitalized within the past 6 months\n* Allergic\u002Fintolerance to colchicine\n* Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir\u002Fritonavir, Saquinavir, Nelfinavir)\n* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)\n* Human immunodeficiency virus (HIV) infection\n* Gout attack ≥ 1 time per year\n* Severe anemia (hemoglobin \\\u003C 8 g\u002Fdl for women and \\\u003C 9 g\u002Fdl for men)\n* eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* uACR \\\u003C200 mg\u002Fg\n* White blood cell count (WBC) \\\u003C3.0 x109\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x Upper Limit of Normal (ULN)\n* Total bilirubin \\>2 x ULN\n* Glucose \\>300mg\u002Fdl\n* Uses nicotine products or other recreational drugs\n* Unable to read or speak English\n* Participant in other conflict clinical trial,\n* Unable to complete the study measurements\n* Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans\n* Unsafe to participate in this study per investigator's judgement.","69 Years",{"count":20,"type":21},[131],"The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.\n\nSuccessful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.",[359,360,361,362,363,364],"Chronic Kidney Disease Mineral and Bone Disorder","Hypertension","Diabetes","Dyslipidemia","Atherosclerotic Cardiovascular Disease (ASCVD)","Chronic Kidney Disease (Stage 3)",[366,367,368,369],"Chronic Kidney Disease","CVD","vascular calcification","Colchicine","2026-06-17",{"date":296,"type":35},{"date":373,"type":21},"2026-07-01",{"date":375,"type":21},"2027-12-31",{"name":41,"class":42},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},"100441563","phase-1-cd40-agonist-flt3-ligand-and-chemotherapy-in-her2-negative-breast-cancer-100441563","NCT05029999","CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer","Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Unresectable Stage III or Stage IV HER2 negative breast cancer (either triple negative or hormone receptor positive)\n\n  * Triple negative breast cancer for this study is defined as estrogen receptor \\\u003C10%, progesterone receptor \\\u003C10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.\n  * Hormone receptor positive breast cancer for this study is defined as either estrogen receptor ≥10% or progesterone receptor ≥10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.\n* Age 18 years or older\n* Performance status ECOG 0-2\n* Life expectancy ≥ 12 weeks\n* Documented progressive disease, based on radiographic, clinical or pathologic assessment, during or subsequent to last anticancer therapy. Patients who need to change systemic therapy for other indications such as toxicity that are otherwise eligible for this study may enroll with approval of the lead principal investigator.\n* For triple negative breast cancer patients, subject is in first to fourth line setting of treatment for metastatic or unresectable disease, and have received 0 to 3 prior regimens for metastatic or unresectable disease.\n* For hormone receptor positive breast cancer patients, subjects must have received prior cyclin dependent kinase inhibitor in the metastatic setting. They may have received up to 3 prior lines of chemotherapy and\u002For antibody drug conjugates for metastatic or unresectable disease.\n* Among triple negative breast cancer patients enrolled in the first line treatment setting, subjects must be PD-L1 negative by 22C3 assay and not be eligible for FDA approved standard of care chemotherapy and anti-PD-1\u002FPD-L1 combination therapy as alternative to this clinical trial. This does not apply if patients have previously received PD-1 or PD-L1 blockade as part of neoadjuvant or adjuvant therapy regimen.\n* Screening laboratory values must meet the following criteria:\n\n  * Neutrophils ≥ 1500\u002FuL\n  * Platelets ≥ 100 x10(9)\u002FL\n  * Hemoglobin ≥ 8 g\u002FdL Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n  * Creatinine ≤ 2 mg\u002FdL\n  * Creatinine clearance \\>30 mL\u002Fminute\n  * AST ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n  * ALT ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n  * Total Bilirubin ≤ 1.5 X ULN (except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin ≤ 2 X ULN)\n  * Alkaline phosphatase ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n* All men as well as women of child bearing potential enrolled in this trial must agree to use effective contraception during the course of the trial and for at least 6 months after discontinuing study treatment. Patients and\u002For partners who are surgically sterile or postmenopausal are exempt from this requirement.\n\n  * A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ( 1) has not undergone a hysterectomy or bilateral oophorectomy OR (2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Provision of consent for pre-treatment and on-treatment biopsies. Biopsy sites must be soft tissue tumor lesions or accessible visceral diseases that can be biopsied with acceptable clinical risk (as judged by the investigator); are large enough to allow for the collection of tumor tissue for proposed correlative studies (e.g., anticipated goal of 6-8 cores preferred when feasible using a ≥ 18 gauge needle with an expected core sample length of 5 mm); and have not been irradiated prior to entry. This does not include bone lesions. This may exclude many lung lesions and small lesions.\n* Measurable disease allowing for serial assessment of at least one target lesion(s) by RECIST 1.1 criteria \\[100\\]. Target lesions selected for tumor measurements should be those where additional (e.g., palliative) treatments are not indicated or anticipated.\n* All residual toxicity related to prior anticancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must resolve to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n* Read, understood, and provided written informed consent, and if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization, after the nature of the study has been fully explained, and must be willing to comply with all study requirements and procedures.\n\nExclusion Criteria:\n\n* Among any patients enrolled in the first line treatment setting, tumors should not be PD-L1+ by 22C3 assays or eligible for FDA approved standard of care chemotherapy and anti-PD-1\u002FPD-L1 combination therapy as alternative to this clinical trial. This does not apply if patients have previously received PD-1 or PD-L1 blockade as part of neoadjuvant or adjuvant therapy regimen.\n* History of severe hypersensitivity reactions to mAbs.\n* Prior treatment with any anti-CD40 antibody or rhuFlt3L product.\n* Treatment with anthracycline in the metastatic setting.\n* Prior progression while on anthracycline based therapy or within 6 months of completing neoadjuvant or adjuvant anthracycline.\n* Prior history of acute myeloid leukemia (AML), or tumor with known Flt3 mutation\u002Famplification\n* Receipt of any antibody targeting T cell check point or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.\n* Chemotherapy or antibody drug conjugate within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.\n* Any kinase inhibitors within 2 weeks prior to the first dose of study treatment.\n* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Use of other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment administration.\n* Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment. Topical, inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the patient is on a stable dose. Non-absorbed intraarticular corticosteroid and replacement steroids (≤ 10 mg\u002Fday prednisone or equivalent) will be permitted.\n* Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases.\n* Patients with known treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment. Continued use of steroids and\u002For anticonvulsants (in the absence of any suspicion of progressive brain metastases) is acceptable if ≤ equivalent of prednisone 10 mg daily. Brain MRI required on screening to document lack of progression.\n* Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting treatment.\n* Active autoimmune disease or history of autoimmune disease or syndrome that required systemic steroids or immunosuppressive medications within the preceding 6 months, except for patients with vitiligo, endocrinopathies, or type 1 diabetes, Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) who have not been hospitalized for asthma in the preceding 6 months will not be excluded from this study.\n* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure (New York Heart Association Class III or IV or EF\\\u003C50%) related to primary cardiac disease, uncontrolled ischemic or severe valvular heart disease or any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, severe\u002Funstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack.\n* For patients with triple negative breast cancer- prior anthracycline therapy with a cumulative doxorubicin-equivalent dose greater than 240 mg\u002Fm2. 240 mg\u002Fm2 anthracycline is equivalent to 4 doses of anthracycline-based chemotherapy in the localized setting (generally 60 mg\u002Fm2 per dose). Notes from physicians demonstrating 4 prior cycles\u002Fdoses of anthracycline or if less than 60 mg\u002Fm2 specifying as such to estimate the total anthracycline dose is sufficient. Exact calculation based on mg received originally is not required.\n* For patients with hormone receptor positive breast cancer who have received a prior anthracycline therapy with a cumulative doxorubicin-equivalent dose exceeding 240 mg\u002Fm2 (as was part of standard-of-care regimens in the past), a cardiology evaluation is recommended to minimize potential risks of heart damage.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. The COVID-19 vaccines available in the United States are not live vaccines and are allowed if the final vaccine dose (of a regimen that requires more than 1 dose) is received at least 1 week prior to study enrollment.\n* History of (non-infectious) pneumonitis or has current pneumonitis. This includes asymptomatic infiltrates on screening chest CT scan that are felt by the investigator to potentially be an inflammatory process (i.e. grade 1 pneumonitis).\n* Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C (antibody screen and if positive confirmed by RNA analysis). If positive results are not indicative of a true active or chronic infection, the patient can be enrolled after discussion with and agreement by the Investigator.\n* Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.\n* Evidence of acute or chronic infection on screening chest radiography.","99 Years",{"count":171,"type":21},[228],"This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.",[389,390],"HER2-negative Breast Cancer","Metastatic Breast Cancer","2026-06-15",{"date":370,"type":35},{"date":394,"type":35},"2022-04-20",{"date":396,"type":21},"2029-04-20",{"name":41,"class":42},7,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":406,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":95},"100409646","phase-2-single-cell-immune-and-non-immune-correlates-of-response-to-neoadjuvant-abemaciclib-100409646","NCT04614194","Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib","Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib and Letrozole in Hormone Receptor Positive Breast Cancer","INCLUSION CRITERIA:\n\n* Clinical stage operable stage I, II, or III invasive mammary carcinoma, which is estrogen receptor or progesterone receptor positive by immunohistochemistry and HER2 negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.\n* Have post-menopausal status, as defined by any of the following: Subjects at least 55 years of age OR Subjects under 55 years of age and amenorrheic for at least 12 months OR follicule stimulating hormone (FSH) values ≥ 40 IU\u002FL and estradiol levels ≤ 40 pg\u002FmL (140 pmol\u002FL) or in postmenopausal ranges per local or institutional reference ranges.\n* Breast tumor ≥1cm in diameter by either physical exam or ultrasound and suitable for pre and post-treatment tissue sampling.\n* Meet either of 2 following criteria, for which neoadjuvant endocrine therapy for 2 weeks is deemed suitable: 1) disease that is planned for surgery as initial therapy, in which 2 weeks of neoadjuvant endocrine therapy is deemed suitable, 2) Disease for which neoadjuvant systemic therapy (either chemotherapy or endocrine therapy) may be planned, in which 2 weeks of neoadjuvant endocrine therapy prior to start of systemic therapy is deemed suitable.\n* At least 18 years of age\n* Performance status ECOG ≤ 2\n* Have adequate organ function (ANC ≥1,500\u002FmcL, Platelets ≥100,000\u002FmcL, Hemoglobin ≥8 g\u002FdL, Total bilirubin ≤1.5 × upper limit of normal, ALT and AST ≤3 × upper limit of normal, Creatinine clearance \\>30 mL\u002Fminute\n* The patient is able to swallow oral medications\n* Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer.\n* Women may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 28 days prior to study enrollment.\n* Subjects have ended hormone replacement therapy at least 7 days prior to receiving the first dose of randomized therapy.\n* Ability to understand and the willingness to sign a written informed consent.\n* A female of childbearing potential, must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. These criteria should not apply to most or all patients on the trial given the inclusion criteria is for post-menopausal patients only who should not be of childbearing potential.\n\nNote: Contraceptive methods may include an intrauterine device \\[IUD\\] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse\u002Fpartner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation.\n\nEXCLUSION CRITERIA:\n\n* Active metastatic breast cancer, inflammatory breast cancer, or locally recurrent breast cancer.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).\n* Females who are pregnant, lactating, or premenopausal.\n* Severe uncontrolled malabsorption condition or disease (i.e. grade 2 or higher diarrhea, severe malnutrition, short gut syndrome).\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Chemotherapy, radiotherapy, or any other cancer therapy for current diagnosis of breast cancer.\n* Subjects may not have received or be receiving any other investigational agents for the treatment of the cancer under study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or other agents used in study.\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, in the opinion of the investigator, would limit compliance with study requirements.","FEMALE",{"count":20,"type":21},[131],"The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy and cyclin dependent kinase inhibitor therapy in patients with hormone receptor positive breast cancer. This will be studied by collecting tumor tissue and blood samples before and after 2 weeks of study treatment with commonly used endocrine therapy and cyclin dependent kinase inhibitor therapy.",[411],"Breast Cancer",{"date":370,"type":35},{"date":414,"type":35},"2021-04-15",{"date":416,"type":21},"2028-04-15",{"name":41,"class":42},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":95},"100603426","restore-study-r61-phase-recovery-and-engagement-for-stimulant-users-on-re-entry-100603426","NCT07136363","RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE","Inclusion Criteria:\n\n* Be 18 years of age or older\n* Have a DSM-5 diagnosis of stimulant use disorder (methamphetamine and\u002For cocaine)\n* Be at risk for or living with HIV\n* Be transitioning to the community from a closed justice setting, such as:\n\nJail Prison Justice-mandated residential substance use program\n\n* Be able to provide informed consent\n* Be willing and able to use a smartphone app (DynamiCare)\n\nExclusion Criteria:\n\n* Severe medical or psychiatric disability making participation unsafe\n* Unable to provide consent or engage with the intervention",{"count":281,"type":21},[80],"Justice-involved individuals face disproportionately high rates of stimulant use disorder and HIV, along with disrupted access to HIV treatment and prevention services like ART and PrEP. Contingency management (CM) is the most effective intervention for stimulant use, but its use in justice-involved populations has been limited by logistical and structural barriers. DynamiCare is an FDA-approved mobile app that delivers behavioral CM and has shown promise in reducing stimulant use, but its impact on HIV-related outcomes remains unknown. The RESTORE study (Recovery and Engagement for Stimulant Users on Re-entry) will evaluate whether combining DynamiCare with patient navigation (DynamiCare-plus) improves PrEP\u002FART initiation and reduces stimulant use among individuals recently released from justice settings. The R61 phase will assess feasibility, acceptability, and preliminary effectiveness among 40 participants. If milestones are met, the R33 phase will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost. This scalable, mobile approach has the potential to address a critical gap in care for a highly vulnerable population.",[430,431,432,433],"HIV","Stimulant Use Disorder","Justice Involved Populations","HIV Prevention","2026-06-12",{"date":391,"type":35},{"date":437,"type":35},"2026-06-01",{"date":439,"type":21},"2027-07-31",{"name":41,"class":42},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":224,"sex":17,"minAge":448,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":43},"100642540","the-return-of-cardiovascular-information-trial-recite-100642540","NCT07613853","The Return of Cardiovascular Information Trial (RECITE)","RECITE","Inclusion Criteria:\n\n* Attendance of the Dallas Heart Study-4 clinical visit\n* Participant confirms ability and willingness to utilize short links\u002FQR codes during clinical visit\n\nExclusion Criteria:\n\n* Did not attend the Dallas Heart Study-4 clinical visit\n* Did not confirm ability and willingness to utilize short links\u002FQR codes\n* Participants for whom a PREVENT-CVD score cannot be calculated (those who did not complete a laboratory collection, and\u002For height\u002Fweight measurements \\[for BMI calculation\\]), and\u002For BP assessment, and\u002For did not complete the medical history questionnaire)","35 Years",{"count":450,"type":21},1500,[80],"The goal of this behavioral interventional trial is to determine how best to communicate personalized cardiovascular risk information and support behavior change among participants enrolled in the Dallas Heart Study (DHS) cohort. The main questions it aims to answer are:\n\n* What are the effects of presenting health information in a coarse vs. granular manner? (This question will be measured by randomizing participants to two groups: one group will get a cover letter with their health information communicated in a more detailed manner, while another group will receive a cover letter which presents their health information in a coarse manner. Two letters will be sent containing the same information regarding their results. 4 months after the second letter, participants will be asked about changes made for their health after receiving the letter)\n* How curious are people about bettering their health after being presented their health information? (This question will be measured by placing QR codes linking educational health videos on each cover letter. Each letter will be sent twice with exactly the same health information but with new QR (Quick Response) codes. QR code use will be tracked by the study staff)\n\nResearchers will assess whether participants who received different style letters had different responses to their health behaviors and medication afterward and will measure this with a follow-up phone call. Researchers will also assess the use of QR codes showing health-related videos (about physical activity, heart-healthy diet, diabetes medication, statin medication) by sending out two different letters with the same health information and format, but with different QR code-linked videos.\n\nParticipants will:\n\n* Receive two letters in the mail, 4 weeks apart, containing their results from the Dallas Heart Study's 4th visit. The cover letter for this report will be randomized and will contain coarse vs. granular presentations of the participant's heart health risk.\n* Receive a follow up call after 4 months to assess: whether they received the letter, whether they understood the information provided, whether they made any health changes after receiving the letter, whether they saw a healthcare provider after receiving the letter, whether the letter prompted a new diagnosis by a doctor, and whether the participant made any medication changes after the letter.",[454,455],"Health Curiosity","Cardiovascular Health Risk Communication",[457,458],"Health information communication","Behavioral intervention trial","2026-06-11",{"date":391,"type":35},{"date":462,"type":35},"2026-04-22",{"date":464,"type":21},"2028-08",{"name":41,"class":42},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":474,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":483,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":43},"100625698","video-vs-direct-laryngoscopy-for-less-invasive-surfactant-administration-100625698","NCT07426016","Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration","Randomized Controlled Trial of Video-Laryngoscopy Intervention or Direct Laryngoscopy for Delivery of Less Invasive Surfactant Administration for Premature Infants","VID LISA","Inclusion Criteria:\n\n* Infants born ≤28 weeks GA successfully resuscitated in the delivery room (DR) and maintained on CPAP • Need for surfactant in the first 36 hours of life based on clinical assessment and\u002For meeting threshold per unit protocol\n\nExclusion Criteria:\n\n* Infants born ≥29 weeks GA or\n* Infants with known congenital anomalies or\n* Infants who are determined by the primary care team to receive comfort care only or\n* Infants who are intubated at any time prior to surfactant administration","0 Hours","3 Days",{"count":477,"type":21},100,[80],"Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs. The goal of the study is to compare the use of video-based visualization to direct visualization during a procedure called less invasive surfactant administration (LISA). The main questions the study aims to answer are: 1) does one method of visualization have a increased rate of giving the medicine successfully on the first attempt? 2) what benefits are there of each method?",[481,482],"Respiratory Distress Syndrome (Neonatal)","Surfactant Deficiency Syndrome Neonatal",[484,485,486],"less invasive surfactant","neonatal","video laryngoscopy",{"date":391,"type":35},{"date":459,"type":35},{"date":490,"type":21},"2028-11",{"name":41,"class":42},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":150,"minAge":499,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":43},"100344828","phase-3-trial-of-curcumin-to-prevent-progression-of-low-risk-prostate-cancer-under-active-surveillance-100344828","NCT03769766","Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance","A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance","Inclusion Criteria:\n\n* Age between 40-89 years\n* Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)\n* May have had biopsy within last 12 months\n* ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location.\n* Gleason score ≤6 with no Gleason pattern 4\n* Clinical stage T1c-T2a\u002Fb\n* Serum PSA ≤15 ng\u002Fml\n* Life expectancy \\> 5 years\n\nExclusion Criteria:\n\n* Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)\n* Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor\n* Use of anabolic steroids or drugs with antiandrogenic properties\n* Prostate volume \\>150 cm³\n* Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation\n* History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed.\n* Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study\n* Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy","40 Years","89 Years",{"count":502,"type":21},291,[504],"PHASE3","This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.",[156],[180,508,509],"active surveillance","curcumin",{"date":391,"type":35},{"date":512,"type":35},"2019-03-11",{"date":514,"type":21},"2030-11",{"name":41,"class":42},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":224,"sex":17,"minAge":18,"maxAge":225,"enrollmentInfo":523,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":43},"100487292","patients-with-and-without-phonotrauma-100487292","NCT05625191","Patients With and Without Phonotrauma","Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma","Control Group:\n\nInclusion Criteria:\n\n1. 18-65 years of age (to avoid confounding physiological factors related to puberty or presbyphonia)\n2. No history of or current voice disorder\n3. Auditory perceptual presentation globally within functional limits (as determined by a voice specialized SLP).\n\nExclusion Criteria:\n\n1. Atypical auditory-perceptual voice presentation\n2. History of voice disorder or laryngeal surgery.\n\nPatient Group:\n\nInclusion Criteria:\n\n1. Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist.\n2. 18-65 years of age\n\nExclusion Criteria:\n\n1. Diagnosis of voice disorder not related to phonotrauma (e.g., vocal fold immobility, laryngeal dystonia, primary muscle tension dysphonia, etc.)\n2. Previous history of laryngeal surgery or voice therapy (to avoid confounding effects of previous treatment).",{"count":477,"type":21},"There is a substantial need to identify objective measures associated with hyperadduction of the vocal folds to recognize those at higher risk of developing phonotrauma so that risk mitigation strategies can be implemented before phonotrauma develops. The overall objective of this proposed project is to investigate the sensitivity and direction of change in cepstral peak prominence (CPP) and the magnitude difference between the first two harmonics of the voice spectrum (H1-H2) in response to varied phonation patterns, which will be addressed using the following two aims:\n\nAim 1: Determine how CPP and H1-H2 change as a function of using pressed voice production in individuals without laryngeal pathology.\n\nAim 2: Examine the sensitivity (minimally detectable change) and responsiveness (minimal clinically important difference) of CPP and H1-H2 to detect changes in different voice production conditions.",[526],"Phonotrauma","2026-06-09",{"date":459,"type":35},{"date":530,"type":35},"2023-01-17",{"date":532,"type":21},"2026-12-31",{"name":41,"class":42},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":540,"maxAge":18,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":95},"100607060","maximizing-laser-therapy-success-for-port-wine-birthmarks-in-pediatric-patients-100607060","NCT07183644","Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients","Inclusion Criteria:\n\n* Diagnosis of Port Wine Stain.\n* Age Range: 2mo to 18 years of age.\n* Stable PWS: The port wine stain should be stable, meaning there is no active inflammation or infection present, and it should not be changing in size or color due to factors like injury or disease.\n* signed Consent: For ethical reasons, participants must be able to provide informed consent. In the case of minors, consent would generally be required from a parent or legal guardian.\n\nGeneral Health: Participants should generally be in good health, with no contraindications for laser therapy, such as certain skin conditions, infections, or hypersensitivity to light.\n\nExclusion Criteria:\n\n* severe allergies to anesthesia\n* active skin infections or inflammation\n* recent laser therapy\n* use of Photosensitizing medications\n* participation in other laser studies","2 Months",{"count":542,"type":21},200,[80],"In this study the investigators aim to optimize Port-Wine-Birthmark (PBW) laser therapy in children in order to reduce the number of laser treatments required for clearance and improve outcomes for refractory cases. This approach also seeks to reduce the frequency with which children require general anesthesia for treatment.",[546],"Port Wine Stains",[548,549,550,551,552],"combined laser therapy","PDL","Nd:YAG laser","port wine stain","port wine birthmark","2026-06-03",{"date":555,"type":35},"2026-06-05",{"date":557,"type":21},"2026-07",{"date":559,"type":21},"2028-09",{"name":41,"class":42},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":224,"sex":17,"minAge":568,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":581,"locationsCount":95},"100396771","cerebellar-tdcs-in-children-with-autism-spectrum-disorder-100396771","NCT04446442","Cerebellar tDCS in Children With Autism Spectrum Disorder","Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* 4-17 years old\n* Diagnosed with ASD and ADOS-2\n* IQ Score no less than 70 (1.5 Standard Deviations below the mean)\n* Language Level (Speech consists of, at minimum, flexible, spontaneous, simple, sentences)\n\nExclusion Criteria:\n\n* Brain implants, metal implants, pacemakers, or biomedical devices\n* Diagnosis of epilepsy\n* Hearing or visual impairments\n* History of brain injury\n* Known brain abnormalities not associated with ASD","4 Years","17 Years",{"count":20,"type":21},[80],"The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I\u002FII area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.",[574],"Autism Spectrum Disorder","2026-06-02",{"date":577,"type":35},"2026-06-04",{"date":579,"type":35},"2019-06-04",{"date":375,"type":21},{"name":41,"class":42},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":589,"maxAge":569,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":602,"leadSponsor":604,"locationsCount":43},"100622445","nudging-parental-actions-for-youth-suicide-prevention-100622445","NCT07383714","Nudging Parental Actions for Youth Suicide Prevention","Nudging Parental Action With A Randomized Controlled Trial of Text Messaging Intervention for Suicide Prevention","Inclusion Criteria:\n\n* Guardian must be able and willing to provide informed consent, and the participant must be able and willing to provide assent.\n* Parent and adolescent willingness and ability to participate in study procedures and complete assessments at baseline, 6 weeks, and 12 weeks.\n* Presentation to the ED for a suicide-related emergency, defined as suicidal ideation within the last 2 weeks or a suicide attempt within the past month.\n* Adolescents aged 12-17 years during the consent.\n* Access to a mobile phone with text messaging capability for the parent\u002Flegal guardian.\n* Ability to communicate in English.\n\nExclusion Criteria:\n\n* Absence of a legal guardian capable of providing consent.\n* Parents\u002Flegal guardians without access to a mobile phone with texting capability.\n* Inability to communicate in English.\n* Adolescents in state custody or under legal restrictions that prevent study participation.\n* Adolescents involved in the justice system in a manner that would interfere with study participation.\n* Adolescents with autism spectrum disorder or intellectual development disorder needing substantial or very substantial support","13 Years",{"count":591,"type":21},129,[80],"The goal of the study is to determine effectiveness of a behaviorally informed text messaging intervention to help parents increase safety practices and reduce their teens' access to lethal means following a suicide-related emergency department visit.",[595,286],"Suicide",[597,598,599],"suicide","digital health","lethal means restriction",{"date":553,"type":35},{"date":391,"type":21},{"date":603,"type":21},"2027-08-31",{"name":41,"class":42},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":43},"100546867","identification-of-metabolic-phenotypes-associated-with-melanoma-metastasis-100546867","NCT06400550","Identification of Metabolic Phenotypes Associated With Melanoma Metastasis","Inclusion Criteria:\n\n* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.\n* Subjects of all races and ethnic origins over age 18.\n\nExclusion Criteria:\n\n* Not a surgical candidate\n* Poorly controlled diabetes",{"count":612,"type":21},400,"The goal of this study is to observe metabolic features associated with human melanoma tumors.",[615],"Melanoma (Skin)",{"date":575,"type":35},{"date":618,"type":35},"2018-08-01",{"date":620,"type":21},"2028-08-01",{"name":41,"class":42},""]