[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"United States\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":675},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,25675,0,25,[9,47,79,109,135,165,196,218,245,267,290,319,351,373,404,433,456,477,502,530,555,575,611,630,653],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100653349","phase-2-pre-pubertal-low-dose-transdermal-estradiol-in-turner-syndrome-100653349",false,"NCT07784582","Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome","Ultra-low Dose Transdermal Estradiol Therapy in Prepubertal Girls With Turner Syndrome and Primary Ovarian Insufficiency.","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Female, aged 8 years up to 11 y and 180 days with karyotype confirmed Turner syndrome\n4. FSH result\\> 10miu\u002FmL in the past 12 months. Since variability in FSH is not uncommon, a single measure of FSH \\>10mIU\u002FmL in the past calendar year will be deemed sufficient for inclusion into the study even if repeat measures may be under 10mIU\u002FmL.\n5. Ability to take the transdermal estradiol medication and be willing to adhere to the treatment regimen\n6. Ability to complete the primary endpoint testing in English. Non-English speakers may be recruited if the participant is capable of performing the English version of the tests.\n\nExclusion Criteria:\n\n1. Spontaneous thelarche with breast Tanner stage 3 or more, spontaneous menarche or history of abnormal uterine bleeding.\n2. Previous estrogen exposure\n3. Cognitive impairment is severe enough to prevent assessment of the primary outcome measures.\n4. Untreated hypothyroidism or celiac disease: Individuals may be recruited if on treatment and stable medication dose in past 3 months.\n5. Subjects known to have Y-chromosome material unless they have undergone gonadectomy and have fully external female genitalia\n6. History of any type of malignancy\n7. History of a known clotting disorder\u002Fdeep venous thrombosis\n8. Any clinically significant abnormality as determined by the principal investigator.","FEMALE","8 Years","12 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a research study to find out if treatment with transdermal estradiol patches started between 8 to 11.5 years is safe in girls with Turner syndrome who have ovarian failure and to see whether it may improve performance on two tests of working speed and short-term memory.",[28,29],"Turner Syndrome","Primary Ovarian Insufficiency",[31,32,33,29],"Turner syndrome","Pre-pubertal","Transdermal estradiol","NOT_YET_RECRUITING","2026-08-24",{"date":37,"type":38},"2026-08-25","ACTUAL",{"date":40,"type":22},"2026-09-01",{"date":42,"type":22},"2027-06",{"name":44,"class":45},"Children's National Research Institute","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100652704","phase-1-base-edited-hematopoietic-stemprogenitor-cell-gene-therapy-for-treatment-of-cxcr4-whim-100652704","NCT07775313","Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","Phase 1\u002F2 Base-Edited Hematopoietic Stem\u002FProgenitor Cell Gene Therapy for Treatment of CXCR4-WHIM","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>= 3 years and weighing \\>=15 kg.\n* Confirmed CXCR c.1000C\\>T, pR334X mutation.\n* Ability to undergo apheresis for stem cell collection.\n* Medical lab data (historical) of neutropenia, or B cell dysfunction (low or absent IgG levels, or on IV gamma globulin.\n* Expected survival of at least 120 days.\n* Must be willing to have blood and tissue samples stored.\n* Participants of reproductive potential must agree to consistently use effective contraception from start of busulfan conditioning through at least one-year post-treatment. Acceptable forms of contraception are:\n\n  * Hormonal contraception in continuously effective use.\n  * Male or female condom with spermicide as indicated.\n  * Diaphragm or cervical cap in consistent and effective pattern of use with a spermicide.\n  * Intrauterine device in-situ\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Acute onset infection as indicated by symptoms such as persistent fevers, or imaging (new pneumonia on CT for example), isolated pathogen and requiring medical intervention.\n* Severe liver dysfunction with transaminases \\> 6 fold upper limit will be excluded until approval by hepatology consult who will provide mitigating plans for liver protection.\n* Renal dysfunction-serum creatinine \\>3.0 x ULN.\n* Coagulation dysfunction- Prothrombin INR or Partial thromboplastin time \\>2 x ULN (patients on controlled anticoagulation agents will not be excluded for therapeutic levels).\n* Known hypersensitivity to busulfan or any component of the product.\n* Contraindications for administration of busulfan, including but not limited to: hypersensitivity, chronic lymphocytic leukemia, acute leukemia in blastic crisis, pregnancy, or lactation.\n* Childhood malignancy (occurring before 18 years of age) in the participant or a first degree relative, or previously diagnosed known genotype of the participant conferring a predisposition to cancer unless approved by the with appropriate consultants and approved by the study PI (no DNA or other testing for cancer predisposition genes will be performed as part of the screen for this protocol).\n* Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant, or would preclude the participant from successful study completion.","ALL","3 Years","75 Years",{"count":58,"type":22},10,[60,25],"PHASE1","Background:\n\nWarts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body. WHIMs is caused by a mutation in the CXCR4 gene. Treatment with drugs can help control the infections but does not cure the disorder. Researchers want to try a treatment where they collect stem cells from a person with WHIMS, use base-editing to replace the bad gene with a healthy version, and return the new cells to the person. This could cure WHIMs.\n\nObjective:\n\nTo test a treatment using base-edited stem cells in people with WHIMs.\n\nEligibility:\n\nPeople aged 3 years and older with WHIMs.\n\nDesign:\n\nThe study has 4 stages.\n\nStage 1: Screening. Participants will be screened at 1 or more visits. They will have a physical exam with blood tests. A sample of tissue and fluid (biopsy) will be taken from the bone marrow in the hip.\n\nStage 2: Apheresis. Blood will be taken from the body through a needle; the blood will pass through a machine that separates out the stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will undergo gene editing.\n\nStage 3: Treatment. Participants will stay in the hospital for about 4 weeks. They will receive 3 drugs to prepare their body for the procedure. Then the edited stem cells will be returned to their bloodstream. They will stay in the hospital until they recover.\n\nStage 4: Follow-up. Participants will have 8 follow-up visits over 5 years. Long-term visits will continue for 15 years.",[63,64,65,66,67],"WHIM","Warts","Hypogammaglobulinemia","Immunodeficiency","Myelokathexis",[69,70],"Gene Editing","base editing",{"date":37,"type":38},{"date":73,"type":22},"2026-08-30",{"date":75,"type":22},"2033-12-31",{"name":77,"class":78},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":54,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100652501","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-upadacitinib-in-pediatric-participants-with-alopecia-areata-100652501","NCT07772492","A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata","Inclusion Criteria:\n\n* Participants must have a diagnosis of severe alopecia areata with SALT score \\>= 50 scalp hair loss at Screening and Baseline\n* No spontaneous scalp hair regrowth over the past 6 months\n* Participants will have current episode of alopecia areata of less than 8 years\n\nExclusion Criteria:\n\n* Participants must not have a current diagnosis of primarily diffuse type of alopecia areata\n* Participants must not have a diagnosis of other types of alopecia that would interfere with evaluation of alopecia areata, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium\n* Participants must not have a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of alopecia areata, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis","6 Years","17 Years",{"count":89,"type":22},300,[91],"PHASE3","Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Some treatment options are available for adults and adolescents with AA, however there is still high unmet need for systemic treatments (treatment that moves throughout the bloodstream) approved for young patients with AA. Treatments may not work for all patients or may stop working over time. Because of this, researchers are developing new AA treatments, like upadacitinib. Upadacitinib is a type of medicine called a Janus- Kinase (JAK) inhibitor and works with the body to fight the inflammation that can cause AA. In this study, different doses (amounts) of upadacitinib are being compared to treatment with placebo (looks like the study treatment but contains no medicine).\n\nUpadacitinib is an investigational JAK inhibitor being developed for the treatment of severe alopecia areata in pediatric patients. This is a randomized, double-blind, placebo-controlled study. Participants are placed in 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Pediatric participants with a diagnosis of severe alopecia areata with SALT score ≥ 50 scalp hair loss will be enrolled. Participants will be at least 6 years old at Screening and less than 18 years old at Baseline. Approximately 300 participants will be enrolled in the study at approximately 120 sites worldwide.\n\nParticipants will receive oral doses of upadacitinib or matching placebo daily, or twice daily, for approximately 160 weeks. The study comprises a 35-day Screening Period, a 24-week placebo-controlled double-blinded treatment period (Period A), a 28-week blinded extension treatment period (Period B), a 108-week blinded long-term extension period (Period C), and a 30-day follow-up period.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[94],"Severe Alopecia Areata",[96,94,97,98],"Alopecia Areata","Upadacitinib","ABT-494","RECRUITING",{"date":37,"type":38},{"date":102,"type":38},"2026-08-20",{"date":104,"type":22},"2032-03",{"name":106,"class":107},"AbbVie","INDUSTRY",4,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":54,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":46},"100652071","miniature-in-line-respirator-100652071","NCT07768215","Miniature In-line Respirator","First-In-Human Trial of Miniature In-Line, Pressure-Cycled, Emergency Respirator Device in Human Organ Donors","* INCLUSION CRITERIA\n\n  1. Diagnosis of brain death\n  2. Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker.\n  3. Male or female, with no age restriction (see size exclusion).\n  4. Decedent transferred to the Gift of Life at Penn Medicine Donor Care Center (study site) for routine organ donor management and organ recovery procedures.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Brain-dead research donor will be excluded if their baseline CO(2) or pulse oximetry is out of the accepted range for the study (defined as end tidal CO(2) between 35- and 45-mm Hg and the O(2) saturation measured by pulse oximetry \\> 94%) while on optimized ventilation.\n2. Brain-dead research donors with severe respiratory disease. This may include:\n\n   * Bullous lung disease - noted on pre-op imaging or by history.\n   * h\u002Fo pneumothoraces\n   * h\u002Fo severe asthma, COPD, or other significant lung disease\n3. Brain-dead research donors with morbid obesity (BMI \\>=40).\n4. Brain-dead research donor body weight of \\\u003C 25kg.\n5. Potential Brain-dead lung transplant donors (as determined by Gift of Life Donor Program staff according to at the time of study site (Donor Care Center) admission)\n6. Intraoperative arterial blood gas values outside the range of normal for pH, PaO2, PaCO2, HCO3, O2Sat as measured in pre-device ABG (while on optimized ventilation).\n\nAcceptable range for Arterial Blood Gas (ABG values)\n\nParameter - pH \u002F Range - 7.35-7.45\n\nParameter - PaO2 \u002F Range - \\>=75 mm Hg\n\nParameter - PaCO2 \u002F Range - 35-45 mm Hg\n\nParameter - HCO3 \u002F Range - 22-26 mEq\u002FL\n\nParameter - SpO2 \u002F Range - 94-100","1 Year","100 Years",{"count":119,"type":22},5,[121],"NA","This first-in-human pilot study will test an investigational miniature breathing device called the Hope inVent. The device is a small, single-use, in-line respirator that connects to a breathing tube and uses compressed oxygen to help move air in and out of the lungs. It has no moving parts and is designed to provide short-term breathing support in situations where standard ventilators may not be available, such as emergencies, disasters, battlefield settings, transport, or ventilator shortages.\n\nThe study will enroll up to 5 brain-dead organ donors who are already receiving mechanical ventilation at the Gift of Life Donor Care Center at the Hospital of the University of Pennsylvania. Donors will only be included after authorization for organ donation and research has been obtained through standard procedures. Donors who may donate lungs or who have significant lung disease will not be included.\n\nDuring the study, investigators will briefly replace the standard ventilator with the Hope inVent device for up to 15 minutes. The standard ventilator will remain immediately available, and the donor will be continuously monitored by the clinical and research teams. Investigators will measure whether the device can maintain acceptable breathing measures, including oxygen level and carbon dioxide level. They will also record breathing pressures and tidal volume, which is the amount of air delivered with each breath. If the device does not perform as expected or if any safety concern occurs, the donor will be returned immediately to the standard ventilator.\n\nThere is no direct benefit to the organ donor. Information from this study may help determine whether this type of simple, low-cost breathing device could be useful for future patients who need emergency or short-term ventilator support when standard ventilators are not available.",[124,125],"Brain Death","Respiration, Artificial",[127,113,128],"Hope inVent Respirator","Pressure-Cycled Ventilation",{"date":37,"type":38},{"date":73,"type":22},{"date":132,"type":22},"2028-12-01",{"name":134,"class":78},"National Institutes of Health Clinical Center (CC)",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":163,"locationsCount":46},"100651778","augmenting-parent-management-training-for-child-temper-outbursts-using-a-digital-tool-100651778","NCT07764536","Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool","Augmenting Parent Management Training With Naturalistic Skills for Child Temper Outbursts Using a Digital Tool","* INCLUSION CRITERIA:\n\nInclusion Criteria for Youth:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into protocol 01-M-0254 for screening purposes\n* Age 8-13 years (8 years 0 months through 13 years 11 months)\n* Parent\u002Fguardian and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property. This criterion is assessed based on the clinical interview conducted with parent\u002Fguardian and child after consenting into protocol 01-M-0254 for screening.\n* On the basis of record review and interviews with child and parent or guardian, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e., CGI-S of 3 or more). This criterion is assessed based on the clinical interview conducted with parent\u002Fguardian and child after consenting into protocol 01-M-0254 for screening.\n* Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement.\n\n  --This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n* At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent.\n* The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document.\n\nInclusion Criteria for Parent or Guardian:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into 01-M-0254 for screening purposes\n* Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool\n* Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement\n* Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for Youth:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments\n* IQ \\\u003C 70\n* Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nExclusion Criteria for Parent or Guardian:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* IQ \\\u003C 70 as assessed via a neuropsychological assessment or via assessment by trained clinical staff\n* Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n* Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment but not including self-help groups).","13 Years",{"count":144,"type":22},200,"OBSERVATIONAL","Background:\n\nPediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT). PMT teaches parents how to reward desired behaviors and not to reward undesired ones. Researchers want to find out if a smartphone app can help parents apply these skills more effectively.\n\nObjective:\n\nTo test a smartphone app to enhance PMT.\n\nEligibility:\n\nChildren aged 8 to 13 years with DBDs. A parent or guardian is also needed.\n\nDesign:\n\nParents will have 12 weekly sessions of PMT. PMT teaches them how to manage their child s mood and behaviors. Parents will learn to actively ignore, praise, set limits, and handle temper outbursts. PMT can be either in person or via video. Sessions last 30 to 60 minutes. They will be video and audio recorded.\n\nParents will be divided into 2 groups. Only 1 group will download a smartphone app. The app helps parents practice PMT skills. It offers videos, a resource library, and alerts when a child may be at risk for various behaviors.\n\nAll parents will be prompted every day to answer questions about their child s mood and their own behavior. These will continue until 12 weeks after their last PMT session.\n\nChildren will also answer questions on their phone daily for 1 week at a time. They will do this on 3 different weeks, each about 2 months apart. They will also have check-ins by phone every 2 weeks for up to 6 months.\n\nParents will have follow-up calls 3, 6, and 12 months after they finish PMT.",[148,149,150,151],"Disruptive Behavior Disorders","Conduct Disorder","Oppositional Defiant Disorder","Attention-deficit\u002FHyperactivity Disorder",[148,153,154,155,156,157,158],"Parent Management Training","Children","Parents","Digital tool","Irritability","Temper outbursts",{"date":37,"type":38},{"date":73,"type":22},{"date":162,"type":22},"2037-12-31",{"name":164,"class":78},"National Institute of Mental Health (NIMH)",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":185,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":192,"leadSponsor":194,"locationsCount":46},"100651303","phase-2-combination-bevacizumab-and-prgn-2012-in-adults-with-recurrent-respiratory-papillomatosis-rrp-100651303","NCT07756840","Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)","A Phase II Study of Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)","* INCLUSION CRITERIA:\n* Histological or cytological diagnosis of RRP confirmed by pathology report. Note: If there is no documentation or archival sample, a biopsy will be done to confirm the diagnosis.\n* Age \\>= 18 years old.\n* A history of 2 or more surgeries or use of IV bevacizumab in order to control laryngeal and\u002For tracheal RRP within 12 months prior to the study treatment initiation.\n* Previous treatment with PRGN-2012 (zopapogene imadenovec \\[Papzimeos\\]).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have an adequate organ and marrow function as defined below:\n\n  * White blood cells (WBC) \\>2,000\u002FmcL\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmcL\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Platelets \\>= 100,000\u002FmcL\n  * Total bilirubin \\\u003C= 1.5 mg\u002FdL. Note: participants with Gilbert s Syndrome must have a total bilirubin \\\u003C 3.0 mg\u002FdL\n  * Aspartate aminotransferase (AST) \\\u003C= 2.5 X institutional upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 X institutional ULN\n  * Creatinine within normal institutional limits OR Creatinine Clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal (calculated using the Cockcroft-Gault formula).\n  * Prothrombin time (PT) \u002F International normalized ratio (INR) and Partial thromboplastin time (PTT) \\\u003C= 1 X institutional ULN. In participants on anticoagulation, coagulation tests should be within a therapeutic range.\n  * Urinalysis Urine dipstick \\\u003C 2+ proteinuria. Participants with \\>= 2+ proteinuria on dipstick urinalysis should undergo a 24- hour urine collection and must demonstrate \\\u003C= 1g of protein in 24 hours to be eligible\n* Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of treatment and up to 6 months after completion of the study treatment.\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of treatment and up to 4 months after the last dose of study drugs. We also recommend men with partners of childbearing potential ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men must not freeze or donate sperm within the same period.\n\n* Women who are breastfeeding or plan to breastfeed must agree to discontinue breastfeeding from study treatment initiation.\n* Ability of participant to understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of significant cardiovascular disease or thromboembolic event: cerebral vascular accident\u002Fstroke, myocardial infarction, unstable angina, congestive heart failure (\\>= New York Heart Association Classification Class II) occurring within 12 months prior to the study treatment initiation\n* Serious cardiac arrhythmia requiring medication as assessed by electrocardiogram (EKG) at screening.\n* Any investigational agents within 4 weeks prior to the study treatment initiation.\n* Systemic medical RRP therapy within 4 weeks or 3 half-lives, whichever is longer prior to the study treatment initiation.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the study treatment initiation. Note: Inhaled, topical intranasal or intraocular steroids, and adrenal replacement doses \\\u003C10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* History of abdominal fistula or gastrointestinal perforation within 12 months prior to the study treatment initiation.\n* Major surgery within 4 weeks prior to the study treatment initiation. Note: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).\n* Non-healing wounds, active ulcer, or untreated bone fracture.\n* History of hemoptysis (\\>2.5 mL of bright red blood per episode) within 1 month prior to the study treatment initiation.\n* History of serious hemorrhage (CTCAE Grade 4) within 12 months prior to the study treatment initiation.\n* Evidence of bleeding diathesis or significant coagulopathy (with or without current therapeutic anticoagulation).\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the study treatment initiation.\n* Inadequately controlled hypertension (defined as systolic blood pressure (BP) \\>150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Note: an average of 3 BP readings on 2 sessions will be used to measure blood pressure if the initial reading indicates inadequately controlled hypertension. Anti-hypertensive therapy to achieve blood pressures below these parameters is allowed.\n* Prior history of hypertensive crisis or hypertensive encephalopathy.\n* Persisting toxicity related to prior therapy of Grade \\>1 per CTCAE. Note: Alopecia, sensory neuropathy Grade \\\u003C= 2 are acceptable.\n* Known, active alcohol or drug abuse.\n* History of allergy to study drug components.\n* History of \\>= Grade 3 per CTCAE infusion-related reaction to bevacizumab or PRGN-2012.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.\n* Uncontrolled symptomatic, intercurrent illness evaluated by medical history, physical exam, and labs, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study, or that would limit compliance with study requirements.","18 Years","120 Years",{"count":175,"type":22},50,[25],"Background:\n\nRecurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths called papillomas to grow in the airway, most often in the voice box, windpipe, or lungs. These growths can make it hard to speak or breathe. Surgery can remove the papillomas, but they often come back. In some cases, they can become cancerous.\n\nObjective:\n\nThis study istesting whether two treatments used together (PRGN-2012, a vaccine-based treatment and bevacizumab, a drug that affects blood vessel growth) can help control RRP and reduce the chance that papillomas will grow back.\n\nEligibility:\n\nAdults aged 18 years and older may be able to join the study if they have RRP and meet certain treatment history requirements. This may include people who have previously received PRGN-2012 or bevacizumab, or people who have needed more than 2 surgeries to remove papillomas.\n\nDesign:\n\nBefore starting treatment, participants will have screening tests to make sure the study is safe for them. These tests may include a physical exam with blood and urine tests, heart function testing, imaging scans, and an endoscopy. During an endoscopy, a thin, flexible tube with a small camera will look at the inside of the nose, throat, voice box, and upper windpipe.\n\nParticipants will receive study treatment during 7 clinic visits over about 6 months. Bevacizumab is given through a vein amd PRGEN-2012 is given as an injection under the skin of the arm or leg. Participants may receive 1 or both drugs at each visit.\n\nAfter completing treatmen, participants will return for 4 follow-up visits over 1 year. These visits may include repeat imaging, blood and urine tests, and other exams. After that, the study team will contact participantsby phone or email every 3 months for 2 years.\n\nIf their RRP gets worse during the follow-up period, they may be able to receive a second course of treatment using the same schedule....",[179,180,181,182,183,184],"Respiratory Recurrent Papillomatosis (RRP)","Human Papillomavirus (HPV)","Papillomavirus Infection","Laryngeal Diseases","Tracheal Diseases","Respiratory Tract Neoplasm",[186,187,188,189],"HPV Vaccine","Gardasil","Papzimeos (zopapogene imadenovec-drba)","Bevacizumab (Avastin)",{"date":37,"type":38},{"date":73,"type":22},{"date":193,"type":22},"2030-07-01",{"name":195,"class":78},"National Cancer Institute (NCI)",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":117,"enrollmentInfo":203,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":214,"leadSponsor":216,"locationsCount":46},"100651137","visual-attention-object-recognition-and-eye-movements-in-healthy-volunteers-100651137","NCT07756853","Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers","An Observational Study of Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and actively pay attention to visual stimuli and respond as appropriate.\n* Participant has visual acuity of 20\u002F25 or better in both eyes.\n* Participant must be 18 years old or older.\n* Participant must understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participant has an ocular, visual, or oculomotor problem that in the opinion of the Principal Investigator (PI) and\u002For clinical associate investigator would interfere with the participant s normal eye movements, visual perception, or required tasks.\n* Participant has a history of eye patching (amblyopia or lazy eye).\n* Participant has a non-ocular condition (e.g., neuropsychological conditions) that in the opinion of the PI and\u002For clinical associate investigator would interfere with the participant s normal eye movements or visual perception.",{"count":204,"type":22},40,"Background:\n\nVision is vital for many of our daily activities. Researchers want to learn more about how we aim our eyes (that is, what images, such as faces, immediately attract our attention) and how we direct our attention (that is, what we see and what we ignore).\n\nObjective:\n\nTo study how healthy adults process and respond to visual images.\n\nEligibility:\n\nHealthy people aged 18 years with no vision problems.\n\nDesign:\n\nParticipants will have 5 to 10 clinic visits over 2 to 4 months. Some participants may have up to 25 visits. Each visit lasts about 1 hour.\n\nParticipants will be screened. They will answer questions about their medical and eye history. They will have a standard eye exam; eye drops will be used to dilate the pupils. (They may skip this exam if they have had an eye exam at the NIH within the past year.)\n\nParticipants will perform eye movement tests. They will sit in front of a computer and view images that appear on the screen. They may be asked to respond to what they see by speaking, moving their hands, looking in a certain direction, or pushing a button. Their eye movements will be tracked.\n\nFor some tests, participants heads may be held steady using a chinrest and head strap. For some tests, they may wear a cap fitted with cameras that use invisible lights in front of their eyes.",[207],"Healthy Volunteer",[209,210,211],"Eye Movement","Visual Attention","Object Recognition",{"date":37,"type":38},{"date":73,"type":22},{"date":215,"type":22},"2031-12-30",{"name":217,"class":78},"National Eye Institute (NEI)",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":54,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":46},"100651059","restoring-vascular-and-insulin-function-to-augment-anti-amyloid-therapy-in-alzheimers-disease-100651059","NCT07756294","Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease","REstoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in ALZheimer'ss Disease (REVITAA-ALZ): A Placebo-controlled Trial of Intranasal Insulin vs. Empagliflozin in Mild Cognitive Impairment (MCI) or Early Alzheimer's Disease (AD) Treated With Anti-Amyloid Targeting Therapy (Lecanemab or Donanemab)","REVITAA-ALZ","Inclusion Criteria:\n\n* Fluent in English\n* Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment\n* Amyloid positive by PET or cerebrospinal fluid criteria\n* Stable medical condition for 3 months prior to screening visit\n* Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician)\n* Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit\n* If receiving an acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or memantine or both, must be stable on a dose for at least 30 days prior to Baseline Visit\n* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study clinician\n* Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities.\n\nExclusion Criteria:\n\n* A diagnosis of dementia other than Alzheimer's disease\n* History of a clinically significant stroke, history of transient ischemic attack within 12 months, or any history of seizures\n* Current evidence or history in past two years of head injury with loss of consciousness, any major psychiatric disorder including psychosis, unstable major depressive disorder, bipolar disorder\n* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus\n* Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit\n* Cancer within the past 2 years with the exception of non-melanoma skin cancers and non-metastatic prostate cancer that has been stable for at least 6 months\n* Pregnancy or possible pregnancy\n* Use of anticoagulants\n* Residence in a skilled nursing facility at screening\n* Use of an investigational agent within two months of screening visit\n* Regular use of alcohol, narcotics, anticonvulsants, anti-Parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case-by-case basis by study clinician)\n* Any history of immunologic disease (e.g. lupus, rheumatoid arthritis, Crohn's disease) or systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives\n* History of a bleeding disorder that is not under adequate control, including a platelet count less than 50,000 or INR greater than 1.5\n* Contraindications for MRI, including claustrophobia or the presence of contraindicated metal implants\u002Fcardiac pacemaker\n* Baseline MRI Findings: More than four microhemorrhages defined as 10mm or less at the greatest diameter; A single macro hemorrhage greater than 10mm at greatest diameter; An area of superficial siderosis; Evidence of vasogenic edema; More than two lacunar infarcts or stroke involving a major vascular territory; Severe subcortical hyperintensities consistent with Fazekas score of 3; Evidence of amyloid beta-related angiitis (ABRA); Cerebral amyloid angiopathy (CAA); Cerebral contusion, encephalomalacia, brain aneurysm or other vascular malformations, central nervous system infection, brain tumor, or other major intracranial pathology that may cause cognitive impairment","55 Years","85 Years",{"count":229,"type":22},30,[25],"The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.",[233],"Alzheimer Disease",[235,236,237],"mild cognitive impairment","mild dementia","insulin",{"date":37,"type":38},{"date":240,"type":22},"2026-09",{"date":242,"type":22},"2028-04",{"name":244,"class":45},"Wake Forest University Health Sciences",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":54,"minAge":172,"maxAge":173,"enrollmentInfo":253,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":266,"locationsCount":46},"100650729","survey-to-determine-incarcerated-persons-views-on-surrogate-decision-making-100650729","NCT07751731","Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making","Survey to Determine Incarcerated Persons Views on Surrogate Decision-Making","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently incarcerated in a United States facility with Edovo educational tablets\n2. Ability to understand the consent form and survey\n3. Willingness to give informed consent\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Inability to read or write in English",true,{"count":254,"type":22},75000,"Background:\n\nAbout 180,000 of the people in US prisons are over 55 years old. Aging people often cannot make medical decisions on their own. People who cannot make their own decisions must rely on a \"surrogate.\" A surrogate is someone who helps the person's doctor make decisions for them. Researchers want to conduct a survey to ask people in prison who they would like to be their surrogates. But first, they need to find out if their survey questions are clear and easy to understand.\n\nObjective:\n\nTo get imprisoned people's feedback on survey questions about surrogate decision making.\n\nEligibility:\n\nPeople currently imprisoned in a US facility with access to Edovo. They must be able to read and write in English.\n\nDesign:\n\nParticipants will answer 26 survey questions. The questions will be on the Edovo Learn software platform. After each question, they will be asked: \"Was this question clear? If not, please explain in the box below what you found unclear. Also, if you have any suggestions for how we might make the question clearer, please include them.\"\n\nParticipants will be asked to imagine themselves in a situation where they cannot make their own medical decisions. They may skip questions or stop the survey if they want. No information that identifies them will be collected.\n\nThe survey will take about 15 minutes.",[257],"Healthy Volunteers",[259,260,261],"Incarcerated","Surrogate","Survey",{"date":37,"type":38},{"date":73,"type":22},{"date":265,"type":22},"2027-02-28",{"name":134,"class":78},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":46},"100649287","phase-4-pelashield-vs-xeroform-100649287","NCT07734519","Pelashield vs Xeroform","A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform","Inclusion Criteria:\n\n* Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.\n* Donor site located in an area amenable to standardized photography and serial appearance assessment.\n* Ability to provide informed consent.\n* Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.\n* Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.\n\nExclusion Criteria:\n\n* Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery\n* Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.\n* Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.\n* Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance\n* Clinical situations in which the treating surgeon anticipates that protocol-based donor-site care cannot be maintained, including cases requiring non-standard dressings or adjunctive local therapies.\n* Anticipated inability to complete follow-up assessments, including inability to obtain evaluable standardized photographs at key time points.\n* Severe uncontrolled systemic conditions likely to significantly impair wound healing, at the discretion of the investigator (e.g., severe immunosuppression or other conditions making reliable donor-site healing unlikely).\n* Allergy to any local anesthetic\n* Allergy or sensitivity to silver\n* Pregnancy",{"count":204,"type":22},[276],"PHASE4","The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform).",[279],"Skin Graft",[281,282,283],"Pelashield","Xeroform","donor site pain",{"date":37,"type":38},{"date":286,"type":22},"2026-10",{"date":288,"type":22},"2027-07",{"name":244,"class":45},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":227,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":305,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":46},"100648586","self-supervised-constraint-induced-movement-therapy-for-stroke-recovery-100648586","NCT07723300","Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery","A Novel Approach to Implementing Constraint-Induced Movement Therapy in Stroke Rehabilitation","Inclusion Criteria:\n\n* Sustained a first-time ischemic or hemorrhagic stroke ≥2 weeks prior to study enrollment\n* Age ≥18 and ≤85\n* Moderate UE hemiparesis as defined by a score ≥13 and ≤47 on the modified UE section of the Fugl-Meyer Assessment (60-point scale with no reflex testing)\n* Ability to actively extend impaired wrist ≥10 degrees\n* UE strength and active range of motion within functional limits on the non-hemiparetic side\n* Ability to follow two-step commands (visual or verbal) as determined by the clinical investigator\n* Nonuse of the more impaired UE as evidenced by an average score ≤2.5 on the Motor Activity Log Amount of Use Scale.\n\nExclusion Criteria:\n\n* Excessive pain in the affected shoulder, arm, or hand as measured by a score ≥6 on a 10-point visual analogue scale\n* Unable to passively reach neutral position for wrist extension and forearm supination\n* Excessive spasticity in the affected wrist or finger flexors\u002Fextensors and elbow flexors, as defined as a score of \\>2 on the Modified Ashworth Scale (MAS)\n* Inability to actively participate in regular therapy sessions (e.g., due to medical complexity, insufficient endurance, transportation, etc.) as determined by participant or by clinical judgement of the evaluating therapist\n* Receiving occupational therapy services for the hemiparetic UE during the two-week intervention window (including after pre-assessment and before post-assessment)\n* Received focal anti-spasticity drug injection (e.g., Botox) to any muscles of the impaired UE within the past 1 month (or plan to at some point during study enrollment)\n* Comorbid diagnosis in addition to stroke (e.g., dementia, peripheral neuropathy) that in the opinion of the investigator could impact study results\n* Presence of moderate to severe unilateral spatial neglect as indicated by clinical observation or failure on a standardized screening tool (e.g., Line Bisection Test or Bells Test).",{"count":298,"type":22},12,[121],"The goal of this clinical trial is to learn how a partially self-supervised constraint-induced movement therapy (sCIMT) program in adults with arm and hand weakness will work after stroke. This study will look at whether the program can help people improve the use of their arm and hand after a stroke while requiring less time with a therapist. The main questions it aims to answer are:\n\n* Does the sCIMT program help people use their affected arm and hand better - after a stroke?\n* Do participants feel that the sCIMT program is useful, easy to follow, and a good fit for their recovery needs?\n* Does taking part in the sCIMT program improve participants' quality of life and daily well-being?\n\nParticipants will:\n\n* Take part in a therapy program 5x\u002Fweek for 2 weeks. The program is designed to help improve the use of the arm and hand affected by stroke.\n* Wear a mitt on the stronger hand during certain practice activities to encourage use of the weaker hand.\n* Complete surveys and tests before and after the program to measure arm and hand use, experiences with the program, and quality of life.",[302,303,304],"Stroke","Stroke (CVA) or TIA","Cerebral Vascular Accident (CVA)\u002FStroke",[302,306,307,308,309,310,311],"Constraint-Induced Movement Therapy","Rehabilitation","CIMT","Upper Extremity Rehabilitation","Neurorehabilitation","Post-Stroke Recovery",{"date":37,"type":38},{"date":314,"type":38},"2026-07-29",{"date":316,"type":22},"2027-12",{"name":318,"class":45},"Ohio State University",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":54,"minAge":327,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":338,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100648396","trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-100648396","NCT07719608","A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine","Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine","RECLAIM-II","Inclusion Criteria:\n\nMeets resistant migraine criteria:\n\n1. Documented diagnosis of 1.1 migraine without aura and\u002For 1.2 migraine with aura and\u002For 1.3 chronic migraine according to ICHD-3\n2. Headache requiring two of the following:\n\n   * Leads to considerable impairment in personal, educational and\u002For occupational areas of functioning (MIDAS rating of severe or very severe)\n   * Concomitant continuous or near continuous headache between migraine attacks\n   * Eight or more monthly migraine days\n3. Lack of 50% reduction in monthly migraine days and\u002For intolerable side effects and\u002For absolute contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs\u002Fantagonists.\n4. Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5. Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase\n\nExclusion Criteria:\n\n* Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms\n* Concurrent use of any invasive or non-invasive neuromodulation.\n* Previous inadequate response to an implantable neuromodulation device for headache or pain management.\n* Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant).\n* Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.\n\nPresence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant).\n\n* Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)\n* Pregnant, nursing or not using contraception.","22 Years","84 Years",{"count":330,"type":22},150,[121],"The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.",[334,335,336,337],"Resistant Migraine","Chronic Migraine Headache","Headache (Migraine)","Headache, Cluster",[339,340,334,341,342],"Neuromodulation","Chronic Migraine","Headache","HIgh Frequency Episodic Migraines",{"date":37,"type":38},{"date":345,"type":22},"2026-12-01",{"date":347,"type":22},"2031-05-01",{"name":349,"class":107},"Salvia BioElectronics",2,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100648344","phase-3-amaze-9-a-research-study-investigating-how-well-zenagamtide-tablets-help-people-with-excess-body-weight-lose-weight-100648344","NCT07720271","AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight","Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)","AMAZE 9","Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18 and older (both inclusive) at time of signing the informed consent.\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) more than or equal to (≥) 6.5% \\[48 millimoles per mole (mmol\u002Fmol)\\] as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.\n* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.",{"count":360,"type":22},950,[91],"The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.",[364,365],"Overweight","Obesity",{"date":37,"type":38},{"date":40,"type":22},{"date":369,"type":22},"2028-08-22",{"name":371,"class":107},"Novo Nordisk A\u002FS",37,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":400,"leadSponsor":402,"locationsCount":46},"100648017","plasma-lipids-dependent-vitamin-e-metabolism-during-dynamic-hyperlipidemia-100648017","NCT07715890","Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","Plasma Lipids-dependent Vitamin E Metabolism During Dynamic Hyperlipidemia","* INCLUSION CRITERIA\n\nCohort 1\n\n1. Males and females between the ages of 18 to 65\n2. BMI 18.5 - 26.9 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations\n4. Normotensive, not on medications for hypertension\n5. Not on glucose-lowering or lipid-lowing medications\n6. Screening labs with baseline HbA1c \\\u003C5.7%, baseline fasting triglyceride \\\u003C 150 mg\u002FdL and LDL \\\u003C100 mg\u002FdL\n7. Liver fat \\\u003C2%\n\nCohort 2\n\n1. Males and females between the ages of 18 to 65\n2. BMI \\>26 kg\u002Fm\\^2 and \\\u003C36 kg\u002Fm\\^2\n3. Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up instructions and evaluations.\n4. Screening labs with baseline HbA1c \\\u003C= 7.5%, agree to be off or stop oral glucose-lowering medications (metformin), baseline fasting triglyceride \\\u003C 500 mg\u002FdL and LDL \\\u003C190 mg\u002FdL, agree to be off or stop oral lipid-lowing medications for 4-10 weeks prior to the inpatient visit.\n5. Liver fat \\\u003C2%\n\nEXCLUSION CRITERIA\n\n1. For women: pregnancy or currently breastfeeding\n2. Subjects \\\u003C18-year-old. This age group has a broad spectrum of hormonal profiles, due to development and puberty, which significantly increases the heterogenicity of the study subjects.\n3. Subjects \\>65-year-old. This age group has significantly increased risk of cardiovascular diseases. To minimize the risk from temporarily suspending lipid- and glucose-lowering medications and stress from serial blood draws, we exclude these individuals.\n4. Heavy alcohol user (males with \\>2 drinks per day or \\>14 drinks per week; female with \\>1 drinks per day or \\>7 drinks per week)\n5. Current smoker, or former smoker who quit smoking \\\u003C15 years ago\n6. Subjects with weight changes greater than 20% baseline body weight over the past 3 months\n7. Subjects with lactose intolerance unwilling to take lactase\n8. Subjects with type 1 diabetes\n9. Subjects with hemoglobin \\\u003C11 g\u002FdL or hematocrit \\\u003C33%\n10. Subjects with abnormal liver function test results\n11. Subjects with liver fat \\>= 2% on abdominal MRI\n12. Subjects with a history of pancreatitis, diabetes ketoacidosis, hyperosmolar hyperglycemic state, advanced atherosclerosis, cardiovascular diseases, kidney diseases, or liver diseases\n13. Subjects with fat malabsorption including: history of gastrointestinal surgery, pancreatic insufficiency, inflammatory bowel disease, celiac disease, moderate-to-severe irritable bowel syndrome, and pathologic mutations impacting lipoprotein metabolism\n14. Subjects on glucocorticoids \\>1 week (not including topical glucocorticoids)\n15. Subjects with HIV\n16. Subjects with uncontrolled psychiatric and\u002For behavioral disorders\n17. Subjects taking diabetes medications other than metformin\n18. Anticipated surgery during the study period\n19. Subjects with severe medication-resistant claustrophobia\n20. Subjects who are unwilling to stop medications, vitamins and\u002For dietary supplements that investigators have requested to be held\n21. Subjects participating in any other clinical study without informing investigators\n22. Any other reason or clinical condition that the investigators judge would interfere with study participation and\u002For be unsafe for a participant or staff member","65 Years",{"count":382,"type":22},48,[121],"Background:\n\nObesity is known to lead to diseases such as diabetes and high cholesterol (or fats) in the blood (hyperlipidemia). But no one knows why. Researchers think that high levels of fat in the blood may block important nutrients, such as vitamin E, from reaching places they are needed in the body.\n\nObjective:\n\nTo learn how high-fat meals affect levels of vitamin E in the blood.\n\nEligibility:\n\nPeople aged 18 to 65 with high blood fat levels. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits in 3 months. The last visit will require them to stay in the clinic for 2 nights.\n\nParticipants will be screened. They will have a physical exam and blood tests.\n\nAfter this visit, all participants must stop taking any dietary supplements.\n\nThose who use them must also stop taking any drugs to lower their blood sugar and blood fats. These participants will have an extra visit for blood tests after 60 days.\n\nThe next visit will include 2 imaging scans:\n\nMagnetic resonance imaging (MRI) of the abdomen. This scan will check for fat in the liver.\n\nDual-energy X-ray absorptiometry (DEXA). This scan measures the levels of body fat.\n\nOn day 1 of the clinic stay, participants will have 2 set meals, with nothing but water after 10 pm.\n\nOn day 2, they will drink high-fat shakes at 8 am, noon, and 4 pm. They will have blood draws every hour for 17 hours, and then every 2 hours until 7 am. The blood will be taken from a tube inserted into a vein and left in place for the day.\n\nOn day 3, they will go home.",[386],"Lipid Metabolism Disorders",[388,389,390,391,392,393,394,395,396,397],"Vitamin E","Vitamin K","Vitamin D","Vitamin C","Postprandial","Fat meal","Sequestration","Hypertriglyceridemia","Fat-Soluble Vitamins","gamma tocopherol",{"date":37,"type":38},{"date":73,"type":22},{"date":401,"type":22},"2029-03-31",{"name":403,"class":78},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":173,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":421,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":430,"leadSponsor":432,"locationsCount":46},"100648006","hepatic-artery-infusion-of-carfilzomib-in-participants-with-liver-metastatic-disease-previously-treated-with-hepatic-artery-infusion-pump-therapy-100648006","NCT07715903","Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","* INCLUSION CRITERIA:\n* Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC).\n* Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as \\>=75% of metastatic disease present in the liver as assessed by the principal investigator.\n* Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation.\n* Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place.\n* Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n* Participants must have an adequate organ and marrow function as defined below:\n\nLeukocytes \\> 3,000\u002FmcL\n\nHemoglobin \\>= 9 mg\u002FdL\n\nAbsolute neutrophil count \\> 1,500\u002FmcL\n\nPlatelets \\> 100,000\u002FmcL\n\nTotal bilirubin \\\u003C 2 X institutional upper limit of normal (ULN)\n\nAspartate aminotransferase (AST) \\\u003C 2.5 X institutional (ULN)\n\nAlanine aminotransferase (ALT) \\\u003C 2.5 X institutional (ULN)\n\nCreatinine \\\u003C2 X institutional (ULN)\n\n* Participants positive for human immunodeficiency virus (HIV) 1\u002F2 antibody must have a negative HIV viral load.\n* Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load.\n* Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load. Note: Participants positive for Hepatitis B surface antigen (HBsAg) are excluded.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device, abstinence, surgical sterilization) at the study entry and up to 6 months after the last dose of the study drug. A participant may request a male partner to use an effective form of contraception to fulfill this requirement (e.g., condom\u002Fbarrier).\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 3 months after the last dose of the study drug. A participant may request a female partner to use an effective form of contraception to fulfill this requirement (e.g., intrauterine device, hormonal contraceptives). Men must not freeze or donate sperm within the same period.\n\n* Women who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with liver metastases amenable to resection.\n* Participants who received floxuridine within 6 weeks prior to the study treatment initiation.\n* Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation.\n* Participants who received any investigational agents within 4 weeks prior to the study treatment initiation.\n* Participants with incontrovertible radiographic evidence of disease progression per the RECIST definition outside of the liver within 3 months prior to the study treatment initiation. Note: Pulmonary lesions less than 1 cm are allowed.\n* Prior radiation to the liver (Yttrium-90 \\[Y-90\\] or External Beam Radiation Therapy \\[EBRT\\]).\n* History of allergic reactions attributed to compounds of similar chemical composition to CFZ.\n* Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, evaluated by medical history, electrocardiogram (EKG), physical exam, and laboratory testing, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.",{"count":412,"type":22},20,[60],"Background:\n\nCancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.\n\nObjective:\n\nTo test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.\n\nEligibility:\n\nPeople aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.\n\nParticipants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.\n\nParticipants will have follow-up visits 1 and 3 months after their last dose of study drug.\n\nAn optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.\n\n...",[416,417,418,419,420],"Colorectal Neoplasms","Neoplasms","Intrahepatic Cholangiocarcinoma","Adrenocortical Carcinoma","Metastasis, Neoplasm",[422,423,424,425,426,427],"Hepatic artery infusion","Carfilzomib","Colorectal Cancer","Intrahepatic cholangiocarcinoma","Adrenocortical Cancer","Measurable liver metastasis",{"date":37,"type":38},{"date":73,"type":22},{"date":431,"type":22},"2031-12-31",{"name":195,"class":78},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":252,"sex":54,"minAge":19,"maxAge":117,"enrollmentInfo":440,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":46},"100647866","screening-protocol-100647866","NCT07712874","Screening Protocol","Screening Evaluation of Volunteers for Studies of Pain","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated interest in, and availability for, participating in NCCIH studies and willingness to comply with the procedures of this protocol.\n* At least 12 years of age\n* No identified acute health concerns (i.e. symptomatic uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, ongoing cancer (excluding skin basal cell carcinoma and squamous cell carcinoma) as evidenced by screening medical history\n* Ability to understand and able to provide written informed consent form.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have active medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as asymptomatic hypertensive urgency, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina. Psychiatric examples are the acute complications of psychiatric disease, such as acute mania, paranoid delusions, or having active panic attacks.\n* Ongoing substance uses disorder or illicit substance use\n* Pregnancy\n\nAdditional exclusion from optional QST procedures:\n\nHas a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions (including stroke and blindness or deafness, a history of brain damage, or psychosis).",{"count":441,"type":22},10000,"This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.",[444],"Pain",[446,257,447,448,449],"Pain screening","Quantitative Sensory Testing","Ecological Momentary Assessment","Patient-Reported Outcomes",{"date":37,"type":38},{"date":73,"type":22},{"date":453,"type":22},"2050-07-02",{"name":455,"class":78},"National Center for Complementary and Integrative Health (NCCIH)",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":473,"leadSponsor":475,"locationsCount":46},"100646501","unified-network-for-integrated-fluid-collection-at-yale-100646501","NCT07689864","Unified Network for Integrated Fluid Collection at Yale","UNIFY","Inclusion Criteria:\n\n* Histological or radiological evidence of a suspected or confirmed solid tumor or hematologic malignancy, OR an individual identified as high-risk for cancer (based on identified germline aberration in a cancer predisposition gene, hormonal or medical risk factors, and\u002For significant family history of malignancy).\n* Willing and able to provide informed consent and HIPAA authorization for participation in UNIFY.\n* If being co-consented for a separate primary research study, the participant must also fulfill the eligibility criteria for that primary research study. Where there is a discrepancy in eligibility criteria between UNIFY and the primary research study, the primary research study's criteria take precedence.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Any medical contraindication to peripheral venipuncture as judged by the treating physician or research team (e.g., severe coagulopathy or other contraindication to additional research blood draw).",{"count":464,"type":22},2500,"UNIFY is a Yale-wide liquid biopsy master repository that prospectively collects Streck-tube blood, dried blood spots (and optional archival tissue) from Yale Cancer Center patients across all tumor types for current and future research.",[467,468],"Molecular Residual Disease","Cancer",[470],"Liquid Biopsy",{"date":37,"type":38},{"date":37,"type":38},{"date":474,"type":22},"2031-08",{"name":476,"class":45},"Yale University",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":484,"minAge":172,"maxAge":173,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":499,"leadSponsor":501,"locationsCount":46},"100645567","il-15-superagonist-with-or-without-vaccine-in-biochemically-recurrent-prostate-cancer-after-previous-stereotactic-body-radiation-therapy-100645567","NCT07686380","IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.\n* Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng\u002Fml following radical prostatectomy or \\>= 2 ng\u002Fml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.\n* Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.\n* Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.\n* Hepatic function eligibility parameters: Bilirubin (total and direct) \\\u003C= upper limit of normal (ULN) (OR in participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C= 1.5 times upper limit of normal.\n* Adequate renal function defined by a calculated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.\n* ECOG performance score 0-1.\n* No other active malignancies within the 36 months prior to the study treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).\n* 18 years of age or older.\n* Individuals must agree to use effective contraception (barrier, vasectomy and\u002For abstinence) for the duration of study therapy and for four months after the last treatment administration. Individuals with partners with birthing potential will be recommended that their partner use a highly effective contraception (includes use of oral, injected or implanted hormonal methods of contraception, placement of certain intrauterine devices (IUD) or intrauterine systems (IUS), hysterectomy, oophorectomy, salpingectomy.\n* Individuals must agree to not donate sperm during the restricted period (for the duration of study therapy and for four months after the last dose of study treatment).\n* Negative CT scan\u002F Magnetic resonance imaging (MRI) for evidence of soft tissue metastasis (visceral or lymph node).\n* Negative Tc99 for evidence of bone disease.\n* Participants must have had prior SBRT to PSMA+ findings beyond the prostate and have had a documented 25% or more PSA rise from post-SBRT nadir\n* Baseline testosterone \\>= 100 ng\u002Fdl.\n* Hematological parameters:\n\n  * Granulocyte count \\>= 1000\u002Fmm\\^3\n  * Platelet count \\>= 100000\u002Fmm\\^3\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Immunocompromised status due to:\n\n  * Human immunodeficiency virus (HIV) seropositivity\n  * HBV or HCV seropositivity\n  * Other immunodeficiency diseases\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed. Participants with diabetes type I, vitiligo, or alopecia are allowed.\n* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n* Chronic administration (defined as daily or every other day for continued use \\> 14 days) of systemic corticosteroids within 28 days before the study treatment initiation. Note: Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, and topical agents) is allowed.\n* Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 28 days prior to the study treatment initiation.\n* Major surgery within 28 days prior to study treatment initiation.\n* Systemic therapy, including any investigational therapy within 28 days prior to the study treatment initiation.\n* Radiation therapy within 14 days prior to the study treatment initiation.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first planned dose of study drugs), myocardial infarction (\\\u003C 6 months prior to the first planned dose of study drugs), or any of the following at time of enrollment: unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II), serious cardiac arrhythmia, or uncontrolled hypertension (SBP\\>170\u002F DBP\\>105).\n* Serious intercurrent medical illness evaluated by medical history and physical exam that would interfere with participant's ability to carry out the treatment program.","MALE",{"count":486,"type":22},65,[25],"Background:\n\nBiochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.\n\nObjective:\n\nTo test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.\n\nEligibility:\n\nPeople aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.\n\nN-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.\n\nParticipants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.\n\nThe drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.\n\nParticipants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.\n\nFollow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.",[490,491],"Recurrent Prostate Cancer","Prostate Cancer",[490,493,494,495,496],"IL-15 Superagonist","N-803","ETBX-071","PSA Vaccine",{"date":37,"type":38},{"date":73,"type":22},{"date":500,"type":22},"2029-01-30",{"name":195,"class":78},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":54,"minAge":508,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":512,"conditions":513,"keywords":517,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":529,"locationsCount":46},"100645474","natural-history-of-trisomy-8-associated-autoinflammatory-disease-triad-and-related-disorders-100645474","NCT07683104","Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Stated willingness to comply with study requirements.\n2. Aged \\\u003C= 99 (ability to be seen at NIH vs. remote visit may be determined by age and location).\n3. Willingness to allow storage of data and specimens for future research.\n\nAdditional Inclusion Criteria for Affected Participants\n\n1. Must have one of the following:\n\n   1. Trisomy 8 mosaicism verified by genetic testing (including but not limited to karyotype, fluorescence in situ hybridization \\[FISH\\], whole genome sequencing \\[WGS\\], whole exome sequencing \\[WES\\], or microarray), or\n   2. Inflammatory mucosal ulcerative disease clinically similar to TRIAD at the discretion of the principal investigator.\n2. Ability of participant or LAR to provide informed consent.\n\nAdditional Inclusion Criteria for Biological Relatives\n\n1. Be an unaffected biological relative of an affected participant.\n2. Ability to provide informed consent.\n3. Willingness to provide at least one biospecimen.\n\nEXCLUSION CRITERIA:\n\nIndividuals with any condition or who are taking any medications that, in the opinion of the investigator, contraindicates participation in the study will be excluded.\n\nCo-enrollment guidelines: Enrollment in this protocol does not preclude individuals from enrolling or participating in any other NIH protocols, including studies of investigational agents. Participants will be asked about their participation in other studies to ensure that blood draws do not exceed NIH limits for research protocols.","1 Day","99 Years",{"count":511,"type":22},750,"Background:\n\nTrisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them.\n\nObjective:\n\nTo gather data and samples from people with and without the trisomy 8 mosaicism.\n\nEligibility:\n\nPeople of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail.\n\nParticipants may have these procedures:\n\nPhysical exam, with blood tests.\n\nTests of brain function and motor skills.\n\nSensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure.\n\nMagnetic resonance imaging (MRI) scan of the brain and\u002For spine.\n\nX-ray of the spine.\n\nUltrasound test of heart function (echocardiogram).\n\nTissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow.\n\nSwabs to collect cells from the mouth, skin, and vagina.\n\nCollection of blood, stool, urine, saliva, hair, and fingernail samples.\n\nX-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary.\n\nHealthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken.",[514,515,516],"Trisomy 8 Mosaicism","Trisomy 8 Associated Autoinflammatory Disease","Mucosal Ulcerations",[518,519,520,521,522,523,524],"Genital Ulcers","Myelodysplastic Syndromes","Mucosal ulcerations","Recurrent fever","Oral aphthous ulcers","Autoinflammatory disease","Trisomy 8 mosaicism",{"date":37,"type":38},{"date":73,"type":22},{"date":528,"type":22},"2056-06-01",{"name":77,"class":78},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":173,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":544,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":554,"locationsCount":46},"100644770","il-12-genetically-engineered-myeloid-cells-in-participants-with-relapsed-refractory-solid-tumors-100644770","NCT07672483","IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors","Phase I Trial of IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors","* INCLUSION CRITERIA:\n* Relapsed or refractory solid tumor malignancies for whom standard measures do not exist or are no longer effective. Must have histologic confirmation of original diagnosis or relapse.\n* Participants must have evaluable (measurable or not measurable) disease.\n* Part B only: Participants must:\n\n  * be willing to undergo mandatory pre- and post-treatment tumor biopsies. Tumor tissue should either be taken from non-target lesions or from target lesions where sampling can be done without impacting lesion measurement\n\nand\n\n--have disease amenable to biopsy to allow to perform pre- and post-tumor biopsies.\n\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy and close monitoring for over 3 months shows no active progression.\n* At least one prior cancer treatment when upfront standard therapy exists. Note: There is no limit to the number or type of prior treatment regimens.\n* The indicated time must have elapsed since any systemic anti-cancer therapy prior to leukapheresis.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n\nNote: Participants who are unable to walk because of paralysis, but who are able to maintain supine position independently in a wheelchair, will be considered ambulatory for the purpose of performance status.\n\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Hemoglobin (Hgb) \\>= 8 g\u002FdL (transfusion independent)\n  * Prothrombin time (PT) \\\u003C= 1.5 X institutional upper limit of normal (ULN) (Part B only, participants undergoing biopsy)\n  * Creatinine clearance \\>= 60 mL\u002Fminute\u002F1.73m\\^2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n  * Aspartate Aminotransferase (AST) \\\u003C= 3 X institutional ULN\n  * Alanine Aminotransferase (ALT) \\\u003C= 3 X institutional ULN\n  * Total bilirubin \\\u003C= 1.5 institutional ULN. Note: In the case of Gilbert's syndrome total bilirubin \\\u003C= 3 X ULN\n  * Serum albumin \\>= 2.7 g\u002FdL\n  * Ejection fraction of \\>= 45% and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram (ECHO).\n  * QTc interval \\\u003C 480 msec\n  * Oxygen saturation \\>92% on room air at rest\n* Participants with a clinical history of prolonged smoking (\\>= 10 pack-years), lung disease, or current or recent history of respiratory symptoms must have a forced expiratory volume in the first second (FEV1) \\> 50%.\n* Participants seropositive for human immunodeficiency virus (HIV) must have an undetectable HIV viral load.\n* Participants seropositive for Hepatitis C virus (HCV) must have an undetectable HCV viral load\n* Participants positive for Hepatitis B surface antigen (HbsAg) must have an undetectable Hepatitis B virus (HBV) viral load.\n* Women of childbearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\nMen able to father a child must agree to use a highly effective method of contraception (surgical sterilization, abstinence or man may request that partner uses the highly effective form of contraception to fulfill this requirement) at the study entry and up to 7 months after the last dose of study drugs. Men able to father a child must not freeze or donate sperm within the same period.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 12 months after the last dose of the study drug(s).\n* Ability and willingness of participant to enroll on protocol 15-C-0028, Follow-Up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials after 5 years.\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with history of primary CNS tumors or leptomeningeal disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, IL-12, or other agents used in the study.\n* Concurrent untreated opportunistic infections as evidenced by history, blood test or imaging at screening.\n* Active systemic infections requiring anti-infective treatment.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) or secondary\u002Facquired immunodeficiency requiring steroids or other non-steroid immunosuppressive agents.\n* History of clonal hematopoiesis of indeterminate potential (CHIP) or myelodysplasia\u002Fmyelodysplastic syndrome (MDS) or monoclonal gammopathy of undetermined significance (MGUS).\n* Participants with symptomatic pleural effusions requiring intervention or with recent history (within 3 months) of pleural effusions that required intervention.\n* Participants with ischemic symptoms (may include chest pain\u002Fpressure, shortness of breath, nausea, vomiting, sweating, and\u002For pain in the neck, shoulder, jaw or arm) confirmed by stress test OR a history of coronary revascularization (unless the participant has a normal cardiac stress test after revascularization and within 12 months prior to leukapheresis).\n* Any form of diagnosed autoimmune disease requiring immune suppression as well as participants with active autoimmune skin diseases such as psoriasis or any history of active systemic autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease-modifying agents within the last 2 years. Exceptions will be allowed for vitiligo and hypothyroidism that has been stable on thyroid replacement medications for \\> 6 weeks prior to leukapheresis.\n* Any participant who developed autoimmunity (\\>= grade 3 per CTCAE v. 6.0) with checkpoint inhibitor use. Note: Exceptions will be allowed for vitiligo and hypothyroidism that has been stable on thyroid replacement medications for \\> 6 weeks prior to leukapheresis.\n* Participants who have a major surgical procedure, other than for diagnosis, within 4 weeks prior to leukapheresis or anticipated to need a major surgical procedure during the study.\n* History of prior solid organ transplantation.\n* Participants that require urgent therapy due to tumor mass effects or spinal cord compression within 2 weeks prior to leukapheresis.\n* Any investigational therapy within 2 weeks prior to leukapheresis.\n* Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in WOCBP at screening. Note: In case of a suspected false-positive serum or urine test result, additional evaluation must be done to rule out pregnancy.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.",{"count":538,"type":22},95,[60],"Background:\n\nMyeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein that helps the immune system kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can activate the immune system to attack cancer cells in solid tumors.\n\nObjective:\n\nTo test IL-12 GEMys in people with cancer.\n\nEligibility\n\nPeople aged 18 years and older with cancer that returned or failed to respond to treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.\n\nParticipants will have daily injections for few days to prepare them to undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will be modified in a lab to create IL-12 GEMys.\n\nParticipants will check in to the hospital. They will receive drugs for 5 days to prepare their body for the treatment. Then they will have their own IL-12 GEMys infused through a needle inserted into a vein. They will stay in the hospital until they are well enough to go home. This may be 7 to 14 days or longer.\n\nSome participants may receive a second treatment with IL-12 GEMys within 2 years after the first.\n\nParticipants will have follow-up visits for about 5 years. These will include imaging scans and blood tests.",[542,543],"Relapsed Solid Tumor Malignancies","Refractory Solid Tumor Malignancies",[545,546,547,548,549],"GEMys","Cd34+ Cells","Lymphodepletion","IFNy","Leukapheresis",{"date":37,"type":38},{"date":73,"type":22},{"date":553,"type":22},"2029-01-15",{"name":195,"class":78},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100643909","phase-3-a-research-study-investigating-how-well-the-medicine-zenagamtide-helps-people-with-excess-body-weight-lose-weight-compared-to-semaglutide-100643909","NCT07668414","A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide","Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)","AMAZE 7","Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18 years or above at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole \\[mmol\u002Fmol\\]) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.",{"count":564,"type":22},650,[91],"The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.",[364,365],{"date":37,"type":38},{"date":570,"type":22},"2026-09-22",{"date":572,"type":22},"2028-10-10",{"name":371,"class":107},43,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":173,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":598,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":610,"locationsCount":46},"100643883","docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100643883","NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms",{"count":583,"type":22},120,[60,25],"Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[587,588,589,590,591,592,593,594,595,596,491,597],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Metastatic Castration Resistant Prostate Cancer",[599,600,601,602,603,604,605],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor",{"date":37,"type":38},{"date":73,"type":22},{"date":609,"type":22},"2037-10-01",{"name":195,"class":78},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":54,"minAge":172,"maxAge":117,"enrollmentInfo":617,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":619,"conditions":620,"keywords":622,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":629},"100642046","pulmonary-hypertension-ph-biorepository-for-translational-research-100642046","NCT07647549","Pulmonary Hypertension (PH) Biorepository for Translational Research","* INCLUSION CRITERIA:\n* Provision of signed and dated informed consent form\n* Males and females aged \\>=18 years old\n* Suspected of or diagnosed with PH\n* Able to understand and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAny individual who does not meet all inclusion criteria or is deemed by the local investigator not to be a blood draw candidate will be excluded from participating in this study.",{"count":618,"type":22},1000,"Background:\n\nPulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. They hope to use this information to find better ways to diagnose and treat PH.\n\nObjective:\n\nTo collect blood samples and health information from people suspected of or diagnosed with PH.\n\nEligibility:\n\nPeople aged 18 years and older who have or may have PH.\n\nDesign:\n\nResearchers will collect information from participants medical records.\n\nParticipants will have blood drawn from a vein. About 3 tablespoons will be collected during the study visit. The visit will last about 1 hour.\n\nParticipants may choose to provide new blood samples at follow-up visits. Updated medical information may also be collected.\n\nParticipants may continue to participate as long as the study is ongoing. Participants may opt out of providing new blood samples but remain in the study.\n\nAll study samples will be stored at the National Institutes of Health. Health information will be stored in secure databases.",[621],"Pulmonary Hypertension",[621,623],"Biorepository",{"date":37,"type":38},{"date":73,"type":22},{"date":627,"type":22},"2036-06-01",{"name":134,"class":78},3,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":54,"minAge":637,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":298},"100641813","phase-1-a-study-to-assess-the-safety-and-effects-of-abbv-1758-following-subcutaneous-or-intravenous-injections-in-participants-with-alzheimers-disease-100641813","NCT07599670","A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants meeting all the following criteria for Alzheimer's disease (AD):\n\n  * In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.\n  * Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).\n* Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.\n\nExclusion Criteria:\n\n* Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.\n* Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and\u002For any history of abnormal laboratory results that are indicative of significant disease(s).\n* Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.\n* Participants with other significant pathological findings on brain MRI at screening, including but not limited to:\n\n  * Evidence of vasogenic edema\n  * 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)\n  * Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)\n  * Any superficial siderosis\n  * Severe white matter disease","50 Years","90 Years",{"count":640,"type":22},210,[60,25],"Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.\n\nABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.\n\nParticipants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.",[644],"Alzheimer's Disease",[644,646],"ABBV-1758",{"date":37,"type":38},{"date":649,"type":38},"2026-05-15",{"date":651,"type":22},"2030-10",{"name":106,"class":107},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":484,"minAge":172,"maxAge":173,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":662,"briefSummary":663,"conditions":664,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":672,"leadSponsor":674,"locationsCount":46},"100641793","multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100641793","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.",{"count":661,"type":22},52,[25],"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[665,491,417,602,666,667],"Adenocarcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[669],"Immune Infiltration",{"date":37,"type":38},{"date":73,"type":22},{"date":673,"type":22},"2028-06-15",{"name":195,"class":78},""]