[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Arizona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":674},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,72,0,25,[9,55,81,109,141,174,194,218,259,292,326,358,377,408,430,455,473,495,516,540,563,576,606,626,645],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100054010","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100054010",false,"NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.","ALL","65 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[27,28,29,30,31,32],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[34,35,36,37,38,39,40,41],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","NOT_YET_RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":21},"2026-10-31",{"date":50,"type":21},"2030-06-01",{"name":52,"class":53},"University of Arizona","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":54},"100053971","the-effect-of-semantic-support-on-word-learning-100053971","NCT05921214","The Effect of Semantic Support on Word Learning","Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children","Inclusion Criteria:\n\n* Native English Speaking\n* Pass pure tone hearing screening or medical report of normal hearing\n* 2-3 Years of age\n* MCDI expressive scale \\\u003C10th percentile\n\nExclusion Criteria:\n\n* Parental report of other diagnoses\n* Enrolled in concurrent treatment elsewhere\n* Nonverbal IQ \\\u003C75 as measured by the Bayley scales\n* Parents unable to consistently bring child to treatment sessions","2 Years","4 Years",{"count":65,"type":21},32,[67],"NA","The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.",[70],"Language Development Disorders",[72],"Late Talkers","RECRUITING","2026-07-09",{"date":45,"type":46},{"date":77,"type":46},"2025-06-10",{"date":79,"type":21},"2026-12-01",{"name":52,"class":53},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":54},"100643558","early-phase-1-glp-1-ra-plus-soc-treatment-in-first-line-metastatic-pancreatic-colorectal-or-hepatocellular-cancer-100643558","NCT07627191","GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","GLP-1 Receptor Agonist Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","Inclusion Criteria:\n\n* Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the \"additional HCC cohort criteria\" below.\n* The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease)\n* Measurable disease per RECIST v1.1 as determined by the investigator\n* Patients must be appropriate candidates for first-line, SOC treatment.\n\n  * SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:\n\n    * Colorectal: FOLFOX or FOLIFIRI +\u002F- bevacizumab\n    * Pancreatic: mFOLFIRINOX\n    * HCC: Tremelimumab\u002FDurvalumab\n  * Patients are eligible who received prior perioperative chemotherapy for curative intent treatment and recurred ≥ 6 months since last dose of chemotherapy.\n* ≥ 18 years old on day of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and\u002For tumor block)\n* Adequate hematologic and organ function laboratory values as follows:\n\n  * The ANC ≥ 1500\u002Fmm3 without colony stimulating factor support;\n  * Platelets ≥ 75,000\u002Fmm3;\n  * Hemoglobin ≥ 9 g\u002FdL;\n  * Bilirubin ≤ 1.5 ´ the ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL;\n  * Serum albumin ≥ 2.8 g\u002Fdl;\n  * ALT and AST ≤ 3.0 ´ ULN;\n  * Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n    * Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72);\n    * Female: Multiply above result by 0.85;\n* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document\n* Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s);\n\nAdditional Inclusion Criteria for HCC Cohort ONLY:\n\n* Histologically or radiologically confirmed hepatocellular carcinoma (per AASLD\u002FEASL criteria)\n* Unresectable or advanced HCC not amenable to curative surgery or locoregional therapy.\n* Barcelona Clinic Liver Cancer (BCLC) stage B or C.\n* Child-Pugh Score Class A; or Child-Pugh Class B7 or B8 at discretion of treating physician\n* Patients with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU\u002FmL or above the limit of detection per local or central lab standard), must be treated with antiviral therapy, as per institutional practice to ensure adequate viral suppression (HBV DNA \\\u003C2000 IU\u002FmL) before enrolment. Patients must remain on antiviral therapy for the duration of their participation in the EAP and for 6 months after the last dose of EAP medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C10 IU\u002FmL or under the limit of detection per local or central lab standard) do not require anti-viral therapy before enrolment. These participants will be tested at every cycle to monitor HBV DNA levels and initiate anti-viral therapy if HBV DNA is detected (≥10 IU\u002FmL or above the limit of detection per local or central lab standard). HBV DNA detectable patients must initiate and remain on anti-viral therapy for time they are on the EAP and for 6 months after the last dose of EAP medication.\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Patients with HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrolment (management of this disease is per local institutional practice).\n\nExclusion Criteria\n\n* The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) for metastatic and\u002For unresectable disease.\n* BMI \\\u003C 25 kg\u002Fm2\n* For colorectal cancer only - Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors.\n* For colorectal cancer only - BRAF V600E mutant tumors.\n* A personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* A prior hypersensitivity reaction to semaglutide or any of the excipients in WEGOVY®. Serious hypersensitivity reaction, including anaphylaxis and angioedema, have been reported with WEGOVY®.\n* Cachexia\n* Subjects on insulin.\n* Subjects with a history of diabetic retinopathy\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  o Cardiovascular disorders including:\n  * For patients being considered for bevacizumab (or bevacizumab biosimilar) only:\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;\n* thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (eg, vena cava filter) within 6 months before the first dose of study treatment.\n\n  * Any of the following within 6 months before the first dose of study treatment:\n* unstable angina pectoris;\n* clinically-significant cardiac arrhythmias;\n* stroke (including transient ischemic attack (TIA), or other ischemic event);\n* myocardial infarction;\n\n  * GI disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Unresolved abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess.\n    * Uncontrolled nausea, vomiting, or abdominal pain.\n  * Other clinically significant disorders that would preclude safe study participation\n* Major surgery within 8 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Females who are known or suspected to be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within screening.\n* Female patients planning on becoming pregnant while on study.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment.\n* Male subjects unwilling to abstain from donating sperm during treatment.\n* Inability to comply with self-administration of GLP-1 RA subcutaneous injections.\n* Subject has known sensitivity to any of the products or components to be administered during dosing.\n* Concurrent use of other semaglutide containing products or any other GLP-1 receptor agonist.\n* Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n* Subject likely to not be available to complete all protocol-required study visits or procedures and\u002For to comply with all required study procedures to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.\n\nAdditional Exclusion Criteria for HCC Cohort ONLY:\n\n* Child-Pugh Score Class B9; or Child-Pugh Class C\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of EAP treatments.\n* History of allogenic organ transplantation (e.g., liver transplant).\n* History of hepatic encephalopathy within the past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy.\n* Clinically meaningful ascites, defined as any ascites requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control, within 2 months before the first EAP treatment dose. Patients on stable doses of diuretics for ascites for ≥2 months are eligible.\n* Patients with main portal vein thrombosis (i.e., thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.\n* Active or previously documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[except for diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). Patients without active disease in the last 5 years are excluded unless discussed with the Treating Physician and considered appropriate for EAP participation. The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients with celiac disease controlled by diet alone\n* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV). HBV positive (presence of HbsAg and\u002For anti-HBcAb with detectable HBV DNA); HCV positive (presence of anti-HCV antibodies); HDV positive (presence of anti-HDV antibodies).\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* History of active primary immunodeficiency.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of EAP treatment. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as pre-medication for hypersensitivity reactions (e.g., CT scan pre-medication)\n* Receipt of live attenuated vaccine within 30 days before first dose of treatment. Note: patients, if enrolled, should not receive live vaccine while receiving study treatment, and up to 30 days after the last dose of study treatment.\n* Previous randomization or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n* Patients who have received anti-PD-1, anti-PD-L1, or anti-CTLA-4 before the first dose of EAP treatment.","18 Years","99 Years",{"count":91,"type":21},30,[93],"EARLY_PHASE1","There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and\u002For feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.",[96,97,98],"Pancreatic Cancer","Colorectal Cancer","Hepatocellular Carcinoma",[100,101],"GLP1 receptor agonists","gastrointestinal cancer","2026-06-30",{"date":104,"type":46},"2026-07-02",{"date":43,"type":21},{"date":107,"type":21},"2028-06-30",{"name":52,"class":53},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":54},"100624280","phase-1-ph-iii-sodium-thiosulfate-for-otoprotection-during-cisplatin-stop-cis-100624280","NCT07407582","Ph. I\u002FII Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)","Phase I\u002FII Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)","Inclusion Criteria:\n\n* Participants have provided informed consent prior to initiation of any study-specific activities.\n* At least 18 years of age, male or female, at the time of signing the informed consent.\n* ECOG Performance Status 0-1\n* Histologically or cytologically confirmed treatment-naïve cancer.\n* Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg\u002Fm2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician\n\nExclusion Criteria:\n\n* Prior cisplatin exposure due to a cancer treatment history\n* Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative\n* Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin\n* History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components\n* Baseline serum sodium \\> 145 mmol\u002FL or any grade ≥ 3 electrolyte abnormality\n* Cisplatin infusion duration greater than 6 hours\n* Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment\n* Subject likely not to be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.",{"count":7,"type":21},[24,118],"PHASE2","The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.",[121,122,123,124],"Solid Tumor Malignancies","Testicular Cancer","Head and Neck Cancer","Thoracic Cancer",[126,127,128,129,130,131,132],"Cisplatin","Otoprotectant","Cancer","Hearing Impairment","Sodium Thiosulfate","Adults","Solid Tumor","2026-06-16",{"date":135,"type":46},"2026-06-18",{"date":137,"type":46},"2026-05-18",{"date":139,"type":21},"2028-04-30",{"name":52,"class":53},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":163,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100641575","veda-study-dhea-vs-estradiol-100641575","NCT07574216","VEDA Study (DHEA vs Estradiol)","The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women","Inclusion Criteria:\n\n* Peri- or post-menopausal status\n* Presence of any genitourinary or vaginal symptom (e.g., dryness, itching, discomfort, dyspareunia)\n* Willingness and ability to use vaginal therapy\n* Ability to provide informed consent\n* English speaker\n* Ages 40-90\n\nExclusion Criteria:\n\n* Use of systemic hormone therapy within the last 6 months\n* Gynecologic malignancy\n* Known allergy to study medications\n* Active vaginal infection at enrollment\n* Prior pelvic radiation",true,"FEMALE","40 Years","90 Years",{"count":153,"type":21},324,[67],"This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.",[157,158,159,160,161,162],"Post-menopause","Pre-menopause","Sexual Function","Menopause","Vaginal Dryness","Painful Intercourse",[164,165],"DHEA","vaginal estrogen","2026-06-15",{"date":168,"type":46},"2026-06-17",{"date":170,"type":21},"2026-06-01",{"date":172,"type":21},"2031-12-31",{"name":52,"class":53},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":54},"100642429","progressive-muscle-relaxation-delivered-via-virtual-reality---an-intervention-for-patients-undergoing-cellular-therapy-100642429","NCT07649512","Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy","PMR Delivered Via VR - a Cellular Therapy Intervention","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age greater than or equal to 18 years old\n3. Either have a planned admission or already be admitted to the in-patient oncology ward (3NW) with cellular therapy needs.\n4. Able to understand English\n5. Able to sit-up in bed or bedside chair space to utilize VR device at the time of enrollment\n6. Able to utilize VR device and computer\u002Flaptop to access necessary resources for participation\n7. Performance Status as defined by European Cooperative Oncology Group (ECOG) score of 0-2\n\nExclusion Criteria:\n\n1. Poor performance status of ECOG 3-4\n2. Recent use of immersive VR programs for stress relief and\u002For entertainment (more than 2 days\u002Fweek within the past 3 months)\n3. Participation in another stress-reduction type interventional study within the past 3 months\n4. Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders\n5. Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed\n6. Having another medical condition or co-morbidity that may prevent use of VR program or physical materials (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection)\n7. Patients with concern for neurotoxicity or acute treatment related neurological issues such as ICANS. ICANS grade 1 maybe eligible to re-enter trial. ICANS grade 2 or greater would be permanently excluded.",{"count":182,"type":21},40,[67],"Patients planned for cellular therapy supplementation such as CAR-T or stem cell transplant who are admitted for atleast 7 days in patient. During that time of admission, patients enrolled will complete a once daily, virtual reality guided progressive muscle relaxation program. Various validated QOL tools will be utilized to assess study results.",[186],"Heme Malignancy","2026-06-09",{"date":133,"type":46},{"date":190,"type":21},"2026-08",{"date":192,"type":21},"2027-05-01",{"name":52,"class":53},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":54},"100636382","social-optimization-study-100636382","NCT07564960","Social Optimization Study","Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity","Inclusion Criteria:\n\n1. Adults (18 Years or Older)\n2. History of lung cancer\n3. at least 12 months since cancer diagnosis\n4. fluent in English\n5. able to attend virtually or in person sessions at the University of Arizona.\n\nExclusion Criteria:\n\n1. Less than 12 months of cancer diagnosis at time of enrollment\n2. undergoing treatment for mood or anxiety health issues at time of enrollment\n3. unable to provide informed consent.",{"count":91,"type":21},[67],"This study tests whether clinical interventions to optimize support receptivity lead to improvements in social integration and quality of life (QOL) amongst long-term lung cancer survivors. The feasibility and acceptability of the intervention and assessment procedures will be examined. Thirty long-term lung cancer survivors will be randomized to a support receptivity intervention or an attention-control condition. Our intervention draws on cognitive behavioral therapy (CBT) strategies to reduce social anxiety, improve social awareness, and promote social integration. We will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder to capture daily social interactions, and 2) repeated self-report sampling where participants answer questions about their social engagement experiences via their personal cell phone.",[205],"Lung Cancer",[207,208,209],"Social support","Psycho-oncology","Lung neoplasms","2026-06-03",{"date":212,"type":46},"2026-06-05",{"date":214,"type":46},"2026-04-27",{"date":216,"type":21},"2026-07-31",{"name":52,"class":53},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":148,"sex":17,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":238,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":54},"100565518","early-phase-1-exercise-as-an-immune-adjuvant-for-allogeneic-cell-therapies-100565518","NCT06643221","Exercise as an Immune Adjuvant for Allogeneic Cell Therapies","Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies","Allo-X","Procedures are in place for protecting against or minimizing the risks to the healthy volunteers recruited for this study. Physical risk to volunteers and matched related donors will be protected through health screening to determine study eligibility, and medical monitoring with an established test termination criterion during the exercise and isoproterenol infusion trials.\n\nTo protect against the remote risk of an adverse cardiac event occurring during exercise and isoproterenol infusion, the study will only enroll volunteers who are considered \"low risk\" for maximal stress testing in accordance with the guidelines published by the American College of Sports Medicine (ACSM) and American Heart Association (AHA). Individuals who are considered \"low risk\" are men and women who are asymptomatic and have no more than one risk factor for cardiovascular disease (CVD). The risks to subjects are therefore extremely low. All infusions will take place in the Clinical and Translational Sciences Research Center (CATS) Infusion Suite, which is a designated University of Arizona campus facility for infusion trials and equipped with appropriate medical personnel and monitoring equipment (i.e. ECG). The graded exercise tests and isoproterenol infusions procedures will be performed under the direction of a licensed and board-certified cardiologist\n\nInclusion Criteria:\n\nParticipants must:\n\n* Be between 21 and 55 years of age.\n* Be classified as 'low-risk' for graded exercise\u002Fstress testing according to ACSM-AHA criteria.\n* Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Currently use tobacco products or have quit within the last 6 months.\n* Have a body mass index (BMI) greater than 34 kg\u002Fm² or waist circumference exceeding 102 cm for men and 88 cm for women.\n* Use any medications known to affect the immune system or regularly take ibuprofen\u002Faspirin, antidepressants, or medications that alter blood pressure or cardiovascular function.\n* Use of hormone replacement therapy.\n* Are pregnant or breastfeeding.\n* Have chronic or debilitating arthritis or have been bedridden in the past three months.\n* Experienced a common illness (e.g., colds) within the past 6 weeks.\n* Have central or peripheral nervous disorders, a history of stroke, or major affective disorder.\n* Are infected with HIV or hepatitis or have any autoimmune disease.\n* Have known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast.\n* Use any prescription medications or have an allergy to beta-blockers.\n* Have a resting heart rate of less than 50 beats per minute.\n* Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions.\n* Are scheduled for surgery.\n\nAdditionally, participants who meet the inclusion criteria but present with more than one of the following cardiovascular disease (CVD) risk factors will be excluded unless cleared by a cardiologist:\n\n* Family History: Myocardial infarction, coronary revascularization, or sudden death before 55 years of age in a father or male first-degree relative, or before 65 years of age in a mother or female first-degree relative.\n* Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg.\n* Dyslipidemia: Total serum cholesterol exceeding 200 mg\u002Fdl.\n* Pre-diabetes: Fasting blood glucose levels between 100 mg\u002Fdl and 126 mg\u002Fdl.","21 Years","55 Years",{"count":229,"type":21},200,[93],"This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue.\n\nThis Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups:\n\n1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice.\n2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells.\n3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise.\n\nParticipants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.",[233,234,35,235,236,237],"Leukemia","Hematopoetic Stem Cell Transplantation","CAR T-Cell Therapy","Lymphoma","Cell Therapy",[239,240,241,242,243,244,245,246,247,248,249,250,251,252],"exercise","cell therapy","beta-blockers","immune function","phosphodiesterase inhibitor","CAR T-cells","NK-cells","cytokine-induced killer cells","cytokine-induced memory-like NK-cells","monoclonal antibodies","leukemia","lymphoma","donor lymphocyte infusion","gamma-delta T-cells",{"date":212,"type":46},{"date":255,"type":46},"2018-01-24",{"date":257,"type":21},"2031-05-31",{"name":52,"class":53},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":148,"sex":149,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":54},"100609432","human-papillomavirus-hpv-self-sampling-options-to-promote-equity-100609432","NCT07214506","Human Papillomavirus (HPV) Self-Sampling Options to Promote Equity","Human Papillomavirus Self-Sampling Options to Promote Equity (HOPE)","HOPE","Inclusion Criteria:\n\n* Women or transgender men with a cervix\n* Ages 30-64 years\n* Due for cervical cancer screening:\n\n  1. No Pap test in the past 3 years, or\n  2. No human papillomavirus (HPV) test in the past 5 years\n* Unhoused or unstably housed\n\nExclusion Criteria:\n\n* History of cervical cancer\n* HIV positive\n* History of total hysterectomy\n* Known pregnancy","30 Years","64 Years",{"count":270,"type":21},100,[67],"This study is testing a new way to help people who are unhoused get screened for cervical cancer. Cervical cancer can often be prevented if it is found early. Many people who lack stable housing usually do not receive regular screenings.\n\nThrough this project, the investigators will bring screening to community locations in Tucson, Arizona, using a mobile health unit (MHU) from the University of Arizona (UA) and El Rio Health. At these sites, participants will receive easy-to-understand education about cervical cancer, learn how to collect their own sample for human papillomavirus (HPV) testing, and get follow-up care if needed.\n\nThe study has two goals:\n\n* First, the investigators will see if this community-based approach helps more people complete cervical cancer screening.\n* Second, the investigators will ask participants, clinicians, and outreach staff for their opinions about the program and its practicality and acceptability.\n\nBy testing this approach, the investigators hope to find a way to make cervical cancer screening more accessible and effective for unhoused individuals.",[274,275,276],"Uterine Cervical Neoplasms","HPV Testing","Pap Smear",[278,279,280,281,282,283],"Cervical cancer screening","HPV self-collection","HPV test","Mobile health unit","Unhoused individuals","Community outreach","2026-05-27",{"date":286,"type":46},"2026-05-29",{"date":288,"type":21},"2026-08-01",{"date":290,"type":21},"2027-05-31",{"name":52,"class":53},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":227,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":54},"100626690","mind-after-midnight-100626690","NCT07438912","Mind After Midnight","The Mind After Midnight: Mechanistic Examination of Nocturnal Wakefulness as a Suicide Risk Factor","MaM","Inclusion Criteria\n\n* Age 18-55 years\n* History of suicidal ideation within the past 6 months\n* Habitual bedtime between 9:00 PM and 1:00 AM\n* Habitual wake time between 6:00 AM and 9:00 AM\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Current suicidal intent requiring immediate clinical intervention\n* Diagnosis of a primary sleep disorder (e.g., untreated obstructive sleep apnea, narcolepsy)\n* Bipolar disorder or psychotic disorder\n* Substance use disorder within the past 3 months\n* Use of medications that significantly affect sleep or circadian rhythms\n* Night shift work or transmeridian travel within the past month\n* Medical or neurological condition that would interfere with participation\n* Pregnancy",{"count":301,"type":21},90,[67],"This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.",[305,306,307,308],"Suicidal Ideation","Circadian Rhythm Disorders","Sleep Deprivation","Sleep Wake Disorders",[310,311,312,313,314,315,316,317],"Nocturnal Wakefulness","Suicide Risk","Circadian Misalignment","Impulsivity","Mood Regulation","Biological Night","Sleep Pressure","Decision-Making","2026-05-19",{"date":320,"type":46},"2026-05-22",{"date":322,"type":46},"2026-03-06",{"date":324,"type":21},"2029-08-31",{"name":52,"class":53},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":348,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100578684","phase-1-radiation-combined-with-bispecific-t-cell-engager-in-dll3-expressing-tumors-100578684","NCT06814496","Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors","RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I\u002FII Study of AMG757 \u002F Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3","RABBIT","Inclusion Criteria:\n\n1. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n2. Subjects ≥ 18 years of age at the time of signing the informed consent.\n3. Histologically or cytologically confirmed relapsed\u002Frefractory:\n\n   1. SCLC\n   2. Other tumors of small cell histology\n   3. High grade \u002F poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer, esthesioneuroblastoma, bladder cancer, testicular cancer, glioblastoma multiforme, cervical cancer; large cell neuroendocrine tumor of lung, non-small cell lung cancers with mixed neuroendocrine features, and Merkel cell carcinoma OR\n   4. DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevelant tumor type, they will be allowed to enroll on the study.\n4. Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.\n5. Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \\[FFPE\\] sample). If no archived tumor tissue is available, we request to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable or unwilling to undergo a pretreatment tumor biopsy due to extenuating circumstances (i.e., cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement with sponsor.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Minimum life expectancy of 12 weeks.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n9. Measurable lesions as defined per RECIST 1.1 within 28 days prior to the first dose of tarlatamab.\n10. Eligible for external beam radiation therapy to a previously unirradiated, measurable lesion as per standard of care.\n\n    1. For the concurrent \u002F sequential cohort of extracranial RT sites:\n\n    i. A minimum of 10 subjects with thoracic lesions (lung, mediastinum, thoracic spine, rib, or other thoracic sites) will be treated ii. Subjects with treated brain metastases are eligible (untreated brain metastases are ineligible) provided they meet the following criteria:\n\n\u003C!-- -->\n\n1. Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.\n2. There is no evidence of radiographic central nervous system (CNS) progression following therapy and by the time of study screening.\n3. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means.\n4. Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n\n   b. For the concurrent\u002Fsequential cohort of cranial RT sites: i. Previously untreated brain lesions \u002F metastases are eligible ii. Subjects with previously irradiated brain lesions are eligible provided they meet one of the following criteria:\n\n\u003C!-- -->\n\n1. Prior PCI or whole brain radiation therapy per standard of care with new and\u002For recurrent brain metastases to be treated with SRS or hfSRT\n2. Prior course(s) of SRS or hfSRT or other localized therapy with new lesion(s) to be treated with whole brain radiation therapy iii. Whole brain re-irradiation will be ineligible iv. Re-irradiation with SRS or hfSRT of previously irradiated lesion with SRS or hfSRT will be ineligible v. Craniospinal irradiation will not be allowed c. For the tarlatamab monotherapy cohort: i. Patient must have at least one measurable lesion, however that lesion does not need to be amenable to RT\n\n1\\. Patients with previously irradiated lesions that have recurred or progressed are eligible 11. Adequate organ function, defined as follows:\n\na. Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109\u002FL ii. Platelet count ≥ 100 x 109\u002FL iii. Hemoglobin \\> 9 g\u002FdL (90 g\u002FL) b. Coagulation function: i. Prothrombin time (PT)\u002Finternational normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.\n\nc. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. hepatic function: i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement) ii. Total bilirubin \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for subjects with liver metastases) e. Pulmonary function: i. No clinically significant pleural effusion ii. Baseline oxygen saturation \\> 90% on room air f. cardiac function (if obtained as part of standard of care): i. Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings\n\nExclusion Criteria:\n\nRe-irradiation, unless it is SRS\u002FhfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS\u002FhfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not amenable to RT (including previously irradiated) will be only allowable on the tarlatamab monotherapy cohort.\n\nDisease Related\n\n1. Subjects are excluded from the study if any of the following criteria apply:\n\n   1. No lesion(s)\u002Fsite(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open)\n   2. Planned re-irradiation of a previously irradiated site\n   3. Leptomeningeal disease requiring craniospinal irradiation\n2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n3. Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n4. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \\> 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.\n\nOther Medical Conditions\n\n1. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of tarlatamab.\n2. History of arterial thrombosis (i.e., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.\n3. Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.\n\n   NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for \\> 48 hours.\n4. History of hypophysitis or pituitary dysfunction.\n5. Exclusion of hepatitis infection based on the following results and\u002For criteria:\n\n   a. Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).\n\n   b. Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.\n\n   c. Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.\n6. Major surgery requiring hospitalization for more than 3 days within 28 days of first dose of tarlatamab.\n7. Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n8. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n9. Human immunodeficiency virus (HIV) infection.\n\n   1. Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines.\n\nPrior\u002FConcomitant Therapy\n\n1. Subject received prior therapy with tarlatamab.\n2. Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.\n\n   Exceptions:\n\n   a. Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.\n3. Has a diagnosis of immunodeficiency (i.e., positive\u002Fnon-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.\n4. The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:\n\n   1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.\n   2. Live viral non-replicating vaccine (i.e., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care (SOC) and institutional guidelines.\n   3. End of study treatment: Live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab.\n\nOther Exclusions\n\n1\\. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab. Contraception methods for female subjects include:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable)\n3. Intrauterine device\n4. Intrauterine hormonal-releasing system\n5. Bilateral tubal ligation\u002Focclusion\n6. Vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success)\n7. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject) 2. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.\n\n   3\\. Female subjects planning to become pregnant while on study through 60 days after the last dose of tarlatamab.\n\n   4\\. Female subjects of childbearing potential with a positive pregnancy test assessed at screening and\u002For day 1 by a highly sensitive urine or serum pregnancy test.\n\n   5\\. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception (use a condom) during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   6\\. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   7\\. Male subjects unwilling to abstain from donating sperm during treatment and for an 60 days after the last dose of tarlatamab.\n\n   8\\. Subject has known sensitivity to any of the products or components to be administered during dosing.\n\n   9\\. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n\n   10\\. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.",{"count":91,"type":21},[24,118],"Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites.\n\nI) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting.\n\nIII) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT.\n\nA nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.",[338,339,340,341,342,122,343,344,345,346,347],"Melanoma","Medullary Thyroid Cancer","Sinonasal Undifferentiated Carcinoma","Esthesioneuroblastoma","Bladder Cancer","Glioblastoma Multiforme","Cervical Cancer","Large Cell Neuroendocrine Carcinoma of the Lung","Non Small Cell Lung Cancer","Merkel Cell Carcinoma",[349],"DLL3 Expressing tumors",{"date":351,"type":46},"2026-05-20",{"date":353,"type":46},"2025-09-08",{"date":355,"type":21},"2030-05",{"name":52,"class":53},2,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":148,"sex":17,"minAge":88,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":375,"leadSponsor":376,"locationsCount":54},"100619526","hypknowledge-nationwide-sleep-extension-100619526","NCT07345767","Hypknowledge Nationwide Sleep Extension","Inclusion Criteria:\n\n1. Be between the ages of 18-60 years old\n2. Have a typical sleep schedule of \\\u003C=6 hours per night\n3. Must have a FitBit device (any model) with Heart Rate Monitor\n4. Must have bedtime between 8 pm and 1 am\n5. Must have a waketime between 5 am and 10 am\n6. Must not have insomnia as determined by diagnosis or score on the Insomnia Severity Index (ISI), or must be treated.\n7. Must not have sleep apnea as determined by diagnosis or STOP-BANG scale, or must be treated.\n8. Must have a computer or smartphone device for daily sleep diaries.\n9. Must have an initial sleep efficiency of at least 85% as determined by sleep diaries and actigraphy.\n\nExclusion Criteria:\n\n1. Any condition that the PI considers would significantly impede participation in the study.\n2. Participant is under 18 years of age or older than 60 years of age\n3. Does not own a FitBit device with Heart Rate Monitor\n4. Sleep \\>6 hours per night.\n5. Typical bedtime before 8 pm or after 1 am\n6. Typical waketime before 5 am or after 10 am\n7. Diagnosed with sleep disorders including insomnia or sleep apnea\n8. Diagnosed mental health disorder which may impact sleep (i.e. Bipolar Disorder)\n9. Taking medications that may affect sleep.\n10. Baseline sleep efficiency less than 85%.","60 Years",{"count":366,"type":21},1038,[67],"The main goal of this study is to evaluate whether a manually determined sleep extension intervention is effective at improving sleep and related outcomes among adults who find it difficult to get enough sleep.",[370],"Short Sleep Duration","2026-05-12",{"date":373,"type":46},"2026-05-14",{"date":288,"type":21},{"date":290,"type":21},{"name":52,"class":53},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":393,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100494213","adaptive-symptom-self-management-immunotherapy-study-100494213","NCT05715255","Adaptive Symptom Self-Management Immunotherapy Study","Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age 18 or older\n* Within 12 weeks after starting ICI treatment for cancer\n* Cognitively oriented to person, place and time (determined by recruiter)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library\n\nExclusion Criteria:\n\n* Currently receiving regular behavioral counseling",{"count":385,"type":21},400,[67],"The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.",[389,390,205,391,392],"Breast Cancer","Colon Cancer","Skin Cancer","Rectum Cancer",[128,394,395,396,397,398,399],"Cancer Survivors","Immunotherapy","Immune Checkpoint Inhibitors","Symptom Management","Psychosocial Oncology","Telephone Intervention","2026-05-11",{"date":373,"type":46},{"date":403,"type":46},"2023-05-08",{"date":405,"type":21},"2027-04-30",{"name":52,"class":53},3,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":148,"sex":149,"minAge":88,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":422,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":429,"locationsCount":4},"100640393","stratafix-vs-pds-fascial-closure-rct-100640393","NCT07574086","Stratafix vs. PDS (Fascial Closure RCT)","A Randomized Controlled Trial Comparing Stratafix vs. PDS Suture for Fascial Closure at Cesarean Delivery: Impact on Postoperative Pain and Narcotic Use","Inclusion Criteria:\n\n* Women of reproductive age ( ≥18 years old to ≤ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≥37 weeks of gestation.\n\nExclusion Criteria:\n\n* Women of reproductive age (≤ 18 years old to ≥ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≤ 37 weeks of gestation.\n* Emergent Cesarean delivery\n* Chronic opioid use or pain disorders\n* Allergy to suture materials\n* Previous classical Cesarean section\n* Intraoperative complications (e.g. hemorrhage, uterine rupture, injury)","45 Years",{"count":229,"type":21},[67],"This proposed prospective, randomized, single-blinded controlled trial will directly compare Stratafix anti-microbial barbed sutures and standard PDS sutures for fascial closure at the time of Cesarean delivery.\n\nPrimary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours.\n\nSecondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS).",[420,421],"Pain Score Reduction","Cesarian Section",[421,420,423],"Opiod use","2026-05-01",{"date":426,"type":46},"2026-05-07",{"date":424,"type":21},{"date":172,"type":21},{"name":52,"class":53},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":444,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":54},"100610535","effectiveness-comparison-of-3d-printed-and-conventional-ear-tip-comfort-in-individuals-with-hearing-loss-100610535","NCT07228845","Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss","Inclusion Criteria:\n\n* Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss\n* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.\n* English speaking.\n\nExclusion Criteria:\n\n* Self reported history of extensive or current outer or middle ear pathology.\n* Self reported history of extensive outer or middle ear surgery.\n* Self reported history of neurological or cognitive disorder.\n* Active ear infection","89 Years",{"count":65,"type":21},[67],"Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.",[441,442,443],"Hearing Aids","Hearing Loss, Bilateral Sensorineural","3D Printing",[445,446,447],"hearing aids","3D printing","hearing loss","2026-04-30",{"date":424,"type":46},{"date":451,"type":46},"2026-03-15",{"date":453,"type":21},"2027-04-25",{"name":52,"class":53},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":148,"sex":17,"minAge":88,"maxAge":436,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":54},"100609619","effectiveness-comparison-of-3d-printed-and-conventional-ear-tip-comfort-in-individuals-with-hearing-in-the-normal-range-100609619","NCT07216937","Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range","Inclusion Criteria:\n\n* Normal hearing thresholds (\\\u003C25 dB HL) at octave frequencies from 250-8000Hz.\n* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.\n* English speaking.\n\nExclusion Criteria:\n\n* history of extensive or current outer or middle ear pathology.\n* history of extensive outer or middle ear surgery.\n* history of neurological or cognitive disorder.",{"count":91,"type":21},[67],"Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit. It will also compare how long each method takes to make and how much each costs.",[441,443],[445,446,466],"hearing healthcare accessibility",{"date":424,"type":46},{"date":469,"type":46},"2025-11-07",{"date":471,"type":21},"2026-06-14",{"name":52,"class":53},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":481,"maxAge":88,"enrollmentInfo":482,"targetDuration":483,"studyType":484,"phases":4,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":492,"leadSponsor":494,"locationsCount":4},"100636707","impact-of-continuous-glucose-monitoring-and-education-intervention-on-glycemic-control-and-behavioral-changes-in-pre-diabetic-adolescents-100636707","NCT07569185","Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents","A Pilot Study Evaluating the Impact of Continuous Glucose Monitoring and Education Intervention on Glycemic Control and Behavioral Changes in Pre-Diabetic Adolescents","PreDiA-CGM","Inclusion Criteria:\n\n* • At least 13 years of age\n\n  * No older than 17 years of age (up to 18th birthday)\n  * Access to a smart-device compatible with a continuous glucose monitor application and wearable biosensor\n  * Diagnosed prediabetes, defined as any of the following:\n\n    * Fasting plasma glucose of 100- 125 mg\u002FdL\n    * 2-hour glucose level on oral glucose tolerance test (OGTT):140-199 mg\u002FdL\n    * HbA1c 5.7%-6.4%\n\nExclusion Criteria:\n\n* • Previous diagnosis of Prader Willi Syndrome\n\n  * Previous diagnosis of hypothalamic obesity\n  * Previous diagnosis of intellectual disability\n  * Previous or planned bariatric surgery\n  * Current use of medication is known to impact weight\n  * Previous diagnosis of diabetes mellitus\n  * Hemoglobin A1c \\>6.5%\n  * Non-English speaking","13 Years",{"count":7,"type":21},"20 Weeks","OBSERVATIONAL","Prediabetes is a condition wherein blood sugar levels are elevated but not sufficiently high enough to diagnose type 2 diabetes mellitus (T2D). Prediabetes is a critical risk factor for the development of T2D in pediatric populations. This progression can occur over a short period of time, limiting the efficacy and impact of existing interventions and recommendations targeting this population. There is growing evidence on the use of continuous glucose monitors (CGMs) in adult prediabetic populations to prevent the development of T2D, though this intervention has not been thoroughly investigated in pediatric populations.\n\nThe investigators are proposing a pilot study of 25 prediabetic adolescents enrolled in a 20-week study. For the initial 10 weeks of the study, the participants will go without CGMs and undergo clinically recommended education on their condition as standard of care. In the 10 weeks following, participants will be given a CGM to wear and instructions on its use. Surveys will be issued to all participants over the entirety of the study to follow behaviors surrounding food and physical activity.",[487],"Pre Diabetes","2026-04-28",{"date":490,"type":46},"2026-05-06",{"date":170,"type":21},{"date":493,"type":21},"2027-07-30",{"name":52,"class":53},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":515,"locationsCount":54},"100565621","a-nutrition--exercise-prehabilitation-intervention-on-inflammatory-biomarkers-in-ai-cancer-patients-100565621","NCT06644560","A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients","A Nutrition and Exercise Prehabilitation Intervention on Inflammatory Biomarkers in American Indian Cancer Patients","Inclusion Criteria:\n\n* Age 18-80 years\n* Diagnosed with cancer of any kind\n* Scheduled at least 3 weeks out from first treatment\n* Receiving care at San Carlos Apache Healthcare Corporation (SCAHC)\n* Able to eat walnuts\n* Able to do moderate-intensity exercise\n\nExclusion Criteria:\n\n* Digestive tract disease that would restrict diet modifications\n* Allergy to the foods intended for the nutrition intervention\n* Uncontrolled cardiac disease or other contraindications to moderate-intensity exercise","80 Years",{"count":91,"type":21},[67],"The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with cancer and measure inflammatory biomarkers to evaluate the preliminary impact of the trial intervention. The central hypothesis is that this community-informed prehab intervention will demonstrate feasibility, patient acceptability, and modulation of host and tumor-microenvironment inflammatory biomarkers.\n\nAim 1: Implement the prehab translational clinical trial for AI patients with cancer scheduled for treatment.\n\nAim 2 Measure host and tumor-microenvironment (TME) biomarkers using paired serum and tissue samples to compare baseline and post-intervention levels of expression. Serum markers include CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin. Tissue markers include Ki67, insulin receptor, TNFa, NFKB, NOS2, and cleaved caspase 3.\n\nAim 3: (optional exploratory aim): Assess differential expression of inflammatory genes in the TME using tumor tissue samples to compare baseline and post-intervention levels of expression. This will be done with a panel that analyzes inflammatory genes only.",[128],[508,509,128],"Nutrition and Exercise Prehabilitation Intervention","Inflammatory biomarkers","2026-04-24",{"date":448,"type":46},{"date":513,"type":46},"2025-11-13",{"date":107,"type":21},{"name":52,"class":53},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":148,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":54},"100609563","the-impact-of-exercise-on-the-tumor-microenvironment-in-patients-with-lung-cancer-100609563","NCT07216209","The Impact of Exercise on the Tumor Microenvironment in Patients With Lung Cancer","Exercise and the Lung Cancer Tumor Microenvironment","Inclusion Criteria:\n\n* lung cancer\n* low risk for submaximal exercise testing in accordance with the risk stratification guidelines published by the American Heart Association and the American College of Sports Medicine (AHA\u002FACSM criteria).\n\nExclusion Criteria:\n\n* younger than 18 years of age\n* select a condition on the ACSM-AHA pre-exercise screening questionnaire indicating that physician approval is required prior to exercise\n* body mass index of \\>30 kg\u002Fm2\n* waist girth of \\>102cm for men and \\>88cm for women\n* have chronic\u002Fdebilitating arthritis\n* have been bedridden in the past three months\n* have common illness (i.e. colds) within the past 6-weeks\n* HIV\n* hepatitis\n* history of stroke\n* major affective disorder\n* autoimmune disease\n* pregnancy or are breast-feeding\n* history of severe anaphylactic reaction to an allergen\n* present with more than one of the following CVD risk factors: family history of myocardial infarction, coronary revascularization, or sudden death before 55 years of age in father or other male first-degree relative or before 65 years of age in mother or other female first-degree relative",{"count":524,"type":21},48,[67],"There is increased interest and knowledge about the lung cancer tumor microenvironment (TME). Investigators hypothesize that patients with better baseline physiologic health will have better post-operative outcomes and that strenuous exercise will alter the TME and genetic make-up of the tumor, improving the tumor immune response. Investigators aim to identify the peri-operative and clinical outcomes that differ based on pre-operative VO2max, HRV and resting heart rate following resection of early-stage lung cancer. The physiologic states that are individual and measurable with wearable devices include but are not limited to VO2max, heart rate variability (HRV), and average resting heart rate. Investgators hypothesize that a patient's pre-operative physiologic function with higher VO2max, HRV and lower resting heart rate will be associated with improved peri-operative and post-operative outcomes. Second, investigators will compare alterations in TME based on targeted pre-operative exercise (60-80% of their VO2 max for 75min\u002Fweek x2 weeks) compared to normal activity adults following resection of early-stage lung cancer. Investigators hypothesize that strenuous exercise in the pre-operative period will impact the TME by increasing levels of cytokines.",[528],"Lung Cancer - Non Small Cell",[239,530,531],"tumor microenvironment","lung cancer","2026-04-16",{"date":534,"type":46},"2026-04-21",{"date":536,"type":46},"2026-01-13",{"date":538,"type":21},"2030-01-15",{"name":52,"class":53},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":148,"sex":17,"minAge":150,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":54},"100529694","suv-pdl1pd1-in-sun-damaged--sun-protected-human-skin-of-participants-100529694","NCT06177106","SUV PDL1\u002FPD1 in Sun Damaged & Sun Protected Human Skin of Participants","An Assessment of Acute Solar UV-induced PD-L1\u002FPD1 Expression in Sun Damaged & Sun Protected Human Skin of Participants With and Without History of SCC","Inclusion Criteria:\n\n* Healthy individuals 40 years of age or older. Note: When the two groups are paired, participants will be balanced within 5 years of age. Ex. From 2.5 years younger or 2.5 years older.\n* Individuals with moderate or severe photodamage of the skin on the forearms and Fitzpatrick skin type II or III (21 CFR 352.72).\n* Individuals with a history of two or more cSCCs within the past 5 years (maximum of 23 enrolled) or individuals with no history of cSCC (maximum of 23 enrolled)\n* Females of childbearing potential will need to undergo a pregnancy test at the enrollment visit, after administration of the ICF (informed consent form) and before exposure to solar simulated light (SSL) Premenopausal female subjects must use an effective method of birth control (such as oral contraceptives, consistent use of barrier contraceptives, IUD (intrauterine device), or other proven method of birth control) during study participation. For the purposes of this study, a woman will be considered postmenopausal if any of the following criteria are met: (1) she has had prior bilateral oophorectomy; (2) she is over the age of 60 years; or (3) she is under the age of 60 years and has not had a menstrual period in 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression.\n* Individuals who are willing to limit sun exposure to the body during the study period and who agree to wear protective clothing when they are outdoors.\n* Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have had the opportunity to ask any questions.\n\nExclusion Criteria:\n\n* Individuals with any inflammation or irritation of the skin at the test areas, or any skin conditions felt by the study healthcare provider to contraindicate enrollment. This includes, but is not limited to, psoriasis or atopic dermatitis within the test areas. (Test area is defined as the 6 mm areas of skin that is exposed to SSL and will be biopsied.)\n* Individuals with a history of untreated skin cancer or melanocytic lesions in the test areas are ineligible. History of such conditions at a body site other than the test areas is not exclusionary if in the opinion of the study healthcare provider it will not pose a risk to the subject.\n* Individuals who have had invasive cancer, chemotherapy or radiation therapy within five years of study enrollment\n* Individuals who are immunosuppressed by virtue of medication or disease. This includes AIDS patients, subjects taking oral steroids, and subjects on immunosuppressants\u002Fimmunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining study healthcare provider\n* Individuals with serious intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or other situations that in the opinion of the examining study physician would limit compliance or interfere with the study regimen.\n* Individuals who have used photosensitizing drugs within 30 days of enrollment, or who will be using a photosensitizing drug during the time of the study, will not be eligible.\n* Individuals who have used any topical medication other than emollients or sunscreen\u002Fsunblock on the test area within 30 days prior to study enrollment. If a study participant requires topical medication to the test area during the study, they will be withdrawn from the study.\n* Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or Imiquimod (Aldara®) anywhere on the body within 30 days prior to study enrollment. Subjects may be reconsidered for eligibility 30 days after the last topical treatment with such medications.\n* Individuals must not take mega-doses of vitamins. Mega-doses are defined as more than 5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences. Such vitamin therapy must be discontinued at least 30 days prior to study entry.\n* Individuals with a history of deliberate natural or artificial sun exposure (tanning) within 30 days of study enrollment are not eligible.\n* Individuals with Fitzpatrick skin type I are ineligible, as the proposed SSL dose could result in a burn of greater than mild severity.\n* Individuals with Fitzpatrick skin type IV, V or VI are ineligible, as they are unlikely to exhibit a salient response in the proposed design.\n* Individuals currently enrolled in or who plan to enroll in another clinical trial. There must be a 30-day period between completing a previous study and enrolling in this study.\n* Individuals with a known allergy to lidocaine are not eligible.\n* Females who are pregnant or nursing.",{"count":548,"type":21},46,[67],"The purpose of this research study is to look at how the proteins and genes in people's skin change when they're exposed to simulated sunlight. The researchers want to see if there are differences between people who've had skin cancer and those who haven't despite having a similar type of skin and history of sun exposure. Since this study is designed to simulate sun exposure to small areas of skin, mild to moderate sunburn and tanned spots at the site of the simulated sunlight exposure is a risk. In addition to simulated sun exposure, patients will also have four 6 mm punch skin biopsies performed. Brief discomfort may be felt when the local painkiller (lidocaine) is injected prior to skin biopsies; however, it is usually minimal. Participation in the study involves 4 visits to the clinic over the course of 4 weeks. Each visit will take no longer than 90 minutes.",[552],"Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation",[554,555],"Sun Damaged Skin","Squamous Cell Skin Cancer","2026-04-15",{"date":532,"type":46},{"date":559,"type":46},"2023-12-26",{"date":561,"type":21},"2027-12-31",{"name":52,"class":53},{"id":564,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":25,"conditions":567,"keywords":568,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":54},"100612531",{"count":20,"type":21},[24],[27,28,29,30,31,32],[34,35,36,37,38,39,40,41],"2026-04-01",{"date":571,"type":46},"2026-04-07",{"date":573,"type":21},"2026-05-31",{"date":50,"type":21},{"name":52,"class":53},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":583,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":587,"conditions":588,"keywords":591,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":605},"100614505","phase-4-endotype-directed-treatment-for-osa-in-down-syndrome-100614505","NCT07280468","Endotype DIrected Treatment for OSA in Down Syndrome","EDIT OSA","Inclusion Criteria:\n\n1. Age 6 years or older\n2. Down syndrome diagnosis\n3. Any gender or ethnicity\n4. Adults without a legally authorized representative must have a caregiver\u002Fsupport person that can co-sign consent and complete study questionnaires.\n\nExclusion Criteria:\n\n1. Currently using and adherent to PAP therapy (\\>4 hours per night for 70% of nights in the past 30 days based on device download or parent\u002Fcaregiver report)\n2. MAO inhibitor use\n3. Urinary retention\n4. Seizure disorder\n5. Untreated or inadequately treated hypothyroidism\n6. Significant traumatic brain injury\n7. Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year\n8. History of current, untreated depression\n9. History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)\n10. 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)","6 Years",{"count":229,"type":21},[586],"PHASE4","Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking (\"cognitive impairment\"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin (\"ato-oxy\") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA.\n\nThe research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.",[589,590],"Obstructive Sleep Apnea (OSA)","Down Syndrome",[592,593,594,595,596,597,598],"Down syndrome","obstructive sleep apnea","ato-oxy","precision medicine","oxygen","atomoxetine","oxybutynin",{"date":571,"type":46},{"date":601,"type":46},"2026-03-14",{"date":603,"type":21},"2030-01",{"name":52,"class":53},5,{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":623,"leadSponsor":625,"locationsCount":54},"100483011","elucidating-the-central-mechanisms-of-action-for-green-light-therapy-in-managing-chronic-pain-100483011","NCT05569486","Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain","Elucidating the Central Mechanism(s) of Action for Green Light Therapy in Managing Chronic Pain","Inclusion Criteria:\n\n* 18 years or older who can speak and understand English\n* Meets the diagnostic criteria for fibromyalgia accroding to the 2016 revisions to the 2010\u002F2011 fibromyalgia diagnostic criteria.\n* Average numeric pain score of 5 out of 10 or greater over the 10 weeks prior to enrolling in the study, and failure of medical therapy to control their pain.\n\nExclusion Criteria:\n\n* Serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. This will be assessed during the screening interview. Patients with psychiatric disorders will have their medical record reviewed prior to enrollment\n* History of color blindness or uncorrected cataracts\n* Subjects receiving remuneration for their medical condition.\n* Genotype of low affinity binders for translocator protein, (TSPO), as patients with low affinity binding TSPO may not have adequate uptake for the radioactive tracer used for the PET scan.",{"count":614,"type":21},70,[67],"Investigators have previously shown that specific colors of light can alter nociception. Green light emitting diode exposure (GLED) provides long-lasting antinociception in rodents, through the visual system. No adverse effects were noted, and motor performance was not impaired. Investigator clinical trials have shown GLED is also effective in decreasing pain intensity of fibromyalgia patients and decreasing the number of headache-days per month in migraine patients. However, investigators do not yet understand the mechanisms by which GLED reduces pain.\n\nUnderstanding the mechanisms of action of GLED will provide additional support for using light therapy as both a treatment and as a possible diagnostic tool. While investigators do not fully understand the mechanisms of action of GLED, investigators do know that it is centrally mediated.\n\nTo better elucidate the mechanism of action for GLED, investigators propose a single-blinded randomized placebo-controlled clinical trial to elucidate the central mechanism(s) of action that GLED therapy has in improving fibromyalgia pain, conducted by a team with a successful record of collaboration. Investigator's hypothesis is that GLED decreases neuroinflammation leading to modulation of the signaling in the ascending and descending pain pathways.",[618],"Fibromyalgia","2026-03-30",{"date":621,"type":46},"2026-04-03",{"date":79,"type":21},{"date":624,"type":21},"2029-12-30",{"name":52,"class":53},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":484,"phases":4,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":54},"100125177","arizona-cancer-center-biospecimen-repository-100125177","NCT00896935","Arizona Cancer Center Biospecimen Repository","DISEASE CHARACTERISTICS:\n\n* Patient who is seen at the Arizona Cancer Center or University Medical Center and will undergo any surgery or procedure for cancer\n\nPATIENT CHARACTERISTICS:\n\n* NA\n\nPRIOR CONCURRENT THERAPY:\n\n* NA\n\nAs this is a biospecimen repository, participation is open to all cancer patients being treated at the Arizona Cancer Center or University Medical Center by investigators on this protocol.",{"count":633,"type":21},10000,"RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.\n\nPURPOSE: This research study is collecting and storing tumor, tissue, and blood samples from patients with pancreatic cancer.",[128],[637],"cancer",{"date":639,"type":46},"2026-04-06",{"date":641,"type":46},"2006-08-01",{"date":643,"type":21},"2030-07",{"name":52,"class":53},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":415,"maxAge":268,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":658,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":54},"100557801","community-partnership-for-telehealth-solutions-to-convey-information-and-enhance-care-100557801","NCT06542835","Community Partnership for Telehealth Solutions to Convey Information and Enhance Care","Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity","PRIME","Inclusion Criteria:\n\n* Ages 45-64\n* Eligible for colorectal cancer (CRC) screening\n* Current patients (seen in the clinic in the last 6 months)\n* Primary speaker of English or Spanish\n* Cell phone listed in Electronic Health Record (EHR)\n* No recent history of CRC screening\n* Resides in one of the neighborhoods included in the main trial\n\nExclusion Criteria:\n\n* Colorectal disease (e.g., ulcerative colitis or colectomy)\n* Personal history of colorectal cancer\n* End-stage or life-threatening diseases\n* Known to be under hospice care\n* Living in a skilled nursing facility\n* Patients who decline research participation will be removed from the patient contact list",{"count":654,"type":21},6000,[67],"Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.",[97],[659,660,661,662,663,664,665,666],"cancer screening","telehealth","video","text messaging","patient navigation","stool testing","fecal testing","Latinx health disparities","2026-03-24",{"date":619,"type":46},{"date":670,"type":46},"2024-07-31",{"date":672,"type":21},"2027-01",{"name":52,"class":53},""]