[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The University of Texas Health Science Center at San Antonio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":644},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,45,72,102,131,160,187,210,237,260,286,307,331,361,385,410,433,456,467,499,526,543,562,593,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053895","tms-for-ptsd-in-youth-100053895",false,"NCT07401225","TMS for PTSD in Youth","Transcranial Magnetic Stimulation as Treatment for Persistent PTSD in Texas Youth","Inclusion Criteria:\n\n1. Males and females; Age 12-20\n2. Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community\n3. Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index\n4. Willing to attend 10 TMS treatment sessions within a 30-day period\n5. Fluent in English\n\nExclusion Criteria:\n\n1. History of seizures\n2. History of head injury with loss of consciousness and concussive sequelae\n3. Brain abnormality such as tumor or other observable abnormality\n4. Currently receiving psychotherapy or TMS treatment\n5. Currently pregnant\n6. MRI contraindications (metal in body, orthodontic braces)\n7. Diagnosis of bipolar 1 or a psychotic disorder","ALL","12 Years","20 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.",[28],"Post Traumatic Stress Disorder (PTSD)",[30,31],"Transcranial Magnetic Stimulation","Transcranial Magnetic Stimulation (TMS)","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2026-05-09",{"date":40,"type":22},"2027-08-31",{"name":42,"class":43},"The University of Texas Health Science Center at San Antonio","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100053516","swallowfit-study-in-parkinsons-disease-100053516","NCT07356414","SwallowFIT Study in Parkinson's Disease","\"SwallowFit,\" an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.","Inclusion Criteria:\n\n1. Adult S-VWP between \\>35-90 years of age\n2. Diagnosis of Idiopathic Parkinson's Disease \\[IDP\\] (either or suspected, tremor-predominant or rigid predominant)\n3. Disability level of Hoehn \\& Yahr stages II-III as indicated in their most recent neurological evaluation\n4. Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \\[MDS-UPDRS\\]-\n5. ADL swallowing item \\>0, or Mann Assessment of Swallowing scale \\[MASA\\] score ≤185.\n6. Able to consume oral nutrition \\[Functional Oral Intake Score ≤ 6\\]\n7. Ambulatory\n8. No change of medication for at least 4 weeks before study inclusion\n\nExclusion Criteria:\n\n1. Classified as Hoehn and Yahr stages IV\n2. Unable to follow 2 step commands\n3. History of other neurological disease potentially causing dysphagia\n4. Dementia (MMSE\\\u003C20; Montreal cognitive assessment (MoCA) ≤ 20)\n5. Severe depression (BDI\\>19)\n6. Severe dyskinesia of head and neck (resulting in problems with MBSS recording)\n7. Severe documented Gastrointestinal disease\n8. History of Gastro-esophageal surgery\n9. History of Head or neck cancer with swallowing impairment or surgical intervention\n10. History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.\n11. Untreated hypertension\n12. Heart disease requiring restricted activity and medical intervention\n13. Speech therapy intervention for swallowing within the past three months\n14. Women who are pregnant, nursing, or who plan to become pregnant during the study","35 Years","90 Years",{"count":55,"type":22},80,[25],"The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.\n\nThe aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.\n\nPatients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.\n\nPatients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.",[59],"PARKINSON DISEASE (Disorder)",[61,62,63,64],"Swallowing","US Service members","Veterans","SwallowFIT","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":68,"type":22},"2026-08-30",{"date":70,"type":22},"2028-06-29",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100486949","multisite-advancement-of-research-on-chronic-posttraumatic-headache-100486949","NCT05620719","Multisite Advancement of Research on Chronic Posttraumatic Headache","Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache","Inclusion Criteria:\n\n* Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with mild or moderate TBI whose headache began or exacerbated within 3 months of a head or neck injury.\n* Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent headache within the past 2 weeks).\n* At least moderate to severe headache-related disability based on a HIT-6 score greater than 50.\n* Participant is stable on headache medication at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks or study physician clinical judgement confirms stability; this includes botulinum toxin injections and devices like Cefaly).\n* Participant has a phone where they can receive reminders and complete the on-line Headache Diaries.\n* Participant speaks and reads\u002Funderstands English well enough to fully participate in the intervention and to reliably complete assessment measures.\n\nExclusion Criteria:\n\n* Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms.\n* Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment.\n* Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confirmed by a clinician through screening or review of clinical notes.\n* Participant demonstrates significant cognitive impairment that could impact treatment adherence\u002Fbenefit.","18 Years","70 Years",{"count":82,"type":22},525,[25],"Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers\\* and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.\n\n\\*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.",[86],"Posttraumatic Headache",[88,89,63,90,91,92],"Cognitive Behavioral Therapy","Telehealth","Military Service Members","Chronic Pain","Headaches","2026-06-22",{"date":95,"type":36},"2026-06-26",{"date":97,"type":36},"2023-08-24",{"date":99,"type":22},"2027-08",{"name":42,"class":43},8,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100643969","the-effects-of-stellate-ganglion-block-sleep-in-us-active-duty-service-members-and-veterans-receiving-prolonged-exposure-therapy-for-ptsd-100643969","NCT07667309","The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD","The Effects of Stellate Ganglion Block on Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n1. Ability to provide informed consent and follow study-related instructions.\n2. Be randomized into the study titled \"Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial.\" NCT05889741\n3. Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.\n\nExclusion Criteria:\n\n1\\. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.","65 Years",{"count":111,"type":22},40,"OBSERVATIONAL","Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate Ganglion Block injection has on their sleep. Participants will wear the headband for 3 nights before the injection and then 3 nights after the injection. Participants will also complete self-report questionnaires regarding their sleep prior to the injection and following the injection. Approximately 40 participants will be included in this study. This study is a nested observational study whereby participants in the parent study who elect to participate will have their sleep assessed using the EEG headband device and self-reported sleep measures performed.",[115],"Post Traumatic Stress Disorder PTSD",[117,118,119,120,121],"Stellate Ganglion Block","Sleep Profiler","PTSD","Sleep","Sleep architecture","2026-06-18",{"date":124,"type":36},"2026-06-25",{"date":126,"type":22},"2026-06-15",{"date":128,"type":22},"2027-06-30",{"name":42,"class":43},2,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":44},"100644091","oil-pulling-whitening-mouthwash-100644091","NCT07667088","Oil Pulling Whitening Mouthwash","Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.","Inclusion Criteria:\n\n1. Adult subjects aged 18-60, that are in good health.\n2. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.\n3. Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.\n4. Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.\n5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.\n6. The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.\n\nExclusion Criteria:\n\n1. Pregnant or nursing by subject report.\n2. Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).\n3. Any active condition in the oral cavity at the discretion of the investigator.\n4. Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.\n5. Subjects that do not brush regularly.\n6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.\n7. Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.\n8. Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.\n9. Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).\n10. Participation in another clinical trial within the last 30 days.\n11. Presence of orthodontic appliances, except for removable retainers.\n12. Signs of advanced enamel wear, dentin exposure, or tooth fractures.","60 Years",{"count":140,"type":22},120,[25],"The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.",[144,145],"Healthy Adult Participants","Tooth Stain",[147,148,149,150,151,152],"tooth whitening","tooth stains","oil pulling","mouthwash","mouth rinse","stain removal",{"date":154,"type":36},"2026-06-24",{"date":156,"type":36},"2026-05-01",{"date":158,"type":22},"2026-08-31",{"name":42,"class":43},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":130},"100591229","phase-1-loncastuximab-and-roflumilast-added-to-r-chop-lo-rituximab-and-roflumilast-rr-chop-for-nave-high-risk-diffuse-large-b-cell-lymphoma-dlbcl-100591229","NCT06977711","Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)","Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Men and women 18 years of age or older.\n2. Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS).\n\n   \\- Patients with Diffuse large B-cell lymphoma\u002F high grade B-cell lymphoma with MYC (myelocytomatosis oncogene) and BCL2 (B-cell lymphoma 2) rearrangements are allowed.\n3. No prior systemic therapy for lymphoma.\n4. Subject has provided informed consent.\n5. Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. Life expectancy of ≥3 months.\n8. Ann Arbor stage II-IV\n9. National Comprehensive Cancer Network - International Prognostic Index (NCCN-IPI) risk score of ≥ 2\n10. Measurable disease, meaning at least 1 lymph node or other lymphomatous lesion with a long axis of ≥1.5 cm by CT imaging, and at least one FDG-avid lesion by FDG-PET scan.\n11. Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography.\n12. Ability to swallow oral tablets without difficulty.\n13. All subjects with preserved reproductive potential must agree to practice abstinence or employ contraceptive measures for the duration of treatment and for 10 months (if female) or 7 months (if male) following final dosing. All male subjects are considered to have reproductive potential.\n\n    Female subjects of reproductive potential are those who:\n\n    i) are not at least 50 years old and have no menses for 24 consecutive months; or ii) have not been rendered surgically sterile (having undergone hysterectomy and\u002For bilateral salpingo-oophorectomy).\n\n    Female subjects of reproductive potential must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin (hCG) within 7 days of first day of drug dosing.\n14. Meet the following clinical laboratory requirements:\n\n    * Creatinine clearance ≥30 ml\u002Fmin by Cockcroft-Gault formula;\n    * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis);\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 3 × ULN;\n    * Platelet count ≥ 50,000\u002FµL, with or without transfusion support;\n    * Absolute Neutrophil Count (ANC) ≥ 1000\u002FµL, with or without chronic granulocyte growth factor support;\n    * Hemoglobin ≥8 g\u002FdL, with or without transfusion support.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to roflumilast.\n2. Allergy or intolerance to loncastuximab\n3. Any active malignancy other than DLBCL\n4. Current participation in another interventional clinical study\n5. Prior allogeneic bone marrow transplant within 12 months of screening date.\n6. Prior autologous stem cell transplant within 6 months of screening date.\n7. Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing.\n8. Active central nervous system (CNS) involvement by lymphoma, including untreated symptomatic epidural disease.\n9. Active uncontrolled infection.\n10. Poorly controlled depressive symptoms and\u002F or currently under management for depression that is poorly controlled.\n11. Significant disease or medical conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.\n12. Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which subjects are not on active anti-cancer therapies and have had no evidence of active malignancy for at least 1 year.\n13. History of major surgery within 3 weeks or minor surgery within 1 week of roflumilast administration. Major surgery includes, for example, any open or laparoscopic entry into a body cavity, or operative repair of fracture; minor surgery includes, for example, open surgical biopsy of palpable\u002Fsuperficial lymph node, or placement of vascular access device.\n14. Other medical or psychiatric illnesses or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.\n15. Corrected QT interval (QTc) prolongation (defined as a QTc \\>450 ms for males and \\>470 ms for females -Fridericia's correction-) or other clinically significant ECG abnormalities as assessed by the investigator.\n16. Baseline serum troponin above the upper limit of normal.\n17. Baseline serum brain natriuretic peptide (BNP )above the age-adjusted upper limit of normal.\n18. Baseline amylase above the upper limit of normal.\n19. Subjects known to be HIV-positive must not have multi-drug resistant HIV infection, cluster of differentiation 4 (CD4) counts \\\u003C 150\u002Fµl or other concurrent AIDS-defining conditions. Serologic screening for HIV is required within the 6 months prior to study enrollment.\n20. Subjects positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C-virus ribonucleic acid (HCV RNA), unless both AST and ALT≤1.25 x ULN and there is no known history of chronic active hepatitis.\n\n    Serologic screening for hepatitis B and C testing is required within the 6 months prior to study enrollment.\n21. Subjects with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C.\n22. Women who are pregnant or breastfeeding.\n23. Current use of any of the following medications: boceprevir, carbamazepine, ciprofloxacin, cobicistat, conivaptan, enzalutamide, fluvoxamine, itraconazole, ketoconazole, mitotane, phenytoin, posaconazole, rifampin, ritonavir, St. John's Wort, telaprevir, voriconazole, or zafirlukast.\n24. Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine.",{"count":168,"type":22},10,[170],"PHASE1","This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants.\n\nThe aims are:\n\n1. To assess the safety and how well the participants tolerate the treatment\n2. Assess the response of the tumor to treatment to estimate complete response\n3. Assess the response of the tumor to treatment to estimate progression-free survival",[173],"Diffuse Large B-cell Lymphoma",[175,176,177,178,179,180],"Lymphoid neoplasms","Loncastuximab","Rituximab","Roflumilast","Lo-RR-CHOP","R-CHOP",{"date":93,"type":36},{"date":183,"type":36},"2025-06-20",{"date":185,"type":22},"2027-04-01",{"name":42,"class":43},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":44},"100569509","evaluation-of-the-integrated-smart-pump-ehr-technology-in-eight-adult-acute-and-intensive-care-units-100569509","NCT06695169","Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units","Comprehensive Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units: A Mixed Method Study","Inclusion Criteria:\n\n* Research Aims 1 (adoption rate) and 2 (frequency and types of alerts and programming error ). We will include all IV medications and fluids delivered via smart infusion pumps within the past 6 months. We anticipate the dataset to include more than 180,000 of medications and fluid administration events.\n* Research Aim 3 (documentation errors ). We will select 200 IV medications that were administered with solutions using chart audit. To be included, the selected IV medications should be diluted with at least 100 ml solution. The choice of the 100 ml cutoff point was based on it being the minimum volume for the majority of IV medication administrations.\n* Research Aims 4, 5, 6, and 7 (usability of the technology, nurse perception, predictors of nurse perception, nurse experience with technology). Eligibility criteria will be confined to registered nurses with at least an associate degree in nursing.\n* Research Aim 8 (multidisciplinary team experience with technology). The inclusion criteria for the group of multidisciplinary representatives encompass participation in pump implementation and pumps-related quality improvement initiatives.\n\nExclusion Criteria:\n\n* Research Aims 1 and 2. Bolus medications will be excluded due to the distinct workflow associated with their administration.\n* Research Aim 3. Medications with solution volumes lower than 100 ml will be excluded.\n* Research Aims 4, 5, 6, and 7. Licensed vocational nurses (LVN) and licensed practical nurses (LPN) will be excluded due to their non-involvement in IV medication administration. Additionally, and for Research Aim # 7, the group of 48 nurses who will engage in the usability testing will not be part of the focus group interviews to ensure a broader participation among nurses.\n* Research Aim 8: Stakeholders from the different hospital's departments and councils (e.g., nursing, biomedical engineering, pharmacy, risk and management, technology committees, etc.) who were not part of the implementation process of infusion pumps in 2018 and 2020 or are not involved in continuous quality initiatives related to infusion pump adoption and quality measures tracking will be excluded.",{"count":195,"type":22},485,"This study looks at the effects of using \"smart pumps\" that connect with the Electronic Health Record (EHR) in 8 adult ICU units.\n\nWe will interview nurses and healthcare team members to learn about any challenges with this technology.\n\nAll nurses in these units will be invited to complete a survey on how easy the technology is to use.\n\nSome nurses will practice giving medications to \"mannequins\" in a simulation lab to see how they work with the pumps.\n\nWe will also look at existing data to find out how many nurses use the technology and what types of alerts or errors come up.\n\nFinally, we will review patient charts to see if using the technology has increased or decreased errors in recording IV medication amounts.",[198],"Nurse's Role",[200,201,202],"Integrated smart pumps","Integrated technology","Chart review","2026-06-12",{"date":126,"type":36},{"date":206,"type":36},"2025-01-31",{"date":208,"type":22},"2026-11-11",{"name":42,"class":43},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":17,"minAge":79,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":44},"100643124","early-phase-1-safety-tolerability-and-pharmacokinetics-of-mcam-in-healthy-adult-participants-100643124","NCT07602335","Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants","A Phase 1, First-In-Human, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MCAM in Randomized Healthy Adult Participants (Double-Blind)","Inclusion Criteria:\n\n1. Is willing and able to provide informed consent and comply with all protocol requirements\n2. Is aged ≥18 years and ≤55 years at time of informed consent\n3. Has a body mass index (BMI) between 18.0 and 32.0 kg\u002Fm2 and body weight (BW) not lower than 50 kg\n4. Participant is a nonsmoker (for at least 3 months prior to Screening) and does not use tobacco-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum)\n5. Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:\n\n   1. Systolic BP between 90 and 145 mmHg\n   2. Diastolic BP between 60 and 90 mmHg\n   3. HR between 60 and 90 beats per minute\n6. Electrocardiogram (ECG) is normal based on 12-lead ECG assessment at Screening:\n\n   1. ECG PR interval between 120 and 200 ms\n   2. ECG QRS interval \\\u003C100 ms\n   3. ECG QT interval (corrected) (QTc) with Fridericia formula (QTcF) \\\u003C450 ms and no history of additional risk factors for Torsades de pointes (TdP)\n   4. No sign of any sinus node dysfunction\n7. Has clinical laboratory parameters (hematology \\[including coagulation\\], clinical chemistry, and urinalysis) within normal ranges. Individual values out of the normal range may be acceptable if judged clinically insignificant by an Investigator.\n8. Has not been dosed in an interventional clinical drug trial within 30 days prior to screening or within 5 half-lives of the last dose of study drug, whichever is longer.\n9. If female, participants who are not of childbearing potential should be surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation\u002Focclusion) or in a post-menopausal state (at least one year without menses). Female participants of childbearing potential will use a highly effective (i.e., failure rate of \\\u003C1%) method of contraception throughout the study and for at least five half-lives following MCAM dosing. Methods of contraception that are considered to be highly effective with a failure rate of \\\u003C1% that are appropriate for this study include the following: a) intrauterine device (IUD)\u002Fintrauterine system (IUS); b) implantable rod; c) bilateral tubal occlusion; d) complete abstinence from sexual intercourse; and e) infertile male partner (e.g., vasectomized \\[with documented evidence of azoospermia\\], permanently sterile following bilateral orchidectomy, or any other documented cause of infertility).\n10. If female, must have a negative serum or urine pregnancy test at Screening and a negative serum or urine test at Admission (day 1)\n11. Male participants who report surgical sterilization will be required to confirm sterility by post-vasectomy semen analysis (PVSA). Participants in whom PVSA confirmation cannot be obtained will be required to use a double-barrier method (e.g., condom with spermicide), same as for the rest of the male participants, or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for at least five half-lives following MCAM dosing.\n12. If male, participants must agree not to donate sperm for the duration of the study and for 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Any significant acute or chronic medical illness\n2. Any history of cancer within 5 years of enrollment, with the exception of fully resected skin basal cell carcinoma\n3. Any major hospitalization or surgery 3 months prior to study drug administration\n4. Has donated or experienced a blood loss of 500 mL or more within 56 days prior to Screening or has donated plasma within 7 days prior to Screening\n5. Poor venous access assessed at Screening\n6. Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court-mandated as part of a plea agreement, entry may be permissible at an Investigator's discretion\n7. Any history of substance use disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5; e.g. a score of ≥2, within a 12-month period) or recent use of an opioid-containing product (e.g., codeine) within 6 months prior to study drug administration\n8. History of, or currently diagnosed with, any clinically significant psychiatric disorder (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition \\[DSM-5\\] and Mini International Neuropsychiatric Interview \\[MINI\\] criteria), which in the opinion of an Investigator could interfere with study participation or study data collection\n9. History of any suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)\n10. Any neurological, renal, cardiac, hepatic, or other medical condition that could interfere with study assessments as determined by and Investigator, or Sponsor\n11. Any significant illness or infection, as determined by an Investigator or Sponsor, within the prior 30 days\n12. Positive urine alcohol or urine drug screen for substance of abuse at Screening\n13. Must not be physically dependent on opioids, as demonstrated by successful completion of the naloxone challenge\n14. Known hypersensitivity to any component of the MCAM drug product, naloxone, or placebo\n15. Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary\u002Fherbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening or 5 half-lives prior to the study\n16. Positive screen for hepatitis B surface antigen (HBsAg), Hepatitis C (HCV) antibody, or HIV-1 and HIV-2 antibodies\n17. Have a procedure planned that would require the use of opioids for pain management within at least 2 weeks after the conclusion of the study (participants may be resistant to opioids for two weeks or longer after study participation)\n18. Is likely, in the opinion of an Investigator, to be non-compliant or uncooperative with study procedures for any reason\n19. If female, are pregnant, nursing, or planning to become pregnant during the study",true,"55 Years",{"count":220,"type":22},24,[222],"EARLY_PHASE1","The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main aim is to measure blood levels of the study drug after oral administration.\n\nResearchers will compare the active study drug to a placebo to test for any differences between the two groups.\n\nParticipants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 4 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Days 5 and 7 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.",[225],"Opioid Use Disorder",[227,228],"Healthy participants","μ-Opioid Receptor","2026-06-08",{"date":231,"type":36},"2026-06-11",{"date":233,"type":22},"2026-08-08",{"date":235,"type":22},"2027-12-31",{"name":42,"class":43},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":259,"locationsCount":44},"100619759","real-world-evaluation-of-the-effectiveness-and-implementation-of-a-digital-health-therapeutic-for-oud-100619759","NCT07348796","Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD","Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)","Inclusion Criteria:\n\n1. Male or female outpatients 18 years of age or older\n2. DSM-5 criteria for opioid use disorder\n3. Ability to access KIOS via smartphone or tablet\n4. Initiated buprenorphine treatment in the past 6 months\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with study requirements\n2. A psychiatric or medical condition interfering with ability to use the app\n3. Incarceration\n4. Suicide risk as determined by the treating medical clinician at the site",{"count":245,"type":22},134,[25],"The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.",[225],[250,251,252],"KIOS app","Digital health","Real-world impact","2026-06-04",{"date":255,"type":36},"2026-06-09",{"date":257,"type":22},"2026-07-15",{"date":40,"type":22},{"name":42,"class":43},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":44},"100643048","sensing-in-sleep-deep-brain-stimulation-100643048","NCT07636720","Sensing in Sleep Deep Brain Stimulation","Sensing in Sleep and Deep Brain Stimulation","Inclusion Criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Males and females; Age 40-80\n3. Subjects with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device to subthalamic nucleus (STN) or Globus pallidus internus (GPi).\n4. Willingness to adhere to the PSG regimen and turn DBS off for one night.\n5. A score of ≥23 on the Montreal Cognitive Assessment (MoCA)\n6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.\n\nExclusion Criteria:\n\n1. History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).\n2. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.\n3. History of Dementia.\n4. Report dopaminergic medication changes in the past month.","40 Years","80 Years",{"count":21,"type":22},[25],"Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep).\n\nFor this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.",[273,274],"Parkinson's Disease and Parkinsonism","Dyssomnia",[276,277,278],"Deep Brain Stimulation","Polysomnography","Sleep Disorders","2026-06-03",{"date":255,"type":36},{"date":282,"type":36},"2026-02-27",{"date":284,"type":22},"2028-02-01",{"name":42,"class":43},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":268,"enrollmentInfo":293,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":294,"conditions":295,"keywords":298,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":44},"100562059","mirragen-diabetic-foot-ulcer-study-100562059","NCT06598241","Mirragen Diabetic Foot Ulcer Study","A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.","Inclusion Criteria:\n\n1. The subject has signed the informed consent form\n2. Subject is male or female aged between ≥ 18 or ≤ 80\n3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer\n4. Index ulcer has not received an application of BBFGM previously\n5. Subjects with insurance coverage for BBGFM\n6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.\n7. The subject is under the care of Physician for the management of Diabetes Mellitus\n8. Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot\n9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2\n10. Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM\n11. The BBGFM will be applied in an outpatient setting\n12. Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator\n\n    1. Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit\n    2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit\n\n    Wagner Grade 3 subjects must have osteomyelitis diagnosed by:\n\n    X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound\n13. Subject does not require a surgical debridement in the operating room\n14. Subjects without active cellulitis at the index ulcer\n15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits\n16. Subject is willing to utilize the offloading device to offload wound\n17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.\n18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:\n\nA.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses\n\nExclusion Criteria:\n\n1. Subject is unwilling to sign informed consent\n2. Subjects who cannot obtain insurance coverage for BBFGM\n3. The BBFGM cannot be applied in an outpatient setting\n4. Index ulcer has previously received an application of BBFGM\n5. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation\n6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application\n7. Subject is pregnant or breast-feeding.\n8. Subject index ulcer associated with carcinoma.\n9. Subject has active Charcot Neuroarthropathy\n10. Subject requires extensive soft tissue and bone debridement in the operating room\n11. Subject has a life expectancy of less than six months as assessed by the investigator.\n12. Subject not in reasonable metabolic control in the judgment of the investigator\n13. Subject with a known history of poor compliance with medical treatments\n14. Subject currently undergoing cancer treatment\n15. Subject has been on oral steroid use of \\\u003C7.5 mg daily for greater than seven consecutive days in 30 days before screening\n16. Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening\n17. The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening\n18. Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.\n19. Subject currently receiving radiation therapy or chemotherapy.\n20. Patient currently on dialysis or planning to start dialysis.\n21. Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator\n22. Subject is unable to sustain off-loading as defined by the protocol\n23. Subject index ulcer that cannot be offload by an offloading device\n24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and\u002For presence of acute cellulitis at the index ulcer\n25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study\n26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound)\n27. The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)\n28. Subject has an allergy to primary or secondary dressing materials used in this trial\n29. In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection",{"count":21,"type":22},"This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.",[296,297],"Diabetic Foot Ulcer","Osteomyelitis Chronic",[299],"Glass fiber matrix","2026-06-02",{"date":253,"type":36},{"date":303,"type":36},"2024-09-20",{"date":305,"type":22},"2026-12",{"name":42,"class":43},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":217,"sex":17,"minAge":109,"maxAge":53,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":44},"100566662","early-phase-1-restor-pkpd-mtori-inhibition-in-older-adults-100566662","NCT06658093","RESTOR: PK\u002FPD mTORi Inhibition in Older Adults","RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK\u002FPD Study of mTOR Inhibition in Older Human Subjects","RESTOR","Inclusion Criteria:\n\nOlder Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2):\n\n1. Age ≥65 to 90 years\n2. Men and women\n3. In good health with all medical problems stable.\n4. Community-dwelling\n5. Agreement to adhere to Lifestyle Considerations throughout study duration.\n6. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nOlder Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2):\n\n1. Resident of nursing home or long-term care facility\n2. Subjects with diabetes or currently taking glucose lowering medications\n3. History of moderate-severe heart disease (New York Heart Classiﬁcation greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one ﬂight of stairs or less; abnormal breath sounds on auscultation); Moderate to severe valvular heart disease\n4. Active cancer or history of cancer treatment within the last 5 years\n5. Chronic inﬂammatory condition, autoimmune disease, or infectious processes (e.g., active tuberculosis, HIV, rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C)\n6. History of a coagulopathy or any medical condition requiring anticoagulation (except low dose ASA)\n7. Renal insuﬃciency with an estimated glomerular ﬁltration rate of \\\u003C30ml\u002Fmin\n8. Uncontrolled hypercholesterolemia \\>350mg\u002Fdl or uncontrolled hypertriglyceridemia \\>500mg\u002Fdl\n9. Anemia or abnormal blood cell counts: hemoglobin level \\\u003C9.0g.dl; white blood count \\\u003C3500\u002Fmm3; neutrophil count \\\u003C2000\u002F mm3; platelet count \\\u003C125,000\u002Fmm3\n10. History of skin ulcers or poor wound healing\n11. Active tobacco use (within 6 months)\n12. Diagnosis of any disabling neurologic disease such as Parkinson's Disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deﬁcits (muscle weakness or gait disorder), severe neuropathy, diagnosis of dementia or Clox1 score less than 10 at the time of screening visit, cognitive impairment due to any reason such that the patient is unable to provide informed consent\n13. Liver disease\n14. Systemic treatment with an immunosuppressant (prednisone, etc.) within the year prior to enrollment\n15. Treatment with drugs known to affect cytochrome P450 (CYP3A4), i.e., diltiazem, erythromycin.\n16. Patients with history of recent (within 6 months) myocardial infarction or active coronary disease\n17. Patients with history of recent (within 6 months) intestinal disorders\n18. History of severe head trauma, brain injury, brain surgery, inﬂammation of the brain, or history of seizure disorder\n19. History of Long-Covid (PASC) within one year\n20. Acute Covid19 or Covid19 infection within the last 6 months\n21. Unwilling to forgo grapefruit juice consumption.\n22. Participation in mTORi study within the prior year. (Note: participants in AIM 1 will be excluded from participating in AIM 2 of the proposed trial.)\n23. Allergic to RAPA or EVERO\n24. Allergic to lidocaine\n25. Recreational drug use\n26. Donated blood over a two-month period prior to study initiation.\n27. Currently using cannabidiol (CBD) or tetrahydrocannabinol (THC) or any preparation contained these, or related, substances.\n28. Currently using hormone replacement or modulating therapies.",{"count":316,"type":22},194,[222],"As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.",[320],"Aging",[322],"mTOR inhibitors","2026-05-27",{"date":325,"type":36},"2026-06-01",{"date":327,"type":36},"2026-03-04",{"date":329,"type":22},"2028-07",{"name":42,"class":43},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":339,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100636443","early-phase-1-teapot-study-multisite-100636443","NCT07565753","TEAPOT Study Multisite","TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study","TEAPOT","Inclusion Criteria:\n\n1. Received a tonsillectomy\n2. Presents to the ED with secondary\\* post-tonsillectomy hemorrhage\n3. Children between age of 2 to 17 years of age (i.e., before their 18th birthday) \\*Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery\u002FPACU).\n\nExclusion Criteria:\n\n1. Known and documented bleeding or clotting disorder.\n2. Known pregnancy.\n3. Patients with known hypersensitivity or allergic response to tranexamic acid.\n4. Parents or guardians who cannot communicate in English or Spanish.\n5. Intubation prior to enrollment.\n6. Previously enrolled patients.","2 Years","17 Years",{"count":342,"type":22},30,[222],"After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.",[346,347],"Hemorrhage, Surgical","Tonsillar Bleeding",[349,350,351],"Tranexamic Acid","Nebulizer","Post tonsillectomy hemorrhage","2026-05-21",{"date":354,"type":36},"2026-05-26",{"date":356,"type":22},"2026-07",{"date":358,"type":22},"2028-09-30",{"name":42,"class":43},3,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":44},"100597300","phase-3-sglt2i-pioglitazone-and-ketone-production-in-t1d-100597300","NCT07056699","SGLT2i, Pioglitazone, and Ketone Production in T1D","Protocol V: San Antonio Site Sub Study: Can Pioglitazone Block SGLT2 Inhibitor-induced Stimulation of Lipolysis, Ketone Production and Liver Glucose Production in Type I Diabetic Patients","Inclusion Criteria:\n\n1. Age \\>18 years\n2. T1DM\n3. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.\n4. Fasting C-peptide concentration \\\u003C0.7 ng\u002Fml\n5. Poor glycemic control (HbA1c=7.0-11.0%)\n6. Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump\n7. Total daily insulin dose ≥0.6 U\u002Fkg per day\n8. Stable insulin dose (±4 units) in the preceding three months.\n9. eGFR≥60 ml\u002Fmin\n10. Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program\n\nExclusion Criteria:\n\n1. T2DM\n2. Daily insulin dose \\\u003C0.6 U\u002Fkg per day\n3. Fasting C-peptide \\>0.7 ng\u002Fml\n4. HbA1c \\\u003C7.0% or \\>11.0%\n5. eGFR\\\u003C60 ml\u002Fmin\n6. Hematuria in urine analysis\n7. Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year. Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study.\n8. Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT \\>3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone.\n9. Evidence of proliferative diabetic retinopathy\n10. Patients enrolled in a heavy exercise program\n11. Patients on ketogenic diet\n12. History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month.\n13. Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea\n14. History of hypersensitivity to dapagliflozin or pioglitazone",{"count":220,"type":22},[370],"PHASE3","Participants are being asked to be in a research study. Scientists do research to answer important questions which might help change or improve treatment of participants disease in the future.\n\nIn patients with Type 1 Diabetes (T1D), Dapagliflozin a Selective Glucose Transporter 2 Inhibitor (SGLT2i) is known to increase production of glucose in the liver, increase breakdown of fats (lipolysis), and increase production of ketones (ketogenesis). Ketones are chemicals produced by the liver when the body breaks down fat for energy instead of glucose. When the level of ketones in the body becomes too high, a condition called ketoacidosis develops. In this study, the study team will investigate whether adding pioglitazone (a medication commonly used to treat type 2 diabetes), can reduce the Dapagliflozin - induced liver glucose production, fat break down (lipolysis) and ketone body production (ketogenesis) in patients with Type 1 Diabetes (T1D).",[373],"Type1diabetes",[375,376,377],"Selective Glucose Cotransporter 2 inhibitors (SGLT2i)","Dapagliflozin","Pioglitazone","2026-05-12",{"date":380,"type":36},"2026-05-14",{"date":382,"type":22},"2026-07-01",{"date":128,"type":22},{"name":42,"class":43},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":408,"leadSponsor":409,"locationsCount":44},"100597040","phase-1-sglt2i-pioglitazone-and-ketone-production-in-t2d-100597040","NCT07053319","SGLT2i, Pioglitazone, and Ketone Production in T2D","Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus","Patients with T2D\n\nInclusion Criteria:\n\n* Ages 30-75 years\n* Body Mass Index (BMI) 21-45 kg\u002Fm2\n* Hemoglobin A1C (HbA1c) = 7.0-11%\n* Estimated glomerular filtration rate (eGFR) \\> 60 ml\u002Fmin\u002F1.73m2\n* Blood Pressure (BP) \\\u003C 145\u002F85 mmHg\n* Participants must be in general good health based on medical history, physical exam, screening blood chemistries, complete blood chemistry (CBC), thyroid stimulating hormone\u002Fthyroxine (TSH\u002FT4), electrocardiogram (EKG), and urinalysis\n* Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program\n* Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU\u002FMET\n* Statin therapy is permissible if the dose has been stable for at least 3 months\n\nExclusion Criteria:\n\n* Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded\n* Patients taking medications (other than SU\u002FMET) known to affect glucose metabolism are excluded\n* Subjects with evidence of proliferative retinopathy or eGFR \\\u003C 60 are excluded\n* Women of childbearing potential are excluded unless they are taking\u002Fusing appropriate contractive medications\u002Fdevices","30 Years","75 Years",{"count":395,"type":22},64,[170],"To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).",[399],"Type 2 Diabetes",[401,402,403,404],"Endogenous glucose production","Ketogenesis","Gluconeogenesis","Lipolysis","2026-05-11",{"date":378,"type":36},{"date":405,"type":36},{"date":128,"type":22},{"name":42,"class":43},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":217,"sex":17,"minAge":79,"maxAge":109,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":130},"100609306","phase-1-the-role-of-glucagon-in-glucose-metabolism-in-humans-with-and-without-bariatric-surgery-100609306","NCT07212868","The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form from participant.\n2. Male or female, ≤65 and ≥18 years old\n3. Subjects with history of gastric bypass surgery and sleeve gastrectomy more than a year since surgery and non-surgical subjects without history of gastrointestinal (GI) surgery\n4. HbA1c ≤6%\n5. Willing to adhere to the study intervention regimen\n6. Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating\n7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions during the study.It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Diabetes\n2. Pregnancy\u002Flactation\n3. Hgb \\\u003C11\n4. Current GI obstruction or chronic diarrhea\n5. Subjects who are not within the age range of 18- 65 years.\n6. Evidence of active cardiorespiratory, hepatic, gastrointestinal or renal disease.\n7. History of allergy to the administered drugs.\n8. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and\u002For any subject unable or unwilling to follow study procedures.\n9. Substance dependence or history of alcohol abuse and\u002For excess alcohol intake\n10. Patients on ketogenic diet\n11. Prisoners or institutionalized individuals\n12. AST (SGOT) \\> 3 times upper limit of normal\n13. ALT (SGPT) \\> 3 times upper limit of normal\n14. History of clinical hypoglycemia documents based on Whipples' triad (ONLY for Aim 2)",{"count":417,"type":22},150,[170],"The goal of this study is to understand the role of glucagon signal on glucose metabolism in individuals with and without bariatric surgery. The study is involved with measuring glucose metabolism with glucagon infusion and glucagon receptor blockade. We use an investigational drug called REMD 477. \"Investigational\" means that the has not yet been approved by the U.S. Food \\& Drug Administration (FDA). REMD-477 is a monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.",[421],"Non-Diabetic",[423,424,425],"glucagon","glucose metabolism","bariatric surgery","2026-05-08",{"date":405,"type":36},{"date":429,"type":36},"2026-02-25",{"date":431,"type":22},"2030-06-30",{"name":42,"class":43},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":44},"100639844","impact-of-ketogenic-diet-on-tumor-microenvironment-in-patients-with-breast-cancer-100639844","NCT07574671","Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer","Inclusion Criteria:\n\n* Be willing and able to provide consent for the study\n* Age ≥ 18 on the day consent is obtained\n* Eastern Cooperative Oncology Group (ECOG) score ≤ 2\n* Patients must be postmenopausal the time of study entry\n* Stage I or II breast cancer using Tumor, Nodes and Metastasis (TNM) stage groups per American Joint Committee on Cancer (AJCC) 8th edition\n* Plan for upfront breast surgery with mastectomy or partial mastectomy and does not require pre-operative systemic therapy per standard of care\n* Must have tissue available from initial breast biopsy performed per standard of care\n* have the ability in the opinion of the investigator to adhere to a ketogenic diet and comply with study requirements such as ability to participate in telemedicine, utilize apps on a smart device, measure glucose\u002Fketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet\n\nExclusion Criteria:\n\n* Clinical indication for neoadjuvant therapy\n* Partial mastectomy or mastectomy planned for less than 3 weeks from study entry\n* Inability to comply with ketogenic diet\n* Consistent use of ketogenic diet within past 3 months\n* Participation in another diet program during study period\n* Nonepithelial breast malignancy such as sarcoma or lymphoma\n* Body Mass Index \\\u003C 18.5\n* Comorbidities and\u002For active or ongoing illness that in the opinion of the investigator will limit patient's ability to safely participate in study\n* Type I diabetes\n* Use of insulin or other oral hypoglycemic drugs for diabetes\n* Has had any of the following within the past 6 months\n\n  * Myocardial infarction or unstable angina\n  * Ventricular arrythmia\n  * Acute decompensated heart failure\n  * Cerebrovascular accident\n  * Hypertensive emergency\n* Uncontrolled hypertension despite antihypertensive use\n* End-stage renal, liver, or cardiac disease\n* genetic disorders that affect lipid metabolism (example: pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, among others)\n* G6PD (glucose-6-phosphate dehydrogenase) deficiency\n* Malabsorption syndromes (such as but not limited to inflammatory bowel disease, history of gastric sleeve, prior bowel resection)\n* History of recurrent kidney stones or predisposition to kidney stones\n* Triglycerides ≥ 500\n* Has known psychiatric or substance use disorders that would interfere with participation in the study",{"count":440,"type":22},12,[25],"This study is testing the effects of a ketogenic diet on patients with early stage breast cancer. Participants will keep to a ketogenic diet for 3 weeks prior to surgery.",[444],"Breast Cancer",[446,447,448],"Ketogenic diet","diet","nutrition","2026-05-04",{"date":426,"type":36},{"date":452,"type":36},"2026-04-02",{"date":454,"type":22},"2028-04",{"name":42,"class":43},{"id":457,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":26,"conditions":460,"keywords":461,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":466,"locationsCount":44},"100623791",{"count":21,"type":22},[25],[28],[30,31],{"date":463,"type":36},"2026-05-06",{"date":38,"type":22},{"date":40,"type":22},{"name":42,"class":43},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":485,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":44},"100484793","in-dementia-clinical-trials-100484793","NCT05592678","δ in Dementia Clinical Trials","Novel Methods for Clinical Trials in Dementia and Cognitive Decline","δND","Inclusion Criteria:\n\n1. Ambulatory outpatient volunteers with co-informants.\n2. Aged 65-100 years\n3. Clinical diagnosis of AD, or MCI.\n4. Capacity to give informed consent.\n5. GDS score (15 item) ≤ 8.\n6. No significant visual or hearing impairments\n7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.\n\nExclusion Criteria:\n\n1. A history of psychosis, including visual hallucinations;\n2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;\n3. History of bradycardia or syncopal events;\n4. Treatment for cancer in the last 5 years (excluding skin cancers);\n5. Major surgery in the last year;\n6. Treatment for a seizure disorder with anticonvulsants;\n7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);\n8. Current treatment with donepezil or any other AChEI or exposure within the last six months\n9. With a recently started Donepezil Rx (\\\u003C 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.\n10. AChEI treatment not appropriate due to negative risk\u002Fbenefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.\n11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.","100 Years",{"count":477,"type":22},200,[25],"The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are:\n\n* Can an intervention's outcome be better assessed by a latent variable (\"δ\") integrating cognitive performance with functional status?\n* Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity?\n* Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention?\n* Is the effect of the intervention in fact medicated by changes in the targeted biomarker?\n\nIn this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called \"adipokines\"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes.\n\nParticipants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.",[481,482,483,484],"Alzheimer's Disease (AD)","Dementia","Cognitive Decline","Mild Cognitivie Impairment (MCI)",[486,487,488,489,490],"adipokines","cognition","dementia","functional status","intelligence","2026-04-30",{"date":493,"type":36},"2026-05-05",{"date":495,"type":36},"2024-08-05",{"date":497,"type":22},"2028-11-30",{"name":42,"class":43},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":138,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":44},"100617378","home-based-heat-therapy-in-spinal-cord-injury-to-improve-cardiovascular-health-100617378","NCT07317843","Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health","Home-Based Passive Heat Therapy-Towards a Scalable Intervention to Improve Cardiovascular Health in Persons With Spinal Cord Injury","IIS_SCIDoD","Inclusion Criteria:\n\n1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.\n2. Participants will be male or female, 18-60 years of age, at the time of Visit 0.\n3. Female participants must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or are postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for =6 months.\n4. Stable SCI (AIS A or B) of longer than 1-year duration.\n5. Use of medications for clinical management of medical problems directly related to SCI is not considered an exclusion criterion. Status such as detrusor instability, muscle spasms, and other common SCI problems (other than those that could alter vascular responsiveness) may be allowed for those SCI participants who have been on stable doses for =6 months. Results from participants taking such medications will be analyzed to determine possible medication-related differences from those on no medications.\n\nExclusion Criteria:\n\n1. Participants who smoke, or:\n2. Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)\n3. Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).\n4. Has a current pressure ulcer or skin breakdown.\n5. Has an active, uncontrolled, autoimmune or inflammatory disorder\n6. Has no history of or current alcohol or substance use disorder\n7. Has a history of heat related illness (e.g., heat stroke)\n8. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes, but is not limited to, a clinically relevant medical or surgical history.\n9. Is unlikely to cooperate with the requirements of the study.",{"count":508,"type":22},48,[25],"The study is designed to investigate the effects of passive heat therapy on blood vessel health in 40 people (48 enrolled with attrition rate of 20%). Following an extensive set of vascular function tests, participants will engage in either a passive heat therapy intervention for 60 minutes, 4 times a week for 8 weeks, or a placebo intervention at a lower temperature. Seven of the 8 weeks of intervention will occur in the home setting. Vascular function tests will be repeated after the 8 weeks to determine if chronic passive heat stress improved vascular health.",[512],"SCI - Spinal Cord Injury",[514,515,516,517,518],"SCI","heat therapy","heat stress","passive heat","vascular function","2026-04-28",{"date":493,"type":36},{"date":522,"type":36},"2026-03-24",{"date":524,"type":22},"2031-07",{"name":42,"class":43},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":339,"maxAge":340,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":344,"conditions":534,"keywords":535,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":542,"locationsCount":44},"100560696","early-phase-1-tranexamic-atomized-for-pediatric-post-operative-tonsillectomy-hemorrhage-pilot-study-100560696","NCT06580509","TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study","TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Pilot and Feasibility Study",{"count":440,"type":22},[222],[346,347],[349,350,351],"2026-04-23",{"date":538,"type":36},"2026-04-24",{"date":540,"type":36},"2026-02-18",{"date":358,"type":22},{"name":42,"class":43},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":44},"100336022","patient-derived-organoid-model-and-circulating-tumor-cells-for-treatment-response-of-lung-cancer-100336022","NCT03655015","Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer","Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)","Inclusion Criteria:\n\n* Read, consented to and signed the IRB-approved informed consent form prior to any study related procedure.\n* Diagnosis of lung cancer or lung mass or lymphadenopathy that will either systemic treatment or tumor resection as part of standard of care\n* Any clinical stage of lung cancer\n* Adult patients ≥18 years of age\n* Able and willing to complete a questionnaire on their environmental\u002Foccupational exposures and smoking\u002Falcohol history\n\nExclusion Criteria:\n\n* At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.",{"count":417,"type":22},"Create a living biobank of PDOs from Stage I-III lung cancer patients.",[553],"Lung Neoplasm","2026-04-16",{"date":556,"type":36},"2026-04-20",{"date":558,"type":36},"2018-10-16",{"date":560,"type":22},"2029-12-01",{"name":42,"class":43},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":569,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":573,"conditions":574,"keywords":580,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":44},"100578440","phase-2-effects-of-tirzepatide-on-muscle-and-vascular-health-in-obese-older-adults-100578440","NCT06811324","Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults","The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults","Inclusion Criteria\n\n* Men and postmenopausal women aged 50 years or older.\n* Body Mass Index (BMI) ≥30 kg\u002Fm².\n* Untreated HbA1c \\\u003C6.5% at baseline.\n* Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.\n* Able to provide informed consent and participate in all study assessments.\n\nExclusion Criteria\n\n* Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.\n* Body Mass Index (BMI) ≥ 40 kg\u002Fm².\n* Moderate to severe gastroesophageal reflux disease based on patient history.\n* Inability to comply with the treatment protocol or to understand the consent form.\n* Chronic Kidney Disease (CKD) Stage 4.\n* Aspartate aminotransferase (AST) \\> 33 U\u002FL or alanine aminotransferase (ALT) \\> 36 U\u002FL.\n* Active pregnancy.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal or family history of multiple endocrine neoplasia type 2 syndrome.\n* Personal history of gastroparesis.\n* Personal history of diabetic retinopathy.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.\n* Concomitant treatment with GLP-1 receptor agonist therapy","50 Years",{"count":21,"type":22},[572],"PHASE2","Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.",[575,576,577,578,579],"Obesity Prevention","Sarcopenia in Elderly","Cardiovascular Function","GLP - 1","Weight Loss",[581,582,583,584,577],"Tirzepatide","GLP-1","Obesity","Sarcopenia","2026-04-10",{"date":587,"type":36},"2026-04-15",{"date":589,"type":36},"2026-04-01",{"date":591,"type":22},"2027-06-01",{"name":42,"class":43},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":606,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":44},"100619094","resectionsynchronous-pulmonary-or-hepatic-oligometastatic-pancreatic-ductal-adenocarcinoma-100619094","NCT07340151","Resection\u002FSynchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma","Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC) Following Pre-operative Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluoracil\u002FFolinic Acid (NALIRIFOX): A Phase II Open-Label Single Arm Trial","PHOLIPANC","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas\n2. Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography\u002FMagnetic Resonance Imaging (CT\u002FMRI) that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT\u002FMRI can be done at an outside facility but must be reviewed by a local radiologist.\n\n   * Definition of limited hepatic metastasis: 1 to 5 metastases in CT\u002FMRI, which are potentially resectable or treatable by ablative procedures.\n\n     * Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT\u002FMRI scan at screening.\n     * Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT\u002FMRI scan at screening.\n   * Definition of limited pulmonary metastasis: 1 to 4 pulmonary nodules seen on CT\u002FMRI, suspicious for pulmonary metastases as per the multidisciplinary tumor board radiologist and surgeon.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Patients ≥18 years at the time of signing the informed consent\n5. Being a candidate for chemotherapy with NALIRIFOX\n6. Patient's written informed consent prior to any trial-specific procedure\n7. Patient's legal capacity to consent to participation in the clinical trial.\n\nExclusion Criteria:\n\n1. Acinar cell carcinoma and\u002For neuroendocrine carcinoma of the pancreas\n2. Symptomatic clinically significant ascites\n3. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.\n4. Evidence of simultaneous pulmonary and hepatic metastases\n5. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given.\n6. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1 staging where Ta=non-invasive; Tis=high-grade, flat non-invasive cancer in situ; T1=relatively small primary tumor that has not spread to surrounding tissues)\n7. Known Human immunodeficiency virus (HIV) seropositivity\n8. Known active or chronic Hepatitis B or Hepatitis C infection\n9. Known glucuronidation deficiency (Gilbert's syndrome)\n10. Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his\u002Fher safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders",{"count":111,"type":22},[25],"This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group.\n\nPatients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy).\n\nIf the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study.\n\nIf the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care.\n\nIf the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.",[605],"Adenocarcinoma of the Pancreas",[607,608,609,610],"Oligometastatic disease","Hepatic oligometastatic adenocarcinoma of the pancreas","Pulmonary oligometastatic adenocarcinoma of the pancreas","Surgical resection","2026-04-09",{"date":613,"type":36},"2026-04-14",{"date":615,"type":36},"2026-03-02",{"date":617,"type":22},"2028-12",{"name":42,"class":43},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":217,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":633,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":44},"100562912","treatment-of-chronic-anger-and-aggression-following-military-related-betrayal-100562912","NCT06609330","Treatment of Chronic Anger and Aggression Following Military-Related Betrayal","Assessment and Treatment of Chronic Anger and Aggression Following Military-Related Interpersonal and Institutional Betrayal: A Pilot Investigation","CART","Inclusion Criteria:\n\n* Adult active duty military service members and veterans aged 18 or older.\n* Endorses a history of military-related betrayal (on the Modified Moral Injury Questionnaire)\n* Endorses problematic anger in the past month (as evidenced by a score of 12 or above on the Dimensions of Anger Reactions; DAR-5)\n* Engaged in at least 1 self-reported act of aggression in the past 1 month (on the Overt Aggression Scale-Modified; OAS-M)\n\nExclusion Criteria:\n\n* Participated in an anger management or trauma-focused intervention within the past 3 months as assessed by self-report.\n* Acute suicidality requiring immediate intervention, such as hospitalization as assessed by the Depressive Symptoms Index-Suicidality Subscale (DSI-SS) combined with follow up clinical interview for elevated scores.\n* Is currently homicidal with plans and intent to hurt a specific person and requiring immediate intervention as measured by self-report and follow-up with clinician if screened positive.\n* Moderate to severe brain injury as measured by inability to comprehend the informed consent document or baseline assessments.\n* Has severe alcohol consumption patterns as evidenced by a score of 19 or above on the Alcohol Use Disorders Identification Test (AUDIT).\n* Experiencing active psychosis or mania as measured by the Prodromal Questionnaire-Brief Version and the Mood Disorders Questionnaire.",{"count":111,"type":22},[25],"The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are:\n\n* Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting\n* Will the treatment help with anger and aggression issues.\n\nResearchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks).\n\nParticipants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.",[631,632],"Anger Problems","Aggression",[634,635,636],"Anger management","Military-related betrayal","Deficit of trust","2026-03-30",{"date":589,"type":36},{"date":640,"type":36},"2025-03-17",{"date":642,"type":22},"2027-01",{"name":42,"class":43},""]