[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Chicago\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,172,0,25,[9,44,69,102,127,151,173,201,223,252,274,298,327,357,381,415,434,455,485,506,530,556,577,600,624],{"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":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637094","phase-1-breakthrough---t1dm-and-chronic-kidney-disease-100637094",false,"NCT07592000","Breakthrough - T1DM and Chronic Kidney Disease","Multicenter, Phase 1\u002F2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islet Transplantation in Patients With T1DM and Chronic Kidney Disease","Participants are eligible for consideration for the study only if all of the following criteria apply at the time of screening Inclusion:\n\n1. Subjects 18-70 years of age.\n2. A diagnosis of T1D ≥5 years with onset of disease at \\\u003C40 years of age.\n3. Ability to provide informed consent.\n4. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).\n5. Involvement in appropriate diabetes management in accordance with the standard of care, using an insulin pump or multiple daily injection (MDI) insulin therapy and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs.\n6. HbA1c level 6.5% to 9.5% inclusive.\n7. Absence of stimulated C-peptide (\\\u003C0.3 ng\u002FmL) in response to a mixed- meal tolerance test (MMTT).\n8. Chronic kidney disease stage 1, 2 or 3a\n9. Impaired awareness of hypoglycemia based on:\n\n   * IAH (HypoA-Q Impaired Awareness Subscale ≥12) and at least one level 3 SHE during the last year or\n   * IAH and time-below-range (\\\u003C70 mg\u002Fdl) ≥4% with level 2 hypoglycemia (\\\u003C54 mg\u002Fdl) ≥1% (in Diabetes Care, Jan 2025, Patrick Choudhary) or\n   * Clarke Score \\>4 or\n   * Recurrent SHE defined by two or more level 3 SHEs in the year prior to screening\n10. If female, must be surgically sterile or postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at screening\u002Fbaseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use 2 forms of highly effective methods of contraception from Screening, throughout the study, and while receiving immunosuppressive therapy for the functioning graft after the conclusion of the study. Contraception use must continue for 90 days after the last administration of the study drug (see Appendix 5). Male participants must refrain from donating sperm for the duration of the study and agree to not donate sperm for 90 days after last administration of the study drug.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) \\>30 kg\u002Fm2.\n2. Weight ≤40 kg.\n3. Insulin requirement \\>60units\u002Fday or \\\u003C15 units\u002Fday.\n4. Untreated and uncontrolled proliferative diabetic retinopathy.\n5. Blood pressure: systolic blood pressure (SBP) \\>140 mmHg or diastolic blood pressure (DBP) \\>90 mmHg.\n6. Chronic kidney disease stage 3b or above.\n7. Diagnosis of macroalbuminuria (ACR\\>300 mg\u002Fg creatinine).\n8. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male participants: intent to procreate during the duration of the study or within 90 days after discontinuation or unwillingness to use effective measures of contraception.\n9. History of malignancy except for completely resected squamous or basal cell carcinoma of the skin.\n10. History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation:\n\n    1. Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable state.\n    2. Patients on aspirin are allowed.\n11. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.\n12. Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of infection is exclusionary.\n13. Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.\n14. Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.\n15. Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.\n16. Baseline PRA over 40%\n17. Previous organ transplant (except failed pancreas or islet transplant)\n18. Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin \\>1.5 ULN.\n19. Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer.\n20. History of substance abuse within the past 6 months.\n21. Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d) left ventricular ejection fraction\\\u003C30%.\n22. Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol \\>130 mg\u002FdL and\u002F or triglycerides \\>200 mg\u002FdL.\n23. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\\\u003C1,000\u002FµL), neutropenia (\\\u003C1,500\u002FµL), or thrombocytopenia (platelets \\\u003C100,000\u002FµL). Participants with lymphopenia are allowed if the Principal Investigator determines there is no additional risk and obtains clearance from a hematologist.\n24. Administration of live attenuated vaccine(s) within 2 months of Screening.\n25. Any previous treatment with Tegoprubart or any other anti-CD40L therapy","ALL","18 Years","70 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Single arm- subject treated with Tegoprubart and everolimus.\n\nThe purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components:\n\n* An investigational drug called Tegoprubart and\n* Human pancreatic islet cells\n\nBoth Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years.\n\nAssess safety, tolerability, and efficacy of transplanted islet cells and immunomodulation with Tegoprubart in combination with anti-thymocyte globulin (ATG), etanercept and with everolimus in adults with brittle T1D and chronic kidney disease (stage 2-3a).",[29,30],"Diabete Type 1","Chronic Kidney Disease","RECRUITING","2026-08-18",{"date":34,"type":35},"2026-08-20","ACTUAL",{"date":37,"type":22},"2027-04-29",{"date":39,"type":22},"2030-01-31",{"name":41,"class":42},"University of Chicago","OTHER",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100652337","phase-4-pain-control-with-ketorolac-and-nerve-block-after-wrist-and-hand-surgery-100652337","NCT07773155","Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery","A Pilot Study to Assess Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Undergoing upper extremity surgery performed by a hand and upper extremity orthopaedic surgeon at the University of Chicago.\n3. Undergoing procedure with regional nerve block\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. Concomitant chronic opioid use\n3. Postoperative opioid use (surgery through POD 14) for condition other than repaired fracture\n4. Medical contraindication to ketorolac use, including pregnancy\n5. Undergoing multiple concurrent surgical procedures\n6. Unable to communicate numerical pain score",{"count":52,"type":22},120,[54],"PHASE4","The purpose of this study is to learn about the effectiveness of different pain control options after hand and wrist surgery, specifically Ketorolac, Tylenol, and a regional nerve block. Ketorolac (Toradol) is a nonsteroidal anti-inflammatory drug (NSAID) that is similar to ibuprofen (Motrin or Advil). Tylenol (acetaminophen) is a commonly used over the counter drug. A nerve block is pain medication that is applied directly to the nerves around the surgical site before the surgery and keeps working to reduce pain in the area for several hours after the surgery. All of these medicines and procedures are approved by the Food and Drug Administration (FDA) for patient care. This study aims to understand if using these medicines in combination helps patients having hand and wrist surgery avoid the need for opioid pain medications.",[57],"Surgery, Upper Extremity",[59],"Wrist Surgery, Hand Surgery, Pain Management","2026-08-14",{"date":62,"type":35},"2026-08-19",{"date":64,"type":35},"2025-03-17",{"date":66,"type":22},"2027-02",{"name":41,"class":42},1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":78,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":68},"100652097","microbiome-determinants-of-adverse-effects-of-stereotactic-radiosurgery-100652097","NCT07767981","Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery","MICRO-ARE-SRS","Inclusion Criteria:\n\n* Admitted to the University of Chicago Medical Center\n* Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Anticipated survival of less than 6 months\n* Known or suspected infectious colitis within the month prior to enrollment\n* Rectal disease that prevents fecal sampling\n* Foreseeable inability to complete the study",{"count":77,"type":22},150,"30 Months","OBSERVATIONAL","This prospective observational study will investigate the relationship between the gut microbiome and adverse effects following stereotactic radiosurgery (SRS). Patients undergoing SRS as part of their standard clinical care will provide blood and stool samples before treatment and during follow-up. Samples will be analyzed to characterize fecal and blood metabolomic profiles and changes in the gut microbiome over time.\n\nThe study has two primary objectives: to determine how stereotactic radiosurgery affects the gut microbiome and associated metabolomic profiles, and to evaluate whether microbiome- and metabolite-associated features are related to the development of adverse effects following SRS. Clinical data and standard-of-care neuroimaging will be collected longitudinally to identify outcomes including radiation necrosis and other adverse radiation effects. Biological profiles from patients who develop these outcomes will be compared with those from patients who do not, as well as within individual patients over time.\n\nThe study aims to identify microbiome and metabolic signatures associated with susceptibility to adverse effects of stereotactic radiosurgery, with the long-term goal of improving risk stratification and informing future approaches to monitoring and treatment.",[82,83],"Adverse Radiation Effects","Radiation Necrosis",[85,82,83,86,87,88,89,90,91,92,93,94,95],"Stereotactic Radiosurgery","Gut Microbiome","Microbiome","Metabolomics","Fecal Metabolomics","Blood Metabolomics","Biomarkers","Neurotoxicity","Radiation Toxicity","Neuro-Oncology","Brain Radiation",{"date":32,"type":35},{"date":98,"type":35},"2025-08-05",{"date":100,"type":22},"2028-09-05",{"name":41,"class":42},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":68},"100341709","a-multi-modality-surveillance-program-for-women-at-high-risk-for-breast-cancer-100341709","NCT03729115","A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer","Chicago Alternative Prevention Study for BreAst CAncer inHigh Risk Women - CAPSBRACA","CAPS","Inclusion Criteria:\n\n* Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.\n\nOR\n\n* Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.\n\nOR\n\n* WISDOM study participant recommended to have MRI every 6 months. OR\n* Patients with history of chest wall radiation received before age 35. AND\n* Must be at least 25 years old.\n* Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.\n* Be able to give informed consent.\n\n  * Patients with prior history of breast or ovarian or any cancer associated with inherited pathogenic mutations in BRCA1\u002F2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.\n  * Willing to travel to the University of Chicago Medicine\n\nExclusion Criteria\n\n* Undergoing active cancer treatment at the time of enrollment.\n* Current pregnancy.\n* Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.\n* Breast surgery within two weeks of study entry.\n* Women with history of bilateral mastectomy are not eligible\n* History of kidney disease or abnormal kidney function.\n* History of dye allergy unless it can be mediated with antihistamines and\u002For steroids\n\n  * Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.\n  * Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.\n  * Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.",true,"FEMALE","25 Years",{"count":114,"type":22},400,[116],"NA","This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.",[119],"Breast Cancer","2026-08-12",{"date":60,"type":35},{"date":123,"type":35},"2019-05-30",{"date":125,"type":22},"2028-12-31",{"name":41,"class":42},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":68},"100651895","recovery-legal-care-randomized-trial-100651895","NCT07764458","Recovery Legal Care Randomized Trial","Health Impact of the \"Recovery Legal Care\" Medical-Legal Partnership","HVIP-MLP","Inclusion Criteria:\n\n* Treatment for an interpersonal violent injury at the University of Chicago Trauma Center (e.g., gunshot, stab wound, assault)\n* Ages 14+ years\n* Able to provide informed consent (18 years and older) or assent (14-17 years)\n\nExclusion Criteria:\n\n* Unable to provide informed consent due to mental status or severe mental illness\n* Prior receipt of legal services at UCMC within the past year\n* Currently imprisoned or incarcerated\n* Residing at a non-Illinois address\n* Non-English speakers","14 Years",{"count":137,"type":22},200,[116],"Hospital-Based Violence Intervention Programs (HVIPs) affiliated with U.S. trauma centers often focus on individual behavior modification to reduce re-victimization. There is a lack of reproducible evidence that has demonstrated effectiveness, given the exclusion of addressing social and economic risks, often the root cause of violent injury and preventable homicide. This study tests a novel Medical-Legal Partnership that offers legal support to address social and economic risks, reduce perceived stress, and reduce firearm injury, while collaborating with the CFVP Coordinating Center for broad trauma center distribution and public health impact.",[141,142,143],"Firearm Injury","Injury Traumatic","Economic Problems","2026-08-11",{"date":60,"type":35},{"date":147,"type":35},"2026-05-11",{"date":149,"type":22},"2027-07-31",{"name":41,"class":42},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":68},"100505100","mobile-health-management-of-hypertension-100505100","NCT05856955","Mobile Health Management of Hypertension","Mobile Health for Enhanced Hypertension Self-Management","Inclusion Criteria:\n\n* Prescribed use of 1 or more antihypertensive medications\n* English-speaking\n* Residence in a disadvantaged neighborhood\n\nExclusion Criteria:\n\n* History of malignant HTN\n* Inability to comprehend the study protocol\n* Institutionalized status\n* Significant sensory or neurocognitive deficit",{"count":159,"type":22},40,[116],"The investigators will pilot test a hypertension self-management intervention for feasibility and acceptability. The investigators will enroll adults (age ≥18) with uncontrolled hypertension, identified from the electronic health record. In this feasibility trial, the research aim is to explore trial design, participant acceptability of the intervention and outcome measures, and to generate data to inform the design of a future randomized controlled trial.",[163],"Hypertension","NOT_YET_RECRUITING","2026-08-07",{"date":167,"type":35},"2026-08-10",{"date":169,"type":22},"2027-09",{"date":171,"type":22},"2028-11",{"name":41,"class":42},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":68},"100651093","pharmacokinetic-study-of-therapeutic-plasma-exchange-100651093","NCT07756242","Pharmacokinetic Study of Therapeutic Plasma Exchange","A Phase 1 Pharmacokinetic Study of Therapeutic Plasma Exchange for Severe Immune-Related Adverse Events From Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Diagnosis of any malignancy.\n* Receiving or recently received an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or combination ICI therapy. Eligible agents may include, but are not limited to, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, and ipilimumab.\n* Received an ICI within 12 weeks prior to planned enrollment, or within a timeframe considered appropriate by the PI for PK evaluation based on the specific ICI agent, dosing history, and assay feasibility.\n* Suspected or confirmed severe or clinically significant immune-related adverse event for which the treating clinical team considers TPE\u002FPLEX clinically appropriate.\n* Planned to undergo or currently undergoing TPE\u002FPLEX at the University of Chicago Medicine.\n* Approval from the patient's primary clinical service for study participation.\n* Able to provide written informed consent, or has a legally authorized representative able to provide consent if permitted by the IRB-approved consent process.\n* In the opinion of the treating team and study team, PK blood sample collection can be performed without delaying or interfering with clinically indicated care.\n\nExclusion Criteria:\n\n* No prior exposure to an immune checkpoint inhibitor.\n* TPE\u002FPLEX is being performed for an indication unrelated to a suspected or confirmed ICI-associated immune-related adverse event.\n* Inability to provide informed consent and no legally authorized representative is available, if applicable.\n* PK blood sample collection is not feasible without delaying, altering, or interfering with clinically indicated care.\n* Any condition that, in the opinion of the investigator or treating team, would make participation in the research procedures unsafe or inappropriate.",{"count":181,"type":22},15,"The purpose of this study is to characterize the pharmacokinetics of one or more ICIs during and after TPE\u002FPLEX in patients with severe irAEs.",[184],"Immune-related Adverse Event",[186,187,188,189,190,191,192,193],"Therapeutic plasma exchange","TPE","Immune Checkpoint Inhibitors","Immune-related Adverse Events","Pharmacokinetics","Pembrolizumab","Nivolumab","Ipilimumab","2026-08-05",{"date":167,"type":35},{"date":197,"type":22},"2026-11",{"date":199,"type":22},"2028-02",{"name":41,"class":42},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":68},"100631567","big-chicago-a-trial-of-basic-income-guarantee-for-young-people-living-with-hiv-100631567","NCT07502365","BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV","Inclusion Criteria:\n\n* Living with HIV for 24 months or longer;\n* Ages 18-35;\n* English-speaking;\n* One or both of the following:\n\n  1. Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;\n  2. Had an unsuppressed viral load at any point within the prior 12-month period (unsuppressed meaning a viral load of 200 copies\u002FmL or higher);\n* Household income at or below 250% of the Federal Poverty Level; and\n* Experiencing financial distress, as based on a financial well-being score of 1-4 (high financial distress).\n\nExclusion Criteria:\n\n* Unwilling\u002Funable to provide informed consent\n* Unable to confirm HIV status\n* Unable to conduct the study in English","35 Years",{"count":209,"type":22},304,[116],"The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.\n\nThe main question it aims to answer is:\n\nCompared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression?\n\nParticipants on the study will be:\n\n* Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.\n* Complete 9 surveys over a 36 month period.\n* Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment.\n* Participants in the Treatment as Usual group will not receive any intervention.\n* HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months).\n* Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months.\n* Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.\n* A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.",[213,214],"HIV","Financial Stress",[213,214],{"date":217,"type":35},"2026-08-06",{"date":219,"type":35},"2026-07-29",{"date":221,"type":22},"2030-07",{"name":41,"class":42},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":233,"studyType":79,"phases":4,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":43},"100625244","outpatient-visits-versus-telehealth-for-postoperative-care-after-minimally-invasive-gynecologic-surgery-100625244","NCT07420114","Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery","Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery: A Randomized Controlled Trial","Telehealth RCT","Inclusion Criteria:\n\n1. Participant has provided written informed consent.\n2. Women over the age of 18.\n3. Ability for patients to complete telehealth visits (i.e. working telephone or internet access) and speak and understand English.\n4. Laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, and hysterectomy.\n5. Undergoing minimally invasive gynecologic surgeries with complex pelvic surgeons (AAGL fellowship-trained).\n\nExclusion Criteria:\n\n1. Conversion to open surgery.\n2. Malignancy noted intraoperatively or on final pathology evaluation.\n3. Surgeon or patient preference for in person clinic follow up.\n4. Pregnancy - pregnancy tests will be completed as part of routine preoperative care on the day of surgery",{"count":232,"type":22},100,"3 Months","Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients.\n\nPrevious scholarship has demonstrated that telemedicine can be a safe alternative to face-to-face postoperative visits for surgical patients, streamlining recovery with no significant delays in the diagnosis of surgical complications. As healthcare systems continue to emphasize value-based care, it is important to assess whether virtual postoperative visits effectively meet patient needs while optimizing resource utilization.\n\nPatient-reported outcomes and satisfaction surveys can help identify potential gaps in care and ensure that telehealth is implemented in a way to maximize both efficiency and quality. Our primary objective is to determine whether patient satisfaction with postoperative telehealth follow-up is non-inferior to in-person clinic visits.",[236],"to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits",[238,239,240,241,242,243,244,245],"telehealth","minimally invasive gynecologic surgery","hysterectomy","myomectomy","excision of endometriosis","laparoscopic surgeries","robotic surgeries","adnexal surgery",{"date":167,"type":35},{"date":248,"type":35},"2026-07-31",{"date":250,"type":22},"2026-12",{"name":41,"class":42},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":68},"100493089","early-phase-1-cardiac-power-output-in-cardiogenic-shock-patients-100493089","NCT05700617","Cardiac Power Output in Cardiogenic Shock Patients","Myocardial Reserve in Advanced Heart Failure Patients","Inclusion Criteria:\n\n1. LVEF ≤ 40%\n2. Referred for RHC for:\n\n   1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR\n   2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR\n   3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR\n   4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI\n3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml\u002Fmin\u002F1.73 m2\n4. Age ≥ 18 years-old\n5. Intent for admission based on RHC data\n\nExclusion Criteria:\n\n1. eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n2. Severe, non-revascularized coronary artery disease\n3. Concurrent acute coronary syndrome\n4. Age \\\u003C 18 years-old\n5. History of significant ventricular arrhythmia without an ICD",{"count":260,"type":22},5,[262],"EARLY_PHASE1","The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.",[265,266],"Heart Failure","Cardiogenic Shock","2026-08-04",{"date":217,"type":35},{"date":270,"type":35},"2023-07-06",{"date":272,"type":22},"2027-12",{"name":41,"class":42},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":297,"locationsCount":43},"100576826","phase-3-optimizing-treatment-of-co-occurring-smoking-and-unhealthy-alcohol-use-among-pwh-in-nairobi-kenya-100576826","NCT06790342","Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya","Inclusion Criteria:\n\n1. Confirmed chart diagnosis of HIV\n2. At least 18 years or age\n3. Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.\n4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)\n5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse\u002Fheavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or \\>7 drinks\u002Fweek over the past 30 days\n6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)\n7. Willingness to accept behavioral and\u002For pharmacologic tobacco and alcohol treatment\n8. Willingness and ability to provide informed consent to participate.\n\nExclusion Criteria:\n\n1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment\n2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)\n3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations\n4. Pregnant, nursing, or becoming pregnant during the study\n5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician\n6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale\n7. Unstable psychiatric illness\n8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period\n9. Expected survival of less than 6 months.","80 Years",{"count":282,"type":22},300,[284],"PHASE3","People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.",[213,287,288],"Tobacco Use","Alcohol Use Disorder",[213,290,291],"Tobacco Cessation","Alcohol Reduction",{"date":293,"type":35},"2026-07-30",{"date":248,"type":22},{"date":296,"type":22},"2029-06-01",{"name":41,"class":42},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100491506","tissue-destruction-and-healing-in-celiac-disease-100491506","NCT05680012","Tissue Destruction and Healing in Celiac Disease","Inclusion Criteria:\n\nGluten challenge group:\n\n1. Age 18 to 75 years old\n2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy\n3. Follow a strict gluten-free diet for at least the 12 consecutive months\n\nGluten de-challenge group:\n\n1. Age 18 to 75 years old\n2. Showing typical celiac disease symptoms\n3. Not on a gluten-free diet\n\nControl group:\n\n1. Age 18 to 75 years old\n2. Females who are not pregnant\n\nExclusion Criteria:\n\nGluten challenge group:\n\n1. Diagnosis of any severe complication of celiac disease\n2. Diagnosis of other chronic, active GI disease\n3. Selective IgA deficiency\n4. Severe reaction to gluten exposure\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n7. Pregnant or lactating\n8. Diagnosis of blood clotting disorders\n\nGluten de-challenge group:\n\n1. History of chronic inflammatory gastrointestinal disease\n2. Gastrointestinal illness within the 4-week period prior to screening\n3. History of lymphoproliferative disease\n4. Uncontrolled blood clotting disorders\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n\nControl group:\n\n1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs\n2. Known intestinal inflammation\n3. Prior gastrointestinal surgery\n4. Taking of antiplatelet agents or anticoagulants\n5. Family history of celiac disease","75 Years",{"count":306,"type":22},220,[116],"The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.",[310],"Celiac Disease",[312,313,314,315,316,317],"gluten-free diet","HLA-DQ2","HLA-DQ8","microbiome","metagenomics","intestinal epithelial cells","2026-07-24",{"date":320,"type":35},"2026-07-28",{"date":322,"type":35},"2023-07-14",{"date":324,"type":22},"2027-07-01",{"name":41,"class":42},3,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":68},"100528601","case-management-dyad-100528601","NCT06162897","Case Management Dyad","Implementation of a Triadic Network Case Management Intervention for Along the Status Neutral HIV Care Continuum","CM2","Gap in HIV or PrEP care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months\n\nSelf-reported financial or food insecurity",{"count":336,"type":22},180,[116],"The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.",[213,340,341],"Pre-exposure Prophylaxis","Case Management",[343,344,345,346,347,348],"linkage to care","viral suppression","case management","retention in care","financial wellbeing","food security","2026-07-17",{"date":351,"type":35},"2026-07-21",{"date":353,"type":35},"2022-09-09",{"date":355,"type":22},"2027-06-30",{"name":41,"class":42},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":68},"100648155","proper-gerd-a-prospective-crossover-study-to-evaluate-probe-placement-optimization-for-reflux-testing-in-women-and-lower-bmi-patients-100648155","NCT07716592","PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients","PROPER-GERD","Inclusion Criteria:\n\n* Adults aged 18-90\n* Typical GERD symptoms (heartburn, regurgitation, chest discomfort)\n* No prior foregut surgery\n* Ability to undergo endoscopy with sedation and consent\n\nExclusion Criteria:\n\n* Known motility disorders (e.g., achalasia)\n* Barrett's esophagus \\>3 cm\n* Pregnancy\n* Chronic opioid use\n* Inability to tolerate endoscopy or EndoFLIP\n* Presence of large type III or IV paraesophageal hernia\n* Previous esophageal or gastric surgery, including previous hiatal hernia repair","90 Years",{"count":366,"type":22},80,[116],"This is a prospective, within-subject controlled study involving simultaneous dual placement of wireless Bravo pH probes in each participant. Patients will receive pH testing when symptomatic for gastroesophageal reflux disease (GERD) to confirm diagnosis as part of standard of care. Each test is 96 hours with a symptom diary, GERD-HRQL, and RSI collected, which is also standard of care for patients presenting with GERD symptoms.",[370],"GERD",[372,373],"symptomatic for GERD","Bravo pH probes i","2026-07-16",{"date":351,"type":35},{"date":377,"type":22},"2026-08",{"date":379,"type":22},"2028-12",{"name":41,"class":42},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":389,"enrollmentInfo":390,"targetDuration":392,"studyType":79,"phases":4,"briefSummary":393,"conditions":394,"keywords":400,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":43},"100647753","transition-care-for-fep-100647753","NCT07713849","Transition Care for FEP","Adapting and Improving Transition Care for First Episode Psychosis","TCT FEP","Inclusion Criteria:\n\n* Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depressive disorder with psychotic features, schizophreniform disorder, or psychosis NOS\n* The diagnosis of one of the psychotic disorders has a duration of less than two years.\n* Able to read, speak, and understand English, which will be assessed through observation.\n* Able and willing to provide written informed consent or assent, in cases where caregivers are considered legal guardians. Dr. Shima, co-I of the study, is a forensic psychiatrist, and particularly adept at judging such ability. Drs. Erickson and Keedy have conducted studies in individuals with psychotic disorders, including FEP and in the context of clinical trials, for years, and are similarly competent to judge whether individuals can provide informed consent. Finally, we will also use an Evaluation to Sign Consent form that documents subjects' verbalized understanding of key aspects of the study.\n* have an estimated IQ of \\> 65, assessed by the Wechsler Test of Adult Reading\n* Eligible caregivers\u002Fproxy informants must be identified by the participant or clinical team as being involved in the participant's discharge planning or follow-up care, be able to provide informed verbal consent, and be able to speak and read English sufficiently to complete study questionnaires. Caregivers may include family members, close supports, or legally authorized representatives.\n\nExclusion Criteria:\n\n* Individuals with substance-induced psychosis or psychosis due to a medical condition will not be included in the study. We will use the Structured Clinical Interview for DSM-5 as well as medical records, and if the subject gives permission, caregiver information in this process\n* Individuals who do not meet criteria for a first episode of psychosis","40 Years",{"count":391,"type":22},75,"6 Weeks","This study is testing a new approach to help people with first episode psychosis transition successfully from the hospital to outpatient mental health care. Many patients lose contact with services after they leave the hospital, which can lead to worse outcomes. The investigators have developed a Transition Care Team (TCT) that works with patients while they are in the hospital and continues to support them after discharge. The team provides therapy, case management, and coordination with community programs that offer ongoing care. The main goal of the study is to find out if this new program increases the number of patients who successfully begin outpatient treatment after hospitalization, compared to usual care. The investigators will also look at whether the program improves symptoms, functioning, and overall well-being.",[395,396,397,398,399],"Schizoaffective Disorders","Bipolar Disorder With Psychotic Features","Schizophrenia Disorders","Major Depressive Disorder With Psychotic Features","Psychosis NOS",[401,402,403,404,405,406],"First Episode Psychosis","Bipolar","Inpatient Unit","Transition Care Team","Schizophrenia","Coordinated Specialty Care","2026-07-14",{"date":409,"type":35},"2026-07-20",{"date":411,"type":35},"2026-05-06",{"date":413,"type":22},"2029-05-06",{"name":41,"class":42},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":68},"100606727","phase-2-a-study-comparing-two-immunotherapy-options-for-human-papillomavirus-positive-hpv-positive-head-and-neck-cancer-after-treatment-100606727","NCT07179315","A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment","A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.","Inclusion Criteria:\n\n* Patients must have history of histologically confirmed squamous cell carcinoma of the oropharynx.\n* Must be HPV positive; testing must be compliant with meeting any one or more of the following criteria:\n* p16 IHC positivity (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al.37).\n* HPV PCR positivity.\n* HPV in situ hybridization (ISH) positivity.\n* Completed curative intent therapy. Acceptable curative intent therapies may include any combination of surgery, radiotherapy, and\u002For chemotherapy is eligible. Curative intent therapy must be completed at least 1 month prior to enrollment.\n* Any T or N stage at time of initial diagnosis is permitted, including patients with unknown primary, supraclavicular or mediastinal nodal involvement at the time of curative intent treatment.\n* Detectable ctHPVDNA in plasma confirmed by NavDx prior to enrollment based on the clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA plasma assay. Patients with detectable ctHPVDNA in plasma from other commercially available CLIA-certified assays are also eligible, however a positive NavDx assay is required and will be obtained during screening.\n* PD-L1 biomarker analysis from a core or excisional biopsy must be performed by IHC using the 22C3 antibody and a CPS score must be calculated for stratification. If unavailable, result from a fine-needle aspirate can also be acceptable. Local testing is acceptable.\n* No definitive clinical or radiographic evidence of disease evaluated by clinical examination and cross-sectional imaging and\u002For PET imaging prior to randomization. Patients with equivocal results on imaging are eligible.\n* Patients must be willing and able to provide written informed consent for the trial.\n* Patients must be at least 18 years of age on day of signing informed consent.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale. An ECOG performance status of 2 is acceptable if the patient was ECOG 0\u002F1 prior to curative intent therapy and is in the midst of recovery from curative intent therapy.\n* Demonstrate reasonable organ function as defined below in Table below\n* System and Laboratory Value\n\n  * Hematological\n\n    * Absolute neutrophil count (ANC): ≥1,500 \u002FmcL\n    * Platelets: ≥100,000 \u002F mcL\n    * Hemoglobin: ≥9 g\u002FdL\n  * Renal\n\n    \\- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤2.0 X upper limit of normal (ULN) OR ≥30 mL\u002Fmin for subject with creatinine levels \\> 2.0 X institutional ULN\n  * Hepatic\n\n    * Serum total bilirubin: ≤ 3 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 2 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* WOCBP must have a negative serum (beta-hCG) at screening.\n\n  * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy.\n  * Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.\n  * Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n  * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.\n* All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.\n\nExclusion Criteria:\n\n* Clinical or radiographic evidence of gross disease that warrants further curative intent therapy or systemic\u002Fpalliative therapy (e.g. platinum containing chemotherapy, cetuximab, pembrolizumab).\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10mg of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Physiologic replacement doses are allowed up to and including 10mg of prednisone\u002Fday or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or typical side effects from radiotherapy are an exception to this criterion and may qualify for the study.\n  * Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Patients who are receiving any other investigational agents.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).\n* Exclusions related to infection or immunodeficiency\n\n  * History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n  * Active infection requiring therapy.\n  * Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n  * Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n  * Notes:\n* Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n* Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Received a live vaccine within 30 days of planned start of study medication.\n\n  o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Exclusions related to cardiac conditions:\n\n  * Participants with a history of myocarditis.\n  * TnT or troponin I TnI \\> 2x institutional ULN at baseline.\n  * Patients with TnT or TnI levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n  * Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n  * Intrauterine device; intrauterine hormone-releasing system;\n  * Bilateral tubal occlusion\u002Fligation;\n  * Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For\n  * Sexual abstinence",{"count":423,"type":22},68,[26],"The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are:\n\n* Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone?\n* Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival.\n\nParticipants will:\n\n* Receive either cemiplimab alone or a combination of cemiplimab and fianlimab.\n* Attend regular follow-up visits for monitoring of treatment efficacy and side effects.\n* Undergo assessments to measure disease progression and response to treatment.",[427],"Head and Neck Cancer",{"date":374,"type":35},{"date":430,"type":35},"2026-06-09",{"date":432,"type":22},"2029-11-30",{"name":41,"class":42},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":441,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":68},"100488450","phase-2-tocilizumab-for-acute-chest-syndrome-100488450","NCT05640271","Tocilizumab for Acute Chest Syndrome","Low-Dose Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease","Inclusion Criteria:\n\n* Adults ≥ 12 years of age\n* Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)\n\nExclusion Criteria:\n\n* Pregnant patients or breastfeeding mothers.\n* Prior treatment with gene therapy or a stem cell transplant.\n* Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.\n* Current neutropenia (absolute neutrophil count \\< 1000\u002Fmm\\^3)\n* Current thrombocytopenia (platelet count \\< 50,000 mm\\^3)\n* Aspartate aminotransferase (AST) or alanine transaminase (ALT) \\> 10 times the upper limit of normal (ULN)\n* History of tuberculosis (TB).\n* Positive purified protein derivative (PPD) TB screening test.\n* On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib\n* On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib\n* Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months:\n\nAbatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab","12 Years",{"count":137,"type":22},[26],"The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.",[446,447],"Sickle Cell Disease","Acute Chest Syndrome","2026-07-13",{"date":407,"type":35},{"date":451,"type":35},"2023-04-10",{"date":453,"type":22},"2027-03",{"name":41,"class":42},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":43},"100354976","volume-supportassist-control-mode-ventilation-and-diaphragmatic-atrophy-100354976","NCT03901924","Volume Support\u002FAssist Control Mode Ventilation and Diaphragmatic Atrophy","A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy","Inclusion Criteria:\n\nsubjects \\> 18 years of age that have been intubated and mechanically ventilated for \\\u003C 36 hours at the time of screening will be eligible for enrollment\n\nExclusion Criteria:\n\n1. pregnancy\n2. cardiopulmonary arrest\n3. history of diaphragmatic paralysis or neuromuscular disease\n4. chronic obstructive pulmonary disease (COPD) or asthma exacerbation with evidence of auto-PEEPing requiring intubation\n5. neuromuscular blockade\n6. expectation to be liberated from ventilator in \\\u003C 24 hours\n7. history of mechanical ventilation in the last 6 months\n8. presence of tracheostomy\n9. high cervical spine injury",{"count":463,"type":22},468,[116],"The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.",[467],"Mechanical Ventilation Complication",[469,470,471,472,473,474,475,476,477],"Diaphragm Atrophy","Ventilator Induced Diaphragm Dysfunction","Mechanical Ventilation","Volume Support Mode","Assist Control Mode","Diaphragm Thickening Fraction","Intubation","Delirium","Ventilator-Free Days","2026-07-10",{"date":448,"type":35},{"date":481,"type":35},"2019-03-04",{"date":483,"type":22},"2027-05",{"name":41,"class":42},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":68},"100645668","effect-of-monosodium-glutamate-on-microbiome-derived-imidazole-propionate-production-in-healthy-volunteers-100645668","NCT07700368","Effect of Monosodium Glutamate on Microbiome-Derived Imidazole Propionate Production in Healthy Volunteers","Inclusion Criteria:\n\n* Age 18 years or older\n* No antibiotic use in the previous 3 months\n\nExclusion Criteria:\n\n* Diagnosis of diabetes or prediabetes (any type)\n* Inflammatory bowel disease or other gastrointestinal disorder\n* Known allergy or intolerance to monosodium glutamate (MSG)\n* Pregnancy or breastfeeding\n* Current participation in another clinical trial\n* High habitual dietary intake of MSG or histidine",{"count":492,"type":22},18,[116],"The goal of this clinical trial is to learn whether dietary monosodium glutamate (MSG), a common food flavor enhancer, increases the blood level of a gut-microbiome-derived compound called imidazole propionate (ImP) in healthy adult volunteers. ImP is a compound made by gut bacteria from the amino acid histidine, and higher blood levels have been linked to problems with blood-sugar control. The main questions this trial aims to answer are:\n\nDoes taking MSG together with L-histidine increase blood ImP levels compared with taking a salt (sodium chloride) placebo together with L-histidine? How do blood ImP levels change over time in response to MSG and L-histidine taken together?\n\nResearchers will compare a 7-day period of L-histidine plus MSG against a 7-day period of L-histidine plus sodium chloride (a salt placebo with matching sodium content) to see whether MSG changes blood ImP levels. Each participant completes both periods in random order and serves as their own comparison.\n\nParticipants will:\n\nTake L-histidine capsules twice daily (morning and evening with meals) during two separate 7-day periods.\n\nDissolve either MSG powder or salt powder in water and drink it twice daily during each period, with the two periods separated by a 7-day break (washout).\n\nGive a fasting blood sample at the start of the study and on day 7 of each period.\n\nOptionally provide a stool sample at the end of each period. Complete a daily treatment diary and a follow-up phone call after the final sample.",[496],"Healthy Adult",[498],"Monosodium glutamate","2026-07-08",{"date":407,"type":35},{"date":502,"type":22},"2026-07-15",{"date":504,"type":22},"2027-12-31",{"name":41,"class":42},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":68},"100591159","tibial-imn-vs-tibial-micromotion-imn-100591159","NCT06976801","Tibial IMN Vs. Tibial Micromotion IMN","Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation","Inclusion Criteria:\n\n1. Age 18 or older\n2. Unstable tibial fracture recommended for surgical intervention\n\nExclusion Criteria:\n\n1. Patients not meeting inclusion criteria (Stable fracture patterns)\n2. Previously non-ambulatory patients\n3. Delayed presentation of fracture (\\>4 weeks)\n4. Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability\n5. Patients with an active infection or wound at the surgical site\n6. Utilizing worker's compensation at the time of screening\n7. Any previous ligament or fracture surgery on the index site\n8. Inflammatory rheumatic disease or other rheumatic disease\n9. Immune compromised patients (hepatitis, HIV, etc.)\n10. Non-English-speaking patients\n11. Unwilling or unable to participate or follow study protocol",{"count":514,"type":22},372,[116],"Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.\n\nWith much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare.\n\nObjectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.\n\nSecondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic\u002Fsonographic outcomes in patients treated with tibial nails.",[518],"Tibial Fracture",[520,521,522],"Unstable tibial fracture","intramedullary nail","micromotion tibial nail fixation",{"date":524,"type":35},"2026-07-09",{"date":526,"type":35},"2025-07-01",{"date":528,"type":22},"2030-12",{"name":41,"class":42},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":544,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":68},"100566177","does-ethyl-chloride-spray-work-100566177","NCT06651788","Does Ethyl Chloride Spray Work?","Does \"Freeze Spray\" Work? Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections","Inclusion Criteria:\n\n* 18 years and older\n* Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections) for the first time\n\nExclusion Criteria:\n\n* Patients with previous injection experiences",{"count":282,"type":22},[116],"A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.",[541,542,543],"Injection Fear","Injection Pain Prevention","Injection Complication",[545,546,547,548,549],"Injection","Freeze spray","corticosteroid injections","Ethyl chloride","Orthopeadics",{"date":524,"type":35},{"date":552,"type":35},"2025-04-01",{"date":554,"type":22},"2028-12-01",{"name":41,"class":42},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":68},"100556493","lets-eat-eating-with-assistive-technology-an-intervention-to-support-children-with-feeding-tubes-and-tracheostomies-100556493","NCT06525818","Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies","Inclusion Criteria:\n\n* Under 3 years of age\n* Reside at a family home\n* Have a gastrostomy feeding tube\n* Have a tracheostomy\n* Live within a 1-hour radius of the University of Chicago or willing to travel to the University of Chicago for enrollment and exit visit.\n\nExclusion Criteria:\n\n• Wards of the state","3 Years",{"count":159,"type":22},[116],"The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person\u002Fvirtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech\u002Flanguage pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:\n\nSpecific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.\n\nSpecific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.\n\nThe investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.\n\nThe weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.",[567,568,569,570],"Feeding Tube","Children With Medical Complexity","Tracheostomy","Feeding Disorder, Infancy or Early Childhood",{"date":478,"type":35},{"date":573,"type":35},"2024-07-08",{"date":575,"type":22},"2027-07-07",{"name":41,"class":42},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":584,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":68},"100550406","using-text-messages-to-improve-oral-chemotherapy-for-adolescents-and-adults-with-acute-lymphoblastic-leukemia-100550406","NCT06446661","Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia","Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages","Inclusion Criteria:\n\n* Age of 15 years or older at time of enrollment\n* Diagnosed with ALL or T-cell lymphoblastic lymphoma\n* Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance. Patients in the pilot phase may have already started maintenance as long as the end of their maintenance therapy is scheduled to occur after the end of the 28-day pilot intervention.\n\nExclusion Criteria:\n\n* Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages\n* Patient does not wish to participate\n* Text messages will be crafted in the patient's preferred language for medical communication, so English fluency is not an enrollment requirement.","15 Years",{"count":586,"type":22},48,[116],"This is a single center 2-phase study to assess effects of using text messages on adherence to oral chemotherapy for patients with acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma.",[590,591],"Acute Lymphoblastic Leukemia","T-cell Lymphoblastic Lymphoma",[593],"Oral Chemotherapy",{"date":478,"type":35},{"date":596,"type":35},"2026-05-19",{"date":598,"type":22},"2028-06-15",{"name":41,"class":42},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":615,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":68},"100584262","achieving-routine-intervention-and-screening-for-emotional-health-100584262","NCT06887049","Achieving Routine Intervention and Screening for Emotional Health","ARISE: Achieving Routine Intervention and Screening for Emotional Health: Randomized Controlled Trial","ARISE","Inclusion Criteria:\n\n* Patient at a participating clinic\n* Type 2 diabetes\n* Adult (18 years or older)\n* A1C \\> 8%\n\nExclusion Criteria:\n\n* Pregnant",{"count":609,"type":22},1250,[116],"The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).",[613,614],"Type 2 Diabetes Mellitus (T2DM)","Diabetes Distress",[616],"diabetes distress screening","2026-07-07",{"date":499,"type":35},{"date":620,"type":35},"2026-03-10",{"date":622,"type":22},"2028-09",{"name":41,"class":42},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":631,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":68},"100549608","kidney-stone-inflammation-100549608","NCT06436235","Kidney Stone Inflammation","Inflammation and Insulin Resistance in Kidney Stone Patients","Inclusion Criteria:\n\n* Stone formers:\n* Age 18-70\n* History of at least one calcium-based kidney stone\n* Healthy Controls:\n* Age 18-70\n* No history of kidney stone or family history of kidney stones\n\nExclusion Criteria (for both groups):\n\n* History of primarily uric acid\n* Cysteine, or struvite stones\n* History of diabetes or impaired glucose tolerance\n* Previous thiazide use\n* Anyone on a medication that cannot be stopped that may affect urine composition\n* Previous bariatric surgery or ileostomy\n* Primary hyperparathyroidism and elevated serum calcium.",{"count":159,"type":22},"This observational study aims to look at the connections between kidney stones, insulin resistance, and inflammation. The researchers hypothesize that people who form calcium kidney stones and have insulin resistance may have higher levels of inflammation because they have more visceral fat (fat around the abdominal organs).\n\nThe study will recruit 20 people who have had calcium kidney stones but don't have diabetes, and 20 healthy people who haven't had kidney stones. All the participants will come to the research center at the University of Chicago Medicine. Participants will have a dual-energy X-ray absorptiometry (DEXA) scan to measure their visceral fat, and give blood and urine samples. The blood will be tested for insulin resistance, inflammatory markers, and other metabolic factors. The urine will be analyzed for substances that increase kidney stone risk.\n\nThe main goal is to see if the kidney stone formers with insulin resistance have more visceral fat compared to those without insulin resistance and the healthy participants. The researchers will also compare inflammatory marker levels between groups, and look at how visceral fat, inflammatory markers, insulin resistance, and urine stone risk factors are related.\n\nThe findings may help explain how kidney stones are connected to metabolic conditions like diabetes and cardiovascular disease. Researchers hope this information will help identify stone formers at risk early and develop preventive treatments in the future.",[634,635],"Kidney Stone","Stone, Kidney",{"date":499,"type":35},{"date":638,"type":35},"2024-06-30",{"date":640,"type":22},"2028-08-01",{"name":41,"class":42},""]