[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Arkansas\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":617},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,46,75,98,120,142,164,189,216,239,263,284,303,325,349,379,405,430,452,476,503,524,553,578,597],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578685","delivering-hope-helping-women-optimize-prenatal-equity-100578685",false,"NCT06814509","Delivering HOPE (Helping Women Optimize Prenatal Equity)","Inclusion Criteria:\n\n* Aged 16-44 years\n* ≤18 weeks pregnant\n* Speak English, Spanish, or Marshallese\n* Valid email address",true,"FEMALE","16 Years","44 Years",{"count":21,"type":22},1440,"ESTIMATED","INTERVENTIONAL",[25],"NA","The overarching research question is: \"Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?\" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000\u002F$2000\u002F$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.",[28,29,30,31,32],"Gestational Weight Gain","Diet, Healthy","Gestational Hypertension","Gestational Diabetes","Pregnancy Complications","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2025-06-24",{"date":41,"type":22},"2029-12-31",{"name":43,"class":44},"University of Arkansas","OTHER",8,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100644904","how-different-levels-of-cpap-affect-oxygen-delivery-and-lung-expansion-in-preterm-infants-100644904","NCT07674953","How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants","Oxygen Delivery in CPAP and Its Relationship With Regional Lung Ventilation in Preterm Infants","Inclusion Criteria:\n\n* Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical\n* The infant must be stable while receiving nasal CPAP at any pressure level at the time of study\n* The infant must be receiving 22-40% at the time of the study\n\nExclusion Criteria:\n\n* Oxygen requirements greater than 40% at time of enrollment\n* currently receiving invasive ventilation or not requiring ventilatory support\n* Major congenital anomalies of the heart and\u002For lungs","ALL",{"count":55,"type":22},10,[25],"With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.",[59,60],"Respiratory Distress Syndrome (Neonatal)","Respiratory Distress of Newborn",[62,63,64,65],"respiratory distress syndrome","CPAP","preterm infant","effective oxygen delivery","2026-06-23",{"date":68,"type":37},"2026-06-30",{"date":70,"type":37},"2026-04-15",{"date":72,"type":22},"2027-06",{"name":43,"class":44},2,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":82,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100610749","ai-algorithm-informed-biopsy-for-prostate-cancer-detection-with-indeterminate-and-low-risk-prostate-mri-lesions-100610749","NCT07231627","AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions","A Prospective Randomized Phase I\u002FII Study of Artificial Intelligence Algorithm-Informed Biopsy for Detection of Prostate Cancer in Patients With Indeterminate and Low-risk Prostate MRI Lesions","Inclusion Criteria:\n\n1. 40 years of age or older.\n2. A recent pMRI performed within last 12 weeks\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n4. Any patient with PIRADS 3 lesions per pMRI, AND elevated PSA (\"=\\> 3.0 ng\u002Fml\" for patients between 40 and 75 years old, and \"=\\> 4.0 ng\u002Fml\" for the patients older than 75 years).\n5. Patients with PIRADS 1-2 lesions per pMRI, AND elevated PSA (\"=\\> 3.0 ng\u002Fml\" for patients between 40 and 75 years old, and \"=\\> 4.0 ng\u002Fml\" for the patients older than 75 years), AND at least one of the following:\n\n   1. High PSA density (0.15 ng\u002Fml\u002Fg or higher),\n   2. suspicious DRE,\n   3. a positive\u002Fhigh-risk blood or urine biomarker test,\n   4. high-risk ancestry (Black\u002FAfrican American),\n   5. those with germline mutations that increase the risk for prostate cancer,\n   6. significant personal medical history,\n   7. significant family history,\n   8. persistent and significant increase in PSA levels (persistently elevated PSA for at least 12 months with an increase of at least 100% or more within 24 months, last level confirmed twice).\n\nExclusion Criteria:\n\n1. Patients younger than 18 years old.\n2. Any patient with PIRADS 4-5 lesion per pMRI.\n3. Any patient with known csPCa (GS ≥7 (3+4)) per biopsy.\n4. Any patient with PCa and managed with active surveillance, surgery or radiation.\n\n   a. (Patients who never scanned with pMRI before, had GS 6 (3+3) PCa only per systematic biopsy, and currently need confirmatory prostate biopsy will be allowed to enroll in the trial).\n5. Medically unfit for anesthesia.\n6. Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions.\n7. Any medical history preventing pMRI or prostate biopsy.\n8. Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas.\n9. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.\n\nInclusion of Women and Minorities: All participants will be men without previous diagnosis for PCa. Men of all ethnic groups and races are eligible for the study. Thus, women will not be included in this study.","MALE","40 Years",{"count":85,"type":22},50,[25],"Use of AI algorithm for PCa detection is feasible, and AI-informed biopsies (AI-targeted and perilesional biopsy) improves csPCa detection in patients with indeterminate MRI lesions and in patients with low-risk MRI lesions and high-risk clinical features.",[89],"Prostate Cancer","2026-06-22",{"date":34,"type":37},{"date":93,"type":22},"2026-06",{"date":95,"type":22},"2029-01",{"name":43,"class":44},1,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":16,"sex":53,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":97},"100551063","the-community-garden-health-block-100551063","NCT06455215","The Community Garden Health Block","Inclusion Criteria:\n\n1. Arkansas resident aged 18-95;\n2. live in community within 1 mile radius of a participating garden;\n3. speak English;\n4. willingness to participate in the garden as a volunteer during the study intervention period;\n5. not previously participated in the garden as a volunteer in past 6 months;\n6. scores as food insecure on 1 of any of the food security measures (i.e. food did not last, could not eat balanced meal, cut the size or skip meals and frequency at which this happens, eat less than you think you should, were hungry but did not eat);\n7. written informed consent;\n8. working phone, home address, and email;\n\n10\\) willingness to complete all survey assessments.\n\nExclusion Criteria:\n\n* Does not live within 1 mile radius of a participating garden.","18 Years","95 Years",{"count":107,"type":22},138,[25],"The goals of this community-based clinical trial are to examine the association between community garden participation and 1) fruit and vegetable intake (primary outcome) and 2) access to healthy food (secondary outcome) among adults aged 18-95 living in low resource communities. Gardens will be randomized to the intervention (n=4 gardens) or control group (delayed intervention, n=3 gardens). Participants will be assigned to one of seven community gardens to receive an 8-week intervention. During the intervention, participants will be asked to volunteer in the garden, participate in garden social activities, participate in healthy cooking demonstrations and educational sessions. Participants will receive educational materials as well. To assess the effects of the intervention, participants will receive a baseline, 8-week, and 6-month survey. Outcome measures will be compared between the intervention and control groups.",[111],"Fruit and Vegetable Consumption",[113],"food security, community gardens, fruit\u002Fvegetable consumption",{"date":66,"type":37},{"date":116,"type":37},"2025-07-15",{"date":118,"type":22},"2028-03-01",{"name":43,"class":44},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":82,"minAge":104,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":141,"locationsCount":4},"100610163","phase-2-low-dose-naltrexone-ldn-for-management-of-fatigue-in-prostate-cancer-patients-on-androgen-deprivation-therapy-adt-100610163","NCT07224009","Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)","Phase II Clinical Trial Evaluating the Safety and Efficacy of Low Dose Naltrexone (LDN) for the Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)","Inclusion Criteria\n\n* Histologically or cytologically confirmed biochemical recurrence and on ADT for at least 3 months. Metastatic castrate-sensitive and castrate-resistant prostate cancer on ADT with or without novel hormonal therapy like apalutamide, darolutamide, enzalutamide and abiraterone.\n* Initiation of hormonal ablative therapy within 3 months of registration.\n* ECOG performance status \\\u003C3.\n* Patients must have normal organ and marrow function as defined below:\n\n  * leukocytes \\>3,000\u002FμL\n  * absolute neutrophil count \\>1,500\u002FμL\n  * platelets \\>100,000\u002FμL\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal\n  * creatinine ≤2.5.0\n  * left ventricular ejection fraction \\>45%\n  * FACIT-F score \\\u003C 43 on screening\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Prior chemotherapy received in the last three months.\n* Patients currently on PARP inhibitors.\n* Currently taking or have taken within 10 days of enrollment.\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Naltrexone or other agents used in the study.\n* History of other malignancies other than nonmelanoma skin cancer, unless in complete remission and off therapy for that disease for at least 5 years.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Any Patient with acute hepatitis and liver failure are excluded.",{"count":128,"type":22},60,[130],"PHASE2","The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.",[133],"Metastatic Prostate Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":137,"type":37},"2026-06-17",{"date":139,"type":22},"2026-07",{"date":95,"type":22},{"name":43,"class":44},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":16,"sex":53,"minAge":104,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":97},"100192135","in-vivo-real-time-detection-of-circulating-melanoma-cells-100192135","NCT01776905","In Vivo Real-time Detection of Circulating Melanoma Cells","Inclusion Criteria:\n\n* Age 18 to 80 years\n* Histological documented diagnosis of melanoma\n* Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)\n* Must be able to sit still for 90 minutes\n\nExclusion Criteria:\n\n* Active infection\n* Current and significant medical or surgical condition as determined by the Investigator\n* Diagnosis or evidence of organic brain syndrome\n* Pregnancy or breastfeeding","80 Years",{"count":150,"type":22},75,"OBSERVATIONAL","The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.",[154],"Melanoma",[154,156],"Cancer","2026-06-15",{"date":137,"type":37},{"date":160,"type":37},"2013-02",{"date":162,"type":22},"2027-07",{"name":43,"class":44},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":53,"minAge":83,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":97},"100619190","essential-amino-acid-supplementation-in-adult-spinal-deformity-patients-100619190","NCT07341399","Essential Amino Acid Supplementation in Adult Spinal Deformity Patients","Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery","Inclusion Criteria:\n\n* Males and Females, 40 to 65 years old\n* Diagnosed with adult spinal deformity\n* Scheduled for ASD corrective procedure at UAMS (\\>2 weeks prior to surgery)\n* Live near Little Rock and scheduled to attend physical therapy in Little Rock\n* COVID-19 negative and\u002F or asymptomatic\n\nExclusion Criteria:\n\n* Subject who does not\u002Fwill not eat animal protein sources.\n* Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I\u002FII diabetes mellitus).\n* Currently pregnant.\n* Gave birth or was lactating within previous 12 months.\n* History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.\n* Clinically significant weight gain or loss (\\>5% change) in the last 12 months.\n* Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin).\n* Diagnosis of autoimmune disease\n* Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.\n* Diagnosis of muscular degenerative\u002Fdystrophy disease\n* Unwilling to fast overnight.\n* Unwilling to avoid using other protein or amino-acid supplements during participation.","65 Years",{"count":173,"type":22},20,[25],"This will be a randomized double-blind placebo controlled clinical trial to determine if supplementing with essential amino acids (EAAs) for two weeks prior to, and 3 months after corrective spinal surgery in adults with spinal deformity can stimulate greater muscle protein turnover and whole-body protein balance, and enhance recovery after surgery when compared to a calorie matched placebo.",[177],"Adult Spinal Deformity",[179,180],"essential amino acids","protein balance","2026-06-10",{"date":183,"type":37},"2026-06-12",{"date":185,"type":22},"2026-07-01",{"date":187,"type":22},"2027-05-15",{"name":43,"class":44},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100634397","phase-1-intratumoral-mmr-vaccine-injection-in-borderline-resectableunresectable-pancreatic-cancer-100634397","NCT07539155","Intratumoral MMR Vaccine Injection in Borderline Resectable\u002FUnresectable Pancreatic Cancer","Phase 1b\u002F2 Study of Intratumoral MMR Vaccine Injection in Borderline Resectable\u002FUnresectable Pancreatic Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Pathologically proven locally advanced adenocarcinoma of pancreas.\n3. Borderline resectable pancreatic cancer that is determined to be unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:\n\n   1. Encasement of gastroduodenal artery up to the common hepatic artery\u002Fshort segment encasement or abutment of the hepatic artery, but without extension to the celiac trunk.\n   2. Venous involvement of SMV or portal vein, less than 180 degrees.\n   3. Tumor abutment of SMA, less than half the circumference of the vessel wall. OR\n\n      Unresectable pancreatic cancer that remains unresectable following completion of SoC chemotherapy and RT as evidenced by any of the following:\n   4. Greater than 180-degree encasement or occlusion\u002Fthrombus of SMA, unresectable SMV, or SMV-portal confluence occlusion.\n   5. Direct involvement of inferior vena cava, aorta, celiac trunk, or hepatic artery, as defined by the absence of fat plane between low-density tumor and these structures on CT scan.\n\n   OR Surgeon deems that the pancreatic cancer is unresectable.\n4. Prior history of treatment with chemotherapy (e.g., FOLFIRINOX, Gemcitabine + Abraxane or NALIRIFOX \\[liposomal irinotecan (Nal-IRI or Onivyde®), Nab Paclitaxel, 5 fluorouracil (5-FU)\u002Fleucovorin and oxaliplatin\\]) and RT. The chemotherapy regimen is per treating physician's choice. The chemotherapy agent for radio sensitization is up to the treating physician (capecitabine, 5FU or gemcitabine).\n\n   a. The chemo-radiation therapy regimen should be completed at least 6 weeks but no more than 12 weeks from planned Day 1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Adequate hematological function (Hemoglobin \\> 9g\u002FdL, White Blood Cell (WBC) count \\> 1500 K\u002FµL, Absolute Neutrophil Count (ANC) \\> 500 K\u002FµL, Platelet count \\> 100 K\u002FµL).\n7. Adequate hepatic function (Total bilirubin ≤ 1.5 x institutional upper limit of normal \\[ULN\\]) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 × ULN, subject is eligible); Aspartate aminotransferase (AST\\[SGOT\\]) or Alanine aminotransferase (ALT\\[SGPT\\]) ≤ 2.5 × institutional ULN; Serum albumin ≥ 3.0 g\u002FdL.\n8. Adequate renal function (i.e., creatinine less than 1.5 times ULN).\n\nExclusion Criteria:\n\n1. Pancreatic cancer that was either resectable before SoC treatment or became resectable following SoC chemotherapy and RT.\n2. Subjects with radiographically proven metastatic disease are excluded.\n3. Subject must not be pregnant and\u002For currently breastfeeding or plan to be.\n4. Subject must not have received any live vaccine, including MMR, within 30 days prior to the dose of study drug.\n5. Subject must not have treatment with any anti-cancer therapy including chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy, including targeted small molecule agents, within 5 half-lives (or 2 weeks if half-life is unknown) prior to day 1.\n6. Subject has no unresolved toxicities, AEs ≥ Grade 2 (NCI CTCAE version 5.0), from prior anticancer therapy.\n7. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.",{"count":173,"type":22},[198,130],"PHASE1","By doing this study, it is the hope to learn whether an injection of the measles, mumps, rubella (MMR) vaccine developed by Merck \\& Co. (Merck's M-M-R® II) into the tumor is safe and effective in making the tumor smaller.",[201,202],"Borderline Resectable\u002FUnresectable Pancreatic Cancer","Non Metastatic Pancreatic Cancer",[204,205,206,207,208],"MMR","Borderline Resectable","Borderline Unresectable","Pancreatic Cancer","Non-Metastatic","2026-06-09",{"date":181,"type":37},{"date":212,"type":22},"2026-08",{"date":214,"type":22},"2028-08",{"name":43,"class":44},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":97},"100552746","rfa-using-multi-tined-electrodes-vstraditional-electrodes-for-lumbar-spondylosis-100552746","NCT06477094","RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis","Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis","Inclusion Criteria:\n\n1. Greater than 18 years of age\n2. Presenting with chronic non-radicular lower back pain\n3. Failure of conservative treatment such as physical therapy or NSAID usage\n4. Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with \\>80% pain relief\n\nExclusion Criteria:\n\n1. History of known coagulopathy\n2. \\> 3 American Society of Anesthesiologists Classification\n3. Pregnancy\n4. Spinal hardware between L3 and S1\n5. Allergies to injection medications\n6. English illiteracy\n7. Pain improvement following physical therapy or NSAID usage\n8. Previous history of attempted lumbar RFA",{"count":7,"type":22},[25],"Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. The current standard of care in patients diagnosed with spondylosis in the lower back is to perform a radiofrequency ablation (RFA) of the lumbar medial branch nerves which carry the pain signals from that region to the brain. RFA accomplishes this by using radio waves transmitted through inserted electrodes. This leads to a temporary lesion or \"burn\"; stopping the pain signals from being transmitted as as well as changing the pain signals themselves. The electrodes themselves do not heat up but instead cause ions in the surrounding tissue to vibrate and heat up. When performing the procedure at the UAMS pain clinic, one can use the Stryker system with a single electrode end which protrudes out of the cannula or the Stratus Nimbus electrode with two prongs which expand in a \"V\"; formation along the sides of the cannula. While testing in chicken tissue shows that the latter electrode type produces a larger lesion size, anecdotal evidence suggests that it may lead to longer term pain relief. As such, the choice is currently left up to physician preference as both are FDA approved for use in this condition. This study is trying to assess if the larger lesion size results in a reduction in impairment of activities of daily living due to pain measured by the patient-reported PROMIS (Patient Reported Measurement Information System)-29 questionnaire. The PROMIS-29 is given to all patients who are seen in the UAMS Pain Clinic at initial and follow-up visits. In this study we would like to randomize what electrode and cannula set is used in RFA for patient's who are already going to be receiving the procedure for treatment for their spondylosis. The study team would then compare the PROMIS outcomes between cases that used the Stryker and Stratus Nimbus electrodes at 1,3,6,9 and 12 months. It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.",[227],"Lumbar Spondylosis",[229,230,227],"Radiofrequency Ablation","Lower Back Pain","2026-06-04",{"date":233,"type":37},"2026-06-08",{"date":235,"type":37},"2024-08-09",{"date":237,"type":22},"2027-09-30",{"name":43,"class":44},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":53,"minAge":83,"maxAge":171,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":97},"100518034","effects-of-lean-pork-loin-intake-on-protein-homeostasis-and-glucose-regulation-in-prediabetic-adults-100518034","NCT06025292","Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults","PORK","Inclusion Criteria:\n\n* 1\\. Males and females ages 40-65 years.\n* 2\\. BMI 25 to ≤40 kg\u002Fm2 (or body fat % ≥25% in males or ≥36% in females)\n* 3\\. Capable of providing informed consent.\n* 4\\. COVID-19 negative and\u002For asymptomatic.\n* 5\\. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period\n* 6\\. HbA1c: 5.7-6.4% or fasting glucose 100-125 mg\u002FdL\n\nExclusion Criteria:\n\n* 1\\. Participant who does not\u002Fwill not eat animal protein sources.\n* 2\\. Allergy to wheat, soy, or common ingredients in plant-based protein products.\n* 3\\. Body mass index \\\u003C25 kg\u002Fm2 or \\>40 kg\u002Fm2.\n* 4\\. Hemoglobin \\\u003C10g\u002FdL at screening.\n* 5\\. Platelets \\\u003C150,000\u002FuL at screening.\n* 6\\. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.\n* 7\\. History of gastrointestinal bypass\u002Freduction surgery.\n* 8\\. Pregnant or lactating individuals.\n* 9\\. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)\n* 10\\. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.\n* 11\\. Currently using prescription blood thinning medications.\n* 12\\. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).\n* 13\\. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.\n* 14\\. Unwilling to avoid using protein or amino-acid supplements during participation.\n* 15\\. Unwilling to fast overnight.\n* 16\\. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.\n* 17\\. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for \\\u003C1 month or with less than one treatment dose (injection) every two weeks",{"count":173,"type":22},[25],"We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.",[250,251],"Hyperglycaemia (Non Diabetic)","Prediabetes",[253,254,255,256],"Lean pork","Muscle Protein Synthesis","Protein","Plant-Based",{"date":233,"type":37},{"date":259,"type":37},"2024-09-11",{"date":261,"type":22},"2027-01-31",{"name":43,"class":44},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":281,"leadSponsor":283,"locationsCount":97},"100598459","improving-outcomes-for-early-postpartum-mothers-in-outpatient-moud-treatment-100598459","NCT07071766","Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment","Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder","Inclusion Criteria:\n\n* 18 years or older\n* Understand and speak English\n* Able to give informed consent\n* Receiving medications for opioid use disorder in the outpatient clinical setting\n* Between 28 weeks gestation and up to 12 months postpartum\n\nExclusion Criteria:\n\n* Unwilling to consent\n* Before 28 weeks gestation and beyond 12 months postpartum at enrollment",{"count":55,"type":22},[25],"Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Medications for opioid use disorder (MOUD; e.g., methadone or buprenorphine) are the recommended standard of care for perinatal women with OUD. Studies indicate that 50-60% of perinatal women with OUD initiate medications during pregnancy; however, over half will prematurely discontinue treatment within the first six months of childbirth due to stressors experienced in the postpartum period. Common stressors that contribute to MOUD treatment discontinuation in this population are return to opioid use, mental health symptoms including depression, parenting-related stressors such as challenges in infant care and bonding, Neonatal Abstinence Syndrome (NAS), child welfare involvement, and feelings of guilt, shame, and stigma. Thus, there is an urgent need to develop effective, recovery-oriented support interventions that promote the initiation and continuity of MOUD treatment in the postpartum period. The current study utilizes community-engaged research methods to identify and prioritize the early parenting-related needs of postpartum women receiving MOUD to inform the adaptation and implementation of an evidence-based parenting intervention for this population receiving outpatient treatment for opioid use disorder.",[274,275,276],"Substance Use Treatment","Perinatal Substance Use","Parenting","2026-06-02",{"date":279,"type":37},"2026-06-03",{"date":185,"type":22},{"date":282,"type":22},"2027-06-30",{"name":43,"class":44},{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":97},"100540181","phase-1-high-dose-ascorbic-acid-hdaa-in-patients-with-plasma-cell-disorders-100540181","NCT06313502","High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders","Inclusion Criteria:\n\n1. Subject has provided informed consent.\n2. Participants who are 18 years of age or older\n3. Subjects who have been previously treated with 3 or more lines of therapy (i.e., proteasome inhibitors, immunomodulatory agents such as lenalidomide, and monoclonal antibodies such as daratumumab) and have progressed within past 6 months.\n4. Subjects who have at least 1x106\u002Fkg CD34 stem cells in storage\n5. Subjects must have measurable disease (as determined by the UAMS clinical lab), including at least one of the criteria below. Tests performed as SOC within 30 days of the first dose may be utilized:\n\n   * M-protein quantities ≥ 0.5 gm\u002Fdl by SPEP\n   * ≥ 200 mg\u002F24-hour urine collection by UPEP\n   * serum-free light chain levels \\> 100 mg\u002FL (milligrams\u002Fliter involved light chain) and an abnormal kappa\u002Flambda (κ\u002Fλ) ratio in subjects without detectable serum or urine m-protein\n   * a serum IgA level ≥ 500 mg\u002FdL for subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement\n   * Non-secretory subjects are eligible provided the subject has \\> 20% BM plasmacytosis, OR multiple plasmacytomas or lesions (≥3) on MRI at the time of diagnosis or study enrollment, OR the presence of lesions (≥ 3) on PET\u002FComputerized Tomography (CT) scan.\n6. Adequate organ function reflects the following:\n\n   * Absolute neutrophil count (ANC) ≥ 0.5 x 109\u002FL without growth factor support for 7 days (14 days if pegfilgastrim).\n   * Platelets ≥ 25 x 109\u002FL without transfusion for 7 days. However, subject can be enrolled if the ANC and platelets are low due to disease\n   * Potassium within normal limits or correctable with supplements\n   * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)\n   * Serum bilirubin ≤ 1.5 x ULN\n   * Estimated serum creatinine clearance of ≥ 45 mL\u002Fmin using the Cockcroft-Gault equation or directly calculated from the 24-hour urine collection method\n   * International normalized ratio (INR) \\\u003C 1.5 x ULN and partial thromboplastin time \\\u003C 1.5 x ULN\n   * Ejection fraction by ECHO or MUGA of ≥ 40% performed\n   * Subjects must have adequate pulmonary function studies (PFTs) \\> 50% of predicted on mechanical aspects (forced expiratory volume, forced vital capacity) and \\> 50% of predicted (adjusted for hemoglobin) on diffusion capacity. If the participant is unable to complete PFTs due to disease-related pain or other circumstances that make it difficult to reliably perform PFTs, documentation of pulmonary function adequate for transplant will occur via a CT scan without evidence of major pulmonary disease and arterial blood gas results.\n7. Subjects must have a performance status of 0-2 based on ECOG performance criteria. Subjects with poor performance status (3-4) based solely on bone pain will be eligible if there is documentation to verify this.\n8. Negative serum or urine pregnancy test (sensitivity of at least 25 mIU\u002FmL) at screening.\n\nExclusion Criteria:\n\n1. Prior allogeneic transplant.\n2. Known hypersensitivity or allergy to ascorbic acid or melphalan, or any Grade 3 or higher AE as a result of test dose given during screening (15 gm).\n3. Subjects must not have a concurrent malignancy unless it can be adequately treated by non-chemotherapeutic intervention. Participants may have a history of prior malignancy without any chemotherapy within 365 days of study entry AND life expectancy exceeding 5 years at the time of study entry.\n4. Subjects must not have life-threatening comorbidities as assessed by the investigator.\n5. History or evidence of MM associated with immunodeficiency states (e.g., hereditary immune deficiency, human immunodeficiency virus (HIV), organ transplant, or leukemia).\n6. Known HIV disease (requires negative test for clinically suspected HIV infection).\n7. Evidence of CNS myeloma.\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recent (within 6 months) myocardial infarction, uncontrolled or symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension on appropriate therapy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n9. Concurrent use of coumadin (warfarin).\n10. Glucose-6-phosphate dehydrogenase deficiency as defined by blood test at screening visit.\n11. Pre-existing renal insufficiency or renal failure, a known history of renal stones, or who are undergoing dialysis.\n12. Diabetic subjects who are insulin dependent.\n13. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study.","100 Years",{"count":292,"type":22},18,[198],"The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg\u002Fm2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg\u002Fm2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerability\n\nPrimary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).\n\nSecondary Objectives\n\nObjectives:\n\n1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects.\n2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status.\n3. Categorize and quantify adverse events compared to historical control.\n4. Determine quality of life parameters using standardized health-related quality of life measures\n5. Determine oxidative stress parameters in plasma during treatment.",[296],"Plasma Cell Disorder",{"date":231,"type":37},{"date":299,"type":37},"2024-07-19",{"date":301,"type":22},"2028-04",{"name":43,"class":44},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":97},"100634396","the-hvip-community-model-100634396","NCT07539142","The HVIP+ Community Model","The HVIP+ Community Model: A Community Violence Prevention Program in a Southern State","Inclusion Criteria:\n\n* Be at least 18 years of age or older\n* Currently live in Central Arkansas\n* Currently being treated for a penetrating gun assault injury at a local hospital\n\nExclusion Criteria:\n\nParticipants must not:\n\n* Report any medical problems that would limit their ability to express thoughts and answer questions (i.e. active intoxication, developmental delays, dementia, psychosis, etc.)\n* Be currently under arrest or in police custody",{"count":311,"type":22},208,[25],"The present study will use an optimization randomized control trial design to test the preliminary efficacy of a Hospital-based Violence Intervention Program (HVIP) in Central Arkansas.",[315,316,317],"Hospital-based Violence Intervention","Community Firearm Violence","Firearm Behaviors","2026-06-01",{"date":277,"type":37},{"date":321,"type":37},"2026-04-20",{"date":323,"type":22},"2028-06",{"name":43,"class":44},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":16,"sex":53,"minAge":331,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":97},"100502551","effects-of-collagen-peptide-supplementation-on-connective-tissue-remodeling-functional-outcomes-and-wound-healing-after-total-knee-arthroplasty-tka-100502551","NCT05823727","Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n* Males and Females, 50 to 75 years old\n* With a body mass index of 20.0 to 39.9 kg\u002Fm2\n* Diagnosed with primary osteoarthritis\n* Scheduled for a TKA at UAMS (two months prior to surgery) at UAMS\n* Live near Little Rock and scheduled to attend physical therapy in Little Rock\n* COVID-19 negative and\u002For asymptomatic.\n\nExclusion Criteria:\n\n* Previously sustained serious knee injury or surgery to ACL in TKA knee\n* Females not postmenopausal\n* Having undergone hormone replacement therapy in the last 12 months.\n* Active diagnosis of blood borne infectious disease","50 Years","75 Years",{"count":334,"type":22},44,[25],"Recruiting will be performed via checking the calendar for scheduled TKA procedures in the \\> 8 weeks by clinical staff in the UAMS orthopedic clinic. Clinic staff will look for basic inclusion\u002Fexclusion criteria in the EMR for those patients. Clinic staff will either contact directly or send contact information to the PI of this study to contact for recruitment purposes. During the initial phone call, study staff will review inclusion\u002Fexclusion criteria to verify eligibility and will discuss study specifics and send a link to the current informed consent form located on the UAMS REDCap server. If the subject wishes to enroll, they will do so via electronic consent through REDCap. REDCap will notify study staff that the consent was signed, then study staff will schedule initial baseline study visit.\n\nVisit 1 and Visit 2 will take place at the RIOA at week 0 and week 24, respectively. Participants will report having fasted overnight, and having abstained from alcohol for 24 hours, vigorous exercise for 24 hours, and caffeine for 12 hours. A blood sample will be drawn upon arrival, followed by a DXA scan to measured bone mineral density (BMD) in both hips and lumbar spine, and for body composition, using CTRAL equipment. Participants will also undergo a body water assessment using BIA to determine deuterium dose. Bilateral handgrip strength will be measured via Dynamometer. Participants will fill out a 3-Day food log, physical activity questionnaire, pain scale, KOOS, VR-12, and the POMS. Participants will be given an 8-week supply of their respective treatment supplement, with instructions and a compliance log (to be filled out monthly). Participants will also be given their dose of deuterium oxide (D2O) to be ingested according to instruction at week 2\\&3, prior to TKA (week 4).\n\nTissue samples for ACL, bone fragments, and synovial fluid will be collected by the PI during TKA surgery. All other assessments will be taken during clinical visits with the participant's physical therapists and their orthopedic doctors. The PI will attend some of these visits to assess wound healing, administer handgrip strength assessment, and to replenish participant treatment supply.",[338],"Knee Osteoarthritis",[340],"collagen peptides, TKA, osteoarthritis, connective tissue","2026-05-26",{"date":343,"type":37},"2026-05-27",{"date":345,"type":37},"2026-05-01",{"date":347,"type":22},"2027-06-01",{"name":43,"class":44},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":16,"sex":53,"minAge":356,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":97},"100484855","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-alaska-100484855","NCT05593484","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska","North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska","Inclusion Criteria:\n\n* Enrolled in one of the participating schools in the 3 regions\n* Children from grades (K-12) that are typically screened within participating schools\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\nN\u002FA","3 Years","21 Years",{"count":359,"type":22},8060,[25],"The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments.\n\nWe will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school.\n\nThis stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \\~2,015 K-12 students\u002Fyear). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.\n\nTimeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.",[363],"Hearing Loss",[365,366,367,368,369,370,371],"Rural","Hearing loss","Telemedicine","Telehealth","School","Disparities","Screening","2026-05-04",{"date":374,"type":37},"2026-05-06",{"date":376,"type":37},"2023-09-01",{"date":282,"type":22},{"name":43,"class":44},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":16,"sex":53,"minAge":356,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":97},"100478735","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-kentucky-100478735","NCT05513833","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky","Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial","Inclusion Criteria:\n\n* Enrolled in school in one of the 14 participating counties\n* Initial entry into elementary school\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\n• N\u002FA","11 Years",{"count":388,"type":22},18000,[25],"This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.",[363],[365,393,394,395,396,397,398,399],"hearing","loss","telemedicine","telehealth","school","disparities","screening",{"date":374,"type":37},{"date":402,"type":37},"2022-09-01",{"date":282,"type":22},{"name":43,"class":44},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100636970","community-health-worker-assessment-for-postpartum-health-100636970","NCT07572604","Community Health Worker Assessment for Postpartum Health","Community Health Worker Assessment for Postpartum Health (CAREPATH)","CAREPATH","Inclusion Criteria:\n\n* Age 16-44 years old\n* ≤ 38 weeks pregnant\n* Ability to speak English, Spanish or Marshallese\n\nExclusion Criteria:\n\n* Type 1 diabetes on an insulin pump followed closely by endocrinology\n* Uncontrolled Type 2 diabetes\n* End stage renal disease followed closely by nephrology\n* ICU admission at any point during pregnancy or delivery hospitalization\n* Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy\u002Fappendectomy)\n* Incarceration\n* Mental disability limiting decision-making capacity\n* Uncontrolled chronic hypertension\n* HELLP syndrome during pregnancy\n* Sickle cell disease\n* Maternal heart condition or heart disease\n* Opioid use disorder\n* Lupus\n* Thrombophilia or blood clots\n* Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum",{"count":414,"type":22},500,[25],"The goal of this randomized controlled trial is to compare the CAREPATH intervention with standard of care on postpartum outcomes among up to 500 postpartum individuals. The CAREPATH includes 3 postpartum telehealth visits from a perinatal CHW.\n\nThe study will address the following aims:\n\nAim 1: Compare: A) CARE PATH and B) standard of care among postpartum individuals on:\n\nAim 1.A: postpartum visit completion.\n\n* Hypothesis 1.A: Patients assigned to the CARE PATH will have higher completion of their postpartum visit compared to those receiving standard of care.\n\nAim 1.B: early detection of postpartum complications.\n\n* Hypothesis 1.B: Patients assigned to the CARE PATH will be more likely to experience early detection of postpartum complications that arise compared to those receiving standard of care.\n\nAim 1.C: hospital readmission and ED visits postpartum.\n\n* Hypothesis 1.C: Patients assigned to the CARE PATH will be less likely to have hospital readmission or an ED visit compared to those receiving standard of care.\n\nAim 2: Explore the impact of A) CARE PATH and B) standard of care on reproductive life planning\u002Fcontraceptive counseling.\n\n* Hypothesis 2: Patients assigned to the CARE PATH will be more likely to report reproductive life planning\u002Fcontraceptive counseling.",[418,419],"Postpartum Complication","Health Care Seeking Behavior",[421,422,423],"Postpartum visit","Postpartum care","Postpartum complications",{"date":425,"type":37},"2026-05-07",{"date":185,"type":22},{"date":428,"type":22},"2029-08-31",{"name":43,"class":44},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":97},"100473120","using-virtual-reality-technology-to-improve-patient-experience-and-quality-of-care-during-brachytherapy-100473120","NCT05440760","Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy","Inclusion Criteria:\n\n* Female, ≥ 18 years of age\n* Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy\n* Able to provide written consent\n\nExclusion Criteria:\n\n* Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound\n* History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras\n* Known history of elevated intraocular pressure\n* Claustrophobia, thalassophobia, cleithrophobia or similar phobias\n* Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen",{"count":173,"type":22},[25],"The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.\n\nThe secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural\u002Facute pain, and need for analgesics or anxiolytics.",[440],"Endocervical Cancer",[442,443],"Brachytherapy","Virtual Reality","2026-04-24",{"date":446,"type":37},"2026-04-30",{"date":448,"type":37},"2022-08-08",{"date":450,"type":22},"2028-12",{"name":43,"class":44},{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":16,"sex":53,"minAge":357,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":97},"100543036","quit-and-screen-project-100543036","NCT06350643","Quit and Screen Project","The Quit and Screen Project","Inclusion Criteria:\n\n* Current National Medical Association (NMA) member\n* Serves a patient clientele who smokes\n* At least 20% of time (1 day per week) devoted to clinical care\n* Currently screens clients for tobacco use in the clinic\n* Have the capacity to refer smokers to a patient navigator\n* Willing to provide informed consent\n* Will provide contact email, address and phone.\n\nExclusion Criteria:\n\n* None","85 Years",{"count":461,"type":22},300,[25],"The Quit and Screen Project seeks to engage healthcare providers in helping adults who smoke to quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic diseases.\n\nThe goal of this clinical trial is to test the feasibility and impact of the Quit and Screen Project alone versus the G02 (Global Knowledge Center for Lung Cancer) Lung Cancer Screening training + the Quit and Screen Project training modules on changes in provider knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes.",[465,466,467],"Knowledge","Attitudes","Behavioral Intention","2026-04-08",{"date":470,"type":37},"2026-04-13",{"date":472,"type":22},"2026-09-01",{"date":474,"type":22},"2027-04",{"name":43,"class":44},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":53,"minAge":331,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":97},"100569431","whey-protein-ingestion-and-glucose-control-in-pre--and-post-diabetic-individuals-100569431","NCT06694155","Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals","DAIRY","Inclusion Criteria:\n\n1. Males and females ages 50-70 years.\n2. Body mass index between 25-45 kg\u002Fm2\n3. Capable of providing informed consent.\n4. COVID-19 negative and\u002For asymptomatic.\n5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.\n6. HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg\u002FdL\n\nExclusion Criteria:\n\n1. Subject who does not\u002Fwill not eat dairy protein sources.\n2. Subjects taking exogenous insulin injections or GLP \u002FGIP injections or other appetite suppressants.\n3. Unwilling to keep a detailed 7 day food journal on two occasions\n4. Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.\n5. Lactose intolerance.\n6. Hemoglobin \\\u003C10g\u002FdL at screening.\n7. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.\n8. History of gastrointestinal bypass\u002Freduction surgery.\n9. Pregnant or lactating individuals.\n10. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)\n11. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.\n12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).\n13. Unwilling to avoid using protein or amino-acid supplements during participation.\n14. Unwilling to fast overnight.\n15. Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.","70 Years",{"count":485,"type":22},40,[25],"To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals",[489],"Prediabetes \u002F Type 2 Diabetes",[491,492,493,494],"Whey Protein","type II diabetes","Protein turnover","Dietary intake","2026-04-03",{"date":497,"type":37},"2026-04-06",{"date":499,"type":37},"2025-01-15",{"date":501,"type":22},"2027-03-01",{"name":43,"class":44},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":290,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100512475","phase-2-candida-therapeutic-vaccine-in-head-and-neck-cancer-patients-to-reduce-recurrence-100512475","NCT05952934","Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence","A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence","Inclusion Criteria:\n\n* Able to provide informed consent\n* Male or female 18 years of age or older\n* Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and\u002For radiation and\u002For chemotherapy and\u002For immunotherapy) within the 120 days prior to the screening visit\n* No Evidence of Disease (NED) based on clinical and radiographic evaluations\n* Willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Positive urine pregnancy test for women of childbearing potential\n* Being pregnant or attempting to be pregnant with the period of study participation\n* Women who are breast feeding or plan to breast feed within the period of study participation\n* Patients who are allergic to Candin®\n* If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study",{"count":511,"type":22},100,[130],"This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.",[515],"Squamous Cell Carcinoma of Head and Neck","2026-04-02",{"date":468,"type":37},{"date":519,"type":37},"2024-02-12",{"date":521,"type":22},"2031-07-31",{"name":43,"class":44},6,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":104,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":97},"100173348","phase-2-solifenacin-compared-to-clonidine-for-reducing-hot-flashes-among-breast-cancer-patients-100173348","NCT01530373","Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients","A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy","Inclusion Criteria:\n\n* Women with a history of invasive breast cancer or DCIS\n* Currently taking aromatase inhibitors or tamoxifen\n* Not receiving hormone replacement therapy for minimum of one month\n* Age 18 years or older\n* Self-reported hot flashes at least fourteen times per week\n* Self-reported hot flashes for at least one month\n* If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.\n\nExclusion Criteria:\n\n* Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.\n* Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)\n* History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record\n* Concurrent or planned chemotherapy or radiotherapy (within next 3 months)\n* Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.\n* Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).\n* Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \\& physical exam and medical record)\n* Hypotension or uncontrolled hypertension (160\u002F95 \\> BP \\\u003C 100\u002F60)\n* Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \\& physical and medical record)\n* History of allergy or adverse reactions to clonidine or solifenacin\n* ECOG status \\> 2 (in bed more than 50% of day)",{"count":532,"type":22},110,[130],"Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).",[536,537],"Hot Flashes","Breast Cancer",[539,540,541,542,543,544],"hot flashes","breast cancer","aromatase inhibitors","solifenacin","clonidine","quality of life","2026-03-03",{"date":547,"type":37},"2026-03-05",{"date":549,"type":4},"2012-02",{"date":551,"type":22},"2028-09",{"name":43,"class":44},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":332,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":575,"leadSponsor":577,"locationsCount":97},"100595232","phase-2-mmulti-immune-hr-multi-target-immunotherapy-for-high-risk-multiple-myeloma-100595232","NCT07029776","MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma","A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)","Inclusion Criteria:\n\n* Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of PD requiring initiation of treatment.\n* Patients must be either untreated or have not received more than two months of MM therapy. However, bisphosphonates and localized radiation are allowed.\n* Patients must have clinical features of high-risk disease, at time of initial diagnosis or initial assessment prior to enrollment, which may include one or more of the following:\n\n  * High-risk cytogenetic abnormalities, including t(4;14), t(14;16), t(14;20), del17p13, del1p, or gain 1q with del1p by FISH, with a cutoff point of 20% or greater.\n  * Beta-2-microglobulin \\>5.5 mg\u002FL with normal kidney function test per the institutional reference.\n  * Presence of extramedullary disease defined as soft tissue plasmacytoma (excluding Paramedullary\u002FParaskeletal plasmacytoma)\n  * ≥ 3 focal lesions on F18-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging\n  * LDH ≥ 360 U\u002FL (Rule out hemolysis and infection; contact Principal Investigator if any doubt.)\n  * Circulating plasma cells ≥5 percent of white blood cells on conventional peripheral blood smear (manual white blood cell differential count) or peripheral blood flow cytometry.\n* ECOG ≤ 2, unless solely due to symptoms of MM-related bone disease.\n* Patients must have a platelet count ≥ 50,000\u002FμL and hemoglobin level of ≥7.5 g\u002Fdl and absolute neutrophilic count (ANC) of 1.0x10\\^9\u002FL unless lower levels are explained by extensive BM plasmacytosis.\n* Patients must be at least 18 years of age and not older than 75 years of age at the time of consent.\n* Patients must have adequate renal function with baseline serum creatinine level \\\u003C 3 mg\u002FdL and estimated creatinine clearance ≥30 mL\u002Fmin. Creatinine clearance may be calculated using Cockcroft-Gault, eGFR (MDRD), or CKD-epi formula and baseline Alanine Aminotransferase (ALT) \\\u003C 3x Upper Limit of Normal (ULN).\n* Patients must have an ejection fraction by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan ≥ 45%\n* Patients must have adequate pulmonary function studies \\> 50% of predicted on mechanical aspects (FEV1, FVC, etc.) and diffusion capacity (DLCO) \\> 50% of predicted. If the patient is unable to complete pulmonary function tests (PFT) due to MM related pain or other conditions, an exception may be granted if the Principal Investigator documents that the patient is a candidate for high dose therapy.\n* Patients must have signed an IRB-approved informed consent form (ICF) indicating their understanding of the proposed treatment and that the protocol has been approved by the IRB.\n* Female subjects must use effective methods of birth control during the course of the study and for 6 months after stopping study medications.\n* Female subjects must not donate eggs during the study and for 6 months after the last dose of study medications.\n* Male subjects must not donate sperm during the study and for 3 months after the last dose of study medications.\n\nExclusion Criteria:\n\n* Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n* Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, low Gleason score prostate cancer on active surveillance or having had surgery\u002Fradiation with curative intent within one year of consent or other cancer for which the patient has not received treatment for one year prior to consent. Other cancers will only be acceptable if the patient's life expectancy exceeds five years.\n* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Or subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Women of childbearing potential (WOCBP) must have a negative pregnancy documented within one week of consent. Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n* Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and patients must be excluded if FEV1 is \\\u003C50% of predicted normal.\n* Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.\n* Active autoimmune disease\n* Active systematic viral, fungal or bacterial infection, requiring systemic therapy.\n* Clinically significant cardiac disease, including Myocardial infarction within 6 months before consent, or Uncontrolled cardiac arrhythmia or unstable or uncontrolled disease\u002Fcondition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class 3-4) (Appendix 1)\n* Patient is:\n\n  * seropositive for human immunodeficiency virus (HIV)\n  * seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]. Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\] must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those with active infection will be excluded. Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.\n  * Seropositive for hepatitis C (except in the setting of a sustained virologic response \\[SVR\\], defined as aviremia at least 12 weeks after completion of antiviral therapy).\n* Patients who received plasmapheresis within 28 days of start of study treatment at Induction with Dara-KRD.\n* Patients with focal radiation therapy within 14 days prior to consent with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.\n* Known history of allergy to Captisol ® (a cyclodextrin derivative used to solubilize carfilzomib).\n* Known history of allergy, hypersensitivity, or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients.\n* Known intolerance or allergy to lenalidomide.",{"count":85,"type":22},[130],"The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).\n\nThe treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.",[564],"Multiple Myeloma (MM)",[566,567,568,569,570,571],"Bispecific Antibodies","High-Risk Newly Diagnosed Multiple Myeloma","Multi-Target Immunotherapy","High-Risk Multiple Myeloma","Teclistamab","Daratumumab","2026-03-02",{"date":545,"type":37},{"date":185,"type":22},{"date":576,"type":22},"2032-04-01",{"name":43,"class":44},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":53,"minAge":104,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":97},"100462414","in-vivo-detection-of-circulating-clots-in-patients-with-thromboembolism-100462414","NCT05301348","In Vivo Detection of Circulating Clots in Patients With Thromboembolism","Inclusion Criteria\n\n* Men and women, 18 years old and older.\n* Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke.\n* Informed consent provided by the subject.\n\nExclusion Criteria\n\n* Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)\n* Acute coronary syndrome (including unstable angina)\n* Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)\n* Intracardiac thrombus\n* Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy\n* Sickle cell disease with vaso-occlusive crisis\n* Sepsis or life-threatening infection\n* Traumatic injury requiring hospitalization (within 30 days prior to enrollment)\n* Pregnancy or breastfeeding\n* Severe mental illness\n* Other conditions deemed by the investigators to put the subject at greater risk",{"count":585,"type":22},30,[25],"Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.",[589],"Thromboembolism","2026-02-18",{"date":592,"type":37},"2026-02-19",{"date":594,"type":37},"2023-07-26",{"date":261,"type":22},{"name":43,"class":44},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":16,"sex":17,"minAge":104,"maxAge":19,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":614,"leadSponsor":616,"locationsCount":523},"100523459","telehealth-multi-component-optional-model-mom-study-100523459","NCT06095960","Telehealth Multi-Component Optional Model (MOM) Study","Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women","Inclusion Criteria:\n\n* Pregnant women between 16-35 weeks gestation\n* Age 18-44 years\n* Ability to speak English, Spanish, or Marshallese\n* Participants may have either a vaginal birth or cesarean section birth\n\nExclusion Criteria:\n\n* Type 1 diabetes on an insulin pump followed closely by endocrinology\n* Uncontrolled Type 2 diabetes\n* End stage renal disease followed closely by nephrology\n* ICU admission at any point during pregnancy or delivery hospitalization\n* Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy\u002Fappendectomy)\n* Incarceration\n* Mental disability limiting decision-making capacity\n* Uncontrolled chronic hypertension\n* HELLP syndrome during pregnancy\n* Sickle cell disease\n* Maternal heart condition or heart disease\n* Opioid use disorder\n* Lupus\n* Thrombophilia or blood clots\n* Need for blood transfusion during delivery hospitalization\n* Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum",{"count":605,"type":22},1500,[25],"The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.",[609],"Maternal Health","2026-02-03",{"date":612,"type":37},"2026-02-05",{"date":519,"type":37},{"date":615,"type":22},"2027-12-31",{"name":43,"class":44},""]