[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Washington University School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":683},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,243,0,25,[9,44,75,107,132,150,167,191,226,253,282,300,320,354,412,439,462,493,512,532,555,580,604,633,652],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100526921","phase-1-radiotherapy-in-combination-with-tti-101-in-borderline-resectable-and-locally-advanced-pancreatic-ductal-adenocarcinoma-100526921",false,"NCT06141031","Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma","Phase I\u002FIB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Pathologically confirmed pancreatic adenocarcinoma that is borderline resectable or locally advanced as defined by NCCN guidelines, with no expected arterial resection\u002Freconstruction.\n* Patients who are borderline resectable must have completed standard of care induction chemotherapy between 1 and 3 weeks prior to planned start of TTI-101 + SBRT. Patients who exceed this window may be considered for enrollment if they complete an additional cycle of induction chemotherapy prior to initiation of study treatment (per provider discretion). The amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction for patients with locally advanced disease.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 70 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL (patients may be transfused to meet this criterion)\n  * Total bilirubin ≤ 2 mg\u002FdL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Serum albumin ≥ 2.8 g\u002FdL\n  * Ionized calcium ≤ 1.5 mmol\u002FL, calcium ≤ 12 mg\u002FdL, or corrected serum calcium ≤ IULN)\n  * Measured creatinine clearance \\> 40 mL\u002Fmin or calculated creatinine clearance \\> 40 mL\u002Fmin by Cockcroft-Gault or by 24-hour urine collection for determination of creatinine clearance (calculations in protocol).\n* Able to swallow pills.\n* INR and aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy (in which case INR and PTT must be within therapeutic range of intended use of anticoagulants)\n* The effects of TTI-101 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use at least 1 highly effective method of contraception from screening through the duration of study participation, and for 30 days after last dose of TTI-101. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform the treating physician immediately.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior treatment for pancreatic cancer in the past 2 years (outside of the induction chemotherapy received for the current diagnosis).\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device overlapping with study treatments within 3 months preceding study entry at the discretion of the PI.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101 or other agents used in the study.\n* Uncontrolled intercurrent illness including but not limited to: ongoing or active infection (fungal, bacterial, or viral (including COVID-19)), sepsis, acute and chronic active infectious disorders (including viral and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy), and chronic pancreatitis. Patients with a recent COVID-19 diagnosis must have fully recovered from all COVID-19 symptoms for 2 weeks prior to the start of study treatment.\n* Significantly impaired cardiac function such as symptomatic congestive heart failure with NYHA Class III or IV, unstable angina pectoris, myocardial infarction within the last 12 months prior to study entry, serious cardiac arrhythmia (including QTc prolongation of \\> 470 ms and\u002For pacemaker), or prior diagnosis of congenital long QT syndrome.\n* Ongoing toxicity due to induction chemotherapy, unless returned to baseline or grade 1 or less (except alopecia and labs noted in inclusion criterion #5).\n* Has had major surgery within 3 weeks prior to starting TTI-101 or has not recovered from major side effects due to surgery.\n* Presence of pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequent). Participants with indwelling catheters for control of effusions or ascites are allowed.\n* History of cerebrovascular accident or stroke within the previous 2 years.\n* History of hepatic encephalopathy.\n* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n* History of malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance or absorption of TTI-101.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 5 days of study entry.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.",[27],"Pancreatic Cancer",[29,30],"borderline resectable","locally advanced","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2024-01-16",{"date":39,"type":21},"2029-06-30",{"name":41,"class":42},"Washington University School of Medicine","OTHER",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100652761","cerebrovascular-reactivity-measurements-with-high-density-diffuse-optical-tomography-100652761","NCT07776444","Cerebrovascular Reactivity Measurements With High-Density Diffuse Optical Tomography","HDDOT CVR","Inclusion Criteria:\n\n* 6-70 Years Old\n* Able to participate in MRI scan without sedation\n* May or may not have HbSS or beta thalassemia null genotypes of sickle cell anemia\n\nExclusion Criteria:\n\n* Significant craniofacial malformation or technical contraindications to DOT monitoring (for HDDOT imaging)\n* Metal in\u002Fon the body that is contraindicated for MRI safety (for MRI imaging)",true,"6 Years","70 Years",{"count":55,"type":21},120,[57],"NA","The purpose of the study protocol is to identify imaging biomarkers for brain tissue under high metabolic stress at risk for permanent injury. We will measure oxygen extraction fraction (OEF) and cerebrovascular reactivity (CVR) in participants with and without perturbations in cerebral oxygen delivery over time to determine each parameter's role in clinical and radiologic neurologic outcomes. Measuring OEF can be done with specialized MRI sequences. Measuring CVR requires a vasoactive response, such as carbon dioxide. In order to deliver carbon dioxide evenly and as safely as possible, we will use RespirACT, an MRI-compatible device, to prevent over-breathing carbon dioxide and allow rapid steady-state physiology to minimize total scan time. We will also use a high density diffuse optical tomography (HD-DOT) cap to assess the measurement of OEF and CVR. This study will investigate both regional OEF and CVR simultaneously to understand each marker's unique developmental trajectory and contribution to stroke risk in children. This work will expand insights into mechanisms of stroke in children and assess the feasibility of the HD-DOT cap for obtaining these insights by comparing a cohort of optical CVR and a cohort of MRI CVR.\n\nIn addition to the MRI and\u002For HD-DOT cap with RespirAct, participants may also have their vitals measured, complete cognitive testing, and complete a blood draw with a study visit. Participants may be followed for up to three years and may complete both an MRI scan and an HD-DOT scan within 1 week-12 months of each other. Participants may be invited back to repeat MRI and\u002For HD-DOT scans 1-2 times over the next three years.",[60,61],"Sickle Cell Disease","Cerebral Stroke",[63,64,65],"cerebrovascular reactivity","magnetic resonance imaging","High density diffuse optical tomography","2026-08-17",{"date":68,"type":35},"2026-08-20",{"date":70,"type":35},"2025-10-01",{"date":72,"type":21},"2032-09-30",{"name":41,"class":42},1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":74},"100652617","phase-2-substance-use-in-pregnancy---optimizing-retention-in-treatment-by-maximizing-opportunities-for-management-100652617","NCT07776457","Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management","Substance Use in Pregnancy- Optimizing Retention in Treatment by Maximizing Opportunities for Management","SUPPORT MOM","Inclusion Criteria:\n\n* Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver\n* Diagnosis of SUD as defined by DSM-5 and\u002For as documented in the clinical record\n* 18 years of age or older\n* Two or more positive domains in first screening for social drivers of health\n* Receiving ongoing care at participating study site\n\nExclusion Criteria:\n\n* Declining follow-up care at participating study site\n* Participated in R61 pilot study for CM\n* Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach\n* Unable to participate in English","FEMALE",{"count":85,"type":21},245,[87],"PHASE2","Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.",[90,91],"Pregnancy","Substance Use Disorder (SUD)",[93,94,95,96,97,98,99],"randomized","pregnancy","prenatal","substance use disorder","contingency management","postpartum","intervention","NOT_YET_RECRUITING",{"date":68,"type":35},{"date":103,"type":21},"2027-01",{"date":105,"type":21},"2030-02",{"name":41,"class":42},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":74},"100646026","phase-2-liposomal-bupivacaine-vs-standard-bupivacaine-for-post-rhinoplasty-analgesia-100646026","NCT07689162","Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia","Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients (≥18 years) undergoing open rhinoplasty of any indication or complexity (e.g., primary, revision, functional, or cosmetic), including autologous grafting of any type (e.g., septal or costal cartilage) or cadaveric grafting.\n\nExclusion Criteria:\n\n* Chronic pain condition requiring ongoing or scheduled analgesic therapy, or any diagnosis associated with chronic pain (e.g., fibromyalgia, chronic headache\u002Fmigraine, neuropathic pain, complex regional pain syndrome), long-term opioid use (≥3 months, any agent), allergy or contraindication to local anesthetics, acetaminophen, ibuprofen \u002F NSAIDs, tramadol, ketamine, Medrol (methylprednisolone) dose pack\n* Concurrent non-nasal surgery planned",{"count":115,"type":21},45,[87],"The purpose of this study is to find out which pain medication is more effective in reducing pain after nose surgery (rhinoplasty). The investigators are looking to find the best treatment to reduce discomfort and improve the healing process for patients having nose surgery.",[119],"Pain, Postoperative",[121,122,123,124],"Otolaryngology","Rhinoplasty","Bupivacaine","Liposomal Bupivacaine",{"date":126,"type":35},"2026-08-18",{"date":128,"type":35},"2026-08-01",{"date":130,"type":21},"2027-07",{"name":41,"class":42},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":74},"100641090","phase-1-feasibility-of-support-tbi-100641090","NCT07625098","Feasibility of SUPPORT-TBI","From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI","Inclusion Criteria:\n\n* Age 18 or older\n* Live in a community setting (not an institutional setting)\n* Sustained a traumatic brain injury more than 6 months prior to enrollment\n* Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended\n* Report low social support (score of less than 50 on the MOS Social Support Survey)\n\nExclusion Criteria:\n\n* Insufficient English language fluency\n* Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)\n* Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)\n* Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)",{"count":140,"type":21},60,[24],"Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others. They often lose friendships, become isolated, and have strained family relationships. This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan. The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions. They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience. This study will determine whether the program is practical to deliver. We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile. Based on what they learn, the investigators will refine this program before testing it on a larger scale. If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.",[144],"TBI Traumatic Brain Injury",{"date":32,"type":35},{"date":66,"type":35},{"date":148,"type":21},"2028-03-31",{"name":41,"class":42},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":74},"100635231","phase-1-engage-tbi-feasibility-study-100635231","NCT07549997","ENGAGE-TBI Feasibility Study","Inclusion Criteria:\n\n* at least 18 years old\n* experienced a TBI \\> 6 months prior to enrollment, confirmed by a physician as documented in their medical record\n* live in the St. Louis area\n* report problems with social participation (retention of \\\u003C 80% of pre-TBI social activities as measured by Activity Card Sort)\n\nExclusion Criteria:\n\n* insufficient English language fluency to participate in the group intervention\n* have active substance use disorder (PRIME-MD MINI)\n* have an untreated psychotic disorder (PRIME-MD MINI)\n* have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, \\\u003C 21)",{"count":157,"type":21},30,[24],"This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.",[161],"TBI (Traumatic Brain Injury)",{"date":126,"type":35},{"date":66,"type":35},{"date":165,"type":21},"2028-04",{"name":41,"class":42},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":51,"sex":17,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":74},"100631899","imat-quality-in-aging-100631899","NCT07506681","IMAT Quality in Aging","Targeting Intramuscular Adipose Quality in Aging","Inclusion Criteria:\n\n* Rapid Assessment of Physical Activity scores between 3 and 5\n* Able to don and doff the weighted vest\n* Access to a smart phone and ability to navigate the phone to enter and manage a zoom intervention\n* Commitment and availability to attend a virtual 40-minute intervention 3x per week for 12 weeks\n\nExclusion Criteria:\n\n* Contraindications to radiation exposure (e.g. Women who are pregnant, previous high radiation exposure)\n* Bleeding disorders\n* Lower extremity trauma\u002Fsurgery\u002Finjury or neuropathy that would impact muscle structure and function or ability to complete exercise intervention\n* Diabetes mellitus, cardiovascular disease, peripheral vascular disease, cancer, stage 4 hypertension, anemia, connective tissue disorder\n* Neurological disorder (e.g. stroke, Parkinson's disease, multiple sclerosis, spinal cord injury)\n* Medications: insulin, glucagon-like peptide-1 (GLP1) agonists, sex hormone replacement therapy, chronic NSAIDs, anticoagulation therapy, cholesterol lowering medications such as statins\n* Unable to safely perform the progressive resistance exercise (e.g. Vestibular or balance issues that make performing the intervention unsafe, severe osteoporosis or general fragility that limits weighted vest tolerance)","65 Years","80 Years",{"count":177,"type":21},16,[57],"This study will test the central hypothesis that fat within the muscle, or intramuscular adipose tissue (IMAT), exhibits elevated damage and pro-inflammatory signaling with aging, both of which are reduced by progressive resistance exercise (PRE). Sixteen older adults 65-80 years old will be recruited and complete a 12 week calf PRE intervention. Calf muscle strength, composition (measured by computed tomography) and muscle biopsies will be collected before and after the intervention. Histology, transcriptomic and secretomic tests will be completed to assess signs of damage and inflammation.",[181],"Aging",[183,184],"aging","muscle",{"date":126,"type":35},{"date":187,"type":21},"2026-10-01",{"date":189,"type":21},"2028-01",{"name":41,"class":42},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":198,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100611479","phase-4-chest-a-collaboration-with-community-health-centers-to-implement-smart-for-asthma-100611479","NCT07241117","CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma","CHEST","The study population can be viewed from the cluster (clinic), clinician, staff, or patient level.\n\nAt the cluster (clinic) level: To be eligible to participate in this study, a cluster (clinic) must meet all the following criteria:\n\n1. Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.\n2. Employment of at least 3 clinicians who commonly manage adult asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).\n3. Data provided to Azara for data queries, and\n4. Willing and able to receive all components of the SMART implementation bundle (i.e., initial educational outreach visit, ongoing practice facilitation\u002Fsupervision, audit \\& feedback, and provision of education of patient-level education aides and SMART asthma action plans and monthly operations committee meetings).\n\nAt the clinician\u002Fclinical staff level:\n\nTo be eligible to participate in this study, a clinician\u002Fclinical staff member must meet all of the following criteria:\n\n1. Provision of a signed and dated informed consent form.\n2. Current state licenses of physician, assistant physician, nurse practitioner, or physician assistant.\n3. Regularly cares for adults with asthma (which may include those trained in family medicine, internal medicine, obstetrics\u002Fgynecology, and\u002For specialty medicine).\n4. Willing and able to integrate the SMART implementation bundle into their practice.\n5. Willing and able to participate for the entire duration of the study, including the pre-implementation, active implementation, and post-implementation periods.\n6. Willing to provide data on prescribing patterns and asthma patient outcomes for the duration of the study.\n\nAt the patient level:\n\nTo be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Age ≥12 years old\n2. Diagnosis of asthma, of any severity, coded (i.e., International Classification of Diseases \\[ICD\\]-10-CM: J45\\*\\*).\n3. The patient has had ≥2 asthma exacerbations in the last year during which systemic corticosteroids were prescribed, and\u002For the encounter contains an active prescription for an inhaler that is congruent with medium-dose (or higher) maintenance inhaled corticosteroids (ICS) inhalers or low-dose (or higher) ICS-long-acting β-agonist (LABA) inhalers with concomitant reliever short-acting β-agonist inhalers.","12 Years",{"count":200,"type":21},2000,[202],"PHASE4","Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy).\n\nThe investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients.",[205],"Moderate to Severe Asthma",[207,208,209,196,210,211,212,213,214,215,216,217,218],"asthma","SMART","moderate to severe asthma","CHEST asthma study","asthma study","asthma action plan","implementation science","hybrid cluster","community health centers","MART","single maintenance and reliever therapy","maintenance and reliever therapy",{"date":32,"type":35},{"date":221,"type":35},"2026-01-06",{"date":223,"type":21},"2028-11-15",{"name":41,"class":42},7,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":51,"sex":232,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":74},"100601356","impact-of-an-electronic-health-record-maintenance-alert-on-psa-screening-rates-in-a-10-hospital-integrated-health-system-100601356","NCT07109427","Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System","Eligibility Criteria:\n\n* Receive care within the BJC Health System\n* Have had at least one primary care physician appointment in the calendar year of PSA screening (primary care)\n* Be male\n* Not have a history of prostate cancer\n* Meet one of the following risk criteria:\n\n  * High Risk for Prostate Cancer\n\n    * African American, between the ages of 40 and 75 (inclusive), or\n    * Family history of prostate, breast, ovarian, and\u002For pancreatic cancer, or\n    * Known familial germline mutation OR\n  * Average Risk for Prostate Cancer\n\n    * Between the ages of 50 and 75 (inclusive)","MALE","40 Years","75 Years",{"count":236,"type":21},40000,[57],"\\- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care:\n\n* Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines.\n* Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices.\n* The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.",[240,241],"Prostate Cancer","Cancer of the Prostate",[243,244,245,246],"PSA Screening","Clinically Significant Prostate Cancer","African American men","Electronic Health Record",{"date":32,"type":35},{"date":249,"type":35},"2025-08-11",{"date":251,"type":21},"2031-08-31",{"name":41,"class":42},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":51,"sex":17,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":74},"100571425","early-phase-1-light-therapy-for-obsessive-compulsive-disorder-ocd-100571425","NCT06720090","Light Therapy for Obsessive-compulsive Disorder (OCD)","Light Therapy for Obsessive-compulsive Disorder: A Circadian Medicine Approach","KLTO","Inclusion Criteria:\n\n1. Primary DSM-5 OCD diagnosis\n2. Bedtime 0100 or later\n3. Age 18-35\n4. English speaking\n\nExclusion Criteria:\n\n1. Subjects must not be currently participating in another research study that would influence their participation in our study.\n2. Diagnostic status\n3. Treatment status\n4. Night shift work or travel more than 1 time zone outside of Central Standard Time (CST) in the past month\n5. Pregnancy status\n6. Medication status\n7. Regular nicotine or marijuana use","17 Years","35 Years",{"count":264,"type":21},40,[266],"EARLY_PHASE1","The goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with OCD and late bedtimes (1am or later). The main question\\[s\\] it aims to answer are:\n\nDoes light therapy reduce OCD symptoms? Does light therapy advance the circadian clock? If there is a comparison group: Researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction.\n\nParticipants will asked to:\n\n1. Wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks\n2. Track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks\n3. Complete a 1-time assessment of sensitivity to light exposure\n4. Complete self-report measures of OCD 4 times\u002Fday at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)",[269],"OCD",[271,272,273,274,275],"ocd","sleep","light therapy","circadian","behavioral treatment",{"date":126,"type":35},{"date":278,"type":35},"2024-12-16",{"date":280,"type":21},"2029-03",{"name":41,"class":42},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":51,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":43},"100504062","brain-organization-development-and-response-to-intervention-in-individual-neonates-100504062","NCT05843396","Brain Organization, Development, and Response to Intervention in Individual Neonates","Inclusion Criteria:\n\n* English speaking\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Prisoners (vulnerable population)\n* Pregnant women \\\u003C18 years of age\n* Active psychosis, mania, suicidal ideation (safety)\n* Active substance dependence\n* Gestational Age \\\u003C35 weeks (neonates)\n* Neonatal encephalopathy (neonates)",{"count":289,"type":21},80,[57],"The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.",[293],"Development, Infant",{"date":32,"type":35},{"date":296,"type":35},"2025-03-31",{"date":298,"type":21},"2030-07",{"name":41,"class":42},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":74},"100440140","phase-1-haploidentical-hematopoietic-stem-cell-transplantation-with-ex-vivo-tcr-alphabeta-and-cd19-depletion-in-pediatric-hematologic-malignancies-100440140","NCT05011422","Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha\u002FBeta and CD19 Depletion in Pediatric Hematologic Malignancies","A Pilot Study of Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha\u002FBeta and CD19 Depletion in Pediatric Hematologic Malignancies","Recipient Inclusion Criteria:\n\n* Must meet at least one of the following disease criteria:\n\n  * B cell ALL in first remission and any of the following:\n\n    * Persistent flow-based MRD at end-of-consolidation:\n\n      * ≥ 1% for NCI SR ALL\n      * ≥ 0.01% for NCI HR ALL\n    * TCF3-HLF t(17;19)\n    * KMT2A rearranged infant ALL, \\\u003C 6 months of age and presenting WBC of \\> 300,000 or poor steroid response (peripheral blasts \\>= 1000 \u002FuL on day 8 of therapy\n    * Other high-risk features not explicitly stated here, after discussion\u002Fapproval with protocol PI.\n  * B cell ALL in second remission and any of the following:\n\n    * Early (\\\u003C36 months from start of therapy) marrow or combined relapse\n    * Late (\\>36 months from start of therapy) marrow or combined relapse with end-of re-induction flow MRD \\>= 0.1%\n    * Early isolated extramedullary relapse (\\\u003C 18 months from start of therapy)\n  * Any B cell ALL in third or greater remission\n  * T cell ALL in first remission\n\n    * End-of consolidation MRD \\> 0.1%\n  * Any T cell ALL in second or greater remission\n  * AML in first remission with any of the following high-risk features:\n\n    * MRD ≥ 1% after first induction course\n    * MRD ≥ 0.1% after second induction course\n    * RPN1-MECOM\n    * RUNX1-MECOM\n    * NPM1-MLF1\n    * DEK-NUP214\n    * KAT6A-CREBBP (if \\>= 90 days at diagnosis)\n    * FUS-ERG\n    * KMT2A-AFF1\n    * KMT2A-AFDN\n    * KMT2A-ABI1\n    * KMT2A-MLLT1\n    * 11p15 rearrangement (NUP98 - any partner gene)\n    * 12p13.2 rearrangement (ETV6 - any partner gene)\n    * Deletion 12p to include 12p13.2 (loss of ETV6)\n    * Monosomy 5\u002FDel(5q) to include 5q31 (loss of EGR1)\n    * Monosomy 7\n    * 10p12.3 rearrangement (MLLT10b - any partner gene)\n    * FLT3\u002FITD with allelic ratio \\> 0.1%\n    * RAM phenotype as evidenced by flow cytometry: bright CD56+, dim to negative CD45 and CD38 and lack of HLA-DR\n    * Other high-risk features not explicitly stated here, after discussion\u002Fapproval with protocol PI.\n  * AML in second or greater remission\n  * Mixed phenotype or undifferentiated leukemia in any CR\n  * Secondary to therapy-associated leukemia in any CR\n  * NK cell lineage leukemia in any CR\n  * Myelodysplastic syndrome (MDS)\n  * Juvenile myelomonocytic leukemia (JMML)\n* May have undergone a prior hematopoietic stem cell transplant provided one of the criteria in Inclusion Criterion #1 are met AND the patient does not have active GVHD (has been off immunosuppression for at least 3 months).\n* Available familial haploidentical donor.\n* Donor and recipient must be identical at a minimum of one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum of 5\u002F10 match is required and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.\n* No more than 30 years of age\n* Lansky or Karnofsky performance status \\> 50%\n* Adequate organ function as defined below:\n\n  * Cardiac: LVEF ≥ 40% at rest or SF ≥ 26%\n  * Hepatic:\n\n    * Total bilirubin \\\u003C 3 x IULN for age\n    * AST(SGOT)\u002FALT(SGPT) \\\u003C 5 x IULN\n  * Renal: GFR ≥ 60 mL\u002Fmin\u002F1.73m2 as estimated by updated Schwartz formula for ages 1-17 years (see Appendix B), 24-hour creatinine clearance, or renal scintigraphy. If GFR is abnormal for age based on updated Schwartz formula, accurate measurement should be obtained by either 24-hour creatinine clearance or renal scintigraphy. Renal function may also be estimated by serum creatinine based on age\u002Fgender. A minimum serum creatinine of 2x upper limit of normal is required for inclusion on this protocol.\n  * Pulmonary:\n\n    * O2 saturation ≥ 92% on room air without positive pressure support\n    * FEV1, FVC, and DLCO ≥ 50% of predicted (for children unable to perform a pulmonary function test, a high-resolution CT chest may be obtained)\n* The effects of these treatments on the developing human fetus are unknown. For this reason, patients of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 24 months following transplant. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nRecipient Exclusion Criteria:\n\n* Available matched related donor. A patient with a matched unrelated donor is eligible if urgent transplantation is required. A prior unrelated donor search is not required for enrollment.\n* Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been complete and there is no evidence of disease.\n* Currently receiving any other investigational agents at the time of transplant.\n* Active CNS or extramedullary disease. History of CNS or extramedullary disease now in remission is acceptable.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to conditioning agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, viral with clinical instability, or fungal), symptomatic congestive heart failure, or unstable cardiac arrhythmia.\n* Presence of significant anti-donor HLA antibodies per institutional standards. Anti-donor HLA Antibody Testing is defined as a positive crossmatch test of any titer (by complement dependent cytotoxicity or flow cytometric testing) or the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay.\n* Presence of a second major disorder deemed a contraindication for HSCT.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of the start of conditioning.\n\nDonor Eligibility Criteria:\n\n* The preferred donor should be an adult aged at least 18 years or older. However, in circumstances where no suitable adult donor is available, consideration may be given to a minor donor aged 12 years or older. This exception only applies when all identified, otherwise eligible adult donors meet one or more of the following criteria:\n\n  * Have a medical condition that poses unacceptable risk, including autoimmune disease, infection, hematologic disorder, malignancy, or a pathogenic germline mutation.\n  * Have comorbidities that preclude safe administration of granulocyte colony-stimulating factor (G-CSF), placement of a pheresis catheter and\u002For a pathogenic germline mutation.\n  * Served as a donor in prior haploidentical HCT.\n  * Significant psychosocial or logistical barriers.\n* Meets the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT).\n* Able to understand and willing to sign an IRB-approved written informed consent document (or that of legally authorized representative, if applicable).","30 Years",{"count":309,"type":21},50,[24],"This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).",[313],"Pediatric Hematologic Malignancies",{"date":32,"type":35},{"date":316,"type":35},"2022-11-03",{"date":318,"type":21},"2029-05-31",{"name":41,"class":42},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":341,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":74},"100514215","microenvironment-tumor-effects-of-radiotherapy---comprehensive-radiobiology-assessment-trial-100514215","NCT05975593","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)","METEOR-CRATR","Inclusion Criteria:\n\n* Confirmation of intent to receive radiotherapy for one of the following diagnoses:\n\n  * Cervical cancer\n  * Pancreatic cancer\n* ECOG performance status ≤ 2\n* At least 18 years old\n* Able to understand and willing to sign an IRB-approved written informed consent document\n\nExclusion Criteria:\n\n* Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician",{"count":140,"type":21},[57],"This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.",[332,333,334,335,336,337,338,27,339,340],"Locally Advanced Cervical Carcinoma","Locally Advanced Cervical Cancer","Locally Advanced Pancreas Cancer","Locally Advanced Pancreatic Carcinoma","Locally Advanced Pancreatic Cancer","Cervical Cancer","Pancreas Cancer","Cancer of the Cervix","Cancer of the Pancreas",[342,343,344,345,346],"Radiotherapy","Chemotherapy","Cervical cancer","Pancreatic cancer","Biospecimen","2026-08-12",{"date":66,"type":35},{"date":350,"type":35},"2024-01-11",{"date":352,"type":21},"2032-12-31",{"name":41,"class":42},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":74},"100635428","phase-1-ficerafusp-alfa-pembrolizumab-and-stereotactic-body-radiotherapy-sbrt-for-head-and-neck-squamous-cell-carcinoma-hnscc-100635428","NCT07552558","Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)","Phase I\u002FII Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx.\n* Baseline resectable disease per the judgment of the treating surgical oncologist.\n* Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T1-2, N1-3 or\n  * T3, any N or\n  * T4, any N\n* Documented tumor PD-L1 CPS ≥ 1 (by PD-L1 IHC pharmDx assay), determined locally.\n* Willing to provide blood and newly obtained core or excisional biopsy of tumor lesion pre-treatment and at the time of surgery for pathologic and correlative analyses.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9 g\u002FdL (without PRBC transfusion in the prior 7 days)\n  * Total serum bilirubin ≤ 1.5 x IULN (except for subjects with documented diagnosis of Gilbert syndrome). For subjects with a documented diagnosis of Gilbert's syndrome, total bilirubin must be ≤ 3.0 × ULN, provided that direct bilirubin is within normal limits\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN\n  * Creatinine clearance (measured or calculated via the Cockcroft-Gault equation or per institutional standards) ≥ 30 mL\u002Fmin\n  * PT\u002FINR or aPTT ≤ 1.5 x IULN (except for subjects receiving anticoagulant therapy)\n* The effects of pembrolizumab and ficerafusp alfa on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days (women) or 90 days (men) after completion of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Currently receiving any other investigational agents.\n* Prior history of grade ≥ 2 intolerance or hypersensitivity reactions to other murine proteins, or the active substances of ficerafusp alfa, pembrolizumab, or any of their excipients.\n* At higher risk of bleeding, including known bleeding diathesis or current active major bleeding, or recent major bleeding episode (within 4 weeks prior to enrollment).\n* Any of the following within 6 months prior to starting study treatment: ST-elevation myocardial infarction, severe\u002Funstable angina, uncontrolled cardiac ventricular arrhythmia, coronary\u002Fperipheral artery bypass graft or stent, cerebrovascular accident\u002Fstroke less than 6 months prior to enrollment, or congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* Chronic hepatitis B virus (HBV) infection with active disease meeting the criteria for anti-HBV therapy but not on a suppressive antiviral therapy prior to initiation of study treatment. HBV testing not required in the absence of known history of infection. Note: Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. These subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.\n* Known history of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible provided they completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) with viral load \\>0 or CD4\\\u003C350. HIV testing is not required in the absence of known history of infection.\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen \\\u003C 10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study entry. Other exceptions may be considered with the PI's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a subject is enrolled in the study.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the principle-Investigator.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.\n* Pregnant or breastfeeding. People of childbearing potential must have a negative pregnancy test at screening and within 7 days of first dose of study treatment.",{"count":115,"type":21},[24,87],"The study is an open-label phase I\u002FII clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.",[365,366],"Head and Neck Squamous Cell Carcinoma","HPV-Negative Squamous Cell Carcinoma",[368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403],"Shortened fractionation radiation","Immunotherapy","Curative treatment","Oral cavity cancer","Tongue cancer","Gum cancer","Jaw cancer","Palate cancer","Lip Cancer","Throat cancer","Mouth cancer","Voice box cancer","Head and neck cancer","Oral cancer","Laryngeal cancer","Mandibular cancer","Alveolar ridge cancer","Hypopharyngeal cancer","Oropharyngeal cancer","OPSCC","OCC","OCSCC","HNSCC","Squamous cell carcinoma","Neoadjuvant therapy","Preoperative treatment","Stereotactic body radiotherapy","Radiation therapy","Targeted therapy","Keytruda","BCA101","PD-1 inhibitor","EGFR inhibitor","Checkpoint inhibitor","Locally advance","HP-negative","2026-08-10",{"date":406,"type":35},"2026-08-13",{"date":408,"type":21},"2026-09-30",{"date":410,"type":21},"2033-11-30",{"name":41,"class":42},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":51,"sex":83,"minAge":233,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":74},"100635165","overcoming-racial-disparities-in-screening-mammography-100635165","NCT07549139","Overcoming Racial Disparities in Screening Mammography","A Personalized Approach to Promote Health Equity by Overcoming Racial Disparities in Screening Mammography","Inclusion Criteria:\n\n* Woman\n* At least 40 years old\n* Self-identify as Black\n* English-speaking\n* Scheduled for a screening mammogram within 8 weeks of study entry\n* Able to understand and willing to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* A previous history of breast cancer\n* Scheduled for a diagnostic mammogram\n* Has a documented or uncorrectable cognitive, hearing, or visual impairment.\n* Too ill to participate (diagnosed with or suffering from a condition that, in the judgment of the investigator, may limit participation in the study).",{"count":420,"type":21},176,[57],"The purpose of this study is to increase screening mammography among Black women by implementing and evaluating a culturally tailored patient-centric program designed to address barriers to screening. By performing a randomized clinical trial, this study aims to develop effective strategies to improve adherence to screening mammography and contribute to reducing health disparities in breast cancer outcomes.",[424,425],"Breast Cancer","Cancer of the Breast",[427,428,429,430,431],"Breast cancer screening","Mammography","Black women","Disparities","No-show rates","2026-08-09",{"date":347,"type":35},{"date":435,"type":21},"2026-10-31",{"date":437,"type":21},"2028-04-30",{"name":41,"class":42},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":453,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":74},"100604875","phase-1-small-cell-lung-cancer-irinotecan-and-cdc2-like-kinase-inhibition-trial-slick-trial-100604875","NCT07155200","Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer that has progressed on at least one line of prior platinum-based chemotherapy, given with or without anti-PD-(L)1 therapy.\n* Presence of measurable disease per RECIST 1.1 criteria\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Total bilirubin ≤ 1.5 x IULN (except participants with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases)\n  * Calculated creatinine clearance \\> 35 mL\u002Fmin by Cockcroft-Gault\n* The effects of cirtuvivint on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 31 weeks after completion of study treatment (either drug). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose treatment or natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial.\n* Previous intolerance to irinotecan. Treatment with prior irinotecan is allowed as along as treatment was not discontinued for treatment related adverse events.\n* Currently receiving any other investigational agents.\n* Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \\\u003C 5 mm are allowed.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cirtuvivint, irinotecan, or other agents used in the study.\n* Concurrent diarrheal illness (such as inflammatory bowel disease) that requires medical therapy.\n* Undergone major surgery within 28 days prior to Cycle 1 Day 1\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.\n* Unresolved grade 2 or higher toxicities from previous treatment with the exception of fatigue, lymphopenia, anemia, endocrine AEs that are being managed with hormone replacement, alopecia, or dysgeusia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.\n* Known retinal abnormalities, including diabetic retinopathy, macular degeneration, other retinal degenerative diseases, or other retinal findings that may place the patient at risk.\n* Patients currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication.\n* Patients with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \\> CTCAE v5.0 Grade 1 (\\>480 msec) based on the mean of triplicate evaluation at Screening. In patients with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for patients with pacemakers should be discussed with the PI.",{"count":446,"type":21},42,[24,87],"Although small cell lung cancer (SCLC) responds dramatically to initial platinum-based chemotherapy, recurrences are nearly universal. The addition of atezolizumab, an immune checkpoint inhibitor, to front-line chemotherapy has recently demonstrated an improvement in overall survival (OS) in extensive stage SCLC (ES-SCLC). Subsequent lines of therapies are associated with modest efficacy in patients with relapsed disease, and the median overall survival is still 12 to 13 months at best.\n\nCirtuvivint is a small molecule inhibitor of the CDC2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs); inhibiting CLKs and DYRKs has been shown in preclinical models to cause tumor growth inhibition and sensitize cancer cells to cytotoxic chemotherapy.\n\nThis study is testing the hypothesis that adding cirtuvivint to chemotherapy in patients with relapsed SCLC will be well tolerated and improve the response rate and progression-free survival (PFS).",[450,451,452],"Small-cell Lung Cancer","Small Cell Lung Carcinoma","Small Cell Lung Cancer",[452,454,455],"CLK Inhibitors","Cirtuvivint",{"date":347,"type":35},{"date":458,"type":35},"2025-12-18",{"date":460,"type":21},"2029-01-31",{"name":41,"class":42},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":51,"sex":17,"minAge":468,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":476,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":74},"100604211","evaluating-the-implementation-and-effectiveness-of-the-pink-and-pearl-campaign-on-lung-cancer-screening-at-christian-hospital-100604211","NCT07146568","Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital","Eligibility Criteria - Interventional Study\n\n* Undergoing screening mammography at Christian Hospital\n* Between the ages of 50-80 years (inclusive)\n\nEligibility Criteria - Survey and Interview Sub-Studies\n\n* Part of the interventional study\n* Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years\n* Can speak and understand English\n* Not diagnosed with a serious health problem that will limit life expectancy (such as previous history of lung cancer, symptoms of lung cancer such as hemoptysis or unexplained weight loss of more than 6.8 kg (15 lb) in the previous year)\n* Willing and able to get treatment if lung cancer is found\n* Able to understand and willing to sign an IRB-approved written informed consent document\n\nEligibility Criteria - Providers\n\n* At least 20 years of age\n* Involved in the breast radiology service or referred at least one patient to the Pink \\& Pearl Campaign\n* Able to provide verbal consent to participate in the interview","20 Years",{"count":470,"type":21},5515,[57],"Inspired by the ongoing Pink \\& Pearl Campaign, the breast radiology service of Christian Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this campaign in its mammography clinics in order to promote awareness, referral, and completion of lung cancer screening (LCS) among eligible women. This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening. The purpose of this study is to evaluate the effectiveness of the Pink \\& Pearl Campaign in improving LCS uptake among LCS-eligible women undergoing mammography at Christian Hospital. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, our specific aims for this proposal are to: a) assess whether the Pink \\& Pearl Campaign increases referrals and uptake\u002Fcompletion of LCS among LCS-eligible women undergoing screening mammography; b) determine median time-to-screening after referral to LCS; and c) evaluate individual and health system factors influencing LCS uptake and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.",[474,475],"Lung Cancer","Cancer of the Lung",[477,478,479,480,481,482,483,484,485,486],"Lung cancer screening (LCS)","Pink and Pearl Campaign","Breast cancer screening (BCS)","Low-dose computed tomography (LDCT)","Smoking history","Health disparities","Screening behavior","Feasibility","Acceptability","Appropriateness",{"date":347,"type":35},{"date":489,"type":35},"2026-02-23",{"date":491,"type":21},"2027-02-28",{"name":41,"class":42},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":502,"phases":4,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":74},"100585128","implementation-and-effectiveness-of-the-bjc-pink-and-pearl-project-on-lung-cancer-screening-100585128","NCT06898333","Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening","Evaluating the Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening","Inclusion Criteria for Participants:\n\n* Undergoing screening mammography\n* Between the ages of 50-80 years (inclusive)\n* Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years\n* Can speak and understand English\n* Ability to understand willingness to provide informed consent.\n\nExclusion Criteria for Participants:\n\n* Diagnosed with a serious health problem that will likely limit life expectancy (such as previous history of lung cancer, symptoms of lung cancer such as hemoptysis or unexplained weight loss of more than 6.8 kg (15 lb) in the previous year)\n\n  * Subjects with symptoms of lung cancer should get a diagnostic CT scan\n* Unable or unwilling to get treatment if lung cancer is found\n\nEligibility Criteria for Providers:\n\n* Older than 20 years of age",{"count":501,"type":21},279,"OBSERVATIONAL","The investigators proposal is ripe for executing as the investigators seek to leverage this \"natural experiment\" initiated by the BJC health system to evaluate the effectiveness of the Pink \\& Pearl Campaign as an implementation strategy to promote lung cancer screening (LCS) uptake among LCS-eligible women undergoing mammography at BJC West County. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, the research questions and specific aims for this proposal are to: a) evaluate the baseline prevalence of LCS among LCS-eligible women; b) assess whether the Pink \\& Pearl Campaign increases referrals and uptake\u002F completion of LCS among LCS-eligible women undergoing screening mammography; and c) evaluate individual and environmental factors influencing LCS uptake, and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.",[474,475],[477,478,479,480,481,482,483,484,485,486],{"date":347,"type":35},{"date":508,"type":35},"2025-05-08",{"date":510,"type":21},"2027-05-31",{"name":41,"class":42},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":174,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":74},"100579884","role-of-katp-channel-loss-in-type-2-diabetes-100579884","NCT06830096","Role of KATP Channel Loss in Type 2 Diabetes","Hyperglycemia Induced Hyperexcitability: A Novel Role for KATP in the Progression of Type 2 Diabetes","BC","Inclusion Criteria:\n\n* Lean-normoglycemic group (n=10): BMI ≥18.5 and \\\u003C25.0 kg\u002Fm², fasting plasma glucose concentration \\\u003C95 mg\u002Fdl, 2-hr oral glucose tolerance test plasma glucose concentration ≤140-mg\u002Fdl, and hemoglobin A1C (HbA1C) ≤5.6%.\n* Obesity-normoglycemic group (n=10): BMI ≥30 and \\\u003C50 kg\u002Fm², fasting plasma glucose concentration \\\u003C95 mg\u002Fdl, 2-hr oral glucose tolerance test plasma glucose concentration ≤140 mg\u002Fdl, and hemoglobin A1C (HbA1C) ≤5.6%.\n* Obesity-impaired fasting glucose group (n=10): BMI ≥30 and \\\u003C50 kg\u002Fm², fasting plasma glucose concentration 100-125 mg\u002Fdl, and 2-hr oral glucose tolerance test plasma glucose concentration \\\u003C200 mg\u002Fdl.\n* Obesity-type 2 diabetes group (n=10): BMI ≥30 and \\\u003C50 kg\u002Fm²; HbA1C 6.5-9.5%, fasting plasma glucose ≥126 mg\u002Fdl, 2-hr oral glucose tolerance test plasma glucose concentration ≥200 mg\u002Fdl and\u002For medical history of T2DM and currently using anti-diabetic medications.\n\nExclusion Criteria:\n\n* Diabetes therapy with insulin at \\>0.5 units\u002Fkg\u002Fday.\n* Any change in diabetes medication in previous 3 months.\n* Unstable weight (\\>2% change during the last 2 months before entering the study).\n* Evidence of significant organ system dysfunction or disease other than obesity and T2D.\n* Regular use of tobacco products.\n* Excessive consumption of alcohol (≥3 drinks\u002Fday for men and ≥2 drinks\u002Fday for women).\n* Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study.\n* Anemia (Hemoglobin \\\u003C10.0 g\u002FdL).\n* Pregnant or breastfeeding.\n* Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.",{"count":264,"type":21},[57],"Insulin is a hormone that is made by β-cells in the pancreas and when released into the bloodstream helps control blood sugar levels. Insulin release is regulated by electrical activity in the β-cell which is generated by the ATP-sensitive potassium (KATP) channel. While reduced KATP activity is associated with increased insulin secretion, animals lacking KATP exhibit reduced secretion. This crossover from hypersecretion to undersecretion with KATP loss mirrors insulin secretion during type 2 diabetes. Intriguingly, evidence from cell and animal models suggest that chronically stimulated β-cells can lose KATP revealing a possible role for KATP loss in the failure of insulin secretion and poor control of blood sugar observed in type 2 diabetes. This study will therefore examine insulin responses following ingestion of a single dose of a sulfonylurea called glipizide that inhibits KATP channels in people with and without type 2 diabetes. The goal is to determine whether KATP channel activity is reduced during type 2 diabetes progression.",[524],"Obesity and Type 2 Diabetes","2026-08-07",{"date":404,"type":35},{"date":528,"type":35},"2025-03-07",{"date":530,"type":21},"2027-03-31",{"name":41,"class":42},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":74},"100534586","enasidenib-for-patients-with-clonal-cytopenia-of-undetermined-significance-and-mutations-in-idh2a-decentralized-trial-100534586","NCT06240754","Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial","A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2: A Decentralized Trial","Inclusion Criteria:\n\n* Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:\n\n  * Hgb \\\u003C10 g\u002FdL\n  * ANC \\\u003C1.8 × 109\u002FL\n  * Platelets \\\u003C100 × 109\u002FL\n* IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.\n* At least 18 years of age.\n* ECOG performance status 0-2\n* Adequate organ function as defined below:\n\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Serum total bilirubin \\\u003C 1.5 x IULN (un upper limit of bilirubin 5 mg\u002FdL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN\n* The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.\n\n  * Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts\n* Active malignancy (defined as \\> 1 cm disease on most recent CT scan in the past 6 months).\n* Currently receiving therapy for solid tumor malignancy or received within the last 6 months.\n* Currently receiving any other investigational agents.\n* Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.\n* Positive direct Coombs test.",{"count":540,"type":21},15,[87],"Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.",[544,545],"Clonal Cytopenia of Undetermined Significance","CCUS Clonal Cytopenia of Undetermined Significance",[544,547,548,549],"CCUS","IDH2","Enasidenib",{"date":404,"type":35},{"date":552,"type":35},"2024-10-10",{"date":39,"type":21},{"name":41,"class":42},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":571,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":74},"100651769","communication-and-hospice-online-with-optimal-support-and-engagement-100651769","NCT07764432","Communication and Hospice Online With Optimal Support and Engagement","Communication and Hospice Online With Optimal Support and Engagement (CHOOSE)","CHOOSE","Eligibility Criteria:\n\n* Family caregiver of cancer patient receiving hospice care from an affiliated hospice organization. Only 1 FCG per patient may be enrolled.\n* At least 18 years of age.\n* Can speak and understand English.\n* Able to access the internet.\n* Has a Facebook account or is willing to create a Facebook account in order to be in this study",{"count":564,"type":21},567,[57],"The project is a multisite, three-group randomized control trial (RCT) with equal and parallel mixed-methods analysis that allows standardized measures combined with rich qualitative data to test hypotheses and answer research questions. Family caregivers (FCGs) of hospice cancer patients will be recruited and randomized into one of three groups: usual hospice care only (UC), usual care online support group (UCOSG) (without communication strategies), and the CHOOSE intervention group (with communication focus).",[568,569,570],"Caregivers","Family Caregivers","Cancer Caregivers",[568,569,570],"2026-08-06",{"date":574,"type":35},"2026-08-14",{"date":576,"type":21},"2027-02-01",{"date":578,"type":21},"2031-04-30",{"name":41,"class":42},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":232,"minAge":18,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":74},"100650982","sipuleucel-t-sip-t-in-combination-with-n-803-in-metastatic-androgen-pathway-modulation-resistant-mapmr-prostate-cancer-100650982","NCT07756593","Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer","A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed prostate adenocarcinoma.\n* Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral).\n* Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng\u002FdL.\n* Eligible for standard of care Sipuleucel-T.\n* Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500 K\u002Fcumm without granulocyte colony-stimulating factor support\n  * Platelets ≥ 100,000 K\u002Fcumm without transfusion\n  * Hemoglobin ≥ 10.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN\n  * Calculated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault\n* PSA ≤ 200 ng\u002FmL.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator.\n* Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment.\n* Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.\n* Prior exposure to Sipuleucel-T.\n* Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed).\n* Currently receiving any other investigational therapeutic or imaging agents.\n* Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a 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 Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Uncontrolled infection with hepatitis A.",{"count":157,"type":21},[24],"This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.",[240,591],"Metastatic Prostate Cancer",[240,369,593,594,591,595,596,597],"Sipuleucel-T","IL-15","Cellular Therapy","Cytokine Therapy","Combination Trial",{"date":404,"type":35},{"date":600,"type":21},"2026-11-30",{"date":602,"type":21},"2031-01-31",{"name":41,"class":42},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":613,"briefSummary":615,"conditions":616,"keywords":618,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":632},"100636742","hfref-polypill-in-sri-lanka-rct-100636742","NCT07569640","HFrEF Polypill in Sri Lanka RCT","Heart Failure With Reduced Ejection Fraction Polypill in Sri Lanka: A Multi-Center Type I Hybrid Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥18 years old)\n2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced left ventricular ejection fraction (EF ≤40%)\n3. New York Heart Association Class II, III, or IV symptoms\n\nExclusion Criteria:\n\n1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).\n2. Significant renal impairment (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2).\n3. Raised serum potassium \\>5 mEq\u002FL.\n4. Symptomatic hypotension or systolic BP \\\u003C100 mmHg as per the average of last 2 of the 3 measurements at visit 1.\n5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.\n6. History of type 1 diabetes mellitus.\n7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly acceptable form of contraception throughout the study (pharmacological or barrier methods).\n8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team\u002F primary physician could interfere with the conduct of the study including outcome assessment.\n9. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n10. Participant's responsible physician believes it is not appropriate for participant to participate in the study.\n11. Inability or unwillingness to provide written informed consent.\n12. Involvement in the planning and\u002For conduct of the study.\n13. Unable to complete study procedures and\u002For plan to move out of the study site area in the next 12 months.",{"count":612,"type":21},1672,[614],"PHASE3","The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up.\n\nPrimary outcome of the study:\n\n1\\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration\n\nSecondary outcomes of the study:\n\n1. Rate of cardiovascular disease mortality over study duration\n2. Rate of recurrent heart failure hospitalizations over the study duration\n3. Rate of all-cause mortality over the study duration\n4. Change in left ventricular ejection fraction at 12-months and end of study assessed by transthoracic echocardiogram\n5. Change in BNP levels at 12 months and end of study\n6. Change in overall and domain specific health-related quality of life at 12-months and end of study assessed by a translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-23)\n7. Change in physician-reported New York Heart Association class at 12-months and end of study\n8. Adherence to guideline-directed medical therapy assessed by pill count and MARS-5 questionnaire at baseline, 1-, 6-, 12-months, and end of study. Persistence assessed as continuation of assigned therapy at each follow-up visit. Dose optimization assessed as proportion achieving target doses (Strength 3 of the polypill, or comparable individual GDMT doses in the comparator arm) at 6-, 12-months, and end of study.\n\nSafety outcomes:\n\n1. Proportion of participants with serious adverse events according to Good Clinical Practice guidelines over study duration\n2. Proportion of participants with adverse events of special interest over study duration\n3. Proportion of participants with adverse events leading to HF drug discontinuation over study duration\n4. Mean change from baseline to 12-months and end of study in serum potassium (mEq\u002FL)\n5. Mean change from baseline to 12-months and end of study in serum creatinine (mg\u002FdL)\n\nParticipants will be randomly assigned 1:1 stratified by sex and site to one of two groups, intervention (experimental arm) or usual care (control arm). The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options. Both groups will be observed over a minimum of 12-months of follow-up to assess key outcomes.",[617],"Heart Failure With Reduced Ejection Fraction",[619,620,621,622,623,624,625],"HFrEF","Heart Failure","Heart Failure with Reduced Ejection Fraction","South Asia","Sri Lanka","Polypill","type I hybrid-effectiveness",{"date":404,"type":35},{"date":628,"type":21},"2026-08",{"date":630,"type":21},"2029-04",{"name":41,"class":42},10,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":79,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":83,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":43},"100600948","substance-use-in-pregnancy---optimizing-retention-in-treatment-100600948","NCT07104123","Substance Use in Pregnancy - Optimizing Retention in Treatment","SUPPORT-MOM","Inclusion Criteria:\n\nConfirmed viable intrauterine pregnancy at any gestational age, or within three years postpartum\n\nSUD as defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or clinician documentation\n\nExclusion Criteria:\n\nDecline follow-up care at study site\n\nRequire immediate hospitalization for unstable medical or psychiatric conditions making them clinically unsuitable to participate in a research study",{"count":264,"type":21},[57],"Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention.\n\nThis pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors.\n\nFindings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.",[91,90,644,645],"Postpartum","Contingency Management",{"date":404,"type":35},{"date":648,"type":35},"2026-02-02",{"date":650,"type":21},"2027-09",{"name":41,"class":42},{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":51,"sex":17,"minAge":660,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":663,"briefSummary":664,"conditions":665,"keywords":671,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":74},"100596775","advancing-biopsychosocial-care-training-initiative-100596775","NCT07049861","Advancing Biopsychosocial Care Training Initiative","Increasing Access to USPSTF-Recommended Obesity Care for Youth and Adults Who Are Recipients of Medicaid: Evaluation of a Comprehensive Multidisciplinary Obesity Care Training Program in FQHCs","ABC Initiative","Study Eligibility Criteria - Provider Trainees:\n\n* Provider Trainees must be PCPs, BHPs, RDNs, or CHWs who work at participating clinics.\n\n  * PCPs that are eligible to participate as Provider Trainees can be any of the following: Medical Doctors (MD), Doctor of Osteopathic Medicine (DO), Physician Assistants (PA), or Nurse Practitioners (NP). PCPs must see patients in a primary care setting and be capable of referring patients to IBT and MNT. PCPs must have already completed their residency (when applicable).\n  * BHPs that are eligible to participate as Provider Trainees must be at least one of the following categories (listed with typical credentials): Licensed Clinical Social Worker (LCSW), Licensed Professional Counselor (LPC), Licensed Marriage and Family Therapist (LMFT), Psychologist (PhD\u002FPsyD), Psychiatric Nurse Practitioner, Psychiatrist (MD).\n  * RDNs that are eligible to participate as Provider Trainees must be Registered Dietitians\u002FRegistered Dietitian Nutritionists.\n  * CHWs must work as Community Health Workers, or in functionally similar role, within participating clinics\n\nStudy Eligibility - EHR Patients: Benefit-Eligible Patients from Participating Clinics\n\n* Benefit-Eligible Patients from Participating Clinics can either be youth (ages 5-20) or adults (ages 21+) and must be recipients of Medicaid, eligible for the MO Medicaid benefit (i.e., Medicaid recipients with obesity), and have been seen at participating FQHC clinics.\n\nExclusion Criteria - Provider Trainees:\n\n* Not at a participating clinic\n* PCPs who do not have the ability to refer to IBT or MNT\n* Resident Doctors\n* A doctor specializing in reproductive health (or related fields)\n\nExclusion Criteria - Benefit-Eligible Patients from Participating Clinics:\n\n* Patients without obesity\n* Patients not on Medicaid\n* Youth under the age of 5\n* Not a patient at a participating clinic","5 Years",{"count":662,"type":21},6200,[57],"This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \\[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.",[666,667,668,669,670],"Weight Management","Obesity Prevention","Obesity and Obesity-related Medical Conditions","Obesity and Overweight","Obesity",[672,673,674,675,670,676],"Training","Implementation","Intensive Behavioral Treatment","Family-based Behavioral Treatment","Obesity Care",{"date":404,"type":35},{"date":679,"type":35},"2025-07-14",{"date":681,"type":21},"2028-12-15",{"name":41,"class":42},""]