[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Colorado, Denver\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":691},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,274,0,25,[9,47,76,102,135,165,185,213,240,262,288,319,349,372,401,425,459,482,524,559,580,607,634,663,682],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053271","implementation-and-interaction-of-clinician-and-patient-facing-tools-aiming-to-intensify-neurohormonal-medicines-for-heart-failure-100053271",false,"NCT06526988","Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure","Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction: I-I-CAPTAIN-HF","IICAPTAIN-HF","Inclusion Criteria:\n\nClinician:\n\n* Clinician (MD, PA, NP) who practices in cardiology outpatient clinics\n* Regularly sees patients with left ventricular ejection fraction (EF) \\\u003C\u002F=40%, where their panel of patients over the last year included at least 10 patients with heart failure with reduced ejection fraction (HFrEF)\n\nPatient:\n\n* Age \\> 18 years\n* LVEF \\\u003C\u002F=40% on most recent cardiology imaging study\n* Has a new or return clinic visit with an enrolled clinician within the next 7 days\n* Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter\n\nExclusion Criteria:\n\nPatient:\n\n* Has a left ventricular assist device\n* Under evaluation for or listed for transplant (or s\u002Fp transplant)\n* Glomerular filtration rate (GFR) less than 20 or on dialysis\n* On hospice care\n* Preferred language neither English or Spanish","ALL","18 Years",{"count":21,"type":22},2200,"ESTIMATED","INTERVENTIONAL",[25],"NA","An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.",[28],"Heart Failure With Reduced Ejection Fraction",[30,31,32,33],"Heart failure","Patient-centered care","Clinical decision support","Guideline-directed medical therapy","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-03-06",{"date":42,"type":22},"2028-09-01",{"name":44,"class":45},"University of Colorado, Denver","OTHER",5,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100053661","the-intersection-of-oncology-care-and-worker-well-being-100053661","NCT05250284","The Intersection of Oncology Care and Worker Well-Being","Inclusion Criteria:\n\n* Males\n* Ages 21 to 70\n* Newly diagnosed with a first primary solid tumor\n* colorectal, lung, and head and neck\n* Currently employed (defined as working 10+ hours per week) with the intention to continue working or return to work\n* Within 2 months of initiating infusion chemotherapy, oral agent, or radiation therapy","MALE","21 Years","70 Years",{"count":57,"type":22},400,"OBSERVATIONAL","The goals of this study will be a greater understanding of cancer patients' well-being experience through the care\u002Ftreatment continuum. An important aspect of the study is an understanding of work- and treatment-related challenges experienced by low-income men, many of whom will be Latino. At the 12-month observation period, the investigators will learn whether these men work long-term and how work status relates to well-being.",[61],"Solid Tumor",[63,64,65,66,67,68],"Newly Diagnosed Primary Solid Tumor","Men","Employed","Chemotherapy","Oral Agent","Radiation Therapy",{"date":37,"type":38},{"date":71,"type":38},"2022-04-04",{"date":73,"type":22},"2027-08-31",{"name":44,"class":45},1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100053788","phase-2-an-evaluation-of-maintenance-therapy-combination-mirvetuximab-soravtansine-and-olaparib-100053788","NCT05887609","An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib","A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer","Inclusion Criteria:\n\n* Provision to sign and date the consent form\n* Stated willingness to comply with all study procedures and be available for the duration of the study\n* Be a woman aged ≥18 years of age\n* Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Patients must have a confirmed diagnosis of high-grade serous or endometrioid EOC, primary peritoneal cancer, or fallopian tube cancer\n* Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of prior platinum therapy (not inclusive of current\u002Fmost recent platinum therapy)\n* Patients must have had documented complete or partial response, or stable disease, as defined by RECIST 1.1, from last line of platinum therapy\n* Patients must have available archival tissue block or slides to confirm FRalpha positivity\n* Patients' tumor must have FRalpha high or medium expression\n* Prior anticancer therapy:\n\n  * Patients must have received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.\n  * Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles\n  * Most recent prior chemotherapy regimen must have been platinum based\n  * Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n  * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n  * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n  * Prior Bevacizumab use is allowed, but concurrent use with study combination is prohibited.\n  * Cycle 1 Day 1 of trial therapy must be within 8 weeks of last dose of previous chemotherapy.\n* Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n  * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n  * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n  * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n  * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n  * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n  * Serum albumin ≥ 2 g\u002FdL\n\nExclusion Criteria:\n\n* Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n* Patients who have progressed through most recent chemotherapy regimen. Stable disease (SD) is permissible.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n* Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions require ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and\u002For monocular vision\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n  * Uncontrolled major seizure disorder\n  * Unstable spinal cord compression\n  * Any psychiatric disorder that prohibits obtaining informed consent.\n  * Active hepatitis B or C infection (whether or not on active antiviral therapy)\n  * Immunocompromised patients, e.g., patient who are known to be serologically positive for human immunodeficient virus(HIV)\n  * Active cytomegalovirus infection\n  * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV\n* Patients with a history of multiple sclerosis (MS) or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n* Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n  * Myocardial infarction ≤ 6 months prior to first dose\n  * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n  * Superior vena cava syndrome\n  * Unstable angina pectoris\n  * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n  * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n  * Uncontrolled cardiac arrhythmias\n* Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n* Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n* Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD) or Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan , including noninfectious pneumonitis\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia\n* Patients requiring use of folate-containing supplements (eg, folate deficiency)\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Patients with prior hypersensitivity to monoclonal antibodies (mAb)\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Women who are pregnant or breastfeeding, and who do not agree to use a highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV and at least 6 months after the last dose of Olaparib. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.\n* Patients who received prior treatment with MIRV or other FRα- targeting agents\n* Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n  * Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Patients with known untreated or symptomatic central nervous system (CNS) metastases\n* Patients with a history of other malignancy within 3 years prior to enrollment\n\n  * Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible\n* Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n* Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Inability to comply with study and follow-up procedures\n* Patients deemed otherwise clinically unfit for clinical trial per investigators discretion","FEMALE","100 Years",{"count":86,"type":22},53,[88],"PHASE2","The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.",[91,92,93],"Ovary Cancer","Peritoneal Cancer","Fallopian Tube Cancer","2026-07-09",{"date":37,"type":38},{"date":97,"type":38},"2023-10-03",{"date":99,"type":22},"2031-01-31",{"name":44,"class":45},6,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":75},"100594629","phase-3-brain-plasticity-and-glp-1-receptor-agonist-treatment-for-obesity-100594629","NCT07021937","Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity","Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial","PLASTIC","Inclusion Criteria:\n\n* English-speaking\n* male or female (sex assigned at birth)\n* 12-18 y\u002Fo with obesity (BMI\\>120% of the 95th %ile)\n* 30-45 y\u002Fo with obesity (BMI\\>35 kg\u002Fm2)\n\nExclusion Criteria:\n\n* treated with glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months\n* currently taking anti-psychotic medications (anti-depressants accepted)\n* diagnosis of type 2 diabetes\n* current or lifetime anorexia nervosa or current bulimia nervosa\n* head injury resulting in loss of consciousness \\>30min\n* neurological disorder (e.g., Parkinson's disease) or history of stroke\n* any contraindication to receiving a MRI (e.g., orthodontal braces)\n* psychological\u002Fbehavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician\n* if female, desiring to become pregnant, or currently pregnant or breastfeeding","12 Years","45 Years",{"count":113,"type":22},120,[115],"PHASE3","Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.",[118],"Obesity\u002FTherapy",[120,121,122,123,124,125],"adolescent","adult","brain function","glucagon-like peptide-1 receptor agonists","eating behaviors","appetite sensations","NOT_YET_RECRUITING","2026-06-30",{"date":129,"type":38},"2026-07-02",{"date":131,"type":22},"2026-06-15",{"date":133,"type":22},"2031-04-30",{"name":44,"class":45},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":18,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":101},"100632647","phase-1-safety-and-tolerability-trial-of-psilocybin-in-healthy-older-adults-100632647","NCT07516405","Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","Psil-Pk","Inclusion Criteria:\n\n* Aged 65-85 years \\& be male, female, or non-binary\n* Generally healthy\n* Have an identified support person\n* Capacity to Consent\n\nExclusion Criteria:\n\n* Unstable medical condition\n* Risk for hypertensive crisis (screening blood pressure \\>140\u002F90 mmHg)\n* Significant central nervous system (CNS) pathology\n* Primary psychotic or affective psychotic disorders\n* Family history of psychotic or serious bipolar spectrum illnesses\n* High risk of adverse emotional or behavioral reaction\n* Active substance use disorders (SUDs)\n* Extensive use of serotonergic hallucinogens\n* High risk of completed suicide\n* History of hallucinogen persisting perception disorder (HPPD)\n* Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10\n* Certain psychiatric conditions\n* Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study",true,"65 Years","85 Years",{"count":147,"type":22},40,[149],"PHASE1","This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.",[152,153],"Healthy Volunteer","Older Adults (65-85 Years)",[155,156,157],"healthy older adults ages 65-85","psilocybin safety","psilocybin tolerability","2026-06-29",{"date":127,"type":38},{"date":161,"type":38},"2026-04-01",{"date":163,"type":22},"2028-03",{"name":44,"class":45},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":75},"100477526","phase-4-effect-of-montelukast-on-kidney-and-vascular-function-in-type-1-diabetes-100477526","NCT05498116","Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes","Inclusion Criteria:\n\n* Age 18-80 years\n* Type 1 diabetes for at least 5 years\n* Urine albumin to creatinine ratio 30-5000 mg\u002Fg on first morning void\n* eGFR 30-89 ml\u002Fmin\u002F1.73m2 at time of screening\n* Blood pressure \\\u003C140\u002F90 mm Hg prior to randomization\n* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks\n* BMI \\\u003C 40 kg\u002Fm2 (FMDBA measurements can be inaccurate in severely obese patients).\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization\n* Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)\n* Able to provide consent\n\nExclusion Criteria:\n\n* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Uncontrolled hypertension\n* Factors judged to limit adherence to interventions\n* Anticipated initiation of dialysis or kidney transplantation within 6 months\n* Current participation in another research study\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Allergy to aspirin\n* Severe hepatic impairment (Child-Pugh Class C)\n* History of major psychiatric disorder\n* Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)\n* Penicillin allergy\n* Iodine allergy\n* Shellfish allergy\n* Current use of phenobarbital, rifampin or carbamazepine","80 Years",{"count":173,"type":22},50,[175],"PHASE4","Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.",[178],"Albuminuria",{"date":127,"type":38},{"date":181,"type":38},"2023-01-26",{"date":183,"type":22},"2027-04",{"name":44,"class":45},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100480004","seattle-biopsy-protocol-versus-wide-area-transepithelial-sampling-in-patients-with-barretts-esophagus-undergoing-surveillance-100480004","NCT05530343","Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance","A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)","SWAT-BE","Inclusion Criteria:\n\nSurveillance Population\n\n* Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia\u002Findefinite for dysplasia with NDBE at last endoscopy can be included)\n* Barrett's esophagus (BE) length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age18-89 years\n* Life-expectancy of at least 2 years\n\nScreening Population\n\n* Undergoing endoscopy for screening of BE\n* BE length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age 18-89 years\n* Expected life-expectancy of at least 2 years\n\nPhysicians\n\n-All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.\n\nExclusion Criteria:\n\nSurveillance Population\n\n* BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of EET\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy\n\nScreening Population\n\n* BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy","89 Years",{"count":195,"type":22},2298,[25],"The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).\n\nBarrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.\n\nEndoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.\n\nPatients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).\n\nPatients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.\n\nWhile both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.\n\nParticipants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.\n\nUp to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.",[199,200,201],"Barrett Esophagus","Barretts Esophagus With Dysplasia","Esophageal Adenocarcinoma",[203,201,204],"Barrett's Esophagus","Dysplasia",{"date":206,"type":38},"2026-07-01",{"date":208,"type":38},"2022-10-03",{"date":210,"type":22},"2026-06",{"name":44,"class":45},14,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":75},"100619653","phase-1-cd64-car-t-cell-therapy-in-adults-with-relapsed-andor-refractory-aml-100619653","NCT07347418","CD64 CAR T Cell Therapy in Adults With Relapsed and\u002For Refractory AML","Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety, Expansion, Persistence, and Preliminary Clinical Activity of Autologous CD64 CAR T Cells in Patients With Relapsed and\u002For Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Subjects must have one of the following diagnoses per the International Consensus Classification (ICC) 2022 criteria:\n\n   a. Acute Myeloid Leukemia (AML).\n3. Refractory OR relapsed AML:\n\n   a. Refractory disease i. ≥5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry, or immunohistochemistry after a minimum of 1 cycle of a hypomethylating agent (HMA) and venetoclax (Ven) combination (Ven\u002FHMA) b. Relapsed disease i. Recurrence of ≥ 5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry or immunohistochemistry.\n4. Subjects must have received at least one prior line of therapy, including at least one line of therapy containing Ven.\n5. Documentation of CD64 expression on ≥70% of myeloid blasts by flow cytometry after the most recent relapse, as determined by standardized and validated multiparameter flow cytometry assay (Hematologics, Inc., Seattle, WA).\n6. Total white blood cell (WBC) count ≤ 25 x 10(to the 9th)\u002FL prior to apheresis. Hydroxyurea is permitted to achieve this\n7. Absolute lymphocyte count (ALC) ≥ 200\u002FµL prior to apheresis OR ALC \\\u003C 200 µL with concurrent lymphocyte subset analysis (CD3, CD4, and CD8 counts) confirming an absolute CD3 count ≥ 150\u002FµL.\n8. Confirmed availability of cells for a rescue stem cell transplant AND subject must be deemed an appropriate candidate for such therapy per institutional standards.\n9. Subjects who have undergone prior allogeneic stem cell transplant must be ≥ 6 months out from transplant and be off systemic immunosuppression for at least 1 month at the time of enrollment with no evidence of active graft versus host disease.\n10. Adequate organ function, defined as:\n\n    1. Creatinine clearance ≥ 30 mL\u002Fmin, based on the CKD-EPI Creatinine Equation (2021).\n    2. AST\u002FALT ≤ 5x upper limit of the normal range, unless considered to be due to leukemic involvement.\n    3. Bilirubin ≤ 3x upper limit of the normal range, unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement.\n    4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air, unless considered to be due to leukemic involvement.\n    5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO\u002FMUGA.\n11. ECOG performance status 0, 1, or 2.\n12. Signed informed consent form.\n13. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in the protocol main text.\n14. Willing to participate in the long-term follow-up protocol that is required if CAR T cell therapy is administered.\n\nExclusion Criteria:\n\n1. Subjects with Acute Promyelocytic Leukemia (APL) with t(15;17)\n2. Receipt of previous chemotherapy for AML, as follows:\n\n   a. Prior to apheresis, the following washout periods apply: i. Hydroxyurea: 1 day ii. Hypomethylating agent and\u002For venetoclax: 7 days iii. Small molecule targeted therapy (including tyrosine kinase inhibitors): 3 half-lives or 7 days, whichever is shorter.\n\n   iv. Immune checkpoint inhibitors or other immunological agents: 5 half-lives or 28 days, whichever is shorter.\n\n   v. Investigational products: 5 half-lives or 28 days, whichever is shorter. vi. Any other systemic chemotherapy: 14 days vii. Allogeneic stem cell transplantation: 180 days viii. Donor lymphocyte infusion (DLI): 60 days ix. Craniospinal or total body radiation: 42 days b. After apheresis and prior to lymphodepletion, no treatment for AML is permitted, with the exception of bridging hydroxyurea with a washout period of 1 day prior to the start of the lymphodepletion regimen.\n3. Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.\n4. Previous treatment with investigational gene or cell therapy (including CAR therapy).\n5. Signs or symptoms indicative of CNS leukemia involvement. A CNS evaluation should be performed if CNS involvement is suspected to rule out CNS leukemia involvement.\n6. Pregnant or lactating (nursing) women.\n7. Known HIV infection or active Hepatitis B or Hepatitis C infection.\n8. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).\n9. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n10. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.\n11. Subjects with cardiac arrhythmia, or arrhythmias that are not stable with medical management, within 2 weeks of the Screening\u002FEnrollment visit.\n12. Any uncontrolled active medical disorder that would preclude participation as outlined.\n13. Evidence of another uncontrolled malignancy.\n\nApheresis Eligibility To proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21 days prior to apheresis, unless otherwise specified.\n\nNote: Disease evaluation (bone marrow aspirate and biopsy) to meet inclusion criteria must be completed within 30 days prior to enrollment.\n\nLymphodepleting Chemotherapy Eligibility To proceed with lymphodepleting chemotherapy, enrolled participants must have specific assessments completed and continue to meet all inclusion criteria within 72 hours of initiation of lymphodepletion\n\nCD64 CAR T Infusion Eligibility\n\nParticipants must meet the following criteria in order for cells to be infused (based on labs obtained within 24 hours of cell infusion):\n\n* CD64 CAR T must have met manufacturing criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA)\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* Performance status determination (ECOG must be 0, 1 or 2).\n* Participant remains clinically stable without evidence of vital sign instability including the lack of supportive vasoactive drugs or intensive care support.\n* Must not have ALT\u002FSGPT and AST\u002FSGOT \\> 10x the ULN or total bilirubin \\> 3x the ULN, (unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement)\n* Adequate renal function, as defined in the Inclusion Criteria.\n* No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator.",{"count":221,"type":22},23,[149],"This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ\u002F4-1BB) costimulatory domains in subjects with refractory or relapsed (R\u002FR) acute myeloid leukemia (AML). This CAR T cell product will be referred to as \"CD64 CAR T\" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R\u002FR AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.",[225,226,227,228],"Refractory Acute Myeloid Leukemia (AML)","Relapsed Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome","AML (Acute Myeloid Leukemia)",[230,231,232,233],"AML","CD64","CAR T","CAR T cell","2026-06-25",{"date":158,"type":38},{"date":210,"type":22},{"date":238,"type":22},"2032-06",{"name":44,"class":45},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":261,"locationsCount":75},"100643876","aerobic-exercise-as-a-countermeasure-for-night-shift-associated-circadian-misalignment-100643876","NCT07668622","Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment","The Impact of Exercise on Cardiometabolic Health During Shiftwork: A Proof of Concept Study","SHIFT-EX","Inclusion Criteria:\n\n* Age 18-40 years\n* Body Mass Index 18.5-\\\u003C40kg\u002Fm\\^2\n* Physically inactive: defined as \\\u003C150 minutes per week of voluntary exercise at moderate intensity or greater and \\\u003C60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months.\n* No plans to relocate within the next 6 months.\n* No plans for extended travel (\\>2 weeks) within the next 3 months.\n* Capable and willing to give informed consent, understand exclusion criteria, and adhere to study conditions.\n* Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures.\n* No contraindications to exercise or limitations on ability to be physically active.\n* Ability to adhere to sleeping, eating, and exercise protocol\n* Willing and able to wear activity\u002Fsleep monitor for 7 consecutive days.\n* For Females:\n* Not currently pregnant or lactating.\n* Not pregnant within the past 6 months.\n* Not planning to become pregnant in the next 6 months\n* Regularly timed menstrual cycles to facilitate measurement of EE in the early follicular phase.\n\nExclusion Criteria:\n\n* Diastolic blood pressure \\>100 mmHG, systolic blood pressure \\>160 mmHG, or resting heart rate \\>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.\n* Diabetes (fasting glucose \\>\u002F=126 mg\u002FdL or Hemoglobin A1C \\>\u002F=6.5%) as measured during the screening visit.\n* Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.\n* Triglycerides \\>400 mg\u002FdL as measured on the screening visit.\n* LDL cholesterol \\>200 mg\u002FdL as measured on the screening visit.\n* Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \\> 480 msec or other significant conduction defects.\n* Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in exercise: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.\n* Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.\n* Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.\n* Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.\n* Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).\n* Regular use of systemic steroids (other than Oral Contraceptive Pills).\n* Regular use of obesity pharmacotherapeutic agents within the last 6 months.\n* Current alcohol or substance abuse.\n* Nicotine use (past 6 months).\n* Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score \\> 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate\n* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the study conditions.\n* Weight loss \\>5% in past 3 months.\n* Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.\n* Primary sleep disorders including but not limited to insomnia, obstructive sleep apnea, periodic limb movements in sleep, restless leg syndrome.\n* Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder).\n* Self-reported long (\\>9.25h) or short sleep (\\\u003C7h) that would make adhering the exercise conditions difficult.\n* Regular use of prescription or over-the-counter medications known to affect sleep (e.g., benzodiazepines, doxepin, zolpidem, trazodone, diphenhydramine HCl, etc.).\n* Regular use of melatonin (\\>\u002F=2 days per week).\n* High consumption of caffeine (\\>500 mg\u002Fd) or unwilling to abstain from caffeine consumption during run-in and in-patient protocol.\n* Planned travel \\>1 time zone away 4 weeks prior to study start or at any time during study protocol.","40 Years",{"count":250,"type":22},16,[25],"This study plans to learn more about whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule are out of sync with their natural body clock (circadian rhythm).",[254,255],"Healthy","Circadian Misalignment","2026-06-19",{"date":234,"type":38},{"date":206,"type":22},{"date":260,"type":22},"2028-07-01",{"name":44,"class":45},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":143,"sex":18,"minAge":111,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},"100636712","increasing-crc-screening-in-community-health-centers-through-mobile-messaging-optimization-100636712","NCT07569250","Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization","CoSMMO","Eligibility Criteria for CHC Patients Cohorts\n\nInclusion Criteria (CHC Patients):\n\n* Adults 45-75 years old\n* Receive care in partner CHCs\n* Are of average risk for colorectal cancer\n* Received a stool-based testing order at their CHC\n* Have a mobile phone and can receive text messages (Aim 1 quantitative cohort only)\n* Fluent in English, Spanish, or another predominant language to be identified by the PI (applicable to patients focus groups cohort only)\n\nExclusion Criteria (CHC Patients):\n\n* Personal or family history of CRC or colorectal polyps\n* History of inflammatory bowel disease\n* Heritable conditions that put them at above average risk for colorectal cancer (e.g., familial adenomatous polyposis)\n\nEligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)\n\n* Adult employees of participating CHCs\n* Job responsibilities include activities related to CRC screening\n\nExclusion Criteria (CHC Staff)\n\n* None","75 Years",{"count":271,"type":22},7220,[25],"The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal.\n\nFirst, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program.\n\n* Clinic patients will participate in focus groups\n* Clinic staff will participate in interviews\n\nSecond, the investigators will test a series of different message versions in two batches (experiments):\n\n* Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions.\n* In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment.\n* In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion.\n* This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients.\n\nLastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run.\n\n-Clinic staff will participate in interviews and surveys.",[275],"Colorectal Cancer",[277,278,279],"colorectal cancer screening","Text messaging","Community Health Centers (CHC)",{"date":281,"type":38},"2026-06-23",{"date":283,"type":22},"2026-12",{"date":285,"type":22},"2032-01",{"name":44,"class":45},4,{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":143,"sex":18,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":75},"100643611","understanding-the-causes-of-idiopathic-scoliosis-through-the-longitudinal-analysis-of-proteomic-markers-the-uncoil-study-100643611","NCT07634627","UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study","UNCOIL","Inclusion Criteria:\n\n* Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50° that are currently being seen for their scoliosis at a Children's Hospital Colorado location\n\nExclusion Criteria:\n\n* Children diagnosed with certain genetic conditions that affect the bones or muscles (Turner syndrome, down syndrome, Marfan syndrome, osteogenesis imperfecta, muscular dystrophy, Ehlers-Danlos syndrome, VATER\u002FVACTERL syndrome, Rett syndrome, Prader Willi syndrome, or Angelman syndrome)\n* Patients with congenital scoliosis, early onset scoliosis (diagnosed before 9 years old), or those who have spine surgery scheduled prior to the first study visit\n* Patients whose spinal curve is \\>50 degrees\n* Those taking medications that may influence protein expression (baclofen, prednisone\u002Fcorticosteroids, antiepileptic medications, diazepam, tizanidine, and\u002For dantrolene)\n* Patients who are pregnant\n* Patients with neurocognitive disorders who are non-verbal and\u002For non-ambulatory\n* Patients who are not receiving care for scoliosis at a Children's Hospital Colorado location","10 Years","17 Years",{"count":298,"type":22},500,"The goal of this observational study is to find clinical, demographic, and protein biomarkers that scoliosis progression (scoliosis curve increases) and\u002For differ between participants with scoliosis versus those without scoliosis. The investigators aim to answer the following questions:\n\n1. Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression?\n2. Do protein levels differ between progressive and non-progressive cases?\n3. Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases?\n4. Do proteins differ between participants with AIS vs those without AIS?\n5. Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions.\n\nParticipants will:\n\n* Participate in two research visits 6-12 months apart at a Children's Hospital Colorado location.\n* Participate in a blood draw at each study visit to collect about 3 tablespoons of blood.\n* Fill out surveys yearly regarding new medical visits, pain, physical function, anxiety and depression, medical and family history, and current medications.",[301,302],"Adolescent Idiopathic Scoliosis (AIS)","Neuromuscular Scoliosis",[304,305,306,307,308,309,310,311],"Adolescent Idiopathic Scoliosis","Proteomics","AIS","Idiopathic Scoliosis","protein biomarkers","biomarkers","plasma proteomics","Neuromuscular scoliosis","2026-06-18",{"date":281,"type":38},{"date":315,"type":38},"2024-12-05",{"date":317,"type":22},"2031-12",{"name":44,"class":45},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":295,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":75},"100599263","multidimensional-sleep-health-intervention-to-optimize-concussion-recovery-100599263","NCT07082218","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial","SCORE","Inclusion Criteria:\n\n* Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \\[PCSI\\] score ≥9)\n* Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria\n* 10-19 years of age (aligned with World Health Organization definition of 'adolescent')\n\nExclusion Criteria:\n\n* History of treatment for pre-concussion sleep-related disorders","19 Years",{"count":329,"type":22},54,[25],"Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.",[333,334,335,336,337],"Concussion (Diagnosis)","Concussion, Mild Traumatic Brain Injury","Treatment","Sleep Health","Depression, Anxiety",[339,340,341],"intervention","mild traumatic brain injury","sleep quality","2026-06-17",{"date":312,"type":38},{"date":345,"type":38},"2025-09-10",{"date":347,"type":22},"2027-06-15",{"name":44,"class":45},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":143,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":101},"100636710","testing-the-impact-of-the-mohr-follow-up-support-100636710","NCT07569224","Testing the Impact of the MOHR Follow-up Support","Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition","Inclusion Criteria:\n\n* Adults, aged 18 years and older.\n* Completion of the MOHR health risk assessment and goal-setting tool\n* Score in the \"at-risk\" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit\u002Fvegetables\n* Patient at one of the participating clinics\n\nExclusion Criteria:\n\n* Incomplete or no MOHR assessment\n* Language preference\u002Fproficiency other than English or Spanish\n* Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).",{"count":357,"type":22},1000,[25],"This study will evaluate the impact of 3 different strategies to increase engagement of participants in My Own Health Report (MOHR) and health behavior change activities over time. This study will evaluate the level of engagement, outcomes, cost and cost-effectiveness of these strategies.",[361],"Implementation Strategy Bundles for Structured Follow-up",[363,364],"Implementation strategy","patient follow-up",{"date":366,"type":38},"2026-06-16",{"date":368,"type":38},"2026-06-02",{"date":370,"type":22},"2029-12-31",{"name":44,"class":45},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":111,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":388,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":75},"100538987","impact-of-menstruation-on-glycemic-response-and-exercise-in-females-with-type-1-diabetes-100538987","NCT06297980","Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes","MERIT","Inclusion Criteria:\n\n* Women 18-45 who have had type 1 diabetes for at least 12 months\n* Premenopausal with either menstrual cycles or currently using oral contraceptives\n\nExclusion Criteria:\n\n* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy",{"count":380,"type":22},150,[25],"The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.",[384,385,386,387],"Type 1 Diabetes","Hypoglycemia","Hyperglycaemia Due to Type 1 Diabetes Mellitus","Menstruation Disturbances",[389,390,391,392,393,394],"type 1 diabetes","menstrual cycle","exercise","hypoglycemia","hyperglycemia","glucose control",{"date":366,"type":38},{"date":397,"type":38},"2024-03-24",{"date":399,"type":22},"2027-10-31",{"name":44,"class":45},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":407,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":75},"100560338","accuracy-of-continuous-glucose-monitors-during-the-perioperative-period-in-youth-with-type-1-diabetes-100560338","NCT06575842","Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants will be 2 to 26 years of age at the time of enrollment.\n2. Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.\n3. Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Currently using hydroxyurea.\n3. A condition that the investigator determines would prevent the patient from participation.","2 Years","26 Years",{"count":113,"type":22},"This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.",[384],[413,414,415,416],"Anesthesia","Continuous glucose monitors","Accuracy","Pediatrics","2026-06-11",{"date":419,"type":38},"2026-06-12",{"date":421,"type":38},"2024-08-21",{"date":423,"type":22},"2027-12-01",{"name":44,"class":45},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":432,"maxAge":145,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":75},"100502446","phase-2-cbd-for-individuals-at-risk-for-alzheimers-disease-100502446","NCT05822362","CBD for Individuals at Risk for Alzheimer's Disease","Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial","Inclusion Criteria:\n\n1. Must be between the ages of 55 - 85 and provide valid informed consent.\n2. Participant must receive a diagnosis of Mild Cognitive Impairment after a careful cognitive and functional evaluation by a clinician, or have symptoms of Mild Cognitive Impairment as determined by the study physician.\n3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.\n4. Montreal Cognitive Assessment (MoCa) score is ≤ 25\n5. Participant must have a CDR score of .5 or 1 on the Clinical Dementia Rating scale (CDR), which includes an assessment of function and is often used to distinguish MCI from dementia. A score of 0.5 indicates mild cognitive impairment but not dementia and a score of 1 indicates mild-to-moderate cognitive impairment.\n6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person for all CDR assessments completed via phone).\n7. Participant must pass a test of consent comprehension\n8. Must be interested in using CBD to help with cognitive function\n9. Must plan on living in the Denver metro area over the next 6 months\n10. Able to attend in-person visits at the study site\n\nExclusion Criteria:\n\n1. Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.\n2. History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)\n3. Any significant systemic illness or unstable medical condition\n4. Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications\n5. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \\& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by the DSM-5-TR\n6. Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.\n7. Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline.\n8. Report using more than 150mg of cannabis edible products per week.\n9. Report using more than 7 grams of cannabis flower product (not including CBD) per week.\n10. Recent history of, or meets criteria for major depression with suicidal ideation.\n11. Reports use of medical CBD.\n12. Liver function enzymes (AST, ALT) that are greater than 2x normal.\n13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).\n14. Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)\n15. Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).","55 Years",{"count":434,"type":22},236,[88],"This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, and behavioral, neurocognitive, and clinical measures, with putative mechanisms of action.",[438],"Mild Cognitive Impairment",[440,441,442,443,444,445,446,438,447,448,449,450,451,452],"Cognition","Cannabidiol","Aging","Memory","Alzheimer's Disease","CBD","MCI","Cognitive decline","Healthy aging","Older adults","Brain","Cannabis","Marijuana",{"date":131,"type":38},{"date":455,"type":38},"2024-01-19",{"date":457,"type":22},"2029-04",{"name":44,"class":45},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":481,"locationsCount":75},"100486402","phase-2-alcohol-use-disorder-and-cannabidiol-100486402","NCT05613608","Alcohol Use Disorder and Cannabidiol","Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies","Inclusion Criteria:\n\n1. Must be ≥21 years old.\n2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).\n3. Expresses desire to reduce or quit drinking.\n4. If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening, or if a male respondent reports consuming 5 or more alcoholic drinks on at least one drinking day per week on average (4 or more if female).\n5. Able to attend in-person visits at the study site.\n6. Participants reporting current nicotine use in any form will be included.\n\nExclusion Criteria:\n\n1. Self-reported DSM-V diagnosis of any other substance use disorder.\n2. Self-report illicit\u002Frecreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.\n3. Uses CBD products for medical reasons.\n4. Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive\u002Fcompulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.\n5. Endorsing item 2 on the C-SSRS measure of suicide risk.\n6. Currently taking any of the following medications:\n\n   1. Those known to have a major interaction with Epidiolex.\n   2. Acute treatment with any antiepileptic medications.\n   3. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and\u002For topiramate).\n7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).\n8. Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.\n9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.\n10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.\n11. Current charges pending for a violent crime (not including DUI-related offenses).\n12. Lack of a stable living situation.\n13. Lack of access to internet.",{"count":467,"type":22},180,[88,115],"This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.",[471],"Alcohol Use Disorder",[473,474,475,476],"alcohol","cannabidiol","cbd","cannabis",{"date":131,"type":38},{"date":479,"type":38},"2023-04-30",{"date":183,"type":22},{"name":44,"class":45},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":505,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100593800","primary-care-pragmatic-real-world-experience-for-automated-insulin-delivery-100593800","NCT07011147","Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery","PREPARE 4 AID","Inclusion Criteria:\n\n1. Age at time of consent \\>18 and \\\u003C89 years\n2. Either 2.a. or 2.b.:\n\n   1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n   2. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)\n3. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1\u002FGIP RA agents\n4. Stable doses of weight loss medications (including GLP-1 RA and GLP-1\u002FGIP RA agents) over the preceding 4 weeks as determined by the investigator.\n5. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and\u002For indirectly, except for a dose reduction or discontinuation.\n6. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study\n7. Willing to comply with all study procedures for the duration of the study\n8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP\n9. Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)\n10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Willing and able to sign and date the Informed Consent Form (ICF)\n12. If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period\n\n    a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).\n\n    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).\n\n    iii. Placement of an intrauterine device or intrauterine hormone-releasing system.\n\n    iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository).\n\n    v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.\n\n    vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.\n13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration\n14. Have hardware and internet access capable of 2-way video and audio communication\n\nExclusion Criteria:\n\n1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)\n2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only\n3. Diagnosis of maturity-onset diabetes of the young (MODY)\n4. Plan to change usual diabetes regimen between screening and study randomization\n\n   1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1\u002FGIP RA medication\n   2. This would NOT include changes to any insulin doses, including pump settings, short- and\u002For long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1\u002FGIP RA); or changing type of type 2 diabetes medication within the same class\n5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface\n6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation\n7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. \"DIY Loop\", \"AAPS\", \"iAPS\" or \"Open APS\")\n8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy\n9. Planned use of hydroxyurea at any dose and\u002For of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.\n10. Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment\n11. Current participation in another diabetes-related clinical trial\n12. History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n13. Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)\n14. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula\n15. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n16. Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication\n17. Any planned surgery during the study that would be considered major in the opinion of the investigator\n18. Pregnant or lactating, or planning to become pregnant in the next 6 months\n19. Renal failure on dialysis or chronic renal disease with a GFR or eGFR \\\u003C30mL\u002Fmin (values within the last two years will be accepted; if none available or \\>2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)\n20. Any condition or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and\u002For benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures iii. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening, a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting iv. Known history of prolonged QTc interval, malignant arrhythmia, or severe congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia, or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n21. Plans to travel outside of the US and its territories for more than four weeks consecutively\n22. Plans not to have internet\u002Fvideo\u002Fphone access for more than one week consecutively\n23. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial\n24. Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)",{"count":490,"type":22},240,[25],"The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:\n\nCan the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?\n\nResearchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.\n\nParticipants will:\n\nUse the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks",[494,495,496,497,498,499,500,501,502,503,504],"Type 1 Diabetes (T1D)","Type 2 Diabetes","Diabetes, Autoimmune","Diabetes Mellitus","Diabetes Mellitus Type 2","Diabetes Mellitus, Type I","Diabetes, Type II","Diabetes","Diabetes Mellitus, Insulin-Dependent","Diabetes Mellitus Type II","Diabetes Type 2 on Insulin",[506,389,507,508,509,510,511,512,513,514,515],"automated insulin delivery","type 2 diabetes","bionic pancreas","closed loop","pancreas, artificial","t1d","t2d","diabetes","insulin","primary care","2026-06-10",{"date":417,"type":38},{"date":519,"type":38},"2026-01-16",{"date":521,"type":22},"2029-04-01",{"name":44,"class":45},2,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":75},"100642996","effects-of-transcranial-magnetic-stimulation-on-social-cognition-cognitive-processing-and-functional-brain-architecture-100642996","NCT07635940","Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture","Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture in Psychopathy","Inclusion Criteria:\n\n* 18-60 years.\n* Elevated psychopathy as defined by the self-report psychopathy scale.\n* IQ \\>= 80.\n* No prior diagnosis or current risk of Autism as defined by the autism spectrum quotient.\n* Negative urine drug screen.\n* At least 7 Days of abstinence from substance use (excluding nicotine)\n* Able to provide informed consent.\n* No change in psychiatric medication regimen, or medication-free, for 4 weeks before study.\n* Adequate English proficiency to complete study procedures and assessments.\n\nExclusion Criteria:\n\n* Current or lifetime DSM-5 psychotic disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or autism spectrum disorder.\n* IQ \\\u003C 80.\n* Clinically significant neurological disorder or medical illness that would make study participation unsafe, including a history of seizures or significant cardiovascular disease.\n* Clinically significant abnormality identified on baseline MRI.\n* Contraindication to MRI or inability to undergo MRI scanning.\n* Current pregnancy or breastfeeding.\n* History of head injury resulting in loss of consciousness greater than 15 minutes.\n* Diagnosis of dementia.\n* Current prescription for benzodiazepines or anticonvulsants.\n* Metal implants or non-removable metal objects above the waist.\n* Lifetime history of prior clinical treatment with transcranial magnetic stimulation (TMS).\n* Serious risk of suicide or homicide.\n* Unable or unwilling to comply with study procedures.\n* History of intractable migraine.\n* Claustrophobia or inability to tolerate enclosed spaces required for MRI procedures.","60 Years",{"count":533,"type":22},60,[25],"This clinical trial will examine whether transcranial magnetic stimulation (TMS), a noninvasive form of brain stimulation, can influence social cognition, cognitive processing, and brain function in adults with elevated psychopathic traits. The study will also evaluate the safety and feasibility of delivering TMS in this population.\n\nParticipants will be randomly assigned to receive either active TMS or sham (placebo-like) TMS. The study will compare outcomes between participants receiving active versus sham TMS and will evaluate changes from before to after TMS exposure.\n\nParticipants will:\n\n* Complete a baseline magnetic resonance imaging (MRI) brain scan.\n* Receive three single-session TMS interventions.\n* Complete a post-intervention MRI brain scan.\n* Complete assessments of social cognition.\n* Complete assessments of cognitive processing.\n\nThe primary objectives are to determine whether TMS can influence social cognition, cognitive processing, and functional brain organization and connectivity in adults with elevated psychopathic traits.",[537],"Psychopathy",[537,539,540,541,542,543,544,545,546,547,548,549,550,551,552],"Transcranial Magnetic Stimulation","Theta Burst Stimulation","Neuromodulation","Social Cognition","Emotion Recognition","Theory of Mind","Social Decision Making","Cognitive Processing","Cognitive Control","Executive Function","Functional Connectivity","Resting-State fMRI","Dorsolateral Prefrontal Cortex","Temporal Parietal Junction","2026-06-09",{"date":417,"type":38},{"date":210,"type":22},{"date":557,"type":22},"2030-08",{"name":44,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":111,"enrollmentInfo":566,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":568,"conditions":569,"keywords":572,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":75},"100238477","longitudinal-study-of-intra-uterine-growth-restriction-100238477","NCT02382601","Longitudinal Study of Intra-Uterine Growth Restriction","Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)","Inclusion Criteria:\n\n* Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.",{"count":567,"type":22},200,"The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.",[570,571],"IUGR","Pregnancy",[571,570,573],"Small for gestational age",{"date":417,"type":38},{"date":576,"type":38},"2015-04",{"date":578,"type":22},"2028-12",{"name":44,"class":45},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":295,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":287},"100354889","phase-1-losartan--sunitinib-in-treatment-of-osteosarcoma-100354889","NCT03900793","Losartan + Sunitinib in Treatment of Osteosarcoma","A Phase I\u002FIb Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma","Inclusion Criteria:\n\n* 1\\. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form and provision of individual to provide assent for study).\n\n  2\\. Stated willingness to comply with all study procedures and be available for the duration of the study.\n\n  3\\. Male or female aged ≥ 10 years old. 4. Histologically confirmed osteosarcoma (at either original diagnosis or relapse) that has either recurred or progressed after at least one prior systemic therapy and for which no curative therapy exists.\n* Patients with surface or periosteal osteosarcoma are not eligible.\n* Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of active recurrence, are acceptable.\n\n  5\\. Disease status\n* Dose Escalation (Part A): Patients must have measurable or evaluable disease.\n* Cohort Expansion (Part B): Patients with measurable or evaluable disease and those with completely resected disease are eligible.\n\n  6\\. Performance status:\n* ECOG performance status (≥18 years old) ≤ 2 or Karnofsky performance score (\\\u003C18 years old)≥ 50.\n\n  7\\. Prior Therapy:\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met (e.g., blood count criteria) the patient is considered to have recovered adequately.\n\n  1. Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).\n  2. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent.\n\n  i. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n\nii. Corticosteroids: ≥ 14 days must have elapsed since last dose of corticosteroid.\n\niii. Hematopoietic growth factors: ≥ 14 days after the last dose of a long- acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor.\n\niv. Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors).\n\nv. Stem cell Infusions: Autologous stem cell infusion, including boost infusion: ≥ 42 days.\n\nvi. Cellular Therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) vii. XRT\u002FExternal Beam Irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow radiation.\n\n* NOTE: Patients with history of cardiac irradiation with mean cardiac dose \\> 15 Gy are not eligible (see exclusion criteria).\n\n  8\\. Adequate bone marrow function, defined as:\n* Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n* Platelet count ≥ 75,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin ≥ 8 g\u002FdL (with or without transfusion) 9. Adequate renal function, defined as:\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2 OR a serum creatinine based on age\u002Fgender.\n\n  10\\. Adequate hepatic function, defined as:\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* SGPT (ALT) ≤ 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n* Serum albumin ≥ 2.8 g\u002FdL 11. Patients with ≥ trace protein on urinalysis at screening will be allowed to enroll in the study at investigator discretion. A baseline urine protein creatinine ratio (UPC) should be obtained for patients with ≥ trace protein on urinalysis for consideration regarding Section 6.3.7 dose modification requirements.\n\n  12\\. Adequate cardiac function, defined as:\n* Current cardiac ejection fraction \\> 50% by biplane Simpson method on echocardiogram\n* QTc ≤ 480 ms 13. Patients with preexisting hyper- or hypothyroidism must be on a stable dose of medication.\n\n  14\\. Ability to take and retain oral medications. NOTE: Medication can be administered via nasogastric or gastrostomy tube.\n\nExclusion Criteria:\n\n1. Patients who underwent major surgery within 14 days prior to start of treatment are not eligible.\n\n   NOTE: Core biopsy or central line placement are considered minor and are allowed within any time limitations.\n2. Patients with uncontrolled coagulopathy or bleeding disorder, or any active bleeding (i.e., gastrointestinal or pulmonary) deemed to be clinically significant by investigator are not eligible.\n3. Patients with history of pulmonary embolism or significant thromboembolic event with the preceding 28 days. Patients with thromboembolic events \\> 28 days before enrollment who are stable on or completed an anticoagulation course are eligible.\n4. Patients with history of cardiac irradiation with mean cardiac dose \\> 15 Gy are not eligible.\n5. Patients with symptomatic cardiac disease (i.e. New York Heart Association or Modified Ross Heart Failure Classification for Children \\> class 2) are not eligible.\n6. Patients with any history of cardiac dysfunction including prior abnormal echocardiogram (ejection fraction \\\u003C 50%), severe or unstable angina, peripheral vascular disease, congenital prolonged QTc syndrome, clinically significant cardiac arrhythmias, stroke, or myocardial infarction are not eligible.\n7. Pregnancy\n\n   * Pregnant or breast-feeding women will not be entered on this study because there is not yet available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in females who are post-menarchal.\n   * Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 3 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. Patients who themselves or their partners have undergone female or male sterilization do not require 2 methods of contraception. Highly effective methods are defined as those with \\\u003C1% failure rate with perfect use and include: oral contraceptive pills (combined or progesterone only), intrauterine devices (IUD), hormonal implant or injection, contraceptive patch, and vaginal ring.\n8. Concomitant medications:\n\n   * Anti-hypertensives: Patients who cannot be controlled to goal blood pressure for gender\u002Fage are not eligible.\n   * Corticosteroids: Patients receiving systemic corticosteroids are not eligible. \\> 14 days must have elapsed since last systemic corticosteroid. Note: patients using topical or inhaled corticosteroids are eligible.\n   * Investigational Drugs: Patients currently receiving another investigational drug are not eligible.\n   * Anti-cancer agents: Patients currently receiving other anti-cancer agents are not eligible.\n   * Drug interactions: Patients who require treatment with medications that are strong inhibitors or inducers of CYP3A4 or inhibitors of CYP2A9 or have received these medications in the 7 days prior to enrollment, are not eligible. Patients who require treatment with enzyme inducing anticonvulsants are not eligible.\n   * Medications that prolong QTc: Patients who require treatment with medications known to prolong QTc are not eligible",{"count":588,"type":22},41,[149],"This study is a Phase 1\u002F1b clinical trial that aims to determine the Maximally Tolerated Dose of Losartan and Sunitinib Combination Therapy. Patients will first be accrued to the Dose Escalation phase of the study, using a 3+3 design. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.",[592],"Osteosarcoma",[416,594,595,596,597,598,599],"Adults","Phase 1","Losartan","Sunitinib","Maximum Tolerated Dose","Recommended Phase 2 Dose","2026-06-08",{"date":417,"type":38},{"date":603,"type":38},"2019-08-26",{"date":605,"type":22},"2029-08-01",{"name":44,"class":45},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":614,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":23,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":75},"100582238","phase-4-safety-of-short-course-of-nsaids-in-pediatric-patients-with-ckd-100582238","NCT06860711","Safety of Short-course of NSAIDs in Pediatric Patients With CKD","Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n* Patients over 18 months of age\n* diagnosis of CKD stages 2-3a, confirmed by CKiD U25 eGFR calculator based on cystatin C laboratory testing within 6 months of surgery\n* Patient is scheduled to undergo a urologic surgery requiring admission or overnight stay in the hospital\n\nExclusion Criteria:\n\n* Diagnosis of CKD stage 1 or 4-5\n* Past medical history of renal transplant\n* Past medical history of nasal polyp\n* Procedure for oncologic indications or on chemotherapy\n* Pregnant patient\n* True allergy to NSAIDs","18 Months","25 Years",{"count":617,"type":22},164,[175],"The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This is currently in the process of developing multi institution collaboration within a Pediatric Urology population, intended to inform future work in a larger patient population.",[621,622],"Chronic Kidney Disease","Pediatric Urology",[624,625,416,626,627],"NSAIDs","CKD","Urology","post-surgical","2026-06-04",{"date":600,"type":38},{"date":631,"type":38},"2025-07-22",{"date":578,"type":22},{"name":44,"class":45},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":23,"phases":644,"briefSummary":645,"conditions":646,"keywords":648,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":661,"leadSponsor":662,"locationsCount":523},"100638970","living-well-with-brain-cancer-a-group-based-intervention-to-promote-whole-person-well-being-100638970","NCT07628647","Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being","Pilot Study of the Living Well With Brain Cancer Intervention","LWBC","Inclusion Criteria:\n\n* Currently living in the United States\n* Aged 18 years or older\n* Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)\n* Treating prescribing provider who follows regularly with participant\n\nExclusion Criteria:\n\n* \\\u003C1 month since initial diagnosis and\u002For \\\u003C1 month since surgical resection\n* Enrollment in hospice\n* Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed\n* Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)\n* Not able to communicate in English at a conversational level",{"count":643,"type":22},64,[25],"The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:\n\n* Is it feasible to conduct this program?\n* Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?",[647],"Brain Cancer",[649,650,651,652,653,654,655,656,657],"Brain cancer","Glioblastoma","Astrocytoma","Ependymoma","Oligodendroglioma","Brain tumor","Mental health","Glioma","Quality of life",{"date":659,"type":38},"2026-06-05",{"date":210,"type":22},{"date":399,"type":22},{"name":44,"class":45},{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":4,"enrollmentInfo":670,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":523},"100581914","phase-1-cirtuvivintolaparib-in-breast-cancer-susceptibility-genehomologous-recombination-deficiency-platinum-resistant-ovarian-cancer-100581914","NCT06856499","Cirtuvivint\u002FOlaparib in Breast Cancer Susceptibility Gene\u002FHomologous Recombination Deficiency Platinum Resistant Ovarian Cancer","Phase I Evaluation of Combination CLK\u002FDYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA\u002FHRD Platinum Resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Woman aged ≥18 years of age\n4. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2\n5. Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer\n6. Patients must have platinum-resistant disease defined as radiographic progression less than 6 months from last dose of most recent platinum therapy\n7. Patients must have measurable disease by defined RECIST 1.1 criteria\n8. Prior anticancer therapy:\n\n   * Patients must have received at least one prior platinum-based chemotherapy regimen\n   * Patients may not have received more than 3 prior lines of systemic therapy\n   * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n   * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n   * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n   * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n   * Prior radiation is allowed and is not considered a line of treatment\n9. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and\u002For the other.\n10. Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy\n11. Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n    * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n    * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n    * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n    * Serum albumin ≥ 2 g\u002FdL\n12. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n13. Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible.\n\nExclusion Criteria:\n\n1. Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n2. Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy\n3. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n4. Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome\u002Facute myeloid leukemia.\n5. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n   * Uncontrolled major seizure disorder\n   * Unstable spinal cord compression\n   * Any psychiatric disorder that prohibits obtaining informed consent.\n   * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy\n6. Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n   * Myocardial infarction ≤ 6 months prior to first dose\n   * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n   * Superior vena cava syndrome\n   * Unstable angina pectoris\n   * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n   * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n   * Uncontrolled cardiac arrhythmias\n7. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n8. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n9. Persistent toxicities (\\>\u002F= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy\n10. Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n    o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n11. Patients with known untreated or symptomatic central nervous system (CNS) metastases\n12. Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n13. Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n14. Inability to comply with study and follow-up procedures\n15. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.",{"count":173,"type":22},[149],"The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.\n\nIf a participant is a good fit for the study, and they enroll in the study, they will:\n\n* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.\n* Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.",[674,675,93],"Endometrioid Ovarian Cancer","Primary Peritoneal Cancer",{"date":628,"type":38},{"date":678,"type":38},"2025-12-08",{"date":680,"type":22},"2029-07",{"name":44,"class":45},{"id":683,"slug":4,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":84,"enrollmentInfo":684,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":89,"conditions":686,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":689,"leadSponsor":690,"locationsCount":46},"100507455",{"count":86,"type":22},[88],[91,92,93],{"date":628,"type":38},{"date":97,"type":38},{"date":99,"type":22},{"name":44,"class":45},""]