[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Alabama at Birmingham\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":650},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,277,0,25,[9,42,67,92,112,144,165,188,209,239,262,301,328,351,376,405,431,456,475,498,520,548,567,600,625],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053830","phase-2-integrative-liver-targeted-therapy-for-diabetic-macular-edema-using-tauroursodeoxycholate-or-traditional-chinese-medicine-100053830",false,"NCT07457632","Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Using \"Tauroursodeoxycholate\" or Traditional Chinese Medicine.","Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.","Inclusion Criteria:\n\n1. Age range 18-89 years\n2. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia\u002Fmacrophages on OCT) with a visual acuity between 20\u002F32 and 20\u002F200.\n3. Written informed consent is provided.\n4. Males and females\n5. Routine laboratory study results CBC and Diff with bilirubin, aspartate aminotransferase and\u002For alanine aminotransferase, and creatinine within normal limits.\n\nExclusion Criteria:\n\n1. History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months.\n2. Eye having undergone YAG capsulotomy in the last 3 months.\n3. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).\n4. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception if they are not trying to get pregnant.\n5. Chronic infectious disease (e.g. HIV, HCV)\n6. Positive urine β-hCG test day of visit or a serum-hCG test within 48 hours prior to the initiation of the study\n7. Other ocular diseases or fundus diseases\n8. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);\n9. Use of cyclooxygenase-2 (COX-2) inhibitors for \\\u003C 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.\n10. Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.\n11. Any degree of hepatic or renal insufficiency that in the investigator's judgement would pose a safety risk with TUDCA or mQJDHW.\n12. Subjects who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.\n13. Subjects who have a medical condition that, in the investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.\n14. Subjects with a current known infection or who are acutely ill.\n15. Subjects with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).\n16. Subjects with thyroid disorders unless euthyroid at screening.\n17. Subjects with cancer not in remission.\n18. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study.\n19. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.\n20. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.\n21. Use of any investigational drug\u002F nutraceuticals within 30 days prior to the baseline visit.","ALL","18 Years","89 Years",{"count":21,"type":22},69,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Diabetic macular edema, a complication of diabetes cannot be managed without addressing systemic inflammation. Liver metabolism and functions are implicated in diabetes and evidence suggests that hepatic metabolic dysfunctions are linked to the neuroinflammation and vascular dysfunctions observed in diabetic retinopathy. Nutraceutical supplements like Tauroursodeoxycholate (a bile acid) and modified Qi Ju Di Huang Wan (a traditional Chinese medicine formula) have been found to reduce hepatic and retinal oxidative stress, provide anti-apoptotic, anti-inflammatory, neuroprotective and hepatoprotective effects. This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema.",[28],"Diabetic Macular Edema (DME)","NOT_YET_RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-10-01",{"date":37,"type":22},"2028-12-31",{"name":39,"class":40},"University of Alabama at Birmingham","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100053719","phase-2-trial-of-selumetinib-and-bromodomain-inhibitor-with-durvalumab-for-sarcomas-100053719","NCT05253131","Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas","Phase 1\u002F2 Trial of the MEK Inhibitor Selumetinib and Bromodomain Inhibitor ZEN-3694 With Durvalumab (MEDI4736), a PD-L1 Antibody for Sarcomas Including Malignant Peripheral Nerve Sheath Tumors","Inclusion Criteria:\n\nInclusion Criteria AGE: ≥ 18 years of age Weight: \\>30 kg Life expectancy of at least 12 weeks\n\nPart A and B (Phase 1): Patients with histologically confirmed soft tissue or bone sarcoma of the following subtypes:\n\n* MFH\u002F undifferentiated pleomorphic sarcoma\n* Unclassified sarcoma\n* Rhabdomyosarcoma\n* Malignant peripheral nerve sheath tumor (MPNST)\n* Osteosarcoma\n* Ewing or Ewing-like sarcoma\n* Synovial sarcoma\n* Desmoplastic small round blue cell tumor (DSRCT)\n\nPatients must have progressed or demonstrated disease that is refractory to standard therapies.\n\nPatients for whom no standard of care treatments exist are eligible.\n\nPart C (Phase 2): Patients with progressive, relapsed, unresectable or metastatic NF associated MPNST.\n\nMEASURABLE DISEASE:\n\nPatients must have evaluable or measurable disease (Phase 1) and measurable disease by RECISTv1.1 (Phase 2).\n\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study excluding chronic grade 1 toxicities and alopecia.\n* No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry.\n* Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks (≥21 days) and 42 days if prior nitrosourea prior to study entry.\n* Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry.\n* Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry. Prior therapy with a MEK, Ras, or Raf inhibitor used for treatment of malignant sarcoma is not allowed. Prior therapy of MEK, Ras, or Raf inhibitor for other tumor such as plexiform neurofibroma or glioma is allowed.\n* Radiation therapy: The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study\n* Radiation therapy: The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry.\n* Stem Cell Transplantation. At least 2 months post-autologous stem cell transplant.\n* Growth Factors. The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry.\n* Karnofsky performance level ≥ 50% (See Appendix II).\n* Patients who are unable to walk because of paralysis or motor weakness, but who are able to use a wheelchair will be considered ambulatory for the purpose of calculating the performance score.\n\nHemoglobin ≥9.0 g\u002FdL (transfusion permissible)\n\n* Peripheral absolute neutrophil count (ANC) of ≥1000\u002FµL\n* Platelet count ≥100,000\u002FµL (transfusion independent (no transfusion within at least 7 days prior to enrollment))\n* Total bilirubin must be ≤ 1.5 times the upper limit of normal (ULN)\n* SGOT (AST)\u002FSGPT (ALT) must be ≤ 3.0 times ULN unless liver metastases are present, in which case it must be ≤ 5x ULN\n\nRENAL FUNCTION:\n\nSerum creatinine ≤ 1.5 times ULN or measured reatinine clearance \\>50 mL\u002Fmin or calculated creatinine clearance \\> 50 mL\u002Fmin by the Cockcroft- Gault formula (Cockgraft and Gault 1976) or by the 24 hour urine collection for determination of creatinine clearance\n\n* Normal ejection fraction (ECHO or cardiac MRI) ≥53% (or the institutional normal; if a range is given then the upper value of the range will be used)\n* QTC or QTcF ≤ 450msec\n\nFertile men and women of childbearing potential must agree to use an effective method of birth control.\n\nFemale participants of childbearing potential must be willing to practice highly effective contraception as detailed below from the time of screening until 3 months after discontinuing the study.\n\nThey must not be breastfeeding and must have negative pregnancy test prior to start of dosing.\n\nFor a female participant to be considered as of not childbearing potential, she should fulfil one of the following:\n\nPost-menopausal women, defined as either women aged more than 50 years and have amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments, or, women under 50 years who have amenorrhea for at least 12 months following cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution.\n\nor\n\n* Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (but not tubal ligation)\n* Have medically confirmed, irreversible premature ovarian failure.\n\nHighly effective methods of contraception are:\n\n* Use of medroxyprogesterone acetate depot injection (Depo-proveraTM). (Please note: use of any other oral, injected, or implanted hormonal methods of contraception cannot be considered highly effective as it is currently unknown whether investigational agents may reduce their effectiveness)\n* Placement of a copper-banded intrauterine device (IUD) or intrauterine system (IUS)\n* Bilateral tubal ligation\n* Vasectomized partner\n\nBarrier methods include:\n\nOcclusive cap (e.g. diaphragm or cervical\u002Fvault caps) with spermicide\n\nMale participants should either be surgically sterile or willing to use an effective barrier method of contraception during the study and for 3 months following the last dose of drug therapy if sexually active with a female of childbearing potential. If not done, storage of sperm prior to receiving drug therapy will be advised to male participants with a desire to have children.\n\nMale subjects must agree to refrain from sperm donation during and until 90 days from drug therapy discontinuation.\n\nCNS DISEASE: Patients with central nervous system disease are eligible or enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression or stable disease at 4 weeks.\n\nExclusion Criteria:History of another primary malignancy except for\n\n* A malignancy treated with curative intent and with no known active disease ≥5 years prior to study entry\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n* Adequately treated carcinoma in situ without evidence of disease\n* Stable optic pathway glioma or low grade glioma not receiving active therapy\n\nHistory of leptomeningeal carcinomatosis.\n\nPatients receiving other anti-cancer agents are not eligible.\n\nPatients who cannot swallow whole pills.\n\nHistory of allogeneic organ transplantation.\n\nCurrent or prior use of immunosuppressive medications within 14 days prior to study entry. The following are exceptions to this criterion:\n\nintranasal, inhaled, topical steroids or local steroid injection (e.g., intra-articular injection)\n\nSystemic corticosteroids used at physiologic doses not to exceed 10mg\u002Fday of prednisone or its equivalent.\n\nSteroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n\nPatients should not receive immunizations with attenuated live vaccines within four weeks of study entry or during study period.\n\nAny recent major surgery within a minimum of 4 weeks prior to starting drug therapy. Placement of vascular access device, percutaneous tumor biopsy, or bone marrows are not considered major surgical procedures and no minimum time frame prior to starting study drug.\n\nPatients who have any known severe and\u002For uncontrolled medical therapy is required.\n\nconditions or other conditions that could affect their participation in the study such as:\n\n* Severely impaired lung function defined as spirometry and DLCO that is 50%of the normal predicted value corrected for hemoglobin and alveolar volume and\u002For O2 saturation that is 88% or less at rest on room air. For patients who do NOT have respiratory symptoms (e.g., dyspnea at rest, known requirement for supplemental oxygen), pulmonary function test is not required.\n* Cardiac conditions as follows:\n\n  * Uncontrolled hypertension (blood pressure ≥150\u002F95 mmHg despite medical therapy.\n  * Acute coronary syndrome within 6 months prior to starting drug therapy\n  * Uncontrolled angina despite medical therapy (Canadian Cardiovascular Society grade II-IV despite medical therapy\n  * Symptomatic heart failure NYHA Class II-IV prior or current cardiomyopathy or severe valvular disease\n  * Prior or current cardiomyopathy including but not limited to the following: Known hypertrophic cardiomyopathy; Known arrhythmogenic right ventricular cardiomyopathy; or Previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45% on echocardiography or equivalent of MUGA) even if full recovery has occurred\n  * Atrial fibrillation with a ventricular rate of \\>100 beats per minute on ECG at rest\n* Uncontrolled infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Active primary immunodeficiency\n* Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis.\n* Current gastrointestinal conditions such as refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of small bowel, symptomatic inflammatory bowel disease, or ulcerative colitis, or partial or complete bowel obstruction.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (colitis, Crohn's), celiac disease, systemic lupus erythematosus, Wegener syndrome, myasthenia gravis, Graves' disease, rheumatoid arthritis, uveitis.\n\nThe following exceptions are:\n\n* Patients with vitiligo or alopecia\n* Patients with hypothyroidism (e.g., following Hashimoto's syndrome) stable on hormone replacement\n* Psoriasis that does not require systemic therapy\n* Patients with celiac disease that is controlled by diet alone\n\n  • Ophthalmological conditions as follows:\n* Current or past history of retinal vein occlusion\n* Known intraocular pressure (IOP)\\>21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma.\n* Subjects with ophthalmological findings secondary to long standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or long standing orbito-temporal PN (such as vision loss, strabismus) will not be considered a significant abnormality for purposes of this study.\n\nAny Supplementation with vitamin E.\n\nHypersensitivity to investigational products, or drugs with similar chemical structures to investigational products.\n\nPatients unwilling or unable to comply with the protocol.\n\nWhile not an exclusion criterion, unless clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medications. In particular, participants should avoid medications that are known to either induce or inhibit the hepatic activity of CYP1A2, CYP2C19, and CYP3A4.","99 Years",{"count":51,"type":22},41,[25],"A multi-institutional open-label phase 1\u002F2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory\u002Funresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory\u002Frelapsed sarcomas. The phase 2 portion will be for patients with refractory\u002Funresectable NF1-associated MPNST.",[55,56,57],"MPNST","NF1","Sarcoma",[55,59,56,60],"Neurofibromatosis 1","sarcoma",{"date":32,"type":33},{"date":63,"type":22},"2026-11-15",{"date":65,"type":22},"2032-11-15",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100054318","biological-and-clinical-underpinnings-of-postoperative-pain---mastectomy-100054318","NCT07271589","Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy","Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy (BAC-UPP 1 Study)","BAC-UPP 1","Inclusion Criteria:\n\n* Participants scheduled for breast surgery\u002Fmastectomy ; 2) age between 18-65; 3) understanding of verbal and written English.\n\nExclusion Criteria:\n\n* 1\\) concurrent medical conditions that could confound the interpretation of the data; 2) HIV positive diagnosis; 3) cardiovascular or pulmonary disease; 4) systemic rheumatoid disease; 5) uncontrolled hypertension (i.e. SBP\u002FDBP of \\> 150\u002F95); 6) current illness accompanied by fever (body temperature \\>38 °C); 7) any other chronic pain condition; 8) conditions resulting in altered nerve sensation; 9) hospitalization due to psychiatric illness within the last 6 months; 10) poorly controlled diabetes; 11) history of stroke; 12) history of seizures; 13) circulatory disorders such AS Raynauds' disease 14) history of drug or alcohol abuse.",{"count":76,"type":22},86,"OBSERVATIONAL","Persistent pain after mastectomy remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after mastectomy and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:\n\n1. We will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.\n2. We will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.\n3. We will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.\n4. We will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.",[80],"Mastectomy",[80,82,83,84,85],"breast surgery","nociception","acute pain","chronic pain",{"date":32,"type":33},{"date":88,"type":22},"2026-09-01",{"date":90,"type":22},"2028-08-31",{"name":39,"class":40},{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":100,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100054301","biological-and-clinical-underpinnings-of-postoperative-pain---colorectal-surgery-100054301","NCT07219160","Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery","Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery (BAC-UPP 2 Study)","BAC-UPP 2","Inclusion Criteria:\n\n* Participants scheduled for colorectal cancer surgery\n* Age between 18-65; 3)\n* Understanding verbal and written English\n\nExclusion Criteria:\n\n* Concurrent medical conditions that could confound the interpretation of the data\n* Human immunodeficiency virus positive diagnosis\n* Cardiovascular or pulmonary disease\n* Systemic rheumatoid disease\n* Uncontrolled hypertension (i.e. SBP\u002FDBP of \\> 150\u002F95\n* Current illness accompanied by fever (body temperature \\>38 °C)\n* Any other chronic pain conditions\n* Conditions resulting in altered nerve sensation\n* Hospitalization due to psychiatric illness within the last 6 months\n* Poorly controlled diabetes\n* History of stroke\n* History of seizures\n* Circulatory disorders such AS Raynauds' disease\n* History of drug or alcohol abuse.",{"count":101,"type":22},128,"Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:\n\n1. The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.\n2. The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.\n3. The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.\n4. The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.",[104],"Colorectal Surgery",[106,83,84,85],"colorectal surgery",{"date":32,"type":33},{"date":88,"type":22},{"date":110,"type":22},"2030-08",{"name":39,"class":40},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":17,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100053248","neural-derived-plasma-exosomal-micrornas-as-promising-novel-biomarkers-for-suicidality-and-treatment-outcome-in-adolescents-100053248","NCT05437588","Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents","Inclusion Criteria:\n\nAll participants:\n\n1. Physically healthy\n2. willing and able to provide informed consent (if under 18 also parent or guardian consent)\n\nMDD participants:\n\n1. A definite diagnosis of DSM-5\n2. a Children's Depression Rating Scale-Revised (CDRS-R) score \\>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \\>=4 rated over the last two weeks.\n\nSuicide attempt group:\n\n1\\. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.\n\nNon-psychiatric controls:\n\n1\\. No history of any major mental illness (excluding specific phobia) or substance use disorder.\n\nExclusion Criteria:\n\n* Exclusion criteria:\n\n  1. Pregnancy or lactation\n  2. post-partum state (being within 2 months of delivery or miscarriage);\n  3. homicide risk as determined by clinical interview\n  4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine\u002Fcaffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.\n  5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months\n  6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.",true,"10 Years","24 Years",{"count":122,"type":22},240,[124],"NA","This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.",[127,128,129,130,131,132,133,134,135],"Major Depressive Disorder","Suicidal Ideas","Suicide, Attempted","MDD","Depression","Depression, Teen","Depression and Suicide","Depression in Adolescence","Suicide","RECRUITING",{"date":32,"type":33},{"date":139,"type":33},"2022-10-01",{"date":141,"type":22},"2027-06-30",{"name":39,"class":40},2,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":118,"sex":17,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":41},"100054259","the-effects-of-exogenous-ketones-on-cognitive-function-100054259","NCT07051655","The Effects of Exogenous Ketones on Cognitive Function","Inclusion Criteria:\n\n* Age 19-55 years\n* BMI 30-40 (obese group) or 18-25 (lean and athlete groups)\n* Sedentary status (\\\u003C2 hrs\u002Fweek of structured physical activity) for obese and lean groups\n* Active athlete status (≥5 days\u002Fweek of structured activity) for athlete group\n\nExclusion Criteria:\n\n* Diagnosed neurological conditions (e.g., Parkinson's disease, multiple sclerosis, schizophrenia, muscular dystrophy, stroke, cerebral palsy)\n* History of seizures\n* Use of medications for diabetes, mood disorders, or attention disorders\n* Pregnant or breastfeeding\n* Current or recent use (within 1 month) of exogenous ketone supplements or adherence to a ketogenic diet","19 Years","55 Years",{"count":153,"type":22},45,[124],"The purpose of this study is to evaluate the acute effects of exogenous ketone monoester (KME) supplementation on cognitive function in three groups of adults aged 19-55 years: (1) obese, sedentary individuals; (2) lean, sedentary individuals; and (3) lean individuals who engage in regular physical activity (e.g., collegiate or amateur athletes). The main questions it aims to answer are to:\n\n* Assess the effects of acute KME supplementation versus placebo on cognitive, sensorimotor, and functional outcomes within groups.\n* Compare cognitive performance across the three groups.\n\nThe primary outcome is cognitive performance assessed using the NIH Toolbox Cognition Battery. Secondary Outcomes include sensorimotor performance, measured using the Senaptec Sensory System, and driving performance, assessed with a driving simulator.",[157,158],"Placebo - Control","Ketone Monoester",{"date":32,"type":33},{"date":161,"type":33},"2025-12-01",{"date":163,"type":22},"2027-07-31",{"name":39,"class":40},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":41},"100053711","understanding-the-impact-of-meal-timing-on-neurological-health-in-adults-with-multiple-sclerosis-100053711","NCT07475377","Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis","Meal Time MS","Inclusion Criteria:\n\n* Diagnosed with relapsing remitting or secondary progressive multiple sclerosis (RRMS or SPMS)\n* If on disease modifying therapy (DMTs), stable for 6 months\n* If not on DMTs, no DMT usage within previous 6 months\n* BMI 18.5-50 kg\u002Fm2\n* Access to a smartphone\n* Responsible for personal eating schedule or able to have input into schedule\n\nExclusion Criteria:\n\n* Relapse within previous 30 days\n* Actively engaged in a weight loss program or unwilling to follow assigned eating schedule\n* Current use of GLP-1 or use within previous 3 months\n* Regularly fasts \\> 12 hours\u002Fday\n* Employed in night shift or rotating shift work\n* Unable to walk 25 feet with or without assistive device (EDSS \\> 6.5).\n* Current use of insulin or sulfonylurea agents\n* Pregnant or breastfeeding\n* Currently enrolled in another trial that would confound results (e.g., exercise studies or other diet studies)","64 Years",{"count":174,"type":22},22,[124],"The goal of this clinical trial is to learn if the time an individual eats each day impacts neurological health in people with multiple sclerosis. The main questions the investigators are asking are:\n\n1. Does meal timing affect biomarkers of neuronal health (neurofilament light chain \\[NfL\\] and BDNF) and inflammation (IL-6, IL-17, TNF-ɑ) in adults with MS.\n2. Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS.\n\nParticipants will be instructed to start and stop eating at specific times each day based on their group assignment and their personal schedule. They will respond to prompts sent to them on their smartphone to record the times they start and stop eating each day.\n\nAs a secondary goal, the study will also explore the feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS. To accomplish this, imaging will be completed in a subset of 8 participants at the beginning and end of the study.",[178],"Multiple Sclerosis",[180,181,178],"Nutrition","Circadian",{"date":32,"type":33},{"date":184,"type":22},"2026-08-01",{"date":186,"type":22},"2027-12-31",{"name":39,"class":40},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":41},"100499762","state-of-hormones-impact-nociceptive-expression-100499762","NCT05787470","State of Hormones Impact Nociceptive Expression","SHINE","Inclusion Criteria:\n\n* self-identification as one of the above gender identities\n* understanding of verbal and written English.\n* participants that have been on\u002Foff hormone treatment for at least 6 months\n\nExclusion Criteria:\n\n* pain in at least 3\u002F7 days\u002Fweek for the past 3 months\n* HIV positive diagnosis\n* cardiovascular or pulmonary disease\n* regular use of opioid pain medications\n* uncontrolled hypertension (i.e. SBP\u002FDBP of \\> 150\u002F95)\n* current illness accompanied by fever (body temperature \\>38 °C)\n* prostatectomy, hysterectomy or oophorectomy\n* hospitalization due to psychiatric illness within the last 6 months.","65 Years",{"count":197,"type":22},120,"The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \\> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20\u002Fgroup). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity\u002Ffemininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.",[200,201],"Pain","Gender Identity","2026-07-01",{"date":204,"type":33},"2026-07-02",{"date":206,"type":33},"2023-03-01",{"date":163,"type":22},{"name":39,"class":40},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100644592","integrating-systematic-patient-reported-evaluations-in-multi-disciplinary-tumor-boards-the-inspire-study-100644592","NCT07671937","INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study","INSPIRE","Inclusion\u002FExclusion Criteria: We will include two populations: (1) patients and (2) clinical team members involved in the MDTB.\n\nInclusion Criteria:\n\n* Inclusions Criteria- Patients:\n\n  1. aged 18 years or older;\n  2. with suspected or confirmed diagnosis of pancreatic, breast, and gynecologic cancer (all stages) within 8 weeks of diagnosis;\n  3. intention to be treated at a participating institution;\n  4. with verbal fluency in English or Spanish; and\n  5. scheduled to be discussed at MDTB.\n* Inclusion criteria - Clinicians:\n\nAll clinical team members participating in the pancreatic, breast, or gynecologic MDTB at a participating site will be included and have pre-emptively agreed to participation.\n\nExclusion Criteria:\n\n* Exclusion criteria - Patients:\n\nIndividuals with plans to receive cancer treatment outside the participating institution and inability to speak English or Spanish.\n\n* Exclusion criteria - Clinician:\n\nClinicians will retain the opportunity to opt-out of participation, in which case their portions of the discussion will not be included in the analysis; however, this is not anticipated based on pilot data.",{"count":217,"type":22},2748,[124],"The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, evaluate the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.",[221,222,223,224,225],"Breast Cancer","Corpus Uteri Cancer","Ovary Cancer","Pancreas Cancer","Other Female Genital Malignant Neoplasms",[227,228,229,230,221,231],"PROs","Multidiscipinary tumor board","INSPIRE intervention","Pancreatic Cancer","gynecologic cancers","2026-06-30",{"date":204,"type":33},{"date":88,"type":22},{"date":236,"type":22},"2031-07",{"name":39,"class":40},3,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":41},"100636837","evaluating-the-impact-of-ketogenic-therapy-on-symptom-severity-and-metabolic-side-effect-profile-among-individuals-living-with-bipolar-disorder-in-a-rural-southern-catchment-area-100636837","NCT07570875","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area","Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area - A Four-Arm Pilot Study","Inclusion Criteria:\n\n* Age \\>18\n* Verified Bipolar Diagnosis per NETSCID\n\nExclusion Criteria:\n\n* Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)\n* Anorexia\n* Pregnancy\n* Severe renal insufficiency\n* Hepatic insufficiency",{"count":247,"type":22},100,[124],"It is the purpose of this pilot study to evaluate a high-fat\u002Flow-carbohydrate \"ketogenic\" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.\n\nWhile existing access and cost barriers can prevent effective treatment of bipolar disorder in the rural south, using food as medicine represents a possible alternative\u002Fadjunctive to traditional high-cost\u002Flow-access medications. Specifically, this study will evaluate the impact of combining a ketogenic diet with existing treatment options, under the conditions of the rural catchment area, to determine the impact and efficacy of this intervention at patient and systems levels.\n\nIf effective, the interventions examined in this pilot study may increase the efficacy, availability and access to care experienced by individuals living with bipolarity in the rural Deep South.",[251],"Bipolar Disorder",[253,254,255],"ketogenic","long-acting injectable","rural",{"date":204,"type":33},{"date":258,"type":22},"2026-08",{"date":260,"type":22},"2026-12",{"name":39,"class":40},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":118,"sex":17,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":143},"100634955","effects-of-exogenous-ketones-on-cognitive-function-in-older-adults-with-prediabetes-100634955","NCT07546409","Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?","Can Exogenous Ketone Supplementation Compensate for Glucose Hypometabolism and Improve Cognitive Processing Speed in Veterans With Prediabetes?","Inclusion Criteria:\n\n* Age 60 to 75 years\n* Able to provide written informed consent\n* Fluent in English\n* No diagnosed cognitive impairment or dementia\n\nClassified as either:\n\n* Prediabetes (based on American Diabetes Association criteria), or Normal glucose regulation (control group)\n* Medically stable and cleared to undergo positron emission tomography and magnetic resonance imaging\n* Willing to comply with study procedures, including metabolic testing, supplement ingestion, and neuroimaging\n\nExclusion Criteria:\n\n* Diagnosis of mild cognitive impairment, dementia, or other neurodegenerative disorder\n* Diagnosis of type 1 diabetes or type 2 diabetes\n* Use of glucose-lowering medications (e.g., insulin, metformin, glucagon-like peptide-1 receptor agonists)\n* History of major neurological disorder (e.g., stroke, traumatic brain injury with loss of consciousness \\>30 minutes, epilepsy, multiple sclerosis)\n* Major psychiatric disorder not stable on treatment\n* Uncontrolled hypertension or significant cardiovascular disease\n* Severe renal, hepatic, or gastrointestinal disease that may affect supplement metabolism\n* Contraindications to magnetic resonance imaging (e.g., non-compatible implanted devices, severe claustrophobia)","60 Years","75 Years",{"count":272,"type":22},20,[124],"Brief Summary\n\nThe goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in brain energy use and thinking speed compared to older adults with normal blood sugar levels. The study will also test whether a single dose of an exogenous ketone supplement can improve brain energy use and cognitive processing speed.\n\nThe main questions it aims to answer are:\n\nDo older adults with prediabetes have lower brain glucose uptake and slower cognitive processing speed compared to those with normal glucose levels?\n\nDoes a single dose of an exogenous ketone monoester supplement improve cognitive processing speed and brain glucose uptake?\n\nResearchers will compare older adults with prediabetes to older adults with normal glucose levels to determine whether differences exist in brain glucose metabolism and cognitive performance. In a subset of participants, researchers will also compare brain and cognitive outcomes before and after consuming a ketone monoester supplement (DeltaG, Oxford, England).\n\nParticipants will:\n\nComplete metabolic testing to determine glucose status\n\nUndergo brain imaging using fluorodeoxyglucose positron emission tomography combined with magnetic resonance imaging (18FDG-PET\u002FMRI) while performing a cognitive processing speed task\n\nConsume a single dose of a commercially available ketone monoester supplement during one study visit\n\nComplete cognitive testing during imaging to measure processing speed and brain activity\n\nThe results of this study will help determine whether early metabolic dysfunction is linked to reduced brain energy use and whether ketones can temporarily support brain function in individuals at risk for dementia.",[276,277],"Prediabetes","Healthy (Controls)",[279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294],"Prediabetic State","Insulin Resistance","Brain Glucose Metabolism","Cerebral Glucose Uptake","Fluorodeoxyglucose F18","Positron-Emission Tomography","Magnetic Resonance Imaging","Functional Magnetic Resonance Imaging","Cognitive Dysfunction","Dementia","Aging","Processing Speed","Ketone Bodies","beta-Hydroxybutyrate","Neuroimaging","Brain Energy Metabolism",{"date":204,"type":33},{"date":297,"type":33},"2025-05-20",{"date":299,"type":22},"2027-05-31",{"name":39,"class":40},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":308,"maxAge":18,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":318,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100572913","hospital-based-continuous-patient-monitoring-system-100572913","NCT06739447","Hospital Based Continuous Patient Monitoring System","Implementing a Hospital-based Continuous Patient Monitoring System Using Consumer Wearable Devices in Ghana","Inclusion Criteria:\n\n* Pediatric patients presenting with traumatic injury\n* Pediatric patients postoperative status after an appendectomy\n\nExclusion Criteria:\n\n* Pediatric patients missing their upper limbs,\n* Pediatric patients who cannot wear a Fitbit on their wrist for known allergies to rubber or those with traumatic or medical conditions that prevent them from being able to comfortably wear a Fitbit on either hand","3 Years",{"count":310,"type":22},250,[124],"In Ghana, and many other low and middle income countries in Africa, manual vital signs monitoring is the prevalent mode of vital signs monitoring because continuous bedside monitors are non-functional. This lack of continuous vital signs monitoring may result in missed opportunities to catch physiologic deterioration.\n\nThe investigators propose to develop a dashboard that is based on the Garmin Venu 3, a consumer wearable device that reliably measures heart rate, SPO2, and respiratory rate, as an alternative to bedside monitors in hospitals in Ghana.",[314,315,316,317],"Trauma","Appendectomy","Pediatric ALL","Vital Signs Monitoring",[319,320,321,322],"Garmin Venu 3","pediatric appendectomy","trauma","vital sign monitoring",{"date":204,"type":33},{"date":88,"type":22},{"date":326,"type":22},"2030-01-30",{"name":39,"class":40},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":118,"sex":17,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":41},"100640425","development-of-healthcare-transition-for-patients-with-congenital-adrenal-hyperplasia-100640425","NCT07611786","Development of Healthcare Transition for Patients With Congenital Adrenal Hyperplasia","Evaluation of a Healthcare Transition Protocol for Patients With Congenital Adrenal Hyperplasia","Inclusion Criteria:\n\nYA Participants\n\n* Diagnosis of congenital adrenal hyperplasia (any subtype or severity)\n* Age ≥16 years\n* Active follow-up within the pediatric endocrinology clinic\n* English-speaking\n* Cognitively able to complete questionnaires with or without assistance\n* Anticipated ability to participate in CAH-T visits during the study period Caregiver Participants\n* Parent, guardian, or primary support person of an enrolled AYA participant Provider Participants\n* Pediatric endocrinologists, nurse practitioners, or transition-related clinical staff involved in CAH care for at least 6 months\n\nExclusion Criteria:\n\n* Significant cognitive impairment precluding participation\n* Inability to complete study procedures\n* Inability to provide informed consent\u002Fassent","16 Years",{"count":337,"type":22},40,"The purpose of this study is to implement and evaluate the feasibility and acceptability of a structured healthcare transition program for adolescents and young adults with congenital adrenal hyperplasia (CAH). The study will also examine preliminary effects of the program on transition readiness, disease-specific self-management knowledge, emergency preparedness, continuity of endocrine care, and health-related quality of life as participants transition from pediatric to adult healthcare services.",[340],"Congenital Adrenal Hyperplasia",[342,343],"congenital adrenal hyperplasia","healthcare transition","2026-06-29",{"date":202,"type":33},{"date":347,"type":22},"2026-07",{"date":349,"type":22},"2029-07",{"name":39,"class":40},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100644927","phase-2-autoantibody-reduction-therapy-for-progressive-idiopathic-pulmonary-fibrosis-100644927","NCT07674745","Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis","Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)","STRIVE II","Inclusion Criteria:\n\n1. Age between 40-85 years old.\n2. A diagnosis of IPF that fulfills latest ATS\u002FERS Consensus Criteria.\n3. A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p \\>10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.\n4. Ability and willingness to give informed consent (no surrogates) and adhere to requirements.\n5. Have eligibility confirmed by a consensus of trial investigators.\n6. Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not become participants in other experimental regimens (other than solely observational registries) for the duration of their participation in this trial (180 days).\n7. Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization.\n8. IPF duration \\\u003C10 years, based on the date of definitive diagnosis.\n9. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1\u002FFVC) \\>0.70\n\nExclusion Criteria:\n\n1. Diagnoses of current infection by clinical or microbial assessments.\n2. Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.\n3. History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.\n4. Coagulopathy, defined as an INR \\>1.6, PTT \\>2x control, fibrinogen \\\u003C100 mg\u002FdL, or platelet count \\\u003C50,000 unless these abnormalities can be reversed.\n5. Uncontrolled diabetes or hypertension (systolic BP \\>160 mm Hg and diastolic BP \\>100 mm Hg) that would contraindicate use of corticosteroids.\n6. Hemodynamic instability, defined as an inotrope or vasopressor requirement.\n7. History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months.\n8. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen \\\u003C10 ng\u002Fdl. AART is not known to promote cancer, and these criteria are within current guidelines.\n9. Unwillingness to accept blood product transfusion.\n10. Diagnosis of major comorbidities expected to interfere with study participation.\n11. Treatment for \\>14 days within the preceding month with \\>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), or with rituximab (or other anti-B-cell biological agents) within the last 6 months.\n12. Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and\u002For substituted (to obviate hemodynamic lability during TPE).\n13. Fertile women who do not agree to contraception or abstinence. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.\n14. An alternative, concordant or historical diagnosis of interstitial lung diseases other than IPF, including idiopathic fibrosis with autoimmune features (IPAF) per clinical domain.1\n15. IgA deficiency, to preclude IVIg reactions.\n16. Listed with the United Network for Organ Sharing (UNOS) for lung transplant at the time of enrollment, to minimize the number of censoring due to very early transplants.\n17. Ongoing suspected or known acute exacerbations of IPF (AE-IPF), defined as new onset (within the last 30 days) of dyspnea with increased hypoxemia or oxygen requirement, and new radiographic infiltrates especially with ground glass opacities (GGO).\n18. Patients taking antifibrotic agents at randomization who have not been on a stable dose for at least 6 weeks: these therapies could be initiated, at the discretion of their attending physicians, at or after the midpoint of their participation in STRIVE II (i.e., three months after randomization).\n19. Patients whose oxygen requirements at rest (per an arterial oxygen saturation \\[SaO2\\] \\>0.92) cannot be met with simple nasal cannula at \\\u003C10L\u002Fmin.\n20. Patients who are not expected to survive 180 days or, in the opinion of the local attending physician, have a high likelihood of not tolerating the trial interventions due to underlying comorbidities or frailties.\n21. \\>10% of whole lung images are emphysematous on High Resolution CT scan\n\n    \\-","40 Years","85 Years",{"count":362,"type":22},52,[25],"This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).",[366],"Idiopathic Pulmonary Fibrosis",[368,369],"Progression","Autoantibodies",{"date":202,"type":33},{"date":35,"type":22},{"date":373,"type":22},"2031-03-31",{"name":39,"class":40},9,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":395,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":41},"100635720","empowering-faith-based-communities-to-provide-personalized-diabetes-self-management-education-and-support-dsmes-in-the-magic-city-100635720","NCT07556354","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study","MCPILOTDSMES","Inclusion Criteria:\n\n* Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis\n* Are aged 18 or older\n* Live in Jefferson County, Alabama\n* Have never participated in a DSMES program\n\nExclusion Criteria:\n\n* Not a resident of Jefferson County, Alabama\n* Completed a DSMES program",{"count":385,"type":22},30,[124],"In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.",[389,390,391,392,393,394],"Blood Cholesterol","Blood Pressure Monitoring","Weight Change","BMI","Diabetes Education","Diabetes (DM)",[396,397,398,399],"dsmes","diabetes education","faith based intervention","remote patient monitoring",{"date":202,"type":33},{"date":347,"type":22},{"date":403,"type":22},"2026-10",{"name":39,"class":40},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":143},"100602820","remote-intervention-to-prevent-overdose-100602820","NCT07128485","Remote Intervention to Prevent Overdose","A Remote Intervention to Prevent Overdose Among People Who Use Stimulants and\u002For Opioids","Inclusion Criteria:\n\n* 18 years old\n* English-speaking and reading\n* Report using illicit opioids and\u002For stimulants (including counterfeit pills) within the past 3 months per the ASSIST\n* Able and willing to provide informed consent\n* Reside in any of the US states where fentanyl test strips are legal with no plans to move out of state for at least 12 months\n* Reside in any of the US states where FTS are legal with no plans to move out of state for at least 12 months\n* Be able and willing to provide the names and contact information of three close contacts to reach if the participant cannot be reached\n\nExclusion Criteria:\n\n* Living in a restricted environment (e.g., prison)",{"count":247,"type":22},[124],"This Type 1 hybrid effectiveness-implementation randomized controlled trial, Remote Fentanyl Test Strip Distribution and Education to Prevent Drug Overdose, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids by reducing overdose rates. It is supported by and included in the HEAL Initiative. This study would be the first national, fully remote trial to assess the impact of fentanyl test strips on overdose outcomes, using a novel 2x2 design crossing fentanyl test strip distribution and education to determine which approach most significantly reduces overdose rates while minimizing costs. This research will inform scalability around mail-based fentanyl test strip distribution and education programs to address the nation's opioid overdose crisis.",[416],"Accidental Overdose of Opiate",[418,419,420,421,422,423],"overdose prevention","fentanyl test strips","fentanyl","opioid use disorder","stimulant use disorder","accidental overdose","2026-06-28",{"date":202,"type":33},{"date":427,"type":22},"2027-01",{"date":429,"type":22},"2027-11",{"name":39,"class":40},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":41},"100645370","phase-1-daily-encapsulated-green-tea-extract-to-mitigate-neuropathic-pain-in-patients-with-established-cancer-associated-neuropathic-pain-100645370","NCT07682324","Daily, Encapsulated, Green Tea Extract to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain","Daily, Encapsulated, Green Tea Extract (GTE) to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain","GTE","Inclusion Criteria:\n\n* 18 years of age or older.\n* Established cancer-associated neuropathic pain.\n* A baseline Douler Neuropathique 4 (DN4) patient-reported neuropathic pain questionnaire score of greater than or equal to 4.\n* A stable pain management medication regimen, with no more than a 10% change in dosage in the past 14 days prior to enrollment.\n* No known allergy to rice or rice flour (basis of placebo).\n\nExclusion Criteria:\n\n* Actively undergoing cancer treatment.\n* Symptoms and\u002For diagnosis of diabetic peripheral neuropathy.\n* Self-describe as consuming more than 3 cups of green tea or matcha beverages on a daily basis.\n* High probability of completing the study and all study-related measures\u002Factivities required by the protocol.",{"count":272,"type":22},[441],"PHASE1","The overall objective of this study is to test an intervention of green tea extract (GTE) to mitigate neuropathic pain in patients, specifically cancer survivors, receiving supportive palliative care. Our central hypothesis is that daily, oral, encapsulated GTE will mitigate neuropathic pain, as longitudinally measured by the validated Douleur Neuropathique 4 (DN4) and blood protein biomarkers reported to be linked to the development and\u002For chronicity of neuropathic pain.",[444,445],"Neuropathic Pain","Cancer Treatment",[447,437,448],"green tea extract","neuropathic pain","2026-06-26",{"date":204,"type":33},{"date":452,"type":22},"2026-09-30",{"date":454,"type":22},"2029-03-01",{"name":39,"class":40},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":472,"leadSponsor":474,"locationsCount":41},"100585980","mobile-thinking-intervention-a-inital-test-100585980","NCT06909422","Mobile Thinking Intervention: A Inital Test","A Mobile Intervention to Enhance Your Mood: A Test of the Acceptability and Efficacy","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or related psychotic disorder OR\n* Identified as being at clinical high risk for psychosis in symptom interviews\n\nExclusion Criteria:\n\n* Recent changes in mental health treatment in past month or two months if on depot",{"count":247,"type":22},[124],"This study will test the inital efficacy of a brief mobile intervention targeting biased thinking.",[467,468],"Schizophrenia","Clinical High Risk for Psychosis (CHR)","2026-06-25",{"date":344,"type":33},{"date":260,"type":22},{"date":473,"type":22},"2028-12",{"name":39,"class":40},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":489,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":41},"100543491","adapting-enhanced-recovery-programs-for-low-health-literacy-patients-100543491","NCT06356558","Adapting Enhanced Recovery Programs for Low Health Literacy Patients","Inclusion Criteria:\n\n* Adult patients \\>= 18 years of age undergoing surgery under an enhanced recovery program (ERPs)\n* Adult caregivers\u002Fproviders, organizational leaders, \\>= 18 years of age with direct or indirect involvement with ERP implementation\n* All genders\n* All race\u002Fethnicities\n* Able to consent\n* English-speaking\n\nExclusion Criteria:\n\n* Child (\\\u003C18 years of age)\n* Patients undergoing operations not included under ERPs\n* Participants unable to consent for the study\n* Participants whose mental state excludes them from being able to understand contents of the informed consent form and\u002For patients whose family members or patient representative do not wish for them to participate in the study",{"count":482,"type":22},1050,[124],"Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities.",[486,487,488],"Surgery","Health Knowledge, Attitudes, Practice","Colorectal Disorders",[486,490,491],"Health Literacy","Enhanced Recovery",{"date":344,"type":33},{"date":494,"type":33},"2026-06-15",{"date":496,"type":22},"2028-05-01",{"name":39,"class":40},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":505,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":41},"100512438","phase-2-newly-diagnosed-stage-iiiiv-ovarian-cancer-neoadjuvant-carbotaxolpembro-maintenance-olaparibpembro-100512438","NCT05952453","Newly Diagnosed Stage III\u002FIV Ovarian Cancer, Neoadjuvant Carbo\u002FTaxol\u002FPembro, Maintenance Olaparib\u002FPembro","A Phase II Study in Newly Diagnosed Stage III\u002FIV Epithelial Ovarian Cancer Evaluating Carbo\u002FTaxol\u002FPembro in Patients Receiving Neoadjuvant Chemotherapy (NACT) Followed by Olaparib\u002FPembro Maintenance","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\n  1. Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer.\n  2. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery.\n  3. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits\u002FL) : carcinoembryonic antigen (CEA; ng\u002FmL) ratio greater than or equal to 25 \\[Vergote, I., et al 2010\\].\n\n     Note: if the serum CA-125\u002FCEA ratio is less than 25, then a workup should be negative for the presence of a non-ovarian cancer to determine eligibility (e.g., breast or gastrointestinal cancers \\[including CRC\\]).\n\n  5\\. Participant is female and at least 18 years of age on the day of signing informed consent.\n\n  6\\. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to enrollment.\n\n  7\\. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow contraceptive guidance during the Treatment Period and for at least 120 days following the last dose of pembrolizumab and olaparib and at least 210 days following the last dose of chemotherapy 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research.\n\n  9\\. Participant has adequate organ function as follows; all screening laboratory tests should be performed within 7 days of enrollment:\n  1. Absolute neutrophil count (ANC) ≥1500\u002FμL\n  2. Platelets ≥100 000\u002FμL\n  3. Hemoglobin ≥8.0 g\u002FdL or ≥5.6 mmol\u002FL\n  4. Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥51 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  5. Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n  7. International normalized ratio (INR) OR prothrombin time (PT); Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\n     Exclusion Criteria:\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. Participant has mucinous, germ cell, or borderline tumor of the ovary.\n  2. Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.\n  3. Participant either has myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or has features suggestive of MDS\u002FAML.\n  4. Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years.\n\n     Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Additionally, participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than I-A; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.\n  5. Participant has known active central nervous system metastases and\u002For carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to enrollment. Stable brain metastases should be established prior to the first dose of study medication.\n\n     Note: Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion \\>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.\n  6. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg dailyof prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n  7. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n     Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n  8. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis).\n  9. Participant has an active infection requiring systemic therapy.\n  10. Participant is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n  11. Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian tube cancer \\\u003C6 months prior to screening.\n  12. Participant has a known psychiatric or substance abuse disorder that would interfere with the ability to cooperate with the requirements of the study.\n  13. Participant has a known history of human immunodeficiency virus (HIV) infection.\n  14. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsag\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n  15. Participant has received prior treatment for advanced or metastatic OC, including radiation or systemic anti-cancer therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, investigational therapy).\n  16. Participant has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, or paclitaxel, and\u002For any of their excipients.\n  17. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation\\>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT syndrome.\n  18. Participant has had an allogenic tissue\u002Fsolid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation.\n  19. Participant has received prior therapy with olaparib or with any other PARP inhibitor.\n  20. Participant has a known hypersensitivity to the components or excipients in olaparib.\n  21. Participant is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks.\n  22. Participant is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.\n\n      Note: a current list of strong\u002Fmoderate inducers of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers\n  23. Participant has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study intervention. Participant received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM CSF\\] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention.\n  24. Participant is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).\n  25. Participant is 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, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n  26. Participant has uncontrolled hypertension, defined as defined as systolic \\>140 mm Hg or diastolic \\>90 mm Hg documented by 2 blood pressure readings taken at least 1 hour apart.\n\n      Note: This applies to participants who will receive bevacizumab.\n  27. Use of antihypertensive medications to control blood pressure is allowed. Participant has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC.\n\n      Note: This applies to participants who will receive bevacizumab.\n  28. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to enrollment Note: This applies only to participants who will receive bevacizumab.\n  29. Participant is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of the first dose of study treatment.\n  30. Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.","FEMALE",{"count":272,"type":22},[25],"this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.",[510],"Ovarian Cancer",[512,513],"newly diagnosed","stage III\u002FIV",{"date":344,"type":33},{"date":516,"type":33},"2025-02-17",{"date":518,"type":22},"2030-12-30",{"name":39,"class":40},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":536,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":547},"100450311","phase-2-asciminib-as-initial-therapy-for-patients-with-chronic-myeloid-leukemia-in-chronic-phase-100450311","NCT05143840","Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase","Asciminib as Initial Therapy With Addition of Lower Dose Tyrosine Kinase Inhibitors for Patients With Chronic Myeloid Leukemia Who do Not Achieve Optimal Response or a Deep Molecular Remission (ALERT CML)","ALERTCML","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Willing and able to give informed consent\n3. Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy\u002Faspirate and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.\n4. Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed with no time restrictions within the eligible time from diagnosis.\n5. ECOG performance status 0-2 (appendix 1)\n6. Adequate organ function:\n\n   * AST and ALT \\\u003C 3 times the institutional upper limit of normal (ULN)\n   * eGFR ≥ 30 mL\u002Fmin as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n   * Total bilirubin \\\u003C 1.5 times the institutional ULN or \\\u003C 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)\n7. Adequately controlled blood pressure, defined as systolic blood pressure of \\\u003C140 mmHq and diastolic of \\\u003C90 mmHg, at the time of enrollment.\n8. Lipase ≤ 1.5 x ULN. For lipase \\> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.\n9. Creatine phosphokinase \\\u003C 2.5 x ULN\n10. Female patients must meet one of the following:\n\n    1. Postmenopausal for at least one year before the screening visit,\n    2. Surgically sterile\n    3. If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug,\n    4. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    5. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n11. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose\n    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n\nExclusion Criteria:\n\n1. Patients with accelerated or blast phase CML (refer to appendix 4)\n2. Active second malignancy requiring active treatment\n3. History of recent (within 12 months) acute pancreatitis or chronic pancreatitis\n4. Subjects who have previously received treatment with asciminib.\n5. Subjects with PLT count \\\u003C 50,000 mm3 or ANC of \\\u003C 500 mm3 or Hemoglobin \\\u003C 8 g\u002FdL\n6. Cardiac or cardiac repolarization abnormality, including any of the following:\n\n   1. History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)\n   2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)\n   3. QTcF at screening greater than or equal to 450 msec (male patients), greater than or equal to 460 msec (female patients) unless patient has a pacemaker\n   4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n   i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ii. Concomitant medication(s) with a \"Known risk of Torsades de Pointes\" per wwwcrediblemeds.org\u002F that cannot be discontinued or replace 7 days prior to starting study drug by safe alternative medication.\n\n   iii. Inability to determine the QTcF interval\n7. Pregnant or lactating\n8. Taking a strong inhibitors or inducers of CYP3A4 or CYP3A4 substrates with narrow therapeutic index (refer to appendix 6) at time of enrollment\n9. Unable to comply with lab appointment schedule and PRO assessments\n10. Another investigational drug within 4 weeks of enrollment\n11. Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol\n12. Patient has undergone a prior allogeneic stem cell transplant\n13. Known clinical history of active HBV infection",{"count":247,"type":22},[25],"This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used:\n\n1. Dasatinib 50 mg daily\n2. Imatinib 300 mg daily\n3. Nilotinib 300 mg daily\n\nPatients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.",[532,533,534,535],"Chronic Myeloid Leukemia, Chronic Phase","Adult CML","Leukemia, Myeloid","Leukemia,Myeloid, Chronic",[537,533,538,539,540],"Chronic Myeloid Leukemia","tyrosine kinase inhibitors","H. Jean Khoury Cure CML Consortium","HJKC3-0004",{"date":344,"type":33},{"date":543,"type":33},"2022-04-22",{"date":545,"type":22},"2032-02",{"name":39,"class":40},8,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":41},"100351599","effect-of-preoperative-mobility-device-training-on-postoperative-fall-incidence-100351599","NCT03857945","Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence","Inclusion Criteria:\n\n* age 18 and older\n* undergoing elective unilateral foot\u002Fankle surgery\n* requiring a period of post-operative non-weight-bearing or partial-weight-bearing period as advised by the operating surgeon.\n\nExclusion Criteria:\n\n* less than 18 years of age\n* wheelchair-bound patients\n* patients with history of previous use of post-operative mobility device(s)\n* patients with ankle fractures, patients with previously diagnosed condition(s) with cognitive, balance, mobility impairment\n* patients undergoing bilateral surgery\n* patients requiring follow ups longer than 6 weeks",{"count":310,"type":22},[124],"The purpose of this study is to determine whether preoperative mobility device training is beneficial in reducing incidence of postoperative falls in patients undergoing elective foot and ankle surgery requiring a postoperative period of no weight-bearing.",[558],"Injury; Muscle, Ankle, and Foot, Multiple",[560],"preoperative mobility device training",{"date":344,"type":33},{"date":563,"type":33},"2019-09-09",{"date":565,"type":22},"2027-05",{"name":39,"class":40},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":118,"sex":505,"minAge":18,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":581,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":143},"100572541","folic-acid-salt-study-fisfa-zambia-100572541","NCT06734611","Folic Acid Salt Study (FISFA Zambia)","Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country","Inclusion Criteria:\n\n* Voluntary participation in the study\n* Do not intend to get pregnant\n* Not lactating or pregnant\n* Live alone or with a partner if they can be compliant and not share the study salt.\n* Aged between 18 and 45 years\n\nExclusion Criteria:\n\n* Pregnant or lactating","45 Years",{"count":310,"type":22},[124],"Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program?\n\nParticipants will:\n\n* Consume salt with folic acid instead of their regular salt for 6 months\n* Have a blood draw 4 times\n* Fill out surveys",[579,580],"Folate Deficiency","Neural Tube Defects",[582,583,584,585,586,587,588,589,590,591,592,593],"folic acid","iodine","salt","serum folate","red blood cell folate","prevention","folate insufficiency","Malnutrition","Nervous System Malformations","Spinal Dysraphism","Vitamin B9","Micronutrients","2026-06-24",{"date":344,"type":33},{"date":597,"type":33},"2026-04-10",{"date":37,"type":22},{"name":39,"class":40},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":505,"minAge":18,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":616,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":624},"100564382","cgm-for-management-of-type-2-diabetes-in-pregnancy-100564382","NCT06628453","CGM for Management of Type 2 Diabetes in Pregnancy","Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy","CGM2","Inclusion Criteria:\n\n* Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater\n* Pregnant with viable fetus at 6 to less than 23 weeks gestation\n* Maternal age 18-50 years old\n\nExclusion Criteria:\n\n* Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions\n* Multiple gestation\n* Major fetal anomaly or two or more minor fetal anomalies\n* Planned delivery outside study consortium\n* Participating in another conflicting interventional study\n* Participation in this trial in a previous pregnancy\n* Patient unable to consent\n* Physician refusal for other reasons","50 Years",{"count":610,"type":22},564,[124],"The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are:\n\n1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose?\n2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose?\n3. What other factors increase the risk of maternal and infant complications?\n\nParticipants will:\n\n1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery\n2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis\n3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits\n4. Have umbilical cord blood collected at delivery for analysis",[614,615],"Type 2 Diabetes Mellitus (T2DM)","Pregnancy",[617,615,618],"Diabetes","CGM",{"date":344,"type":33},{"date":621,"type":33},"2025-04-08",{"date":349,"type":22},{"name":39,"class":40},7,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":505,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":640,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":41},"100553857","time-restricted-eating-for-postpartum-weight-loss-100553857","NCT06491537","Time-restricted Eating for Postpartum Weight Loss","Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women","Time4Mom","Inclusion Criteria:\n\n* 18 years of age or older\n* Experienced a healthy singleton pregnancy\n* 6-16 weeks postpartum at enrollment\n* Body mass index ≥25 at enrollment\n* Willing to consent\n\nExclusion Criteria:\n\n* Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)\n* Current treatment for severe psychiatric disorder (such as schizophrenia)\n* Self-reported diagnosis of anorexia or bulimia\n* Current use of medication expected to significantly impact body weight\n* Current substance abuse\n* Participation in another dietary and\u002For weight management intervention postpartum\n* Performing overnight shiftwork \\>1x\u002Fweek\n* Regularly fasting ≥14 hr\u002Fday or completing twelve or more 24-hr fasts within the past year\n* Unable to understand and communicate in English",{"count":634,"type":22},60,[124],"This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight\u002Fobesity.",[638,639],"Postpartum Weight Retention","Overweight and Obesity",[641,642,643],"postpartum","weight management","time-restricted eating",{"date":344,"type":33},{"date":646,"type":33},"2025-05-22",{"date":648,"type":22},"2029-02-01",{"name":39,"class":40},""]