[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cortisol-excess\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cortisol-excess":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100615736","phase-2-trial-against-intractable-type-2-diabetes-captain-t2d-100615736",false,"NCT07296484","Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","CAPTAIN-T2D","Inclusion Criteria:\n\n* From Screening 1\n\n  * Age at least 18 years.\n  * HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the current \\[as of Screening 1\\] regimen).\n  * Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3 months prior to Screening 1 and without change between Screening 1 and Day 1) (An ADM dose will be deemed adequate if it is at or above the maximal labelled dose, or a sub-maximal, but not starting, dose if limited by tolerability (confer with MM if less than half-maximal dose).\n  * Adequate total daily insulin is defined as at least 0.3 units\u002Fkg\u002Fday. Insulin dose will be deemed stable with adjustments of up to 20% total daily dose during the 3 months prior to Screening 1 or between Screening 1 and Day 1.\n  * Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.\n  * At least one of the following\n\n    * ≥3 stable and adequate ADMs;\n    * diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);\n    * hypertension requiring ≥2 adequately dosed AHMs;\n    * adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and\n    * adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;\n    * evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);\n    * or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.\n\nAt DST • Post-DST cortisol level \\>1.8 µg\u002FdL and serum dexamethasone ≥140 ng\u002FdL. Patients with an established diagnosis of neoplastic hypercortisolism do not require a DST.\n\nAt Screening 2\n\n* HbA1c ≥7.5% at Screening 2. At Day 1\n* No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.\n\nExclusion Criteria:\n\n* New-onset diabetes (onset \\\u003C1 year in the past).\n* Unwillingness to maintain with current glucose-lowering regimen during the trial.\n* Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.\n* Unwillingness to comply with CGM or other trial procedures.\n* Investigator considers the patient will otherwise be unwilling or unable to complete the trial.\n* Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.\n* Evidence for significant hypoglycemia while on their current diabetic treatment regimen(This includes episodes of symptomatic Level 3 hypoglycemia requiring external assistance for recovery, or CGM-documented prolonged \\[\\>15 min\\] or repeated episodes of either Level 2 hypoglycemia leading to \\>1%, or Level 1 hypoglycemia leading to \\>4%, in \"time below range\" within 3 months prior to Screening 1 or between Screening 1 and Day 1).\n* Any of the following in medical history:\n\n  * Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);\n  * A hemoglobinopathy or other condition which may interfere with measurement of HbA1c (e.g., sickle cell disease HbSS or other variants HbEE thalassemia, hemolytic anemia, recent blood transfusion);\n  * Hypersensitivity or severe reaction to dexamethasone;\n  * Pheochromocytoma, or suspicion thereof;\n  * Anorexia, or other eating disorder;\n  * Glucocorticoid resistance;\n  * Multiple sclerosis;\n  * Significant hepatic impairment (e.g., Child-Pugh Class B or C);\n  * Idiopathic thrombocytopenic purpura;\n  * Untreated or inadequately controlled moderate-to-severe sleep apnea (apnea-hypopnea index ≥15). (Patients whose condition has been well controlled with Continuous Positive Airway Pressure (CPAP) use for at least 3 months prior to Screening 1 are not excluded. Patients with a STOP-BANG score 5-8 should be referred for a sleep study outside the trial and may rescreen if found not to have moderate-to-severe sleep apnea);\n  * Current alcohol consumption \\>14 units\u002Fweek or \\>4 units in a single day for males, or \\>7 units\u002Fweek or \\>3 units in a single day for females. (Patients with a CAGE score 2-4 should be evaluated further outside the trial and may be rescreened if found not to have an alcohol \\[or other substance\\] use disorder);\n  * Untreated or inadequately controlled major depressive disorder, generalized anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia.(Patients whose condition has been well controlled with stable medical therapy, or has been asymptomatic, for at least 3 months prior to Screening 1 are not excluded); or\n  * Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.\n  * Any of the following in medication history:\n  * Any of the excluded medications listed in Section 6.9;\n  * Any investigational drug within 4 weeks or within less than five times the drug's half-life, whichever is longer, prior to Screening 1 or between Screening 1 and Day 1;\n  * Woman of childbearing potential (WOCBP) not willing to adhere to highly effective contraception or strict abstinence for the duration of the trial and for 90 days post completion\u002Fdiscontinuation; and\n  * Pregnancy (including a positive urine test) or current breast feeding.\n\nFrom Screening 2\n\n• Prior probability of undiagnosed endogenous Cushing syndrome based on either of:\n\n* wo morning serum cortisol values after dexamethasone suppression \\>5.0 mcg\u002FdL together with plasma dexamethasone \\>140 ng\u002FmL; or\n* a morning serum cortisol value after dexamethasone suppression \\>1.8 mcg\u002FdL, together with plasma dexamethasone \\>140 ng\u002FmL and any one of the following that is not attributable to an etiology other than endogenous Cushing's syndrome:\n* supraclavicular\u002Fdorsocervical fat accumulation;\n* irounding of the face (especially compared with prior photos);\n* skin changes (violaceous striae, skin thinning, or excessive bruising);\n* proximal muscle weakness on exam; or\n* history of deep vein thrombosis\u002Fpulmonary embolism.\n* Plans for, or medically unable to forego, treatment for endogenous Cushing syndrome or ACS within the next 8 months. (For clarity, patients with EnCS or ACS, not having such treatment plans, and medically able to forego treatment for 8 months may enroll if otherwise eligible).\n* Severe, poorly controlled hypertension (mean systolic BP \\>160 mmHg or mean diastolic BP \\>100 mmHg) at Screening 2 or between Screening 2 and Day 1, including by at-home monitoring. (Such patients will be eligible to rescreen for Part 2 when they restore BP \\\u003C160\u002F100 mmHg for 1 month on a new stable medication regimen).\n* Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).\n* Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) \\\u003C45 mL\u002Fmin\u002F1.73 m².\n* Poorly controlled hyperthyroidism\u002Fhypothyroidism (confirmed by TSH or Free thyroxine \\[fT4\\]).\n* Liver enzymes \\>3 × upper limit of normal (ULN) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or bilirubin \\>1.5 × ULN.(excepting benign conditions such as Gilbert's)\n* Known hypersensitivity to clofutriben or to any of the product","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).",[27,28],"Type 2 Diabetes","Cortisol Excess",[30,31,32],"hypercortisolism","Cortisol excess","elevated cortisol","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-11-29",{"date":41,"type":21},"2028-06-30",{"name":43,"class":44},"Sparrow Pharmaceuticals","INDUSTRY",60,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":68,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":79},"100550145","cerebrovascular-disease-quality-of-life-code-qol-100550145","NCT06443268","Cerebrovascular Disease: Quality of Life (CODE: QoL)","CODE:QoL","Control group:\n\nInclusion criteria:\n\n* over 18 years old\n* No previous stroke OR previous stroke \\>3 years ago\n* No significant disability (maximum mRS 1)\n* ambulatory patients at the University Hospital of Zurich (USZ), Dept. of Neurology\n* Patients' AND caregiver's ability to give informed consent\n* Patients' AND close relative's \u002F caregiver's willingness to participate\n\nExclusion criteria:\n\n• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months\n\nMain Group:\n\nInclusion criteria:\n\n* over 18 years old\n* Patients diagnosed with either transient ischemic attack, ischemic stroke or intracerebral hemorrhage and their caregivers\n* Caregiver of a patient as described above, age over 18 years\n* Hospitalized or ambulatory patients at the University Hospital of Zurich (USZ) included within 28 days from event.\n* Patients' AND caregiver's ability to give informed consent\n* Patients' AND caregiver's willingness to participate\n\nExclusion criteria:\n\n• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months",true,{"count":55,"type":21},680,"OBSERVATIONAL","The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers.\n\nThe main question is:\n\n• to discover the factors associated with quality of life and stress in patient-caregiver dyads.\n\nParticipants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data.\n\nResearchers will compare a group of participants without stroke to establish a comparable baseline.",[59,60,61,62,28,63,64,65,66,67],"Quality of Life","Stroke, Acute","Sexual Behavior","Stress","Incontinence, Urinary","Caregiver Burden","Transient Ischemic Attack","Intracerebral Hemorrhage","Cerebrovascular Disorders",[69],"Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden","2024-05-29",{"date":72,"type":37},"2024-06-05",{"date":74,"type":37},"2023-05-27",{"date":41,"type":21},{"name":77,"class":78},"University of Zurich","OTHER",1]