[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"methylprednisolone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:methylprednisolone":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100620140","phase-4-efficacy-and-safety-of-methylprednisolone-after-flow-diverter-stent-implantation-in-unruptured-intracranial-aneurysms-100620140",false,"NCT07353749","Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms","Efficacy and Safety of Methylprednisolone in Preventing Adverse Cerebrovascular Events After Flow-Diverter Stent Implantation in Patients With Unruptured Intracranial Aneurysms: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* （1）Aged ≥ 18 years; （2）Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA;\n\n  （3）IA size ranging from 3 to 25 mm;\n\n  （4）The patient and\u002For their authorized representative can understand the study purpose, voluntarily participate, and sign the informed consent form;\n\n  （5）Patients scheduled to receive flow diverter treatment;\n\n  （6）Patients willing to complete follow-up evaluations in accordance with the clinical study protocol.\n\nExclusion Criteria:\n\n* （1）Patients with two or more multiple aneurysms who require secondary treatment within one month; （2）Female patients who are planning to become pregnant, are pregnant, or are breastfeeding;\n\n  （3）Pre-onset modified Rankin Scale (mRS) score ≥ 2;\n\n  （4）Patients complicated with systemic infectious diseases (latent or active stage), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, or ocular herpes simplex; patients with contraindications to glucocorticoids, such as active peptic ulcer and severe fungal infection;\n\n  （5）Ruptured aneurysms, recurrent aneurysms, infectious aneurysms, dissecting aneurysms; complicated with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc.;\n\n  （6）Patients with symptomatic cerebrovascular stenosis ≥ 70%;\n\n  （7）Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 30 days;\n\n  （8）Patients scheduled to undergo other surgical\u002Finterventional procedures within 30 days;\n\n  （9）Patients with severe comorbidities unsuitable for anesthesia or surgical treatment, such as major diseases of the heart, lungs, liver, spleen, and kidneys, atrial fibrillation, brain tumors, severe active infections, disseminated intravascular coagulation, and severe psychiatric history;\n\n  （10）Patients who cannot receive antiplatelet aggregation or anticoagulant therapy;\n\n  （11）Hypersensitivity to methylprednisolone sodium succinate;\n\n  （12）Patients receiving long-term hormone therapy (≥ 1 week) due to other comorbidities before surgery;\n\n  （13）Patients taking hepatic enzyme-inducing drugs, such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and aminoglutethimide; or patients taking hepatic enzyme-inhibiting drugs, such as erythromycin and ketoconazole;\n\n  （14）Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate \\\u003C 30 ml\u002Fmin or serum creatinine \\> 220 μmol\u002FL (2.5 mg\u002Fdl));\n\n  （15）Systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg that is uncontrollable with oral antihypertensive drugs;\n\n  （16）Blood glucose \\\u003C 2.8 mmol\u002FL or \\> 22.2 mmol\u002FL;\n\n  （17）Patients who have received a vaccine injection within the past month or have a plan for vaccination;\n\n  （18）Patients who cannot understand or are unwilling to complete follow-up evaluations in accordance with the clinical study protocol;\n\n  （19）Patients with advanced diseases with an expected life expectancy of \\\u003C 6 months;\n\n  （20）Patients currently participating in other clinical trials.","ALL","18 Years",{"count":19,"type":20},864,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Study Title: Testing Methylprednisolone to Prevent Strokes After a Stent Procedure for Brain Aneurysms\n\nWhat is the purpose of this study? This study aims to find out if a short course of a steroid medicine called methylprednisolone can help prevent strokes and other brain-related complications in patients who have a \"flow diverter\" stent placed to treat an unruptured brain aneurysm. The main goal is to see if this treatment reduces the combined number of new strokes (both clot-related and bleeding-related) or brain injury-related deaths within the first 30 days after the procedure.\n\nWho can participate? Adults aged 18 or older with an unruptured brain aneurysm (size 3-25mm) who are scheduled to receive a flow-diverting stent and can provide informed consent may be eligible. Key reasons someone might not be able to join include: having multiple aneurysms needing quick treatment, being pregnant or breastfeeding, having a history of recent stroke, having active infections or stomach ulcers, having severe kidney disease, having very high\u002Funcontrolled blood pressure or blood sugar, or already being on long-term steroid therapy.\n\nWhat will happen in the study?\n\nThis is a multicenter, randomized, double-blind study. This means:\n\nParticipants will be randomly assigned (like flipping a coin) to one of two groups.\n\nOne group will receive methylprednisolone. The other group will receive a placebo (an inactive substance that looks identical).\n\nNeither the participants nor their doctors will know which treatment is being given.\n\nAll participants will receive the standard care for the stent procedure and aftercare.\n\nHow long will the study last? The treatment period is short (around the time of the procedure). Participants will be closely monitored in the hospital and will have a follow-up visit around 30 days after the procedure to check their health status.\n\nWhat will be measured? The researchers will mainly track whether participants have any stroke or brain injury-related death in the first 30 days. They will also check for other complications like bleeding, infections, and changes in daily function and quality of life. Safety will be monitored throughout.\n\nHow many people will take part? The study plans to enroll approximately 864 participants across multiple hospitals.\n\nStudy Dates:\n\nThe study is expected to start enrolling patients in January 2026 and finish in August 2027.\n\nWho is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.",[26,27,28,29,30],"Unruptured Intracranial Aneurysms","Cerebrovascular Event","Hemorrhagic Stroke","Methylprednisolone","Flow Diverter",[32,33,29,27],"Flow-diverter devices","Intracranial aneurysm","NOT_YET_RECRUITING","2026-01-17",{"date":37,"type":38},"2026-01-20","ACTUAL",{"date":40,"type":20},"2026-01-30",{"date":42,"type":20},"2027-09-01",{"name":44,"class":45},"Duan Chuanzhi","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100587176","phase-4-neuroendoscopic-hematoma-evacuation-combined-with-methylprednisolone-sodium-succinate-in-the-treatment-of-basal-ganglia-intracerebral-hemorrhage-at-the-early-stage-100587176","NCT06924983","Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage","A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage.","NEMP-BGH","Inclusion Criteria:\n\n1. Aged between 18 and 80 years old.\n2. Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.\n3. Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A \\* B \\* C \\* 1\u002F2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.\n4. The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.\n5. The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.\n6. The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.\n7. The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.\n8. The patient and their legal representative should sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).\n2. Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.\n3. Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.\n4. A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.\n5. Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.\n6. Platelet count \\\u003C 75 × 10⁹\u002FL.\n7. Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) \\> 1.4.\n8. Expected to require long-term anticoagulation and antiplatelet therapy.\n9. A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled.\n10. Myocardial infarction occurred within the recent 30 days.\n11. Known to have a high embolism risk, including patients with mechanical heart valves implanted in the body, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible.\n12. Severe liver function impairment, with alanine aminotransferase (ALT) \\> 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) \\> 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m².\n13. Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.\n14. Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc.\n15. Allergic to drugs or devices related to the operation.\n16. Pregnant or lactating women, or those planning to become pregnant within one year.\n17. In the terminal stage of any disease with an expected lifespan of less than 6 months.\n18. Currently participating in other clinical trials or having been previously enrolled in this trial.\n19. The patient or his\u002Fher legal guardian is unwilling to sign the written informed consent form.","80 Years",{"count":57,"type":20},100,[23],"The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.",[61,62,29,63],"Stroke","Intracerebral Hemorrhage Basal Ganglia","Surgery","2025-04-10",{"date":66,"type":38},"2025-04-13",{"date":68,"type":20},"2025-05-01",{"date":70,"type":20},"2027-01-31",{"name":72,"class":45},"Yong Jiang",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":90,"locationsCount":46},"100586917","phase-4-neuroendoscopic-hematoma-evacuation-combined-with-methylprednisolone-sodium-succinate-in-the-treatment-of-lobar-intracerebral-hemorrhage-at-the-early-stage-100586917","NCT06921616","Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Lobar Intracerebral Hemorrhage at the Early Stage.","A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Lobar Intracerebral Hemorrhage at the Early Stage.","HEMS","Inclusion Criteria:\n\n1. The age ranges from 18 to 80 years old.\n2. Diagnosed as spontaneous intracerebral hemorrhage (ICH) by cranial computed tomography (CT) examination, with the bleeding site located in the lobar region of the brain.\n3. Calculate the hematoma volume according to the cranial CT examination, which should be within the range of 30 to 80 ml, and the shift of the midline structure at the level of the pineal gland is less than 3 mm. The formula for calculating the hematoma volume V (cubic centimeters) is V = A × B × C × 1\u002F2. Here, A represents the longest diameter (in centimeters) of the largest hematoma layer on the horizontal position of the plain CT scan, B refers to the widest diameter (in centimeters) of the hematoma perpendicular to A on this plane, and C stands for the thickness (in centimeters) of the hematoma shown on the CT film.\n4. The time interval from the onset of the disease to randomization is within 24 hours. In case the actual onset time is not clear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.\n5. The National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points at the time of randomization.\n6. The Glasgow Coma Scale (GCS) score is between 5 and 14 points at the time of randomization.\n7. The modified Rankin Scale (mRS) score is 0-1 points prior to the onset of the disease.\n8. The patient and his or her legal representative sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Hemorrhage in other locations (e.g., hemorrhage in infratentorial sites such as the basal ganglia, thalamus, brainstem, or cerebellum).\n2. Hemorrhage due to other causes (e.g., hemorrhage resulting from aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage due to coagulation disorders) or complicated by aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.\n3. Patients with intraventricular hemorrhage or those in whom intracerebral hemorrhage (ICH) has ruptured into the ventricles and who are considered to require external ventricular drainage.\n4. A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the past 30 days.\n5. Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.\n6. Platelet count \\\u003C 75 × 10⁹\u002FL.\n7. Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) \\> 1.4.\n8. Expected to require long-term anticoagulation and antiplatelet therapy.\n9. A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled.\n10. Myocardial infarction occurring within the past 30 days.\n11. Known to have a high embolism risk, including patients with mechanical heart valves implanted in vivo, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible.\n12. Severe liver function impairment, with alanine aminotransferase (ALT) \\> 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) \\> 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m².\n13. Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.\n14. Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc.\n15. Allergic to drugs or devices related to the operation.\n16. Pregnant or lactating women, or those planning to become pregnant within one year.\n17. In the terminal stage of any disease with an expected lifespan of less than 6 months.\n18. Currently participating in other clinical trials or having been previously enrolled in this trial.\n19. The patient or his\u002Fher legal guardian is unwilling to sign the written informed consent form.",{"count":82,"type":20},396,[23],"The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous lobar intracerebral hemorrhage within 24 hours after the onset.",[61,86,29,63],"Intracerebral Hemorrhage Lobar",{"date":66,"type":38},{"date":68,"type":20},{"date":70,"type":20},{"name":72,"class":45}]