[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tokyo Women's Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644585","phase-3-evaluating-the-response-guided-therapy-with-neoadjuvant-endocrine-therapy-to-optimize-adjuvant-treatment-in-premenopausal-hrher2--breast-cancer-jcog2402-youg-hope-100644585",false,"NCT07671885","Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+\u002FHER2- Breast Cancer (JCOG2402, Youg HOPE)","A Randomized Phase III Study of Response-Guided Therapy Following Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+\u002FHER2- Breast Cancer (JCOG2402, Young HOPE)","Young HOPE","Inclusion Criteria:\n\n1. Women aged 18 years or older\n2. ECOG PS 0-1\n3. HR-positive\u002FHER2-negative breast cancer\n4. ER expression ≥ 10%\n5. cN0; HG 1: 3 cm\\\u003CT≤5 cm, HG 2: 2 cm\\\u003CT≤5 cm or HG3: 1 cm\\\u003CT≤5 cm cN1; cT\\\u003C5 cm and HG 1\u002FHG 2\n6. Premenopausal women with spontaneous menses within 12 months\n7. No distant metastasis of breast cancer\n8. No prior diagnosis of breast cancer.\n9. No multiple regions of breast cancer\n10. No contralateral breat cancer\n11. Adequate organ function\n\nExclusion Criteria:\n\n1. Presence of active double cancer (synchronous malignancy requiring treatment).\n2. Ongoing infectious disease requiring systemic therapy. Fever ≥38.0°C at the time of registration.\n3. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.\n4. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.\n5. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg\u002Fday of prednisolone or other immunosuppressive agents.\n6. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.\n7. Uncontrolled hypertension.\n8. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.\n9. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)\n10. Positive for HIV antibodies (HIV testing is not mandatory.)\n11. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.","FEMALE","18 Years",{"count":20,"type":21},950,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Young HOPE\u002FJCOG2402 is a multicenter, randomized phase III study designed to evaluate response-guided therapy following neoadjuvant endocrine therapy to optimize adjuvant treatment in premenopausal HR+\u002FHER2- Breast Cancer.\n\nPremenopausal women with intermediate-risk HR-positive\u002FHER2-negative breast cancer derive benefit from the addition of chemotherapy to endocrine therapy. However, previous studies have demonstrated that patients who achieve an endocrine response (Ki-67 ≤10%) following neoadjuvant endocrine therapy have excellent outcomes without chemotherapy, irrespective of menopausal status. These findings suggest that endocrine therapy response may serve as a predictive biomarker to identify premenopausal patients who can safely omit chemotherapy.\n\nThe primary objective of this study is to evaluate the non-inferiority of an ET response-guided treatment strategy compared with standard surgery followed by adjuvant therapy. The study aims to increase the proportion of patients who can be treated with endocrine therapy alone by omitting chemotherapy in those with highly endocrine-sensitive disease.\n\nEligible patients are randomized 1:1 to upfront surgery or neoadjuvant endocrine therapy with an aromatase inhibitor and ovarian function suppression. The primary endpoint is EFS. Secondary endpoints include overall survival, relapse-free survival, distant recurrrence-free survival, HR-QOL, the rate of endocrine therapy alone in adjuvant therapy, ET response rate in an Arm B, the rate of non-menopause and safety. A total of 950 patients will be enrolled. Randomization is stratified by cN0 vs cN1, HG1 or 2 vs 3, and institution.\n\nThe JCOG2402 trial addresses an unmet need in adjuvant therapy of premenopausal HR-positive, HER2-negative breast cancer with intermediate risk and may contribute to the establishment of a new treatment strategy.",[27],"Breast Cancer",[29,30,31],"Premenopausal women","HR+HER2-","neoadjuvant endocrine therapy","RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":36},"2026-01-28",{"date":40,"type":21},"2039-01-27",{"name":42,"class":43},"Tokyo Women's Medical University","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100636168","pemafibrate-for-symptomatic-icas-rct-100636168","NCT07562178","Pemafibrate for Symptomatic ICAS RCT","Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)","PPAR-ICAS","Inclusion Criteria:\n\n1. Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \\>=4) between 24 hours and 3 years from onset at enrollment.\n2. Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial artery: intracranial internal carotid artery, middle cerebral artery (M1\u002FM2), anterior cerebral artery (A1), vertebral artery (V4), basilar artery, or posterior cerebral artery (P1).\n3. Fasting triglycerides (TG) 150-499 mg\u002FdL, or non-fasting TG 175-499 mg\u002FdL, measured within 4 weeks prior to consent.\n4. Men or women aged \\>=18 years at the time of consent.\n5. Ability to obtain written informed consent from the patient or a legally authorized representative.\n\nExclusion Criteria:\n\n1. Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection).\n2. Patients with \\>=70% stenosis of the extracranial carotid artery (NASCET criteria).\n3. Patients with neurological deterioration within 24 hours prior to enrollment.\n4. Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment.\n5. Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery).\n6. Patients who meet any contraindication to pemafibrate, including:\n\n(1) History of hypersensitivity to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as Child-Pugh B or C; (3) Cholelithiasis; (4) Pregnancy or suspected pregnancy; (5) Concomitant use of cyclosporine or rifampin. 7. Patients who have taken pemafibrate or any fibrate within 12 weeks prior to consent.\n\n8\\. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia.\n\n11\\. Patients with severe systemic comorbidities with an expected survival \\\u003C12 months.\n\n12\\. Patients who may be pregnant, are pregnant, or are breastfeeding. 13. Any other condition for which the principal or sub-investigator judges participation to be inappropriate.","ALL",{"count":55,"type":21},270,[57],"NA","The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA).\n\nThe main questions this study aims to answer are:\n\n1. Does pemafibrate lower the chance that ICAS gets worse over 12 months?\n2. Does pemafibrate improve TG levels and other vascular risk markers?\n3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months?\n\nResearchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking.\n\nParticipants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (\\>=150 mg\u002FdL) or non-fasting (\\>=175 mg\u002FdL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy.\n\nParticipants will:\n\n* Be randomly assigned to a pemafibrate group or a non-pemafibrate group\n* Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function\n* Have blood tests and clinical assessments at baseline and during follow-up\n* Undergo brain CTA at study entry and again at 12 months\n* Undergo brain MRI\u002FMRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule\n* Be followed for vascular events, functional outcome, and adverse events for 1 year",[60,61,62],"Intracranial Atherosclerotic Disease (ICAD)","Hypertriglyceridaemia","Stroke (CVA) or TIA","2026-06-12",{"date":65,"type":36},"2026-06-16",{"date":67,"type":36},"2026-05-26",{"date":69,"type":21},"2028-12-31",{"name":42,"class":43},19,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":53,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100598043","simultaneous-bilateral-radiofrequency-thalamotomy-for-medication-refractory-essential-tremor-100598043","NCT07066358","Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor","Inclusion Criteria:\n\n* Adults aged 20 to 70 years.\n* Diagnosis of essential tremor by a neurologist or neurosurgeon specializing in movement disorders.\n* Refractory to standard pharmacological therapy (e.g., propranolol, primidone, benzodiazepines, or alprenolol).\n* Mini-Mental State Examination (MMSE) score ≥ 27.\n* Able to undergo MRI.\n* Provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* History or evidence of bleeding tendency.\n* MRI contraindications (e.g., metallic implants, severe claustrophobia).\n* Presence of intracranial pathology on preoperative MRI that would interfere with surgery.\n* Pregnant or breastfeeding individuals.\n* Any other condition that the principal investigator deems inappropriate for study participation.","20 Years","70 Years",{"count":81,"type":21},5,[57],"This study aims to evaluate the safety and effectiveness of simultaneous bilateral radiofrequency thalamotomy for patients with medication-refractory essential tremor (ET). Essential tremor is a common neurological condition that causes involuntary shaking, often affecting the hands and interfering with daily activities such as writing, eating, or using tools. While medications such as propranolol and primidone can help some patients, others experience limited or no benefit.\n\nIn this study, five adult participants diagnosed with essential tremor that does not respond to standard medications will undergo simultaneous bilateral stereotactic radiofrequency lesioning of the ventral intermediate nucleus (Vim) of the thalamus. This procedure involves precisely targeting both sides of the Vim to reduce tremor in both arms during a single surgical session.\n\nPrior to surgery, participants will undergo brain MRI for surgical planning, as well as clinical evaluations including the Clinical Rating Scale for Tremor (CRST), Quality of Life in Essential Tremor Questionnaire (QUEST), the Scale for the Assessment and Rating of Ataxia (SARA), mood scales (BDI, BAI, AES), and cognitive function testing.\n\nThe surgery will be performed under local anesthesia using a stereotactic frame and intraoperative imaging. Tremor reduction will be assessed postoperatively and at 1, 3, and 6 months. The primary outcome is the improvement in CRST scores at 6 months. Secondary outcomes include quality of life (QUEST), ataxia symptoms (SARA), mood and cognitive changes, and adverse events.\n\nThis research is being conducted at Tokyo Women's Medical University. The study is IRB-approved and participants will be monitored closely throughout the 6-month follow-up period. Any complications or adverse events, such as temporary speech or swallowing difficulties, will be recorded and managed appropriately. The goal of this study is to explore whether performing thalamotomy on both sides simultaneously is a safe and effective treatment option for patients with severe and medication-resistant essential tremor.",[85],"Essential Tremor",[87,88],"thalamotomy","intraoperative MRI","2025-07-15",{"date":91,"type":36},"2025-07-18",{"date":93,"type":36},"2025-07-03",{"date":95,"type":21},"2026-12",{"name":42,"class":43},1,""]