[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brazilian Clinical Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"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":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100593622","radical-cystectomy-or-radio-chemotherapy-as-preferred-treatment-for-invasive-bladder-cancer-100593622",false,"NCT07008833","Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer","Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer","REDEMPTED","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age.\n2. Pure or predominant urothelial carcinoma (including other histologic subtypes, with the exception of small cell carcinoma, as a minority component).\n3. Performance status of 0 to 1, according to the Eastern Cooperative Oncology Group (ECOG) criteria.\n4. Life expectancy of ≥ 3 months.\n5. Histologically confirmed T2, T3, or T4a stage bladder cancer (pure or predominant urothelial carcinoma) cN0 or cN1 or cN2 (if lymph nodes within the surgical and radiation fields and size ≤ 2 cm).\n6. Patients who are candidates for neoadjuvant cisplatin and have undergone TURBT (preferably maximal) prior to treatment.\n7. Adequate bladder function (defined as the ability to store and void urine effectively, without symptoms of dysfunction or incontinence).\n8. Neutrophil count ≥ 1500\u002Fmm³.\n9. Platelet count ≥ 100,000\u002Fmm³.\n10. Hemoglobin count \\> 10 g\u002FdL.\n11. Glomerular filtration rate greater than 40 mL\u002Fmin.\n12. Serum bilirubin \\\u003C 1.5 times the upper limit of the normal reference range and SGOT and SGPT \\\u003C 1.5 times the upper limit of the normal reference range.\n13. Absence of comorbidities that contraindicate treatment.\n14. Capable of giving signed and dated informed consent prior to any mandatory study-specific procedures, sampling, and analyses, which includes compliance with the requirements and restrictions listed in the informed consent form and study protocol.\n15. For inclusion in i) optional exploratory genetic research and ii) optional biomarker research, patients must meet the following criteria:\n\n    * Provide informed consent for genetic research prior to sample collection.\n    * Provide informed consent for biomarker research prior to sample collection.\n    * If a patient declines to participate in optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.\n\nExclusion Criteria:\n\n1. Presence of multiple primary tumors or multiple foci of carcinoma in situ (CIS) (including in the upper tract) that are not candidates for bladder preservation with radiochemotherapy (definition at the discretion of the investigator).\n2. Age \\> 80 years.\n3. Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested.\n4. Metastatic or unresectable disease.\n5. Sensory neuropathy Grade ≥ 2.\n6. Hearing impairment Grade ≥ 2.\n7. Having a known additional malignancy that has progressed or required active treatment in the last 5 years, except superficial bladder cancer and\u002For carcinoma in situ, basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n8. Clinically significant cardiovascular disease - functional class III-IV according to the New York Heart Association (NYHA) Classification of heart failure.\n9. Patients considered to be at high medical risk due to severe and uncontrolled disease, active or non-malignant systemic disease, and severe or potentially severe infection that may affect response to treatment or increase the risk of adverse events.\n10. Immunocompromised patients.\n11. Inflammatory bowel disease.\n12. Patients with known active hepatitis (i.e., hepatitis B or C).\n13. Patients receiving any prior systemic chemotherapy in the last 5 years for other tumors and at any time for muscle-invasive bladder cancer.\n14. Patients who have received prior systemic immunotherapy at any time, either in the setting of non-muscle-invasive bladder cancer or in treatment for other types of cancer.\n15. Prior pelvic radiotherapy.\n16. Patients, male or female, who do not agree to use an effective method of contraception throughout treatment and until 6 months after discontinuation of treatment.\n17. Women who are pregnant or currently breastfeeding. 18. The investigator's judgment that the patient should not participate in the study if the patient is unlikely to comply with the procedures, restrictions, and requirements.\n\n19\\. Prior Randomization to the present study.","ALL","18 Years","80 Years",{"count":21,"type":22},336,"ESTIMATED","INTERVENTIONAL",[25],"NA","Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:\n\nThis is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments.\n\nThe study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.",[28],"Muscle Invasive Bladder Cancer",[30,31,32],"Bladder cancer","Radiochemotherapy","Radical cystectomy","NOT_YET_RECRUITING","2026-02-10",{"date":36,"type":37},"2026-02-12","ACTUAL",{"date":39,"type":22},"2026-06",{"date":41,"type":22},"2032-02",{"name":43,"class":44},"Brazilian Clinical Research Institute","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100546585","phase-4-anti-inflammatory-and-anti-thrombotic-therapy-with-colchicine-and-low-dose-rivaroxaban-for-major-adverse-cardiovascular-events-reduction-in-ischemic-stroke-100546585","NCT06396858","Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke","A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke","ARCHIMEDES","Inclusion Criteria:\n\n* Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days;\n* Receiving standard therapy for acute management of ischemic stroke;\n* For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study.\n\nExclusion Criteria:\n\n* Modified Rankin score of 4 or more at randomization;\n* Refusal to provide consent;\n* Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \\\u003C15 mL\u002Fmin\u002F1.73 m2;\n* Severe liver failure (child C);\n* Indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation);\n* Previous hemorrhagic stroke or history of intracranial hemorrhage;\n* Systemic treatment with a potent CYP 3A4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3A4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine);\n* History of inflammatory bowel disease or chronic diarrhea;\n* Prolonged treatment (\\> 1 month) with immunosuppressants or systemic corticosteroids;\n* History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);\n* Pregnancy or breastfeeding;\n* Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.",{"count":55,"type":22},4500,[57],"PHASE4","The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.",[60],"Ischemic Stroke",[62,63,64,65],"Stroke","Anticoagulation","rivaroxaban","colchicine",{"date":67,"type":37},"2026-02-11",{"date":69,"type":22},"2026-07",{"date":71,"type":22},"2027-12",{"name":43,"class":44},""]