[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leprosy-multibacillary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leprosy-multibacillary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100632615","accuracy-of-the-polymerase-chain-reaction-of-ulnar-perineural-subcutaneous-aspirate-guided-by-ultrasound-for-the-diagnosis-and-monitoring-of-leprosy-cure-100632615",false,"NCT07515989","Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure","Does not exist","Inclusion Criteria:\n\nIndividuals aged 14 years or older;\n\nClinical suspicion of leprosy based on dermatologic or neurologic examination OR;\n\nPresence of peripheral nerve enlargement or skin lesions compatible with leprosy;\n\nAbility to provide written informed consent.\n\n\\-\n\nExclusion Criteria:\n\nPrevious treatment for leprosy;\n\nContraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy);\n\nLocal infection at the puncture site;\n\nInability or unwillingness to provide informed consent.","ALL","14 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"NA","\\*\\*Brief Summary\\*\\*\n\nLeprosy is a chronic granulomatous infectious disease caused by \\*Mycobacterium leprae\\* or \\*Mycobacterium lepromatosis\\*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. The diagnosis of leprosy is primarily clinical and epidemiological, supported by laboratory methods such as bacilloscopy and biopsy; however, these tests have limited sensitivity, particularly due to the bacillus' tropism for peripheral nerve structures.\n\nUltrasonography has emerged as a non-invasive imaging method capable of detecting morphological changes in peripheral nerves, including nerve enlargement, fascicular abnormalities, and inflammatory hypervascularization. Despite its diagnostic value, ultrasonography alone cannot detect the presence of the bacillus.\n\nThis prospective cohort study aims to evaluate the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using subcutaneous perineural aspirate. Patients with suspected leprosy attending the Leprosy Outpatient Clinic at the University Hospital of Brasília will undergo clinical evaluation, ultrasound examination of the ulnar nerves, and ultrasound-guided subcutaneous perineural aspirate for molecular detection of \\*Mycobacterium leprae\\* DNA and RNA using real-time PCR and RT-PCR.\n\nParticipants will be followed for one year, with assessments performed at diagnosis and after one year of treatment. The study will compare clinical, imaging, and molecular findings to determine whether perineural subcutaneous aspirate combined with ultrasonography improves early detection and diagnostic accuracy compared with conventional methods such as bacilloscopy and biopsy.\n\nThe study aims to contribute to improved diagnostic strategies for leprosy, enabling earlier detection of neural involvement and potentially reducing disease transmission and long-term disability.",[26,27,28,29,30,31],"Leprosy","Leprosy Neuropathy","Leprosy, Multibacillary","Leprosy--Patients","Mononeuropathies","Polyneuropathies",[26,33,34,35,36,37,38],"Slit Skin smear","Polimerase chain reaction","RLEP","16S","Sod","Periferal Nerve Ultrassound","RECRUITING","2026-04-02",{"date":42,"type":43},"2026-04-07","ACTUAL",{"date":45,"type":43},"2026-01-01",{"date":47,"type":20},"2027-08-31",{"name":49,"class":50},"University of Brasilia","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100627419","epidemiological-clinical-diagnostic-and-therapeutic-characteristics-of-hansens-disease-in-costa-rica-2018-2025-100627419","NCT07448389","Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Hansen's Disease in Costa Rica (2018-2025)","Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025","Inclusion Criteria:\n\n* Confirmed diagnosis of Hansen's disease.\n* Diagnosis between 1 January 2018 and 31 December 2025.\n* Any age or sex.\n* Available digital clinical record.\n* Case reported in national surveillance (VE-01).\n* Diagnosed or treated in Costa Rican public health institutions.\n\nExclusion Criteria:\n\n* Cases whose diagnosis was reviewed and reclassified as another disease.",{"count":60,"type":20},130,"OBSERVATIONAL","The goal of this observational retrospective study is to characterize the epidemiologic, clinical, diagnostic, and therapeutic features of Hansen's disease cases in Costa Rica between 2018 and 2025. The main questions it aims to answer are:\n\nWhat are the epidemiologic and clinical characteristics of confirmed Hansen's disease cases in Costa Rica?\n\nWhat diagnostic methods, treatments, complications, and outcomes are observed in routine care?\n\nAll confirmed Hansen's disease cases recorded in national surveillance and with available clinical records during 2018-2025 will be included. Data will be obtained from electronic health records and Ministry of Health reports without participant contact.",[26,64,29,65,28,27],"Hansen's Disease","Lepromatous Leprosy",[26,67,68,69],"Costa Rica","Hansen's disease","Hansen","NOT_YET_RECRUITING","2026-03-06",{"date":73,"type":43},"2026-03-09",{"date":75,"type":20},"2026-05",{"date":77,"type":20},"2026-12",{"name":79,"class":80},"Caja Costarricense de Seguro Social","OTHER_GOV",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100457979","phase-2-efficacy-and-tolerability-of-adjunct-metformin-for-multibacillary-leprosy-100457979","NCT05243654","Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy","Efficacy and Tolerability of Adjunct Metformin in Combination With Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Phase 2 Trial in Indonesia","MetLep","Inclusion Criteria:\n\n* Participant is a male or female, aged ≥18 and ≤65 years.\n* Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 28 days.\n* Participant is willing and able to give informed consent for participation in the trial.\n* Participant is willing to adhere to study follow-up schedule for 48 weeks.\n\nExclusion Criteria:\n\n* Participant has received MDT \\>28 days for the current episode of MB leprosy, prior to study enrolment.\n* Presence of leprosy reaction and\u002For nerve function impairment requiring systemic corticosteroids on screening\u002Fenrolment evaluation.\n* Participants who have been treated for leprosy in the past.\n* Chronic systemic corticosteroid use for any other medical condition on screening evaluation (chronic use defined as ≥ 2 weeks).\n* History of diabetes mellitus or diabetes mellitus diagnosed on screening evaluation (random blood glucose is elevated ≥200 mg\u002FdL (or ≥11,1 mmol\u002FL) or fasting blood glucose ≥ 126 mg\u002FdL (or ≥7.0 mmol\u002FL)).\n* History of hypoglycaemia (random blood glucose \\\u003C55 mg\u002FdL (or \\\u003C3.0 mmol\u002FL).\n* History of cardiac failure, ischaemic heart disease, alcoholism, history of lactic acidosis or states associated with lactic acidosis such as shock or pulmonary insufficiency, and conditions associated with hypoxia.\n* History of intolerance or hypersensitivity to metformin.\n* Estimated glomerular filtration rate (eGFR) ≤30 mL\u002Fmin\u002F1.73m2 calculated by the CKDEPI equation.\n* AST or ALT ≥3 times the upper limit of normal (ULN) on screening evaluation.\n* Any serious medical condition for which participation in the trial, as judged by the investigator or treating physician, could compromise the well-being of the subject or prevent, limit or confound protocol-specified assessments.\n* HIV-positive on screening evaluation.\n* Female participant of childbearing age who is pregnant (clinically confirmed or urine dipstick for human chorionic gonadotrophin hormone) or breastfeeding.\n* Use of metformin within 12 weeks prior to study enrolment.\n* Use of other regular hypoglycaemic agents, including insulin.\n* Participation in another research trial involving an investigational product within 12 weeks prior to study enrolment.","18 Years","65 Years",{"count":92,"type":20},166,[94],"PHASE2","This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks.\n\nThe main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.",[26,28,97],"Neglected Tropical Diseases",[26,99,100],"Multibacillary leprosy","Skin-NTD","2025-08-04",{"date":103,"type":43},"2025-08-07",{"date":105,"type":43},"2022-10-01",{"date":107,"type":20},"2026-09-30",{"name":109,"class":50},"Oxford University Clinical Research Unit Indonesia",6]