[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mononeuropathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mononeuropathies":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,85],{"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":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100605729","ultrasound-evaluation-of-hematoma-risk-after-needle-emg-in-patient-on-doac-therapy-100605729","NCT07166302","Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy","U-HAND","Inclusion Criteria:\n\n* Subjects must understand the nature of the study and must provide signed and dated written informed consent prior to conducting any study-related procedures\n* Willing and able to comply with all protocol procedures\n* subjects confirmed the daily (and recent) intake od direct anticoagulants in strandard dosing.\n* no other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is taken.\n\nExclusion Criteria:\n\n* Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject\n* other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is recently taken.",{"count":60,"type":20},70,"7 Days","OBSERVATIONAL","Approximately 30 minutes after needle EMG, patients who are taking direct oral anticoagulants (DOACs) will undergo an ultrasound examination to evaluate for the presence of possible intramuscular hematomas at the muscles where the EMG needle was inserted. These hematomas are considered a potential adverse effect of needle EMG.\n\nThe aim of the study is to determine whether needle EMG can be considered a safe procedure in this group of patients, without posing a risk of intramuscular hematoma formation.",[65,66,67,68,30,31,69],"Direct Acting Anticoagulant Adverse Reaction","Needle Injury","EMG","Peripheral Neuropathies","Neuromuscular Diseases (NMD)",[71,72,73,74],"electromyography","hematoma","ultrasonography","anticoagulants","2025-09-03",{"date":77,"type":43},"2025-09-10",{"date":79,"type":20},"2025-09",{"date":81,"type":20},"2026-12-31",{"name":83,"class":50},"Masaryk University",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":51},"100558073","spinal-cord-stimulation-for-intractable-mononeuropathy-100558073","NCT06546371","Spinal Cord Stimulation for Intractable Mononeuropathy","Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study","SCIMONO","Inclusion Criteria:\n\n* Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)\n* Symptoms refractory to conventional medical management for at least 6 months according to treating physician\n* 18 years or older\n* Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)\n* Stable or absent concomitant analgesics\n\nExclusion Criteria:\n\n* Mononeuropathy located in the head or torso\n* Mononeuropathy by avulsion at the plexus brachialis\n* Life expectancy \\\u003C1 year\n* Anticoagulant drug therapy or disturbed coagulation\n* Immune-compromised patients\n* Pregnancy\n* Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)\n* Patients with psychological factors or addiction that require treatment","18 Years",{"count":95,"type":20},12,[23],"Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the \"Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials\" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.\n\nObjective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.\n\nStudy design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.\n\nStudy population: 12 patients suffering from intractable peripheral mononeuropathic pain.\n\nIntervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.\n\nMain study parameters\u002Fendpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.",[30,99],"Spinal Cord Stimulation","2025-02-27",{"date":102,"type":43},"2025-03-03",{"date":104,"type":43},"2024-05-13",{"date":106,"type":20},"2025-05",{"name":108,"class":50},"Erasmus Medical Center"]