[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myalgic-encephalomyelitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myalgic-encephalomyelitis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"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":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100555358","phase-1-lumbrokinase-for-adults-with-long-covid-post-treatment-lyme-disease-syndrome-and-myalgic-encephalomyelitischronic-fatigue-syndrome-100555358",false,"NCT06511050","Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Inclusion Criteria:\n\n* Any gender\n* Aged 18+\n* Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected as part of the baseline survey).\n* Diagnosed with only one of the following conditions:\n* Long Covid\n* Documented clinical history of confirmed or suspected acute COVID-19 infection a minimum of 3 months prior to contact with the study team\n* Formal diagnosis of Long Covid from a physician\n* Post-treatment Lyme disease syndrome\n* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:\n\n  * Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition Erythema Migrans History of possible exposure to a high incidence county or state (or an adjacent area) Erythema migrans rash\n\n    * EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)\n    * EM 1A: MOA self-report \\& medical record documentation of rash \\> 5 cm\n    * EM 1B: MOA: self-report and medical record documentation of EM rash but not size\n    * EM 1C: MOA: self-report \\& rash misdiagnosed in medical record as cellulitis\u002Fspider bite\n    * EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR\n    * Disseminated \"objective\" manifestation with lab test confirmation of Bb infection\n    * Clinical history includes at least one of the following symptoms\u002Fsigns, which are not better accounted for by another cause (MOA: medical records and\u002For self-report).\n    * Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic Signs (with objective measures) : Encephalopathy, Polyneuropathy\n    * Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis\n    * Lyme arthritis: Recurrent joint swelling in one or more joints\n    * Dermatologic: Disseminated EM (\"satellite\") or Acrodermatitis atrophicans AND\n    * Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report \\& documentation)\n  * Group 2. Probable\n\n    * 2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation Class 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR\n    * 2B. EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR\n    * 2C. Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR\n    * 2D. Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM)\n* (MOA: medical records, lab test and self-report)\n* (MOA: lab test and self-report)\n* ME\u002FCFS\n* Formal diagnosis of ME\u002FCFS prior to 2020 from a physician\n* Actively symptomatic such that the 2011 International Criteria for ME\u002FCFS is met at time of screening\n\nExclusion Criteria:\n\n* Current use of antiplatelet or anticoagulation regimen\n* Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.\n* Pregnancy or lactation\n* Known allergy to earthworms (Lumbrokinase is a supplement that is derived from earthworms)\n* Past medical history of a bleeding or clotting disorder\n* Has a scheduled surgery during, or immediately after, the study period","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:\n\n* Long Covid (LC)\n* Post-treatment Lyme disease syndrome (PTLDS)\n* Myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS)",[27,28,29,30],"Long Covid","Post-treatment Lyme Disease Syndrome","Chronic Fatigue Syndrome","Myalgic Encephalomyelitis",[27,32,33,34,35],"Lyme Disease","ME\u002FCFS","Lumbrokinase","Post-treatment Lyme disease syndrome","RECRUITING","2026-03-11",{"date":39,"type":40},"2026-03-13","ACTUAL",{"date":42,"type":40},"2024-10-09",{"date":44,"type":20},"2026-12",{"name":46,"class":47},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":48},"100457428","a-3-day-course-for-cfsme-100457428","NCT05236465","A 3-day Course for CFS\u002FME","A 3-day Course for Adults With Chronic Fatigue Syndrome\u002FMyalgic Encephalopathy (CFS\u002FME): a Randomized Controlled Trial","Inclusion Criteria:\n\n* CFS\u002FME diagnosis based on the Canada Consensus Criteria.\n* At least 50% out of school\u002Fwork.\n* Readiness to change (corresponding to the preparation phase in transtheoretical model)\n* Has given informed consent.\n\nExclusion Criteria:\n\n* Assessed by a General Practitioner (GP):\n* Underlying physical illness or mental disorder that may explain the symptoms.\n* Suicide risk\u002Fprevious suicide attempts.\n* Pregnancy.\n* Bedridden and in need of continuous care.\n* Insufficient Norwegian speaking or writing skills to participate in the 3-day course and fill out questionnaires.","65 Years",{"count":58,"type":20},100,[60],"NA","Chronic fatigue syndrome\u002FMyalgic encephalomyelitis (CFS\u002FME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS\u002FME is a challenging health problem as well as a societal problem.\n\nIn recent years, a doubling of the number of patients with a CFS\u002FME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS\u002FME. Municipalities have expenses in form of care, rehabilitation and other measures.\n\nThere is a lack of effective treatment for CFS\u002FME. Evidence-based knowledge is highly needed.\n\nIf the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.",[29,30],[64,65,66,67,68,69,70,71],"Health education","Chronic Fatigue Syndrome\u002FMyalgic Encephalopathy (CFS\u002FME)","RCT","3-day Course","Physical function","Fatigue","Cognitive techniques","Behavioral activation","2025-11-25",{"date":74,"type":40},"2025-11-26",{"date":76,"type":40},"2022-03-21",{"date":78,"type":20},"2028-12-01",{"name":80,"class":47},"Norwegian University of Science and Technology",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":48},"100496198","the-long-covid-19-wearable-device-study-100496198","NCT05741112","The Long COVID-19 Wearable Device Study","Inclusion Criteria:\n\n* Is at least 18 years old.\n* Has a self\u002Fand or physician diagnosis of:\n* Long COVID (based on the WHO working definition),\n* ME\u002FCFS (myalgic encephalomyelitis \u002F chronic fatigue syndrome, self-diagnosis based on IOM criteria), and\u002For\n* POTS (Postural Orthostatic Tachycardia Syndrome).\n* Is interested in tools to manage ME\u002FCFS, POTS, and\u002For Long COVID symptoms.\n* Owns a wearable device they are willing to use for this study or does not own a device and agrees to utilize a study-provided one.\n* Agrees to wear the device throughout the study period, share the data with the study, and sync data at least weekly.\n* Has access to a smartphone or tablet to enable syncing wearable data and viewing device feedback.\n* Agrees to disclose involvement in other ME\u002FCFS, POTS, and\u002For Long COVID interventions such as medical treatment, self-management, and other interventional studies.\n* Agrees to complete at least 75% of the study surveys.\n\nExclusion Criteria:\n\n* As long as they meet inclusion there is no exclusion",{"count":88,"type":20},100500,[60],"To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and post-exertional malaise.",[92,93,94,30,29,95],"Long COVID","Postural Orthostatic Tachycardia Syndrome","Dysautonomia","Long Covid19","2025-05-09",{"date":98,"type":40},"2025-05-11",{"date":100,"type":40},"2023-11-16",{"date":102,"type":20},"2025-12-01",{"name":104,"class":47},"Scripps Translational Science Institute"]