[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypotension-symptomatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypotension-symptomatic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100586803","epidural-electrical-stimulation-to-support-hemodynamic-management-in-individuals-with-parkinsons-disease-100586803",false,"NCT06920134","Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease","Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease","PD-HemON","Inclusion Criteria:\n\n1. \\> 18 years old\n2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)\n3. Confirmed orthostatic hypotension with a test for verticalization\n4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians\n5. Must provide and sign the Informed Consent before any study-related procedures\n6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;\n7. Able to understand and interact with the study team in French or English\n8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments\n\nExclusion Criteria:\n\n1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery\n2. The inability to withhold antiplatelet\u002Fanticoagulation agents perioperatively\n3. History of myocardial infarction or cerebrovascular events within the past 6 months\n4. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator\n5. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist\n6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)\n7. Inability to follow study procedures.\n8. Spinal anatomical abnormalities precluding surgery\n9. Presence of any indications requiring frequent MRIs.\n10. Current pregnancy or current breastfeeding\n11. Lack of effective or acceptable contraception for women of childbearing capacity\n12. Intention to become pregnant during the study\n13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator\n14. Participation in another interventional study that might confound study endpoint evaluations\n15. Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons","ALL","18 Years","90 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"NA","The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.",[28,29,30,31,32],"Hypotension Symptomatic","Parkinson's Disease","Orthostatic Hypotension, Dysautonomic","Multiple System Atrophy (MSA) With Orthostatic Hypotension","Multiple System Atrophy - Parkinsonian Subtype (MSA-P)",[34,35,36,37],"orthostatic hypotension","parkinson's disease","autonomic failure","hypotension","RECRUITING","2025-11-14",{"date":41,"type":42},"2025-11-18","ACTUAL",{"date":44,"type":42},"2025-07-03",{"date":46,"type":22},"2031-05-01",{"name":48,"class":49},"Ecole Polytechnique Fédérale de Lausanne","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":72,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100510835","phase-3-early-initiated-vasopressor-therapy-in-the-emergency-department-100510835","NCT05931601","Early Initiated Vasopressor Therapy in the Emergency Department","Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial","VASOSHOCK","Inclusion Criteria:\n\n* At least 18 years of age\n* Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as:\n\n  1. SBP \\\u003C 100mmHg or MAP \\\u003C 65 mmHg combined with lactate \\> 2.0 mmol\u002FL,\n  2. Physician defined blood pressure for the individual patient combined with a lactate \\> 2.0 mmol\u002FL\n  3. Either SBP \\\u003C 100mmHg or MAP \\\u003C 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician.\n* Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival.\n* Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion.\n\nExclusion Criteria:\n\n* Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.\n* Fertile women (\\\u003C60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.\n* Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.\n* Known allergy to noradrenaline.",{"count":60,"type":22},320,[62],"PHASE3","The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED).\n\nThe main questions it aims to answer are:\n\nIf early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can\n\n* Improve time to shock control.\n* Reduce the need for ICU admittance.\n* Decrease mortality.\n\nParticipants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay.\n\nAfter completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers.\n\nPatients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves.\n\nResearchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.",[65,66,67,68,28,69,70,71],"Shock","Shock, Septic","Hypotension","Hypotension and Shock","Hypovolemia","Hypovolemic Shock","Hypovolemic",[73,74,75,76,77],"Peripherally infused noradrenaline","Fluid therapy","Fluid treatment","Non-hemorrhagic shock and hypotension","Emergency Department","2025-06-26",{"date":80,"type":42},"2025-07-01",{"date":82,"type":42},"2023-12-08",{"date":84,"type":22},"2027-01-31",{"name":86,"class":49},"Odense University Hospital",8]