Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 4:03 AM
Study NCT ID:
NCT01151150
Status:
COMPLETED
Last Update Posted:
2011-07-26
First Post:
2010-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Phenomenon of "Chronic Lyme"; an Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, CSF'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Lyme Borreliosis']}, 'descriptionModule': {'briefSummary': 'The current study is set up to chart clinically and laboratory findings in Norwegian patients with symptoms attributed by themselves or their doctor to ongoing chronic Bb infection. Objectives is to assess laboratory findings in relation to established diagnostic criteria and to form a picture of the burden of symptoms and illness perception in this group of patients. The study is essentially exploratory, and is supposed to raise rather than to test hypotheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are eligible if they themselves or their physician suspected that they suffer from ongoing chronic Bb infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms attributed by themselves or their doctor to ongoing chronic Bb infection\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01151150', 'briefTitle': 'The Phenomenon of "Chronic Lyme"; an Observational Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'orgStudyIdInfo': {'id': 'Chronic Lyme'}}, 'contactsLocationsModule': {'locations': [{'zip': '4633', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sølandet Hospital HF', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Unn Ljøstad PhD, MD', 'oldOrganization': 'Sorlandet Hospital HF'}}}}