Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 4:39 AM
Study NCT ID:
NCT04713306
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender Differences in Parkinsonian Patients- a Swedish Register Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1217}, 'targetDuration': '14 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences between gender', 'timeFrame': '2006-2020', 'description': 'investigations, medications,NonMotorSymptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NonMotorSymptoms, medication, National Registries'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: The complex impact of gender has been studied in different perspectives of health and disease in the literature. However, few attempts have been made to compile data from systematic disease specific registrations Swedish National Quality Registers play an important role in collecting large amounts of diagnose specific data, symptoms, and treatments. The subset Parkinson Registry has been in use for more than 20 years and are represented in all counties and hospitals where neurological care is provided in Sweden and offer optimal conditions to describe gender specific differences in the use of diagnostic tools, lead times and symptom profiles.', 'detailedDescription': 'Aim: To study differences between gender in diagnostic tools, pharmacological interventions, and self-reported symptoms in Parkinson´s Disease (PD).\n\nMETHODS:\n\nData were extracted from the Swedish Neuro Registers, one of the Swedish National Quality Registers. A mix of urban and rural parts of the country were chosen and data were divided by gender. Self-reported first experienced PD related symptom was used to define the starting point when processing the data. Zero to three years from this point was defined as early symptoms and over three years as late symptoms.\n\nCONCLUSION:\n\nDifferences between gender were seen in all chosen aspects, both diagnostically. Distinctions were also prominent in reported NonMotorSymptoms (NMS) profiles. These findings should be important to take into consideration for patients, professional staff, and caregivers in the daily work with gender mixed PD groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cohorts from rural areas and larger cities of Southern Sweden with diagnosed parkinsonism.', 'genderDescription': 'yes self-representation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants registered in the Swedish Neuro Registers.\n* Parkinson´s Disease\n* Acceptance of extraction of data\n\nExclusion Criteria:\n\n* non parkinsonian patients\n* Participants in the Registries who have not given allowance of extraction of data.'}, 'identificationModule': {'nctId': 'NCT04713306', 'briefTitle': 'Gender Differences in Parkinsonian Patients- a Swedish Register Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Jönköping County'}, 'officialTitle': 'Gender Differences in Diagnostic Tools, Medication, Time to Medication and Non-motor Symptoms in Parkinsonian Patients- a Swedish Register Study', 'orgStudyIdInfo': {'id': 'XXXXX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants in the Swedish Neuro Register', 'description': 'Participants are patients with parkinsonian symptoms'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 551 85', 'city': 'Jönköping', 'country': 'Sweden', 'facility': 'FUTURUM', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}], 'overallOfficials': [{'name': 'Johan Lokk, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Jönköping County', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Jonkoping University', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}