Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT02681458
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2016-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hasanyazdanfar@yahoo.com', 'phone': '00985136631004', 'title': 'Dr. Hassan Yazdanfar', 'organization': 'Islamic Azad University of Mashhad'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Serious and Other Adverse Events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Drug Users', 'description': 'Case group that consisted of drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-drug Users', 'description': 'Control group that consisted of non-drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '718', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Users', 'description': 'Case group that consisted of drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}, {'id': 'OG001', 'title': 'Non-drug Users', 'description': 'Control group that consisted of non-drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to two months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug Users', 'description': 'Case group that consisted of drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}, {'id': 'FG001', 'title': 'Non-drug Users', 'description': 'Control group that consisted of non-drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '718'}, {'groupId': 'FG001', 'numSubjects': '718'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '645'}, {'groupId': 'FG001', 'numSubjects': '656'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '1436', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug Users', 'description': 'Case group that consisted of drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}, {'id': 'BG001', 'title': 'Non-drug Users', 'description': 'Control group that consisted of non drug users with fungal infections\n\nDirect Examination: It was an observational study and subjects received their routine treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '90'}, {'value': '36.8', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '86'}, {'value': '37.55', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '602', 'groupId': 'BG000'}, {'value': '581', 'groupId': 'BG001'}, {'value': '1183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '718', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '1436', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'hair, nail, cutaneous lesions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1436}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2016-01-31', 'resultsFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-13', 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users', 'timeFrame': 'up to two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin and Subcutaneous Tissue Fungal Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran', 'detailedDescription': 'There were two groups with overall members of 1436. Statistically, the investigators have used "Likelihood ratio " and " Exact\'s Fisher" tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'people from northeast region of Iran referring to Methadone clinics. there were no limitations of age and sex.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected fungal lesions\n\nExclusion Criteria:\n\n* non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing'}, 'identificationModule': {'nctId': 'NCT02681458', 'briefTitle': 'Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran', 'organization': {'class': 'OTHER', 'fullName': 'Islamic Azad University of Mashhad'}, 'officialTitle': 'The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users', 'orgStudyIdInfo': {'id': 'IslamicAUM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug Users', 'description': 'Case group that consisted of drug users with fungal infections', 'interventionNames': ['Other: Direct Examination']}, {'label': 'Non-drug Users', 'description': 'Control group that consisted of non drug users with fungal infections', 'interventionNames': ['Other: Direct Examination']}], 'interventions': [{'name': 'Direct Examination', 'type': 'OTHER', 'description': 'It was an observational study and subjects received their routine treatment.', 'armGroupLabels': ['Drug Users', 'Non-drug Users']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Islamic Azad University of Mashhad', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Hassan Yazdanfar, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'assistant professor of mycology and parasitology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators have not decided about this issue yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Islamic Azad University of Mashhad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of parasitology and mycology department', 'investigatorFullName': 'Hassan Yazdanfar', 'investigatorAffiliation': 'Islamic Azad University of Mashhad'}}}}