Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-31 @ 11:41 AM
Study NCT ID:
NCT01638312
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2012-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of Method of Fructose Identification in Urine to Detect the Viral Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jijits@cc.kmu.edu.tw', 'phone': '886-7-3121101', 'title': 'JihJin Tsai, MD', 'phoneExt': '6358', 'organization': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Serious and Other (Not Including Serious) Adverse Events were not collected', 'eventGroups': [{'id': 'EG000', 'title': '"HIV Infected Patients"', 'description': 'Serious and Other (Not Including Serious) Adverse Events were not collected', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '"Healthy Controls"', 'description': 'Serious and Other (Not Including Serious) Adverse Events were not collected', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '"HIV Infected Patients"', 'description': '20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%'}, {'id': 'OG001', 'title': '"Healthy Controls"', 'description': 'Healthy people\n\nGraphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.\n\n2."Healthy people" was subjective judgments of participants, no other test as proof.\n\n3.Graphical analysis of HIV-infected subjects'}], 'classes': [{'title': 'Positive in waveform', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Negative in waveform', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants provided urine samples once', 'description': 'This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.\n\n1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.\n\nσ≧10 abnormal positive (+) σ\\<10 normal negative (-)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '"HIV Infected Patients"', 'description': 'The people had infected HIV'}, {'id': 'FG001', 'title': '"Healthy Controls"', 'description': "The people didn't have infected HIV"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '"HIV Infected Patients"', 'description': 'The people had infected HIV'}, {'id': 'BG001', 'title': '"Healthy Controls"', 'description': "The people didn't have infected HIV"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.15', 'spread': '10.27', 'groupId': 'BG000'}, {'value': '31.87', 'spread': '9.46', 'groupId': 'BG001'}, {'value': '32.38', 'spread': '9.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2012-01-20', 'resultsFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-03', 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform', 'timeFrame': 'Participants provided urine samples once', 'description': 'This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.\n\n1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.\n\nσ≧10 abnormal positive (+) σ\\<10 normal negative (-)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV, fructose'], 'conditions': ['Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage. There will be 20 samples from the HIV-infected patients and 30 samples from the heath controls. The study will collect 10ml urine and examined fructose and fructose-diphosphate using the polarographic method.', 'detailedDescription': 'The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the person who has HIV infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n\nExclusion Criteria:\n\n* who are in highly active antiretroviral therapy(HARRT) therapy'}, 'identificationModule': {'nctId': 'NCT01638312', 'briefTitle': 'Development of Method of Fructose Identification in Urine to Detect the Viral Infection', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Development of Fast and Simple Method of Fructose Identification in Urine to Detect the Viral Infection in Early Stage', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20110188'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV infection patient and health people', 'description': 'The study does not have intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Tropical Medicine Center, Kaohsiung Medical University Chung-Ho Memorial Hospital'}], 'overallOfficials': [{'name': 'JihJin Tsai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Medicines Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}