Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT01249833
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2010-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Oseltamivir on Cognitive Function in Subjects With Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joanne@tmginvestigators.com', 'phone': '4169297717', 'title': 'Joanne Morris, Clinical Research Quality Manager', 'organization': 'Trial Management Group Inc.'}, 'certainAgreement': {'otherDetails': 'If Sponsor has not submitted a manuscript for publication for this multi-center study within 12 months of study completion/termination, the PI will be free to publish separately. Sponsor can review results communications prior to public release and can embargo communications for up to 90 days if the proposed publication contains information relating to patentable items. If Sponsor believes proposed communications contain any confidential information, Sponsor has the right to remove it.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days', 'otherNumAtRisk': 59, 'otherNumAffected': 8, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza', 'otherNumAtRisk': 63, 'otherNumAffected': 8, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Attention Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'OG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}], 'classes': [{'categories': [{'measurements': [{'value': '-70.0', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-39.7', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.4', 'ciLowerLimit': '-60.7', 'ciUpperLimit': '-0.1', 'estimateComment': 'The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:\n\n* Reaction Time Subtest\n* Cued Reaction Time Subtest\n\nThe lower the value, the better the attention.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects for whom data was collected at both baseline and Day 4. Oseltamivir group: baseline data available for 58 of 59 randomised subjects and Day 4 data for 53 subjects (53 subjects analysed). Standard of Care Alone group: baseline data available for 61 of 63 subjects and Day 4 data for 55 subjects (55 subjects analysed).'}, {'type': 'SECONDARY', 'title': 'Change in Working Memory Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'OG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '1.14', 'ciUpperLimit': '6.42', 'estimateComment': 'The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Working memory assessed with the Dot Memory Test.\n\nThe higher the value, the better the working memory.', 'unitOfMeasure': 'Number of correct answers', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects with data collected at both Baseline and Day 4. Oseltamivir Group: Baseline values collected for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline values collected for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed)'}, {'type': 'SECONDARY', 'title': 'Change in Processing Speed Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'OG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}], 'classes': [{'categories': [{'measurements': [{'value': '-551.9', 'spread': '77.6', 'groupId': 'OG000'}, {'value': '-555.8', 'spread': '78.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.9685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-190.1', 'ciUpperLimit': '197.9', 'estimateComment': 'The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Processing speed assessed with the animal number decoding subtest\n\nThe lower the value, the better the processing speed', 'unitOfMeasure': 'Millliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects for whom data was collected at both Baseline and Day 4. Oseltamivr Group: Baseline data available for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline data available for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mood Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'OG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}], 'classes': [{'title': 'Change in Alertness Assessment', 'categories': [{'measurements': [{'value': '19.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Change in Calmness Assessment', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Change in Contentedness Assessment', 'categories': [{'measurements': [{'value': '16.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '5.7', 'estimateComment': 'The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.', 'groupDescription': 'Alertness: the higher the value, the greater the alertness.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.7219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.6', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.9', 'estimateComment': 'The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.', 'groupDescription': 'Calmness: the higher the value, the greater the calmness.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.1162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-.8', 'ciUpperLimit': '7.4', 'estimateComment': 'The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.', 'groupDescription': 'Contentedness: the higher the value, the greater the contentedness.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales).\n\nThe range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm.\n\nEach scale was anchored such that the lower the value, the better the mood.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects with data collected at both Baseline and Day 4. Baseline data was available for all randomized subjects in both groups; Day 4 data was available for 54 of 59 randomized subjects in the Oseltamivir Group (54 analysed) and for 58 of 63 randomized subjects in the Standard of Care Alone Group (58 analysed).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'FG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oseltamivir', 'description': 'Added to standard of care for influenza\n\nOseltamivir: Oseltamivir 75mg BID for 5 days'}, {'id': 'BG001', 'title': 'Standard of Care Alone', 'description': 'Standard of care for influenza'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '66'}, {'value': '32.0', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '57'}, {'value': '34.0', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest Education Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Grade 5 - 11', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'High School Graduate', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '1 - 3 Years College', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': "Bachelor's Degree", 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Post-Graduate', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from Symptom Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '51.5'}, {'value': '36.7', 'groupId': 'BG001', 'lowerLimit': '5.3', 'upperLimit': '55.0'}, {'value': '35.0', 'groupId': 'BG002', 'lowerLimit': '2.0', 'upperLimit': '55.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data was not collected for 1 patient in each group in error'}, {'title': 'Baseline Symptom Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '21'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '21'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'description': 'Participants recorded the severity of 7 influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia, and feverishness) using a 4-point scale (0, absent; 3, severe) each day for 14 days. Symptom severity was assessed by summing the severity rating (0-3) for the seven symptoms at each day.', 'unitOfMeasure': 'symptom score', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'BG000', 'lowerLimit': '36.3', 'upperLimit': '39.5'}, {'value': '38.1', 'groupId': 'BG001', 'lowerLimit': '36.5', 'upperLimit': '39.3'}, {'value': '38.1', 'groupId': 'BG002', 'lowerLimit': '36.3', 'upperLimit': '39.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Degrees centigrade', 'dispersionType': 'FULL_RANGE'}, {'title': 'Health Assessment Question', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Subjects rated their general health status each day using an 11-point VAS (0 = worst possible health; 10 = normal health for someone your age).', 'unitOfMeasure': 'Score', 'dispersionType': 'FULL_RANGE'}, {'title': 'Influenza Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Strain A', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Strain B', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assessed through Rapid Antigen Test', 'unitOfMeasure': 'Participants'}, {'title': 'Cognitive/Mood Conditions', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'ADHD', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Anxiety', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Depression', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2010-11-26', 'resultsFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2010-11-26', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-18', 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Mood Assessment', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales).\n\nThe range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm.\n\nEach scale was anchored such that the lower the value, the better the mood.'}], 'primaryOutcomes': [{'measure': 'Change in Attention Assessment', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:\n\n* Reaction Time Subtest\n* Cued Reaction Time Subtest\n\nThe lower the value, the better the attention.'}], 'secondaryOutcomes': [{'measure': 'Change in Working Memory Assessment', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Working memory assessed with the Dot Memory Test.\n\nThe higher the value, the better the working memory.'}, {'measure': 'Change in Processing Speed Assessment', 'timeFrame': 'Change from baseline at Day 4', 'description': 'Processing speed assessed with the animal number decoding subtest\n\nThe lower the value, the better the processing speed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Cognition', 'Attention', 'Simple Reaction Time', 'Alertness', 'Calmness', 'Contentment', 'Mood'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.', 'detailedDescription': 'Primary Objective:\n\nTo determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.\n\nSecondary Objectives:\n\nTo determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.\n\nSupportive Objectives:\n\n1. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.\n2. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.\n3. To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult men and women, 18 - 65 years of age (inclusive)\n2. Indicative symptoms/signs of uncomplicated acute illness due to influenza infection (A or B strains) that started within a maximum of 2 days prior to Visit 1 as per the Tamiflu® Canadian product label. Signs and symptoms may include the following:\n\n * Fever\n * Respiratory symptoms (cough, coryza, sore throat, rhinitis)\n * Constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)\n3. Positive rapid antigen test for influenza (A or B strains) at Visit 1\n4. Negative urine pregnancy test at Visit 1 for women of childbearing potential; women of childbearing potential who are sexually active must agree to use a suitable form of contraception during the study. Acceptable birth control measures include: hysterectomy, birth control pills, tubal ligation, intrauterine device, hormonal injections and implants, double barrier methods (such as a condom with a diaphragm or a condom with spermicide), and abstinence. Oral contraceptives must be in stable use for 2 or more cycles prior to screening. Intrauterine device (IUD) must be in use at least 30 days prior to study drug administration. Barrier methods must be in use at least 14 days prior to study drug administration.\n5. Subjects must:\n\n * have daily access to a computer at home with: internet access (preferably high-speed for optimal performance but dial-up can be used as well); Microsoft operating system; Internet Explorer browser capability and an e-mail account. A Macintosh (Mac) computer cannot be used.\n * be capable of and willing to complete the required online assessments in English according to the protocol schedule\n * be willing to abstain from the use of an antiviral medication if they are randomised to the standard of care treatment arm\n * have provided written informed consent prior to the initiation of any study procedures\n\nExclusion Criteria:\n\n1. More than 2 days since the onset of influenza symptoms\n2. Subjects who, in the Investigator\'s judgment, require treatment with an antiviral medication as per the Canadian "Clinical Recommendations for Patients Presenting with Respiratory Symptoms During the 2009 - 2010 Influenza Season" (see Appendix D)\n3. Clinical suspicion of infection with a respiratory virus other than influenza\n4. Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation\n5. History of conditions that may potentially affect cognitive function during the study, such as underlying neurologic conditions, depression or depressive disorders (unless the condition and treatment have been stable for 3 months), seasonal affective disorder (SAD), or any other cognitive impairment or dementia\n6. Intermittent use of sedative-hypnotics; subjects who have been taking a fixed dose of a sedative-hypnotic every day for a period of at least 30 days may be included provided that they continue the same regimen throughout the study.\n7. Intermittent or chronic use of psychiatric medications (with the exception of antidepressants that have been stable for 3 months) or anti-epileptic drugs\n8. Nursing home residents\n9. Known allergy to oseltamivir phosphate or any of the inactive ingredients of Tamiflu®\n10. Women who are pregnant, or planning to become pregnant, or who are lactating\n11. Current alcohol or drug abuse or substance dependence\n12. Participation in another clinical trial with an investigational drug within the last 30 days\n13. Patients vaccinated for influenza within 6 months of study enrollment\n14. In the Investigator\'s judgment, the subject will not be able to adhere to the protocol requirements or is not suitable for study participation for any reason'}, 'identificationModule': {'nctId': 'NCT01249833', 'acronym': 'FOCUS', 'briefTitle': 'Effect of Oseltamivir on Cognitive Function in Subjects With Influenza', 'organization': {'class': 'NETWORK', 'fullName': 'Trial Management Group Inc.'}, 'officialTitle': 'Randomised, Open-label, Multi-Centre, Phase IV Study Assessing the Effect of Oseltamivir Treatment on Cognitive Function in Subjects With Confirmed Influenza Virus Infection', 'orgStudyIdInfo': {'id': 'CAI-001-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oseltamivir', 'description': 'Added to standard of care for influenza', 'interventionNames': ['Drug: Oseltamivir']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care alone', 'description': 'Standard of care for influenza'}], 'interventions': [{'name': 'Oseltamivir', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': 'Oseltamivir 75mg BID for 5 days', 'armGroupLabels': ['Oseltamivir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Collette', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Lai', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Topsail Road Medical Clinic', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'city': 'Collingwood', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Moran Medical Centre', 'geoPoint': {'lat': 44.4834, 'lon': -80.21638}}, {'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Kanani', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Herman', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Milestone Research', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKDS Research Inc', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': 'Orléans', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Family First Medical Centre', 'geoPoint': {'lat': 45.45732, 'lon': -75.50433}}, {'zip': 'L1V 2A6', 'city': 'Pickering', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Steeple Hill Medical Centre', 'geoPoint': {'lat': 43.90012, 'lon': -79.13289}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Martyn Chilvers - London Road Diagnostic Clinic and Medical Centre', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': "Dr. Michael O'Mahony - London Road Diagnostic Clinic and Medical Centre", 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Strathroy', 'state': 'Ontario', 'country': 'Canada', 'facility': 'DCTM Clinical Trials Group Ltd.', 'geoPoint': {'lat': 42.9551, 'lon': -81.62232}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Gupta', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Woodstock', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Devonshire Clinical Research Inc.', 'geoPoint': {'lat': 43.13339, 'lon': -80.7497}}, {'zip': 'S4P 3X1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Regina Medical Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'overallOfficials': [{'name': "Dr. O'Mahony, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Road Diagnostic Clinic and Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trial Management Group Inc.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}