Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01243320
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Sponsor:
Organization:
Raw JSON
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Munger, Pharm.D.', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '10ppm Oral Solution', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '32ppm Oral Solution', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '4.3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mmhg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '0.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mmhg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '1.3'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Sodium Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral 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'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.02'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Chloride Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver 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'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.6'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urea Nitrogen Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In CreatinineBlood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.03'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Glucose Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '8.7'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Alkaline Phosphatase Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '1.1'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'u/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Aspartate Aminotransferase Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '1.2'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'u/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Alanine Aminotransferase Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '-0.3'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'u/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Total Protein Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.001', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'g/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Total Bilirubin Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.3'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Albumin Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.0004'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'g/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Calcium Blood Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.04'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.003', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In White Blood Count Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '0.19'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '0.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'k/uL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Red Blood Count Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '-0.0001'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'm/uL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Hemoglobin Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.03'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'gm/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Hematocrit Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '0.07'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Mean Corpuscular Volume Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'fL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Mean Corpuscular Hemoglobin Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'pg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Mean Corpuscular Hemoglobin Concentration Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'gm/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Platelet Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '15'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'k/uL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Granulocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '1.1'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '2.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Lymphocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '2.6'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change In Monocytes Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Basophils Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}, {'value': '0.001', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Eosinophil Blood Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sputum Reactive Oxygen Species Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '2.38'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-1.23', 'upperLimit': '0.35'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'uM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change to Interleukin-8 Receptor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '-1.53', 'upperLimit': '5.9'}, {'value': '6.39', 'groupId': 'OG001', 'lowerLimit': '-5.83', 'upperLimit': '18.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change to Interleukin-1 Alpha Receptor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0005', 'groupId': 'OG000', 'lowerLimit': '-0.0007', 'upperLimit': '0.0006'}, {'value': '0.0197', 'groupId': 'OG001', 'lowerLimit': '-0.0014', 'upperLimit': '0.0408'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change to Interleukin-1 Beta Receptor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000', 'lowerLimit': '-0.011', 'upperLimit': '0.044'}, {'value': '0.027', 'groupId': 'OG001', 'lowerLimit': '-0.058', 'upperLimit': '0.112'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Monocyte Chemotactic Protein 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.028', 'groupId': 'OG000', 'lowerLimit': '-0.084', 'upperLimit': '0.028'}, {'value': '-0.004', 'groupId': 'OG001', 'lowerLimit': '-0.026', 'upperLimit': '0.017'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Quinone Oxidoreductase 1 Gene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10ppm Oral Silver', 'description': 'ASAP Solution 10 ppm: Silver nanoparticles at 10ppm'}, {'id': 'OG001', 'title': '32ppm Oral Silver', 'description': 'ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0043', 'groupId': 'OG000', 'lowerLimit': '-0.0115', 'upperLimit': '0.029'}, {'value': '-0.0279', 'groupId': 'OG001', 'lowerLimit': '-0.4671', 'upperLimit': '0.4114'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.'}], 'periods': [{'title': '10ppm Oral Silver (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '10ppm Oral Silver (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '10ppm Oral Silver (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '32ppm Oral Silver (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': '10 ppm Silver, then 32 ppm Silver'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2010-11-16', 'resultsFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-28', 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sodium Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Potassium Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Chloride Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Carbon Dioxide Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Urea Nitrogen Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In CreatinineBlood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Glucose Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Alkaline Phosphatase Blood Level', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Aspartate Aminotransferase Blood Level', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Alanine Aminotransferase Blood Level', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Total Protein Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Total Bilirubin Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Albumin Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Calcium Blood Level', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In White Blood Count Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Red Blood Count Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Hemoglobin Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Hematocrit Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Mean Corpuscular Volume Blood Levels', 'timeFrame': '14 days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Mean Corpuscular Hemoglobin Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Mean Corpuscular Hemoglobin Concentration Blood Levels', 'timeFrame': '14 days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Platelet Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Granulocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Lymphocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change In Monocytes Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Basophils Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Eosinophil Blood Levels', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Sputum Reactive Oxygen Species Change', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change to Interleukin-8 Receptor', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change to Interleukin-1 Alpha Receptor', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change to Interleukin-1 Beta Receptor', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Monocyte Chemotactic Protein 1', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Change in Quinone Oxidoreductase 1 Gene', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}], 'secondaryOutcomes': [{'measure': 'Change Systolic Blood Pressure', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Mean Change in Diastolic Blood Pressure', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}, {'measure': 'Mean Change in Heart Rate', 'timeFrame': '14 Days', 'description': 'All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23811290', 'type': 'DERIVED', 'citation': 'Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm. Silver has been used for its bactericidal properties. The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be \\> 18-80 years old will be included.\n\nExclusion Criteria:\n\n* Females of child-bearing potential, defined as women physically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means will be excluded unless they are using 2 barrier birth control methods (i.e., diaphragm, condom, intrauterine device, sponge or spermicide) or hormonal contraceptive method.\n* Any female subject who is nursing will be excluded. Subject with has a history of heavy metal allergy (including silver) or a history of asthma or COPD or renal impairment defined by a creatinine clearance below 30 ml/min.\n* Subjects with symptoms of an active upper respiratory infection at time of consent will also be excluded.'}, 'identificationModule': {'nctId': 'NCT01243320', 'briefTitle': 'In Vivo Assessment of Silver Biomaterial Nano-Toxicity', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'In Vivo Assessment of Silver Biomaterial Nano-Toxicity', 'orgStudyIdInfo': {'id': '40281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10ppm Oral Silver', 'description': 'Oral Dose of 10ppm', 'interventionNames': ['Drug: 10ppm Oral Silver Particle']}, {'type': 'EXPERIMENTAL', 'label': '32ppm Oral Silver', 'description': 'Oral Dose of 32ppm', 'interventionNames': ['Drug: 32ppm Oral Silver Particle']}], 'interventions': [{'name': '10ppm Oral Silver Particle', 'type': 'DRUG', 'description': 'Silver nanoparticles at 10ppm', 'armGroupLabels': ['10ppm Oral Silver']}, {'name': '32ppm Oral Silver Particle', 'type': 'DRUG', 'description': 'Silver nanoparticles at 32ppm', 'armGroupLabels': ['32ppm Oral Silver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital and Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Mark A Munger, Pharm.D>', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'mark munger', 'investigatorAffiliation': 'University of Utah'}}}}