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ID
45584
Descrição
Principal Investigator: Scott D. Boyd, MD, PhD, Stanford University, Stanford, CA, USA MeSH: Influenza Vaccines,Aged https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000666 The study sequenced antibody heavy chain gene rearrangements from human subjects receiving influenza vaccination.
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Versões (1)
- 28/01/2023 28/01/2023 - Chiara Middel
Titular dos direitos
Scott D. Boyd, MD, PhD, Stanford University, Stanford, CA, USA
Transferido a
28 de janeiro de 2023
DOI
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Licença
Creative Commons BY 4.0
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dbGaP phs000666 B and T Cell Determinants of Influenza Vaccine Responses in the Elderly
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This data table contains subject IDs and consent group information.
- This data table contains mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype table includes age at the start of the the study, participant gender, EBV and CMV status.
- This sample attributes table includes tissue type, analyte type, year in vaccination study, and days following vaccination.
Similar models
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This data table contains subject IDs and consent group information.
- This data table contains mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype table includes age at the start of the the study, participant gender, EBV and CMV status.
- This sample attributes table includes tissue type, analyte type, year in vaccination study, and days following vaccination.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.1
Item
*Inclusion:*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.2
Item
Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment
boolean
C0001779 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.3
Item
General good health and ambulatory at time of enrollment
boolean
C1277245 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.4
Item
No acute illness at time of vaccination
boolean
C1298908 (UMLS CUI [1,1])
C4061114 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C4061114 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.5
Item
Willing and able to sign Informed Consent
boolean
C0021430 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.6
Item
Available for follow-up for the planned duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.7
Item
Acceptable medical history by screening evaluation and brief clinical assessment
boolean
C1879533 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C4534461 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C4534461 (UMLS CUI [1,5])
Elig.phs000666.v1.p1.8
Item
All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.9
Item
*Exclusion:*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.10
Item
Off-study vaccination during the period of the study
boolean
C1518546 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0489652 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0489652 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.11
Item
Allergy to egg or egg products
boolean
C0559469 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.12
Item
Allergy to vaccine components, including thimerosal
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.13
Item
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
boolean
C0205177 (UMLS CUI [1,1])
C0442893 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0743842 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0442893 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0743842 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Elig.phs000666.v1.p1.14
Item
History of immunodeficiency
boolean
C0262926 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.15
Item
Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
boolean
C0008679 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.16
Item
Blood pressure > 150 systolic or > 95 diastolic at Visit 1
boolean
C0428883 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0871470 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.17
Item
Chronic Hepatitis B or C
boolean
C0524910 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.18
Item
Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (< 20mg predisone - equivalent/day) may be acceptable after review by the investigator.
boolean
C0332185 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2825233 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C3539185 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
C1527415 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1704362 (UMLS CUI [3,3])
C0031831 (UMLS CUI [3,4])
C0521116 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2825233 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C3539185 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
C1527415 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1704362 (UMLS CUI [3,3])
C0031831 (UMLS CUI [3,4])
Elig.phs000666.v1.p1.19
Item
Autoimmune disease
boolean
C0004364 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.20
Item
History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
boolean
C0262926 (UMLS CUI [1,1])
C0019045 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
C0205272 (UMLS CUI [1,4])
C1522577 (UMLS CUI [1,5])
C1708385 (UMLS CUI [1,6])
C0019045 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
C0205272 (UMLS CUI [1,4])
C1522577 (UMLS CUI [1,5])
C1708385 (UMLS CUI [1,6])
Elig.phs000666.v1.p1.21
Item
Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
boolean
C0521116 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C4700122 (UMLS CUI [1,4])
C0728963 (UMLS CUI [1,5])
C0031831 (UMLS CUI [1,6])
C1704362 (UMLS CUI [1,7])
C0521116 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C2963157 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C0633084 (UMLS CUI [2,5])
C0732282 (UMLS CUI [2,6])
C0031831 (UMLS CUI [2,7])
C1704362 (UMLS CUI [2,8])
C0457083 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C4700122 (UMLS CUI [1,4])
C0728963 (UMLS CUI [1,5])
C0031831 (UMLS CUI [1,6])
C1704362 (UMLS CUI [1,7])
C0521116 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C2963157 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C0633084 (UMLS CUI [2,5])
C0732282 (UMLS CUI [2,6])
C0031831 (UMLS CUI [2,7])
C1704362 (UMLS CUI [2,8])
Elig.phs000666.v1.p1.22
Item
Receipt of blood or blood products within the past 6 months
boolean
C1709854 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
C0371802 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.23
Item
Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
boolean
C3843040 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0043227 (UMLS CUI [1,3])
C0678341 (UMLS CUI [1,4])
C0439801 (UMLS CUI [1,5])
C1321605 (UMLS CUI [1,6])
C0004936 (UMLS CUI [1,2])
C0043227 (UMLS CUI [1,3])
C0678341 (UMLS CUI [1,4])
C0439801 (UMLS CUI [1,5])
C1321605 (UMLS CUI [1,6])
Elig.phs000666.v1.p1.24
Item
Receipt of inactivated vaccine within 14 days prior to vaccination
boolean
C1709854 (UMLS CUI [1,1])
C0042212 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
C0042212 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Elig.phs000666.v1.p1.25
Item
Receipt of live, attenuated vaccine within 60 days of vaccination
boolean
C1709854 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0042211 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0042211 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.26
Item
History of Guillain-Barré Syndrome
boolean
C0262926 (UMLS CUI [1,1])
C0018378 (UMLS CUI [1,2])
C0018378 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.27
Item
Pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.28
Item
Use of investigational agents within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.29
Item
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1516879 (UMLS CUI [1,5])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1516879 (UMLS CUI [1,5])
Elig.phs000666.v1.p1.30
Item
Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])