ID

17565

Beskrivning

Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth; ODM derived from: https://clinicaltrials.gov/show/NCT00106964

Länk

https://clinicaltrials.gov/show/NCT00106964

Nyckelord

Versioner (1)
  1. 2016-09-24 2016-09-24 -
Uppladdad den

24 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility HIV Infection NCT00106964

Engelsk

Eligibility HIV Infection NCT00106964

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented hiv+
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
age 12 to < 25 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
history of no or one hepatitis b vaccination
Beskrivning

Hepatitis B vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0474232
not pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
Beskrivning

Gender Sex Behavior Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036864
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of > 1 hepatitis b vaccination
Beskrivning

Hepatitis B vaccination Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C1265611
serologic evidence of past or present hepatitis b infection: anti-hepatitis b surface antigen (hbsag), hbs-ag or anti- hepatitis b core antigen (hbcag)
Beskrivning

Hepatitis B Evidence Serologic | Hepatitis B Virus Surface Antibody | Hepatitis B Surface Antigens | Antibody to hepatitis B core antigen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
UMLS CUI [2]
C0369334
UMLS CUI [3]
C0019168
UMLS CUI [4]
C0312631
previous allergic reaction to hepatitis a or b vaccinations or to yeast, thimerosal or aluminum.
Beskrivning

Allergic Reaction Hepatitis A immunization | Allergic Reaction Hepatitis B vaccination | Allergic Reaction Yeasts | Allergic Reaction Thimerosal | Allergic Reaction Aluminum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0419735
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0474232
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0043393
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0039867
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0002367
active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
Beskrivning

Opportunistic Infections | Therapeutic procedure Bacterial Infections Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0029118
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0004623
UMLS CUI [2,3]
C0205404
presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
Beskrivning

Toxicity Grade

Datatyp

boolean

Alias
UMLS CUI [1]
C2826262
anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
Beskrivning

Steroid therapy Long-term anticipation | Anti-Inflammatory Agents, Non-Steroidal | inhaled steroids | Topical corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0443252
UMLS CUI [1,3]
C0679106
UMLS CUI [2]
C0003211
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0304604
receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
Beskrivning

Pharmaceutical Preparations Restricted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0443288
receipt of immune globulin product or plasma product within 6 months preceding randomization
Beskrivning

Immunoglobulins | Human plasma, blood product

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0304926
receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
Beskrivning

Blood product Licensed | Transfusion | Vaccine Licensed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0023636
UMLS CUI [2]
C0005841
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0023636
known or suspected diseases of the immune system, other than hiv, or treatment for a malignancy within 3 months of randomization.
Beskrivning

Immune System Diseases | HIV | Therapeutic procedure Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0019682
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0006826
other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
Beskrivning

Other medical condition | Surgical aspects

Datatyp

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0038895
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Similar models

Eligibility HIV Infection NCT00106964

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
HIV Seropositivity
Item
documented hiv+
boolean
C0019699 (UMLS CUI [1])
Age
Item
age 12 to < 25 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B vaccination
Item
history of no or one hepatitis b vaccination
boolean
C0474232 (UMLS CUI [1])
Pregnancy
Item
not pregnant.
boolean
C0032961 (UMLS CUI [1])
Gender Sex Behavior Contraceptive methods
Item
females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis B vaccination Quantity
Item
history of > 1 hepatitis b vaccination
boolean
C0474232 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hepatitis B Evidence Serologic | Hepatitis B Virus Surface Antibody | Hepatitis B Surface Antigens | Antibody to hepatitis B core antigen
Item
serologic evidence of past or present hepatitis b infection: anti-hepatitis b surface antigen (hbsag), hbs-ag or anti- hepatitis b core antigen (hbcag)
boolean
C0019163 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0369334 (UMLS CUI [2])
C0019168 (UMLS CUI [3])
C0312631 (UMLS CUI [4])
Allergic Reaction Hepatitis A immunization | Allergic Reaction Hepatitis B vaccination | Allergic Reaction Yeasts | Allergic Reaction Thimerosal | Allergic Reaction Aluminum
Item
previous allergic reaction to hepatitis a or b vaccinations or to yeast, thimerosal or aluminum.
boolean
C1527304 (UMLS CUI [1,1])
C0419735 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0043393 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0039867 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0002367 (UMLS CUI [5,2])
Opportunistic Infections | Therapeutic procedure Bacterial Infections Serious
Item
active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
boolean
C0029118 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0004623 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Toxicity Grade
Item
presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
boolean
C2826262 (UMLS CUI [1])
Steroid therapy Long-term anticipation | Anti-Inflammatory Agents, Non-Steroidal | inhaled steroids | Topical corticosteroids
Item
anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
boolean
C0149783 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0679106 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0304604 (UMLS CUI [4])
Pharmaceutical Preparations Restricted
Item
receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
boolean
C0013227 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Immunoglobulins | Human plasma, blood product
Item
receipt of immune globulin product or plasma product within 6 months preceding randomization
boolean
C0021027 (UMLS CUI [1])
C0304926 (UMLS CUI [2])
Blood product Licensed | Transfusion | Vaccine Licensed
Item
receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
boolean
C0456388 (UMLS CUI [1,1])
C0023636 (UMLS CUI [1,2])
C0005841 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C0023636 (UMLS CUI [3,2])
Immune System Diseases | HIV | Therapeutic procedure Malignant Neoplasms
Item
known or suspected diseases of the immune system, other than hiv, or treatment for a malignancy within 3 months of randomization.
boolean
C0021053 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Other medical condition | Surgical aspects
Item
other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
boolean
C3843040 (UMLS CUI [1])
C0038895 (UMLS CUI [2])
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