ID

39551

Beskrivning

Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders; ODM derived from: https://clinicaltrials.gov/show/NCT01126853

Länk

https://clinicaltrials.gov/show/NCT01126853

Nyckelord

Versioner (1)
  1. 2020-01-27 2020-01-27 -
Rättsinnehavare

See clinicaltrials.gov

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27 januari 2020

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Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01126853

Engelsk

Eligibility Hepatitis B NCT01126853

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry.
Beskrivning

Comprehension Study Protocol | Protocol Compliance | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0021430
available for follow-up during the study period.
Beskrivning

Patient Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
has had at least two complete courses of monovalent hepatitis b vaccine, and has documented antihbs igg titers of <10miu/ml within 6 months of completion of the most recent course of vaccination.
Beskrivning

Course Quantity Hepatitis B vaccine | Hepatitis B Virus Surface Antibody Immunoglobulin G Titer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2066344
UMLS CUI [2,1]
C0369334
UMLS CUI [2,2]
C0020852
UMLS CUI [2,3]
C0475208
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic to any components of the vaccine.
Beskrivning

Hypersensitivity Vaccine Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
previous serious adverse events associated with the hepatitis b vaccine
Beskrivning

Serious Adverse Event Associated with Hepatitis B vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C2066344
received one or more doses of twinrix in the past
Beskrivning

Twinrix Dose Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0593953
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
chronic hepatitis b infection, defined as ever having had a positive hbsag, hbcab or hepb rna test
Beskrivning

Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis B Virus RNA Test Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0262506
UMLS CUI [4,1]
C0019169
UMLS CUI [4,2]
C0035668
UMLS CUI [4,3]
C0039593
UMLS CUI [4,4]
C1514241
pregnant, or planning to become pregnant during the study period.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
received dose of hepatitis b immune globulin, or immune globulin, in last 6 months
Beskrivning

Hepatitis B immune globulin Dose | Immunoglobulin Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0062525
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C0178602
immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination, including:
Beskrivning

Immunocompromised patient | Therapy Reducing Effectiveness Vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C1280519
UMLS CUI [2,4]
C0042196
1. hiv infection;
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
2. lymphoma, multiple myeloma, leukemia or other blood dyscrasia;
Beskrivning

Lymphoma | Multiple Myeloma | Leukemia | Hematological Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0023418
UMLS CUI [4]
C0018939
3. systemic lupus erythematosis or other connective tissue disorder;
Beskrivning

Lupus Erythematosus, Systemic | Connective Tissue Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0009782
4. renal failure (baseline serum creatinine >150um, or requires dialysis);
Beskrivning

Kidney Failure | Creatinine measurement, serum | Requirement Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0011946
5. nephrotic syndrome;
Beskrivning

Nephrotic Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0027726
6. active neoplastic disease (except localized skin cancer);
Beskrivning

Neoplastic disease | Exception Localised skin tumour

Datatyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0849656
7. any requirement for corticosteroids >20mg/day for >1 week in the six months prior to randomization;
Beskrivning

Requirement Adrenal Cortex Hormones U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0456683
8. cytotoxic therapy (e.g. chemotherapy for cancer) received within the six months prior to randomization
Beskrivning

Cytotoxic Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0677881
9. radiation therapy received in the six months prior to randomization;
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
10. hemoglobinopathy;
Beskrivning

Hemoglobinopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019045
11. any immunodeficiency disorder; or
Beskrivning

Immunodeficiency disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
12. prior solid organ or allogeneic stem cell or bone marrow transplant.
Beskrivning

Solid organ transplant | Allogeneic hematopoietic stem cell transplant | Bone Marrow Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2]
C4255274
UMLS CUI [3]
C0005961
plans to receive cytotoxic therapy or radiation therapy during the study period.
Beskrivning

Cytotoxic Therapy Planned | Therapeutic radiology procedure Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Hepatitis B NCT01126853

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Study Protocol | Protocol Compliance | Informed Consent
Item
have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Patient Available Follow-up
Item
available for follow-up during the study period.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Course Quantity Hepatitis B vaccine | Hepatitis B Virus Surface Antibody Immunoglobulin G Titer
Item
has had at least two complete courses of monovalent hepatitis b vaccine, and has documented antihbs igg titers of <10miu/ml within 6 months of completion of the most recent course of vaccination.
boolean
C0750729 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2066344 (UMLS CUI [1,3])
C0369334 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C0475208 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Vaccine Component
Item
allergic to any components of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Serious Adverse Event Associated with Hepatitis B vaccine
Item
previous serious adverse events associated with the hepatitis b vaccine
boolean
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C2066344 (UMLS CUI [1,3])
Twinrix Dose Quantity
Item
received one or more doses of twinrix in the past
boolean
C0593953 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis B Virus RNA Test Positive
Item
chronic hepatitis b infection, defined as ever having had a positive hbsag, hbcab or hepb rna test
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0262506 (UMLS CUI [3])
C0019169 (UMLS CUI [4,1])
C0035668 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
C1514241 (UMLS CUI [4,4])
Pregnancy | Pregnancy, Planned
Item
pregnant, or planning to become pregnant during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Hepatitis B immune globulin Dose | Immunoglobulin Dose
Item
received dose of hepatitis b immune globulin, or immune globulin, in last 6 months
boolean
C0062525 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Immunocompromised patient | Therapy Reducing Effectiveness Vaccination
Item
immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination, including:
boolean
C0085393 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
HIV Infection
Item
1. hiv infection;
boolean
C0019693 (UMLS CUI [1])
Lymphoma | Multiple Myeloma | Leukemia | Hematological Disease
Item
2. lymphoma, multiple myeloma, leukemia or other blood dyscrasia;
boolean
C0024299 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0023418 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
Lupus Erythematosus, Systemic | Connective Tissue Disease
Item
3. systemic lupus erythematosis or other connective tissue disorder;
boolean
C0024141 (UMLS CUI [1])
C0009782 (UMLS CUI [2])
Kidney Failure | Creatinine measurement, serum | Requirement Dialysis
Item
4. renal failure (baseline serum creatinine >150um, or requires dialysis);
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0011946 (UMLS CUI [3,2])
Nephrotic Syndrome
Item
5. nephrotic syndrome;
boolean
C0027726 (UMLS CUI [1])
Neoplastic disease | Exception Localised skin tumour
Item
6. active neoplastic disease (except localized skin cancer);
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0849656 (UMLS CUI [2,2])
Requirement Adrenal Cortex Hormones U/day
Item
7. any requirement for corticosteroids >20mg/day for >1 week in the six months prior to randomization;
boolean
C1514873 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Cytotoxic Therapy
Item
8. cytotoxic therapy (e.g. chemotherapy for cancer) received within the six months prior to randomization
boolean
C0677881 (UMLS CUI [1])
Therapeutic radiology procedure
Item
9. radiation therapy received in the six months prior to randomization;
boolean
C1522449 (UMLS CUI [1])
Hemoglobinopathy
Item
10. hemoglobinopathy;
boolean
C0019045 (UMLS CUI [1])
Immunodeficiency disorder
Item
11. any immunodeficiency disorder; or
boolean
C0021051 (UMLS CUI [1])
Solid organ transplant | Allogeneic hematopoietic stem cell transplant | Bone Marrow Transplantation
Item
12. prior solid organ or allogeneic stem cell or bone marrow transplant.
boolean
C0730400 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
Cytotoxic Therapy Planned | Therapeutic radiology procedure Planned
Item
plans to receive cytotoxic therapy or radiation therapy during the study period.
boolean
C0677881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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