ID

15244

Beskrivning

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02327676

Länk

https://clinicaltrials.gov/show/NCT02327676

Nyckelord

Versioner (1)
  1. 2016-05-23 2016-05-23 -
Uppladdad den

23 maj 2016

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02327676

Engelsk

Eligibility Hepatitis B, Chronic NCT02327676

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg)
Beskrivning

Child | Body Weight | Able to swallow emtricitabine Oral Capsule

Datatyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0005910
UMLS CUI [3,1]
C2712086
UMLS CUI [3,2]
C1331250
hbsag positive for more than 6 months
Beskrivning

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
hbeag positive patients: hbv dna ≥ 5log10 copies/ml
Beskrivning

Hepatitis B e antigen positive | Hepatitis B Virus DNA

Datatyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0012854
hbeag positive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
Beskrivning

Hepatitis B e antigen positive | Alanine aminotransferase measurement | Biopsy of liver | Knodell Fibrosis Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0193388
UMLS CUI [4]
C3898641
hbeag negative patients: hbv dna ≥ 4log10 copies/ml
Beskrivning

Hepatitis B e Antigens Negative | Hepatitis B Virus DNA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C0205160
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0012854
hbeag positive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
Beskrivning

Hepatitis B e antigen positive | Alanine aminotransferase measurement | Biopsy of liver | Knodell Fibrosis Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0193388
UMLS CUI [4]
C3898641
nucleoside/nucleotide naive patients
Beskrivning

Therapy naive Nucleosides | Therapy naive Nucleotides

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0028621
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0028630
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
- diagnosed hcc with afp and ultrasound, ct or mri
Beskrivning

Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0201539
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
creatine ＞130μmol/l or ccr < 70ml/min
Beskrivning

Creatine measurement | cyclocreatine

Datatyp

boolean

Alias
UMLS CUI [1]
C0302272
UMLS CUI [2]
C0056742
hemoglobin <100g/l
Beskrivning

Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
neutrophils <1.5e+9/l
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
plt<80e+9/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
coinfected with hav,hev,hcv,hdv or hiv
Beskrivning

Coinfection Hepatitis A Virus | Coinfection Hepatitis E virus | HCV coinfection | Coinfection Hepatitis Delta Virus | Coinfection HIV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0376325
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0085294
UMLS CUI [3]
C1698259
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0011220
UMLS CUI [5,1]
C0275524
UMLS CUI [5,2]
C0019682
ana ＞ 1:100
Beskrivning

Antibodies, Antinuclear

Datatyp

boolean

Alias
UMLS CUI [1]
C0003243
uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
Beskrivning

Cardiovascular Diseases | Kidney Diseases | Lung diseases | nervous system disorder | Digestive System Disorders | Metabolic Diseases | Immune System Diseases | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0012242
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0021053
UMLS CUI [8]
C0006826
drug abuse or alcohol addiction
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
Beskrivning

Lamivudine | adefovir | Tenofovir | entecavir | telbivudine

Datatyp

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0050175
UMLS CUI [3]
C0384228
UMLS CUI [4]
C0971023
UMLS CUI [5]
C1453933
long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
Beskrivning

Use of Immunosuppressive Agents Long-term | Use of Immunomodulators Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1527392
UMLS CUI [2,3]
C0443252
underwent liver transplantation or liver transplantation in schedule
Beskrivning

Transplantation of liver | Scheduled

Datatyp

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0205539
allergic to nucleoside or nucleotide analogues
Beskrivning

Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide Analog

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0028630
UMLS CUI [2,3]
C0243071
pregnancy or in breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis B, Chronic NCT02327676

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Child | Body Weight | Able to swallow emtricitabine Oral Capsule
Item
children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg)
boolean
C0008059 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C2712086 (UMLS CUI [3,1])
C1331250 (UMLS CUI [3,2])
Hepatitis B surface antigen positive
Item
hbsag positive for more than 6 months
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B Virus DNA
Item
hbeag positive patients: hbv dna ≥ 5log10 copies/ml
boolean
C0392390 (UMLS CUI [1])
C0019169 (UMLS CUI [2,1])
C0012854 (UMLS CUI [2,2])
Hepatitis B e antigen positive | Alanine aminotransferase measurement | Biopsy of liver | Knodell Fibrosis Score
Item
hbeag positive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
boolean
C0392390 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
C3898641 (UMLS CUI [4])
Hepatitis B e Antigens Negative | Hepatitis B Virus DNA
Item
hbeag negative patients: hbv dna ≥ 4log10 copies/ml
boolean
C0019167 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0019169 (UMLS CUI [2,1])
C0012854 (UMLS CUI [2,2])
Hepatitis B e antigen positive | Alanine aminotransferase measurement | Biopsy of liver | Knodell Fibrosis Score
Item
hbeag positive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
boolean
C0392390 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
C3898641 (UMLS CUI [4])
Therapy naive Nucleosides | Therapy naive Nucleotides
Item
nucleoside/nucleotide naive patients
boolean
C0919936 (UMLS CUI [1,1])
C0028621 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C0028630 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
- diagnosed hcc with afp and ultrasound, ct or mri
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Creatine measurement | cyclocreatine
Item
creatine ＞130μmol/l or ccr < 70ml/min
boolean
C0302272 (UMLS CUI [1])
C0056742 (UMLS CUI [2])
Hemoglobin
Item
hemoglobin <100g/l
boolean
C0019046 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophils <1.5e+9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
plt<80e+9/l
boolean
C0032181 (UMLS CUI [1])
Coinfection Hepatitis A Virus | Coinfection Hepatitis E virus | HCV coinfection | Coinfection Hepatitis Delta Virus | Coinfection HIV
Item
coinfected with hav,hev,hcv,hdv or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0085294 (UMLS CUI [2,2])
C1698259 (UMLS CUI [3])
C0275524 (UMLS CUI [4,1])
C0011220 (UMLS CUI [4,2])
C0275524 (UMLS CUI [5,1])
C0019682 (UMLS CUI [5,2])
Antibodies, Antinuclear
Item
ana ＞ 1:100
boolean
C0003243 (UMLS CUI [1])
Cardiovascular Diseases | Kidney Diseases | Lung diseases | nervous system disorder | Digestive System Disorders | Metabolic Diseases | Immune System Diseases | Malignant Neoplasms
Item
uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0012242 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
Substance Use Disorders
Item
drug abuse or alcohol addiction
boolean
C0038586 (UMLS CUI [1])
Lamivudine | adefovir | Tenofovir | entecavir | telbivudine
Item
previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
boolean
C0209738 (UMLS CUI [1])
C0050175 (UMLS CUI [2])
C0384228 (UMLS CUI [3])
C0971023 (UMLS CUI [4])
C1453933 (UMLS CUI [5])
Use of Immunosuppressive Agents Long-term | Use of Immunomodulators Long-term
Item
long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
boolean
C1524063 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C1527392 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
Transplantation of liver | Scheduled
Item
underwent liver transplantation or liver transplantation in schedule
boolean
C0023911 (UMLS CUI [1])
C0205539 (UMLS CUI [2])
Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide Analog
Item
allergic to nucleoside or nucleotide analogues
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0028630 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or in breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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