ID

27855

Descripción

Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels; ODM derived from: https://clinicaltrials.gov/show/NCT01337791

Link

https://clinicaltrials.gov/show/NCT01337791

Palabras clave

Versiones (1)
  1. 2/12/17 2/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT01337791

Inglés

Eligibility Chronic Hepatitis B NCT01337791

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 20-40 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
gestational age between 12-30 weeks
Descripción

Gestational Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017504
serum hbsag and hbeag positivity
Descripción

Hepatitis B surface antigen positive | Hepatitis B e antigen positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
hbv dna levels >6log10 copies/ml
Descripción

Hepatitis B DNA Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3641250
alt >1x uln (40 iu/ml) and < 10x uln.
Descripción

Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis a, c, d, e or hiv
Descripción

Coinfection Hepatitis A | HCV coinfection | Coinfection HDV | Coinfection Hepatitis E virus | HIV coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019159
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0011220
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0085294
UMLS CUI [5]
C4062778
evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
Descripción

Liver carcinoma | Liver disease Decompensated | Comorbidity renal | Comorbidity Cardiovascular | Comorbidity respiratory | Comorbidity Neurological

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205434
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0022646
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C3887460
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0521346
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205494
concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
Descripción

Immunomodulators | Cytotoxic agent | Steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2]
C0304497
UMLS CUI [3]
C0038317
clinical signs of threatened miscarriage in early pregnancy
Descripción

Sign or Symptom Threatened abortion Early pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0000821
UMLS CUI [1,3]
C0747845
evidence of fetal deformity by 3-dimensional ultrasound examination
Descripción

Deformity Fetal | Ultrasonography Three-dimensional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0302142
UMLS CUI [1,2]
C0521457
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0450363
the biological father of the child had chb
Descripción

Natural father Chronic Hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0337494
UMLS CUI [1,2]
C0524909
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Similar models

Eligibility Chronic Hepatitis B NCT01337791

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 20-40 years
boolean
C0001779 (UMLS CUI [1])
Gestational Age
Item
gestational age between 12-30 weeks
boolean
C0017504 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
serum hbsag and hbeag positivity
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Hepatitis B DNA Measurement
Item
hbv dna levels >6log10 copies/ml
boolean
C3641250 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >1x uln (40 iu/ml) and < 10x uln.
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Coinfection Hepatitis A | HCV coinfection | Coinfection HDV | Coinfection Hepatitis E virus | HIV coinfection
Item
co-infection with hepatitis a, c, d, e or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0011220 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0085294 (UMLS CUI [4,2])
C4062778 (UMLS CUI [5])
Liver carcinoma | Liver disease Decompensated | Comorbidity renal | Comorbidity Cardiovascular | Comorbidity respiratory | Comorbidity Neurological
Item
evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
boolean
C2239176 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0022646 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C3887460 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0521346 (UMLS CUI [5,2])
C0009488 (UMLS CUI [6,1])
C0205494 (UMLS CUI [6,2])
Immunomodulators | Cytotoxic agent | Steroids
Item
concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
boolean
C1527392 (UMLS CUI [1])
C0304497 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Sign or Symptom Threatened abortion Early pregnancy
Item
clinical signs of threatened miscarriage in early pregnancy
boolean
C3540840 (UMLS CUI [1,1])
C0000821 (UMLS CUI [1,2])
C0747845 (UMLS CUI [1,3])
Deformity Fetal | Ultrasonography Three-dimensional
Item
evidence of fetal deformity by 3-dimensional ultrasound examination
boolean
C0302142 (UMLS CUI [1,1])
C0521457 (UMLS CUI [1,2])
C0041618 (UMLS CUI [2,1])
C0450363 (UMLS CUI [2,2])
Natural father Chronic Hepatitis B
Item
the biological father of the child had chb
boolean
C0337494 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
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