ID

39549

Beschreibung

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus; ODM derived from: https://clinicaltrials.gov/show/NCT01488526

Link

https://clinicaltrials.gov/show/NCT01488526

Stichworte

Versionen (1)
  1. 26.01.20 26.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Januar 2020

DOI

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Eligibility Hepatitis B Infection NCT01488526

Englisch

Eligibility Hepatitis B Infection NCT01488526

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented chb infection with hbsag positive > 6 months
Beschreibung

Hepatitis B, Chronic | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
hbeag+ chb pregnant women
Beschreibung

Hepatitis B e antigen positive | Hepatitis B, Chronic | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0032961
gestational age between 30-32 weeks
Beschreibung

Gestational Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0017504
hbv dna > 6 log10 copies/ml (or >200,000 iu/ml)
Beschreibung

Hepatitis B DNA Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C3641250
both mother and father of the child are willing to consent for the study
Beschreibung

Informed Consent Parent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
major exclusion criteria:
Beschreibung

Exclusion Criteria Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
co-infection with hepatitis a, c, d, e, hiv-1 or sexually transmitted disease (std)
Beschreibung

Coinfection Hepatitis A | HCV coinfection | Coinfection Hepatitis D | Coinfection Hepatitis E | Coinfection HIV-1 | Sexually Transmitted Diseases

Datentyp

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]
C0011226
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0085293
UMLS CUI [5,1]
C0275524
UMLS CUI [5,2]
C0019704
UMLS CUI [6]
C0036916
decompensated liver disease or significant co-morbidity
Beschreibung

End Stage Liver Disease | Comorbidity Significant

Datentyp

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0750502
history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
Beschreibung

Previous Abortion | Defect Fetal | Congenital malformation Pregnancy Previous

Datentyp

boolean

Alias
UMLS CUI [1]
C0000790
UMLS CUI [2,1]
C1457869
UMLS CUI [2,2]
C0521457
UMLS CUI [3,1]
C0000768
UMLS CUI [3,2]
C0032961
UMLS CUI [3,3]
C0205156
antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
Beschreibung

Antiviral Agents | Renal Insufficiency Due to Adefovir | Renal tubular disorder Due to Adefovir

Datentyp

boolean

Alias
UMLS CUI [1]
C0003451
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0050175
UMLS CUI [3,1]
C0151747
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0050175
requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
Beschreibung

Management Chronic disease | Requirement Pharmaceutical Preparations Other | Biological Response Modifiers | Cytotoxic agent | Steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C0008679
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205394
UMLS CUI [3]
C0005525
UMLS CUI [4]
C0304497
UMLS CUI [5]
C0038317
the biological father of the child had chb
Beschreibung

Father Chronic Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0524909
clinical signs of threatened miscarriage in early pregnancy
Beschreibung

Sign or Symptom Threatened miscarriage Early pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0000821
UMLS CUI [1,3]
C0747845
evidence of hepatocellular carcinoma
Beschreibung

Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
maternal alanine aminotransferase (alt) > or = 5 x upper limit of normal (u/ml), or total bilirubin > or = 2, or glomerular filtration rate (gfr) < 100, or albumin < 25 g/l
Beschreibung

Alanine aminotransferase increased maternal | Serum total bilirubin measurement maternal | Glomerular Filtration Rate maternal | Albumin measuremen maternal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151905
UMLS CUI [1,2]
C0026591
UMLS CUI [2,1]
C1278039
UMLS CUI [2,2]
C0026591
UMLS CUI [3,1]
C0017654
UMLS CUI [3,2]
C0026591
UMLS CUI [4,1]
C0201838
UMLS CUI [4,2]
C0026591
evidence of fetal deformity by ultrasound examination
Beschreibung

Deformity Fetal Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0302142
UMLS CUI [1,2]
C0521457
UMLS CUI [1,3]
C0041618
patient is participating other clinical study
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Ähnliche Modelle

Eligibility Hepatitis B Infection NCT01488526

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Hepatitis B surface antigen positive
Item
documented chb infection with hbsag positive > 6 months
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Hepatitis B e antigen positive | Hepatitis B, Chronic | Pregnancy
Item
hbeag+ chb pregnant women
boolean
C0392390 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
Gestational Age
Item
gestational age between 30-32 weeks
boolean
C0017504 (UMLS CUI [1])
Hepatitis B DNA Measurement
Item
hbv dna > 6 log10 copies/ml (or >200,000 iu/ml)
boolean
C3641250 (UMLS CUI [1])
Informed Consent Parent
Item
both mother and father of the child are willing to consent for the study
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Coinfection Hepatitis A | HCV coinfection | Coinfection Hepatitis D | Coinfection Hepatitis E | Coinfection HIV-1 | Sexually Transmitted Diseases
Item
co-infection with hepatitis a, c, d, e, hiv-1 or sexually transmitted disease (std)
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0011226 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0085293 (UMLS CUI [4,2])
C0275524 (UMLS CUI [5,1])
C0019704 (UMLS CUI [5,2])
C0036916 (UMLS CUI [6])
End Stage Liver Disease | Comorbidity Significant
Item
decompensated liver disease or significant co-morbidity
boolean
C0745744 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Previous Abortion | Defect Fetal | Congenital malformation Pregnancy Previous
Item
history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
boolean
C0000790 (UMLS CUI [1])
C1457869 (UMLS CUI [2,1])
C0521457 (UMLS CUI [2,2])
C0000768 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
Antiviral Agents | Renal Insufficiency Due to Adefovir | Renal tubular disorder Due to Adefovir
Item
antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
boolean
C0003451 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0050175 (UMLS CUI [2,3])
C0151747 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0050175 (UMLS CUI [3,3])
Management Chronic disease | Requirement Pharmaceutical Preparations Other | Biological Response Modifiers | Cytotoxic agent | Steroids
Item
requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
boolean
C0376636 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0005525 (UMLS CUI [3])
C0304497 (UMLS CUI [4])
C0038317 (UMLS CUI [5])
Father Chronic Hepatitis B
Item
the biological father of the child had chb
boolean
C0015671 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
Sign or Symptom Threatened miscarriage 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])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alanine aminotransferase increased maternal | Serum total bilirubin measurement maternal | Glomerular Filtration Rate maternal | Albumin measuremen maternal
Item
maternal alanine aminotransferase (alt) > or = 5 x upper limit of normal (u/ml), or total bilirubin > or = 2, or glomerular filtration rate (gfr) < 100, or albumin < 25 g/l
boolean
C0151905 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2,1])
C0026591 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3,1])
C0026591 (UMLS CUI [3,2])
C0201838 (UMLS CUI [4,1])
C0026591 (UMLS CUI [4,2])
Deformity Fetal Ultrasonography
Item
evidence of fetal deformity by ultrasound examination
boolean
C0302142 (UMLS CUI [1,1])
C0521457 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial
Item
patient is participating other clinical study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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