ID

27887

Beschrijving

The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00556504

Link

https://clinicaltrials.gov/show/NCT00556504

Trefwoorden

  1. 04-12-17 04-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 december 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C NCT00556504

Eligibility Chronic Hepatitis C NCT00556504

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcv strain confirmed as genotype i;
Beschrijving

Hepatitis C virus genotype 1

Datatype

boolean

Alias
UMLS CUI [1]
C3532919
elevated alt (≥1.5 x upper limit of normal)during last 6 months
Beschrijving

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
females of childbearing potential with a negative serum pregnancy test
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
subject must be willing to sign a written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
subject must be willing and able to adhere to dose and visit schedule.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum afp levels > 400 ng/ml
Beschrijving

serum alpha-fetoprotein (AFP) measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0546833
liver biopsy within 12 months prior to study entry showed liver cirrhosis with metavir system fibrosis score of 3-4, or hepatocellular carcinoma (hcc);
Beschrijving

Liver Cirrhosis METAVIR Fibrosis Score Biopsy of liver | Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C3897040
UMLS CUI [1,3]
C0193388
UMLS CUI [2]
C2239176
co-infection with hepatitis b virus (hbv);
Beschrijving

HBV coinfection

Datatype

boolean

Alias
UMLS CUI [1]
C2242656
anti-hiv positive;
Beschrijving

HIV antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0920548

Similar models

Eligibility Chronic Hepatitis C NCT00556504

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus genotype 1
Item
hcv strain confirmed as genotype i;
boolean
C3532919 (UMLS CUI [1])
Alanine aminotransferase increased
Item
elevated alt (≥1.5 x upper limit of normal)during last 6 months
boolean
C0151905 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
females of childbearing potential with a negative serum pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Informed Consent
Item
subject must be willing to sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
subject must be willing and able to adhere to dose and visit schedule.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
serum alpha-fetoprotein (AFP) measurement
Item
serum afp levels > 400 ng/ml
boolean
C0546833 (UMLS CUI [1])
Liver Cirrhosis METAVIR Fibrosis Score Biopsy of liver | Liver carcinoma
Item
liver biopsy within 12 months prior to study entry showed liver cirrhosis with metavir system fibrosis score of 3-4, or hepatocellular carcinoma (hcc);
boolean
C0023890 (UMLS CUI [1,1])
C3897040 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2])
HBV coinfection
Item
co-infection with hepatitis b virus (hbv);
boolean
C2242656 (UMLS CUI [1])
HIV antibody positive
Item
anti-hiv positive;
boolean
C0920548 (UMLS CUI [1])

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