ID

14911

Beschreibung

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02250807

Link

https://clinicaltrials.gov/show/NCT02250807

Stichworte

  1. 07.05.16 07.05.16 -
Hochgeladen am

7. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Chronic Hepatitis C NCT02250807

    Eligibility Chronic Hepatitis C NCT02250807

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects with confirmed hepatitis c virus (hcv) with hcv rna greater than (>) 10000 international unit per milliliter (iu/ml)
    Beschreibung

    Hepatitis C virus | Hepatitis C virus RNA

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0220847
    UMLS CUI [2]
    C0369335
    subjects who are treatment naive or treatment-experienced.
    Beschreibung

    Therapy naive | Therapeutic procedure Experience

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0919936
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0596545
    subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
    Beschreibung

    Biopsy of liver | Transient elastography

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0193388
    UMLS CUI [2]
    C2748260
    subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, ct scan or magnetic resonance imaging [mri]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (hcc)
    Beschreibung

    Liver Cirrhosis | Diagnostic Imaging Hepatic | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2,1]
    C0011923
    UMLS CUI [2,2]
    C0205054
    UMLS CUI [3]
    C1456803
    UMLS CUI [4]
    C0040405
    UMLS CUI [5]
    C0024485
    women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
    Beschreibung

    Childbearing Potential | Contraceptive methods | Sexual Abstinence Heterosexuality | childbearing problem

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0700589
    UMLS CUI [3,1]
    C0036899
    UMLS CUI [3,2]
    C0019421
    UMLS CUI [4]
    C1657137
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    evidence of clinical hepatic decompensation
    Beschreibung

    hepatic; decompensation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1394798
    any liver disease of non-hcv etiology
    Beschreibung

    Liver diseases | Etiology aspects Hepatitis C virus

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2,1]
    C0015127
    UMLS CUI [2,2]
    C0220847
    subjects with a past history of treatment with an approved or investigational daa
    Beschreibung

    Past Therapeutic procedure DIRECT ACTING ANTIVIRALS

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1444637
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C3653501
    co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening)
    Beschreibung

    Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | Human Immunodeficiency Virus 1 (HIV-1) Antibodies Positive Laboratory Test Result | Human Immunodeficiency Virus 2 (HIV-2 ) Antibodies Positive Laboratory Test Result

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0275524
    UMLS CUI [1,2]
    C0019704
    UMLS CUI [2,1]
    C0275524
    UMLS CUI [2,2]
    C0019707
    UMLS CUI [3,1]
    C1254603
    UMLS CUI [3,2]
    C1335447
    UMLS CUI [4,1]
    C1255639
    UMLS CUI [4,2]
    C1335447
    infection/co-infection with hcv non-genotype 4
    Beschreibung

    Communicable Diseases Hepatitis C virus genotype 4 | Coinfection Hepatitis C virus genotype 4

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C3532922
    UMLS CUI [2,1]
    C0275524
    UMLS CUI [2,2]
    C3532922

    Ähnliche Modelle

    Eligibility Chronic Hepatitis C NCT02250807

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Hepatitis C virus | Hepatitis C virus RNA
    Item
    subjects with confirmed hepatitis c virus (hcv) with hcv rna greater than (>) 10000 international unit per milliliter (iu/ml)
    boolean
    C0220847 (UMLS CUI [1])
    C0369335 (UMLS CUI [2])
    Therapy naive | Therapeutic procedure Experience
    Item
    subjects who are treatment naive or treatment-experienced.
    boolean
    C0919936 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C0596545 (UMLS CUI [2,2])
    Biopsy of liver | Transient elastography
    Item
    subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
    boolean
    C0193388 (UMLS CUI [1])
    C2748260 (UMLS CUI [2])
    Liver Cirrhosis | Diagnostic Imaging Hepatic | Ultrasonics (sound) | X-Ray Computed Tomography | Magnetic Resonance Imaging
    Item
    subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, ct scan or magnetic resonance imaging [mri]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (hcc)
    boolean
    C0023890 (UMLS CUI [1])
    C0011923 (UMLS CUI [2,1])
    C0205054 (UMLS CUI [2,2])
    C1456803 (UMLS CUI [3])
    C0040405 (UMLS CUI [4])
    C0024485 (UMLS CUI [5])
    Childbearing Potential | Contraceptive methods | Sexual Abstinence Heterosexuality | childbearing problem
    Item
    women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
    boolean
    C3831118 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    C0036899 (UMLS CUI [3,1])
    C0019421 (UMLS CUI [3,2])
    C1657137 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    hepatic; decompensation
    Item
    evidence of clinical hepatic decompensation
    boolean
    C1394798 (UMLS CUI [1])
    Liver diseases | Etiology aspects Hepatitis C virus
    Item
    any liver disease of non-hcv etiology
    boolean
    C0023895 (UMLS CUI [1])
    C0015127 (UMLS CUI [2,1])
    C0220847 (UMLS CUI [2,2])
    Past Therapeutic procedure DIRECT ACTING ANTIVIRALS
    Item
    subjects with a past history of treatment with an approved or investigational daa
    boolean
    C1444637 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C3653501 (UMLS CUI [1,3])
    Coinfection HIV-1 | Coinfection Human immunodeficiency virus 2 (HIV-2) | Human Immunodeficiency Virus 1 (HIV-1) Antibodies Positive Laboratory Test Result | Human Immunodeficiency Virus 2 (HIV-2 ) Antibodies Positive Laboratory Test Result
    Item
    co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening)
    boolean
    C0275524 (UMLS CUI [1,1])
    C0019704 (UMLS CUI [1,2])
    C0275524 (UMLS CUI [2,1])
    C0019707 (UMLS CUI [2,2])
    C1254603 (UMLS CUI [3,1])
    C1335447 (UMLS CUI [3,2])
    C1255639 (UMLS CUI [4,1])
    C1335447 (UMLS CUI [4,2])
    Communicable Diseases Hepatitis C virus genotype 4 | Coinfection Hepatitis C virus genotype 4
    Item
    infection/co-infection with hcv non-genotype 4
    boolean
    C0009450 (UMLS CUI [1,1])
    C3532922 (UMLS CUI [1,2])
    C0275524 (UMLS CUI [2,1])
    C3532922 (UMLS CUI [2,2])

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