ID

14911

Descripción

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

Palabras clave

Versiones (1)
  1. 7/5/16 7/5/16 -
Subido en

7 de mayo de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Chronic Hepatitis C NCT02250807

Inglés

Eligibility Chronic Hepatitis C NCT02250807

1 formularios  
Inclusion Criteria
Descripción

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)
Descripción

Hepatitis C virus | Hepatitis C virus RNA

Tipo de datos

boolean

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

Therapy naive | Therapeutic procedure Experience

Tipo de datos

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
Descripción

Biopsy of liver | Transient elastography

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinical hepatic decompensation
Descripción

hepatic; decompensation

Tipo de datos

boolean

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

Liver diseases | Etiology aspects Hepatitis C virus

Tipo de datos

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
Descripción

Past Therapeutic procedure DIRECT ACTING ANTIVIRALS

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C3532922
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C3532922
Volver a la parte superior de la página

Similar models

Eligibility Chronic Hepatitis C NCT02250807

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial