ID

27918

Descripción

Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00910975

Link

https://clinicaltrials.gov/show/NCT00910975

Palabras clave

Versiones (1)
  1. 5/12/17 5/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

Inglés

Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
anti-hcv positive for > 6 months
Descripción

Hepatitis C antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281863
genotype 1
Descripción

Hepatitis C virus genotype 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3532919
clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
Descripción

Indication Therapeutic procedure | Inflammation Biopsy of liver | Fibrosis Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0021368
UMLS CUI [2,2]
C0193388
UMLS CUI [3,1]
C0016059
UMLS CUI [3,2]
C0193388
negative pregnancy test (for fertile women)
Descripción

Gender Fertile Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
antiviral or immune modulating treatment the last 6 months
Descripción

Antiviral Therapy | Immunomodulation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1963758
hepatitis b or hiv infection (hbsag, anti-hiv)
Descripción

Hepatitis B | HIV Infection | Hepatitis B Surface Antigens | HIV Antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019168
UMLS CUI [4]
C0019683
other significant chronic liver disease
Descripción

Chronic liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0341439
history of bleeding esophageal varices or other signs of decompensation
Descripción

Bleeding esophageal varices | Signs Decompensation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2,1]
C0220912
UMLS CUI [2,2]
C0231187
neutrophiles < 1.0 x 109/l or platelets < 50 x 109/l. s-creatinine > 2 x uln
Descripción

Neutrophil count | Platelet Count measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
history of severe psychiatric disorder
Descripción

Mental Disorders, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
Descripción

Autoimmune Disease | Heart Disease Severe | Organ Transplantation | Stem cell transplant | Malignant Neoplasms | Thyroid Disease | Retinal Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0029216
UMLS CUI [4]
C1504389
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0040128
UMLS CUI [7,1]
C0035309
UMLS CUI [7,2]
C0205082
drug abuse, current or during the last year
Descripción

Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
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Similar models

Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C antibody positive
Item
anti-hcv positive for > 6 months
boolean
C0281863 (UMLS CUI [1])
Hepatitis C virus genotype 1
Item
genotype 1
boolean
C3532919 (UMLS CUI [1])
Indication Therapeutic procedure | Inflammation Biopsy of liver | Fibrosis Biopsy of liver
Item
clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0021368 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0016059 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Gender Fertile Pregnancy test negative
Item
negative pregnancy test (for fertile women)
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antiviral Therapy | Immunomodulation
Item
antiviral or immune modulating treatment the last 6 months
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
Hepatitis B | HIV Infection | Hepatitis B Surface Antigens | HIV Antibodies
Item
hepatitis b or hiv infection (hbsag, anti-hiv)
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019168 (UMLS CUI [3])
C0019683 (UMLS CUI [4])
Chronic liver disease
Item
other significant chronic liver disease
boolean
C0341439 (UMLS CUI [1])
Bleeding esophageal varices | Signs Decompensation
Item
history of bleeding esophageal varices or other signs of decompensation
boolean
C0155789 (UMLS CUI [1])
C0220912 (UMLS CUI [2,1])
C0231187 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Creatinine measurement, serum
Item
neutrophiles < 1.0 x 109/l or platelets < 50 x 109/l. s-creatinine > 2 x uln
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Mental Disorders, Severe
Item
history of severe psychiatric disorder
boolean
C4046029 (UMLS CUI [1])
Autoimmune Disease | Heart Disease Severe | Organ Transplantation | Stem cell transplant | Malignant Neoplasms | Thyroid Disease | Retinal Disease Severe
Item
autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
boolean
C0004364 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0029216 (UMLS CUI [3])
C1504389 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0040128 (UMLS CUI [6])
C0035309 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Drug abuse
Item
drug abuse, current or during the last year
boolean
C0013146 (UMLS CUI [1])
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