ID

43813

Beschrijving

Tolerability of Peginterferon Plus Ribavirin for Chronic Hepatitis C and HIV for Patients Receiving Antiretroviral Medication vs Not Receiving Antiretroviral Medication; ODM derived from: https://clinicaltrials.gov/show/NCT00296972

Link

https://clinicaltrials.gov/show/NCT00296972

Trefwoorden

Versies (3)
  1. 02-02-17 02-02-17 -
  2. 03-02-17 03-02-17 -
  3. 20-09-21 20-09-21 -
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20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00296972

Engels

Eligibility Chronic Hepatitis C NCT00296972

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
hepatitis c genotype 1 infection·
Beschrijving

Hepatitis C virus genotype 1 Infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C3532919
UMLS CUI [1,2]
C3714514
detectable plasma hcv-rna roche>1000copies/ml, >600iu/ml
Beschrijving

Hepatitis C RNA Detectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0855840
UMLS CUI [1,2]
C3830527
chronic liver disease consistent with chc infection on a biopsy obtained within the past 24 months
Beschrijving

Chronic liver disease Consistent with Chronic Hepatitis C Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [1,4]
C0005558
patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, ct scan, or mri scan without evidence of hepatocellular carcinoma and a serum afp <100 ng/ml within 2 months of randomization
Beschrijving

Liver Cirrhosis | Liver Cirrhosis Incomplete | Transabdominal Ultrasound | CT of abdomen | MRI scan - abdominal | Liver carcinoma Evidence of | Alpha one fetoprotein measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205257
UMLS CUI [3]
C2348813
UMLS CUI [4]
C0412620
UMLS CUI [5]
C3842374
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0332120
UMLS CUI [7]
C0201539
patients with cd4 cell count ³ 350 cells /µl
Beschrijving

CD4 Count determination procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0243009
patients on stable highly active antiretroviral therapy (haart) for at least 12 weeks prior to baseline with the exception of patients receiving didanosine
Beschrijving

Highly Active Antiretroviral Therapy Stable | Didanosine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0887947
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0012133
hiv-1 rna is < 5000 copies/ml
Beschrijving

Human immunodeficiency virus 1 RNA Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0369499
UMLS CUI [1,2]
C0242485
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
ifn, pegylated interferons, viramidine, levovirin, or ribavirin therapy at any previous time
Beschrijving

Interferons | pegylated interferon alfa | ribavirin amidine | Ribavirin

Datatype

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0907160
UMLS CUI [3]
C0073221
UMLS CUI [4]
C0035525
patients with evidence of active hepatitis b infection. ( presence of hbsag)
Beschrijving

Hepatitis B Evidence of | Hepatitis B Surface Antigens Present

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
history or evidence of decompensated liver disease and/or a child-pugh score > 5, bleeding from esophageal varices, hepatic malignancy
Beschrijving

Decompensated liver disease Evidence of | Child-Pugh Classification | Bleeding esophageal varices | Malignant neoplasm of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C4050412
UMLS CUI [3]
C0155789
UMLS CUI [4]
C0345904
abnormal bloodwork ie absolute neutrophil <1,hbg <110, platelets <70,creatinine <50
Beschrijving

Hematologic function Abnormal | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0201976
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Similar models

Eligibility Chronic Hepatitis C NCT00296972

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus genotype 1 Infection
Item
hepatitis c genotype 1 infection·
boolean
C3532919 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Hepatitis C RNA Detectable
Item
detectable plasma hcv-rna roche>1000copies/ml, >600iu/ml
boolean
C0855840 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Chronic liver disease Consistent with Chronic Hepatitis C Biopsy
Item
chronic liver disease consistent with chc infection on a biopsy obtained within the past 24 months
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
Liver Cirrhosis | Liver Cirrhosis Incomplete | Transabdominal Ultrasound | CT of abdomen | MRI scan - abdominal | Liver carcinoma Evidence of | Alpha one fetoprotein measurement
Item
patients with cirrhosis or incomplete cirrhosis must have an abdominal ultrasound, ct scan, or mri scan without evidence of hepatocellular carcinoma and a serum afp <100 ng/ml within 2 months of randomization
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C2348813 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C3842374 (UMLS CUI [5])
C2239176 (UMLS CUI [6,1])
C0332120 (UMLS CUI [6,2])
C0201539 (UMLS CUI [7])
CD4 Count determination procedure
Item
patients with cd4 cell count ³ 350 cells /µl
boolean
C0243009 (UMLS CUI [1])
Highly Active Antiretroviral Therapy Stable | Didanosine
Item
patients on stable highly active antiretroviral therapy (haart) for at least 12 weeks prior to baseline with the exception of patients receiving didanosine
boolean
C0887947 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0012133 (UMLS CUI [2])
Human immunodeficiency virus 1 RNA Measurement
Item
hiv-1 rna is < 5000 copies/ml
boolean
C0369499 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Interferons | pegylated interferon alfa | ribavirin amidine | Ribavirin
Item
ifn, pegylated interferons, viramidine, levovirin, or ribavirin therapy at any previous time
boolean
C0021747 (UMLS CUI [1])
C0907160 (UMLS CUI [2])
C0073221 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
Hepatitis B Evidence of | Hepatitis B Surface Antigens Present
Item
patients with evidence of active hepatitis b infection. ( presence of hbsag)
boolean
C0019163 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Decompensated liver disease Evidence of | Child-Pugh Classification | Bleeding esophageal varices | Malignant neoplasm of liver
Item
history or evidence of decompensated liver disease and/or a child-pugh score > 5, bleeding from esophageal varices, hepatic malignancy
boolean
C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C4050412 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0345904 (UMLS CUI [4])
Hematologic function Abnormal | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Creatinine measurement, serum
Item
abnormal bloodwork ie absolute neutrophil <1,hbg <110, platelets <70,creatinine <50
boolean
C0221130 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
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