ID

39625

Description

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01197157

Link

https://clinicaltrials.gov/show/NCT01197157

Keywords

Versions (1)
  1. 2/5/20 2/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01197157

English

Eligibility Hepatitis C NCT01197157

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 and <60.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
liver biopsy showing chronic hepatitis with significant fibrosis using ishak scoring system.
Description

Chronic Hepatitis Biopsy of liver | Fibrosis Ishak Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0016059
UMLS CUI [2,2]
C2986945
compensated liver disease; serum bilirubin < 1.5 mg/dl, inr no more than 1.5, serum albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
Description

Compensated liver disease | Serum total bilirubin measurement | International Normalized Ratio | Serum albumin measurement | Platelet Count measurement | Hepatic decompensation Absent | Hepatic Encephalopathy Absent | Ascites Absent

Data type

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0523465
UMLS CUI [5]
C0032181
UMLS CUI [6,1]
C1394798
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0019151
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0003962
UMLS CUI [8,2]
C0332197
acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.
Description

Index Hematological Acceptable | Index Biochemical Acceptable | Hemoglobin measurement | Gender | Neutrophil count | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0918012
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C1879533
UMLS CUI [2,1]
C0918012
UMLS CUI [2,2]
C0205474
UMLS CUI [2,3]
C1879533
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0201976
willing to be treated and to adhere to treatment requirements
Description

Treatment Compliance

Data type

boolean

Alias
UMLS CUI [1]
C4319828
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
major uncontrolled depressive illness.
Description

Major Depressive Disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205318
solid organ transplantation.
Description

Solid organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0730400
autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
Description

Autoimmune Diseases | Exacerbation Due to PEGINTERFERON | Exacerbation Due to Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0982327
UMLS CUI [3,1]
C4086268
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0035525
untreated thyroid disease.
Description

Thyroid Disease Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0332155
pregnant or unwilling to comply with adequate contraception.
Description

Pregnancy | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
Description

Comorbidity Severe | Hypertension, severe | Heart failure | Coronary heart disease | Poorly controlled diabetes mellitus | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C4013784
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0010068
UMLS CUI [5]
C0554876
UMLS CUI [6]
C0024117
known hypersensitivity to drugs used to treat hcv.
Description

Hypersensitivity Anti-hepatitis C (HCV) Agents,

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4324240
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Similar models

Eligibility Hepatitis C NCT01197157

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 and <60.
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis Biopsy of liver | Fibrosis Ishak Score
Item
liver biopsy showing chronic hepatitis with significant fibrosis using ishak scoring system.
boolean
C0019189 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0016059 (UMLS CUI [2,1])
C2986945 (UMLS CUI [2,2])
Compensated liver disease | Serum total bilirubin measurement | International Normalized Ratio | Serum albumin measurement | Platelet Count measurement | Hepatic decompensation Absent | Hepatic Encephalopathy Absent | Ascites Absent
Item
compensated liver disease; serum bilirubin < 1.5 mg/dl, inr no more than 1.5, serum albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
boolean
C3839044 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1394798 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0019151 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0003962 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Index Hematological Acceptable | Index Biochemical Acceptable | Hemoglobin measurement | Gender | Neutrophil count | Creatinine measurement, serum
Item
acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.
boolean
C0918012 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Treatment Compliance
Item
willing to be treated and to adhere to treatment requirements
boolean
C4319828 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Major Depressive Disorder Uncontrolled
Item
major uncontrolled depressive illness.
boolean
C1269683 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Solid organ transplant
Item
solid organ transplantation.
boolean
C0730400 (UMLS CUI [1])
Autoimmune Diseases | Exacerbation Due to PEGINTERFERON | Exacerbation Due to Ribavirin
Item
autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
boolean
C0004364 (UMLS CUI [1])
C4086268 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0982327 (UMLS CUI [2,3])
C4086268 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Thyroid Disease Untreated
Item
untreated thyroid disease.
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Pregnancy | Contraceptive methods Unwilling
Item
pregnant or unwilling to comply with adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Severe | Hypertension, severe | Heart failure | Coronary heart disease | Poorly controlled diabetes mellitus | Chronic Obstructive Airway Disease
Item
severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4013784 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0010068 (UMLS CUI [4])
C0554876 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
Hypersensitivity Anti-hepatitis C (HCV) Agents,
Item
known hypersensitivity to drugs used to treat hcv.
boolean
C0020517 (UMLS CUI [1,1])
C4324240 (UMLS CUI [1,2])
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