ID

39722

Description

To Study the Efficacy and Safety of Renessans in Chronic HCV Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01463592

Link

https://clinicaltrials.gov/show/NCT01463592

Keywords

Versions (1)
  1. 2/12/20 2/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01463592

English

Eligibility Hepatitis C, Chronic NCT01463592

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
following groups of the people will be enrolled for the study.
Description

Groups People Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C1516879
patients suffering from chronic hcv infection as evident with a positive serology for anti hcv antibody and raised alt.
Description

Hepatitis C, Chronic | Serology positive Hepatitis C Antibodies | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0166049
UMLS CUI [3]
C0151905
both males and females
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age group: 18 - 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
following groups of people will be excluded from the study
Description

Groups People Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0332196
pregnant females
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
body mass index more than 25
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
uncontrolled diabetes mellitus, hypertension, ischemic heart disease, renal failure, respiratory failure, chronic infections, gall stone disease or renal stone disease.
Description

Diabetic - poor control | Hypertensive disease | Myocardial Ischemia | Kidney Failure | Respiratory Failure | Chronic infectious disease | Cholelithiasis | Nephrolithiasis

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0151744
UMLS CUI [4]
C0035078
UMLS CUI [5]
C1145670
UMLS CUI [6]
C0151317
UMLS CUI [7]
C0008350
UMLS CUI [8]
C0392525
patients known to have hypersensitivity to iodine compounds in the past.
Description

Iodine compounds allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571817
psychiatric disorders except mild anxiety disorders.
Description

Mental disorders | Exception Mild anxiety

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0231401
patients suffering from auto immune diseases e.g. rheumatoid arthritis, sle, or thyroid diseases.
Description

Autoimmune Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Thyroid Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0040128
patients suffering from concomitant hbv infection, hiv infection or any other chronic liver disease.
Description

Hepatitis B | HIV Infection | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0341439
bilirubin more than 2mg/dl, albumin less than 3.0 gms/dl, inr more than 1.5, hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
Description

Serum total bilirubin measurement | Albumin measurement | International Normalized Ratio | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0032181
serum sodium less than 130mmol/l.
Description

Serum sodium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523891
patients who have received the interferon treatment in the past.
Description

Interferon therapy In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C1444637
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Similar models

Eligibility Hepatitis C, Chronic NCT01463592

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Groups People Enrollment
Item
following groups of the people will be enrolled for the study.
boolean
C0441833 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Hepatitis C, Chronic | Serology positive Hepatitis C Antibodies | Alanine aminotransferase increased
Item
patients suffering from chronic hcv infection as evident with a positive serology for anti hcv antibody and raised alt.
boolean
C0524910 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
Gender
Item
both males and females
boolean
C0079399 (UMLS CUI [1])
Age
Item
age group: 18 - 55 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Groups People Excluded
Item
following groups of people will be excluded from the study
boolean
C0441833 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Pregnancy
Item
pregnant females
boolean
C0032961 (UMLS CUI [1])
Body mass index
Item
body mass index more than 25
boolean
C1305855 (UMLS CUI [1])
Diabetic - poor control | Hypertensive disease | Myocardial Ischemia | Kidney Failure | Respiratory Failure | Chronic infectious disease | Cholelithiasis | Nephrolithiasis
Item
uncontrolled diabetes mellitus, hypertension, ischemic heart disease, renal failure, respiratory failure, chronic infections, gall stone disease or renal stone disease.
boolean
C0421258 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0151744 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C1145670 (UMLS CUI [5])
C0151317 (UMLS CUI [6])
C0008350 (UMLS CUI [7])
C0392525 (UMLS CUI [8])
Iodine compounds allergy
Item
patients known to have hypersensitivity to iodine compounds in the past.
boolean
C0571817 (UMLS CUI [1])
Mental disorders | Exception Mild anxiety
Item
psychiatric disorders except mild anxiety disorders.
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0231401 (UMLS CUI [2,2])
Autoimmune Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Thyroid Diseases
Item
patients suffering from auto immune diseases e.g. rheumatoid arthritis, sle, or thyroid diseases.
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
Hepatitis B | HIV Infection | Chronic liver disease
Item
patients suffering from concomitant hbv infection, hiv infection or any other chronic liver disease.
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0341439 (UMLS CUI [3])
Serum total bilirubin measurement | Albumin measurement | International Normalized Ratio | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
bilirubin more than 2mg/dl, albumin less than 3.0 gms/dl, inr more than 1.5, hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
boolean
C1278039 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Serum sodium measurement
Item
serum sodium less than 130mmol/l.
boolean
C0523891 (UMLS CUI [1])
Interferon therapy In the past
Item
patients who have received the interferon treatment in the past.
boolean
C0279030 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
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