ID

39722

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01463592

Nyckelord

Versioner (1)
  1. 2020-02-12 2020-02-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01463592

Engelsk

Eligibility Hepatitis C, Chronic NCT01463592

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Groups People Enrollment

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Gender

Datatyp

boolean

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Groups People Excluded

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

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

Body mass index

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Iodine compounds allergy

Datatyp

boolean

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

Mental disorders | Exception Mild anxiety

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hepatitis B | HIV Infection | Chronic liver disease

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Serum sodium measurement

Datatyp

boolean

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

Interferon therapy In the past

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C1444637
Tillbaka till toppen

Similar models

Eligibility Hepatitis C, Chronic NCT01463592

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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