ID

17553

Description

Efficacy of Silymarin for Acute Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT00412763

Link

https://clinicaltrials.gov/show/NCT00412763

Keywords

Versions (2)
  1. 9/23/16 9/23/16 -
  2. 9/23/16 9/23/16 -
Uploaded on

September 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis NCT00412763

English

Eligibility Hepatitis NCT00412763

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00412763
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
Description

Signs and Symptoms Consistent with Acute hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0267797
recent (<1 month) history of illness.
Description

Illness Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332185
elevation of alt > 2.5 normal.
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
at least 13 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history suggestive of severe drug-induced acute hepatitis.
Description

Drug-Induced Hepatitis Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1262760
UMLS CUI [1,2]
C0205082
children 12 years and younger.
Description

Child | Age

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
suspected hypersensitivity to silymarin or vitamin preparations.
Description

Hypersensitivity Silymarin | Hypersensitivity Vitamins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0037135
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042890
evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
Description

Liver diseases Advanced Evidence of | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0155789
UMLS CUI [4]
C0019151
patients who are critically ill, with multisystem failure or cancer.
Description

Critical Illness | Multiple Organ Failure | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0026766
UMLS CUI [3]
C0006826
substance abuse such as iv drugs.
Description

Substance Use Disorders | intravenous drug Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0683092
UMLS CUI [2,2]
C1546935
any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
Description

Condition Study Subject Participation Status Inappropriate | Condition Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Hepatitis NCT00412763

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00412763
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Signs and Symptoms Consistent with Acute hepatitis
Item
patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
boolean
C0037088 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0267797 (UMLS CUI [1,3])
Illness Recent
Item
recent (<1 month) history of illness.
boolean
C0221423 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Alanine aminotransferase increased
Item
elevation of alt > 2.5 normal.
boolean
C0151905 (UMLS CUI [1])
Age
Item
at least 13 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drug-Induced Hepatitis Severe
Item
history suggestive of severe drug-induced acute hepatitis.
boolean
C1262760 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Child | Age
Item
children 12 years and younger.
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Silymarin | Hypersensitivity Vitamins
Item
suspected hypersensitivity to silymarin or vitamin preparations.
boolean
C0020517 (UMLS CUI [1,1])
C0037135 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042890 (UMLS CUI [2,2])
Liver diseases Advanced Evidence of | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy
Item
evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2])
C0155789 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Critical Illness | Multiple Organ Failure | Malignant Neoplasms
Item
patients who are critically ill, with multisystem failure or cancer.
boolean
C0010340 (UMLS CUI [1])
C0026766 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
Substance Use Disorders | intravenous drug Abuse
Item
substance abuse such as iv drugs.
boolean
C0038586 (UMLS CUI [1])
C0683092 (UMLS CUI [2,1])
C1546935 (UMLS CUI [2,2])
Condition Study Subject Participation Status Inappropriate | Condition Interferes with Protocol Compliance
Item
any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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