ID

39559

Descrição

Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India; ODM derived from: https://clinicaltrials.gov/show/NCT01772121

Link

https://clinicaltrials.gov/show/NCT01772121

Palavras-chave

  1. 28/01/2020 28/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT01772121

Eligibility Hepatitis B NCT01772121

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to provide written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
male or female, age >= 18
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to comply with the visit procedure
Descrição

Compliance behavior Trial Visits

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0008952
prior diagnosis of chronic hcv infection or chronic hbv infection
Descrição

Chronic Hepatitis C Previous | Chronic Hepatitis B Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0205156
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
Descrição

Difficulty with Collection of blood specimen | Poor venous access Phlebotomy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C0005834
UMLS CUI [2,1]
C0577866
UMLS CUI [2,2]
C0190979
history of bleeding disorder
Descrição

Blood Coagulation Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
blood loss requiring transfusion or > 3 g/dl decrease in hemoglobin within 4 days of the visit
Descrição

Blood Loss Requirement Transfusion | Hemoglobin decreased

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0005841
UMLS CUI [2]
C0162119
knowingly co-infected with hcv/hbv or with hiv
Descrição

HCV coinfection | HBV coinfection | HIV coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
currently undergoing therapy for chronic hepatitis c or chronic hepatitis b
Descrição

Therapy Chronic Hepatitis C | Therapy Chronic Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0524910
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0524909
currently receiving treatment with any other investigational agent or device --
Descrição

Investigational New Drugs | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
enrolled in another clinical study evaluating a treatment or procedure
Descrição

Study Subject Participation Status | Clinical Trial Evaluation Therapy | Clinical Trial Evaluation Procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C1261322
UMLS CUI [3,3]
C0184661

Similar models

Eligibility Hepatitis B NCT01772121

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, age >= 18
boolean
C0001779 (UMLS CUI [1])
Compliance behavior Trial Visits
Item
willing and able to comply with the visit procedure
boolean
C1321605 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Chronic Hepatitis C Previous | Chronic Hepatitis B Previous
Item
prior diagnosis of chronic hcv infection or chronic hbv infection
boolean
C0524910 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Difficulty with Collection of blood specimen | Poor venous access Phlebotomy
Item
history of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
boolean
C0332218 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0577866 (UMLS CUI [2,1])
C0190979 (UMLS CUI [2,2])
Blood Coagulation Disorder
Item
history of bleeding disorder
boolean
C0005779 (UMLS CUI [1])
Blood Loss Requirement Transfusion | Hemoglobin decreased
Item
blood loss requiring transfusion or > 3 g/dl decrease in hemoglobin within 4 days of the visit
boolean
C3163616 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
C0162119 (UMLS CUI [2])
HCV coinfection | HBV coinfection | HIV coinfection
Item
knowingly co-infected with hcv/hbv or with hiv
boolean
C1698259 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Therapy Chronic Hepatitis C | Therapy Chronic Hepatitis B
Item
currently undergoing therapy for chronic hepatitis c or chronic hepatitis b
boolean
C0087111 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
Investigational New Drugs | Investigational Medical Device
Item
currently receiving treatment with any other investigational agent or device --
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial Evaluation Therapy | Clinical Trial Evaluation Procedure
Item
enrolled in another clinical study evaluating a treatment or procedure
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0008976 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])

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