ID

17512

Description

Leukapheresis for Research on HCV-Coinfected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00076427

Link

https://clinicaltrials.gov/show/NCT00076427

Keywords

Versions (1)
  1. 9/20/16 9/20/16 -
Uploaded on

September 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00076427

English

Eligibility Hepatitis C NCT00076427

1 forms  
Criteria
Description

Criteria

adult (18 years old or older)
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
either monoinfected with hcv or coinfected with hcv and hiv
Description

Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019693
willingness to give informed consent.
Description

Informed Consent Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
willing to undergo genetic testing
Description

Genetic testing Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0679560
UMLS CUI [1,2]
C0600109
willing to have samples stored for future research.
Description

Sample Storage Related research Future

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0035168
UMLS CUI [1,5]
C0016884
must have a referring physician or clinic that will continue to provide medical care.
Description

referring physician Medical care Continuing | Clinic Referring Medical care Continuing

Data type

boolean

Alias
UMLS CUI [1,1]
C1709880
UMLS CUI [1,2]
C0496675
UMLS CUI [1,3]
C0549178
UMLS CUI [2,1]
C0442592
UMLS CUI [2,2]
C0205543
UMLS CUI [2,3]
C0496675
UMLS CUI [2,4]
C0549178
note: an hcv/hiv coinfected individual is defined as any individual with all the following: 1) positive elisa and western blot test for hiv, and 2) positive serology and/or positive hcv rna test; an hcv monoinfected individual is defined as any individual with all of the following: 1) positive serology and/or positive hcv rna test, and 2) negative elisa test for hiv
Description

Hepatitis C | HIV Infection | HIV ELISA test positive | HIV TEST WESTERN BLOT POSITIVE | Hepatitis C virus Serology positive | HCV viral load Positive | HIV ELISA test negative

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0745002
UMLS CUI [4]
C0745009
UMLS CUI [5,1]
C0220847
UMLS CUI [5,2]
C0242089
UMLS CUI [6,1]
C1868902
UMLS CUI [6,2]
C1514241
UMLS CUI [7]
C1319034
inclusion criteria for group 1:
Description

Inclusion criteria Group 1

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0441861
must be willing and able to make follow up visits for leukapheresis and blood draws at least once in the next 6 months
Description

Follow-up visit Leukapheresis Willing | Follow-up visit Blood draw Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0023416
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C0005834
UMLS CUI [2,3]
C0600109
inclusion criteria for group 2:
Description

Inclusion criteria Group 2

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0441865
must be referred by a physician for the purposes of confirming hcv diagnosis, complications from hcv, or standard hcv treatment management.
Description

Hepatitis C Diagnosis | Hepatitis C Complication | Hepatitis C Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0009566
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C2936643
exclusion criteria for both groups
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
have any other condition, which the investigator considers a contraindication to study participation.
Description

Condition Contraindication Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C2348568
exclusion for group 1:
Description

Exclusion Criteria Group 1

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0441861
evidence of liver failure on liver biopsy, abdominal ultrasound, or liver function blood tests
Description

Liver Failure Evidence of | Biopsy of liver | Transabdominal Ultrasound | Liver function Hematologic Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0193388
UMLS CUI [3]
C2348813
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C0018941
receiving hcv therapy at the time of enrollment
Description

Therapeutic procedure Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
platelet count < 50,00 per ml
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hematocrit < 28 percent.
Description

Hematocrit level

Data type

boolean

Alias
UMLS CUI [1]
C0518014
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Similar models

Eligibility Hepatitis C NCT00076427

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Age
Item
adult (18 years old or older)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C | HIV Infection
Item
either monoinfected with hcv or coinfected with hcv and hiv
boolean
C0019196 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Informed Consent Willing
Item
willingness to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Genetic testing Willing
Item
willing to undergo genetic testing
boolean
C0679560 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Sample Storage Related research Future
Item
willing to have samples stored for future research.
boolean
C0370003 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0035168 (UMLS CUI [1,4])
C0016884 (UMLS CUI [1,5])
referring physician Medical care Continuing | Clinic Referring Medical care Continuing
Item
must have a referring physician or clinic that will continue to provide medical care.
boolean
C1709880 (UMLS CUI [1,1])
C0496675 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0442592 (UMLS CUI [2,1])
C0205543 (UMLS CUI [2,2])
C0496675 (UMLS CUI [2,3])
C0549178 (UMLS CUI [2,4])
Hepatitis C | HIV Infection | HIV ELISA test positive | HIV TEST WESTERN BLOT POSITIVE | Hepatitis C virus Serology positive | HCV viral load Positive | HIV ELISA test negative
Item
note: an hcv/hiv coinfected individual is defined as any individual with all the following: 1) positive elisa and western blot test for hiv, and 2) positive serology and/or positive hcv rna test; an hcv monoinfected individual is defined as any individual with all of the following: 1) positive serology and/or positive hcv rna test, and 2) negative elisa test for hiv
boolean
C0019196 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0745002 (UMLS CUI [3])
C0745009 (UMLS CUI [4])
C0220847 (UMLS CUI [5,1])
C0242089 (UMLS CUI [5,2])
C1868902 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C1319034 (UMLS CUI [7])
Inclusion criteria Group 1
Item
inclusion criteria for group 1:
boolean
C1512693 (UMLS CUI [1,1])
C0441861 (UMLS CUI [1,2])
Follow-up visit Leukapheresis Willing | Follow-up visit Blood draw Willing
Item
must be willing and able to make follow up visits for leukapheresis and blood draws at least once in the next 6 months
boolean
C0589121 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0589121 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Inclusion criteria Group 2
Item
inclusion criteria for group 2:
boolean
C1512693 (UMLS CUI [1,1])
C0441865 (UMLS CUI [1,2])
Hepatitis C Diagnosis | Hepatitis C Complication | Hepatitis C Standard of Care
Item
must be referred by a physician for the purposes of confirming hcv diagnosis, complications from hcv, or standard hcv treatment management.
boolean
C0019196 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
Exclusion Criteria
Item
exclusion criteria for both groups
boolean
C0680251 (UMLS CUI [1])
Condition Contraindication Study Subject Participation Status
Item
have any other condition, which the investigator considers a contraindication to study participation.
boolean
C0348080 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Exclusion Criteria Group 1
Item
exclusion for group 1:
boolean
C0680251 (UMLS CUI [1,1])
C0441861 (UMLS CUI [1,2])
Liver Failure Evidence of | Biopsy of liver | Transabdominal Ultrasound | Liver function Hematologic Tests
Item
evidence of liver failure on liver biopsy, abdominal ultrasound, or liver function blood tests
boolean
C0085605 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0193388 (UMLS CUI [2])
C2348813 (UMLS CUI [3])
C0232741 (UMLS CUI [4,1])
C0018941 (UMLS CUI [4,2])
Therapeutic procedure Hepatitis C
Item
receiving hcv therapy at the time of enrollment
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelet count < 50,00 per ml
boolean
C0032181 (UMLS CUI [1])
Hematocrit level
Item
hematocrit < 28 percent.
boolean
C0518014 (UMLS CUI [1])
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