ID

36007

Description

Can Vitamin D Supplementation Improve Hepatitis C Cure Rates; ODM derived from: https://clinicaltrials.gov/show/NCT02053519

Link

https://clinicaltrials.gov/show/NCT02053519

Keywords

  1. 4/9/19 4/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 9, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C NCT02053519

Eligibility Hepatitis C NCT02053519

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants will be eligible if they
Description

Study Subject Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
have confirmed hepatitis c with positive pcr for genotype 1 or 3
Description

Hepatitis C | PCR positive Genotype Specified

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C3888499
UMLS CUI [2,2]
C1148363
UMLS CUI [2,3]
C0205369
are planned to commence on standard eradication therapy for hcv
Description

Eradication Planned Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C3178994
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0019196
aged 18 or over
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria are:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
hepatitis c genotype other than 1 or 3
Description

Hepatitis C virus genotype | Exception Genotype Specified

Data type

boolean

Alias
UMLS CUI [1]
C1148363
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1148363
UMLS CUI [2,3]
C0205369
contraindications to interferon / ribavirin therapy
Description

Medical contraindication Interferon With Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3652465
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C0035525
egfr <30 ml/min (by mdrd4 method)
Description

Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C2170215
currently decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
o ascites, encephalopathy or variceal bleeding
Description

Ascites | Encephalopathy | Bleeding varices

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0085584
UMLS CUI [3]
C0333106
history of renal calculi
Description

Kidney Calculi

Data type

boolean

Alias
UMLS CUI [1]
C0022650
serum calcium <2.15 mmol/l or >2.60 mmol/l
Description

Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
history of sarcoidosis, metastatic malignancy
Description

Sarcoidosis | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0036202
UMLS CUI [2]
C0027627
hepatocellular carcinoma (current or previous)
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
taking >400 units/day of vitamin d
Description

Vitamin D U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C0456683
hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
of childbearing potential and not taking reliable contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
unable to provide written informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Hepatitis C NCT02053519

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Eligible
Item
participants will be eligible if they
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
Hepatitis C | PCR positive Genotype Specified
Item
have confirmed hepatitis c with positive pcr for genotype 1 or 3
boolean
C0019196 (UMLS CUI [1])
C3888499 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Eradication Planned Hepatitis C
Item
are planned to commence on standard eradication therapy for hcv
boolean
C3178994 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Age
Item
aged 18 or over
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
exclusion criteria are:
boolean
C0680251 (UMLS CUI [1])
Hepatitis C virus genotype | Exception Genotype Specified
Item
hepatitis c genotype other than 1 or 3
boolean
C1148363 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Medical contraindication Interferon With Ribavirin
Item
contraindications to interferon / ribavirin therapy
boolean
C1301624 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0035525 (UMLS CUI [1,4])
Renal function GFR estimation by MDRD
Item
egfr <30 ml/min (by mdrd4 method)
boolean
C2170215 (UMLS CUI [1])
Decompensated liver disease
Item
currently decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Ascites | Encephalopathy | Bleeding varices
Item
o ascites, encephalopathy or variceal bleeding
boolean
C0003962 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
Kidney Calculi
Item
history of renal calculi
boolean
C0022650 (UMLS CUI [1])
Serum calcium measurement
Item
serum calcium <2.15 mmol/l or >2.60 mmol/l
boolean
C0728876 (UMLS CUI [1])
Sarcoidosis | Neoplasm Metastasis
Item
history of sarcoidosis, metastatic malignancy
boolean
C0036202 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Liver carcinoma
Item
hepatocellular carcinoma (current or previous)
boolean
C2239176 (UMLS CUI [1])
Vitamin D U/day
Item
taking >400 units/day of vitamin d
boolean
C0042866 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent
Item
of childbearing potential and not taking reliable contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent Unable
Item
unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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