ID

13085

Description

Oral Collagen for Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00000401

Link

https://clinicaltrials.gov/show/NCT00000401

Keywords

  1. 1/15/16 1/15/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 15, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Rheumatoid Arthritis NCT00000401

Eligibility Rheumatoid Arthritis NCT00000401

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically stable ra and unlikely to require adjustment of doses of dmards, nsaids, prednisone, or anti-tnfα therapies for the treatment phase of the study
Description

rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
meets american college of rheumatology (acr) 1988 revised criteria for ra
Description

acr criteria

Data type

boolean

Alias
UMLS CUI [1]
C0003873
onset of disease at age 16 or older
Description

onset of disease at age 16 or older

Data type

boolean

Alias
UMLS CUI [1]
C0277793
onset of disease at least 3 months prior to enrollment
Description

onset of disease at least 3 months prior to enrollment

Data type

boolean

Alias
UMLS CUI [1]
C0277793
pbmc - ifnγ - α1(ii)/pbs stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit
Description

pbmc - ifnγ - α1(ii)/pbs stimulation index

Data type

boolean

agree to discontinue herbal remedies described in this protocol
Description

herbal drug

Data type

boolean

Alias
UMLS CUI [1]
C1360419
agree to use acceptable forms of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry
Description

participation in another clinical research study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
currently taking greater than 7.5 mg prednisone daily
Description

prednisone

Data type

boolean

Alias
UMLS CUI [1]
C0032952
intra-articular corticosteroid injections within 30 days prior to study entry
Description

intra-articular corticosteroid injections

Data type

boolean

Alias
UMLS CUI [1]
C2064783
concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
Description

concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
beef allergy
Description

beef allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0452849
use of fish oil within 4 weeks of study entry
Description

fish oil

Data type

boolean

Alias
UMLS CUI [1]
C0556145
previous use of auranofin or cyclophosphamide (all other dmards are allowed)
Description

auranofin or cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1]
C0004320
UMLS CUI [2]
C0010583
previous autologous or heterologous stem cell transplantation
Description

stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1504389
active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
intolerance to citrus juices or colorless carbonated beverages
Description

citrus juice

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2347777
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0007025

Similar models

Eligibility Rheumatoid Arthritis NCT00000401

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
rheumatoid arthritis
Item
clinically stable ra and unlikely to require adjustment of doses of dmards, nsaids, prednisone, or anti-tnfα therapies for the treatment phase of the study
boolean
C0003873 (UMLS CUI [1])
acr criteria
Item
meets american college of rheumatology (acr) 1988 revised criteria for ra
boolean
C0003873 (UMLS CUI [1])
onset of disease at age 16 or older
Item
onset of disease at age 16 or older
boolean
C0277793 (UMLS CUI [1])
onset of disease at least 3 months prior to enrollment
Item
onset of disease at least 3 months prior to enrollment
boolean
C0277793 (UMLS CUI [1])
pbmc - ifnγ - α1(ii)/pbs stimulation index
Item
pbmc - ifnγ - α1(ii)/pbs stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit
boolean
herbal drug
Item
agree to discontinue herbal remedies described in this protocol
boolean
C1360419 (UMLS CUI [1])
contraception
Item
agree to use acceptable forms of contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
participation in another clinical research study
Item
participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
prednisone
Item
currently taking greater than 7.5 mg prednisone daily
boolean
C0032952 (UMLS CUI [1])
intra-articular corticosteroid injections
Item
intra-articular corticosteroid injections within 30 days prior to study entry
boolean
C2064783 (UMLS CUI [1])
concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
Item
concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
beef allergy
Item
beef allergy
boolean
C0020517 (UMLS CUI [1,1])
C0452849 (UMLS CUI [1,2])
fish oil
Item
use of fish oil within 4 weeks of study entry
boolean
C0556145 (UMLS CUI [1])
auranofin or cyclophosphamide
Item
previous use of auranofin or cyclophosphamide (all other dmards are allowed)
boolean
C0004320 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
stem cell transplantation
Item
previous autologous or heterologous stem cell transplantation
boolean
C1504389 (UMLS CUI [1])
malignancy
Item
active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
boolean
C0006826 (UMLS CUI [1])
citrus juice
Item
intolerance to citrus juices or colorless carbonated beverages
boolean
C0020517 (UMLS CUI [1,1])
C2347777 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0007025 (UMLS CUI [2,2])

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