ID

39448

Description

Pilot Study of Vitamin D Supplementation in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01388855

Link

https://clinicaltrials.gov/show/NCT01388855

Keywords

Versions (1)
  1. 1/11/20 1/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01388855

English

Eligibility Heart Failure NCT01388855

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
65 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
new york heart association functional class ii or iii symptoms
Description

Symptoms New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
ability to communicate in english or through a translator
Description

Able to communicate English Language | Translator

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0040713
competent to sign the informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-morbidity that would negatively impact quality of life (e.g. severe arthritis, or fibromyalgia)
Description

Comorbidity Impairing Quality of life | Arthritis Severe | Fibromyalgia

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0034380
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0016053
co-morbidity that would negatively impact vitamin d metabolism (glomerular filtration rate-15-29%, significant liver dysfunction
Description

Comorbidity Impairing Vitamin D metabolism | Glomerular Filtration Rate | Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1159433
UMLS CUI [2]
C0017654
UMLS CUI [3]
C0086565
on a pharmaceutical agent that could lower vitamin d levels (e.g. glucocorticoids, anticonvulsants)
Description

Pharmaceutical Preparation Lowering Serum vitamin D level | Glucocorticoids | Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2003888
UMLS CUI [1,3]
C0428586
UMLS CUI [2]
C0017710
UMLS CUI [3]
C0003286
taking >600 iu vitamin d (cholecalciferol or ergocalciferol) daily
Description

Intake Vitamin D IU per day | Cholecalciferol | Ergocalciferol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0042866
UMLS CUI [1,3]
C0439465
UMLS CUI [2]
C0008318
UMLS CUI [3]
C0014695
moderate or severe cognitive impairment
Description

Moderate cognitive impairment | Severe cognitive impairment

Data type

boolean

Alias
UMLS CUI [1]
C3839816
UMLS CUI [2]
C3554639
contraindication to vitamin d supplementation: history of hypercalcemia or conditions that increase the risk of hypercalcemia (sarcoidosis, tuberculosis or lymphoma)
Description

Medical contraindication Vitamin D supplementation | Hypercalcemia | Condition At risk Hypercalcemia | Sarcoidosis | Tuberculosis | Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4524013
UMLS CUI [2]
C0020437
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0020437
UMLS CUI [4]
C0036202
UMLS CUI [5]
C0041296
UMLS CUI [6]
C0024299
wheelchair bound (ambulation is a component of the qol questionnaire
Description

WHEELCHAIR CONFINEMENT

Data type

boolean

Alias
UMLS CUI [1]
C0241735
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Similar models

Eligibility Heart Failure NCT01388855

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
65 years of age or older
boolean
C0001779 (UMLS CUI [1])
Symptoms New York Heart Association Classification
Item
new york heart association functional class ii or iii symptoms
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Able to communicate English Language | Translator
Item
ability to communicate in english or through a translator
boolean
C2364293 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0040713 (UMLS CUI [2])
Informed Consent
Item
competent to sign the informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Impairing Quality of life | Arthritis Severe | Fibromyalgia
Item
co-morbidity that would negatively impact quality of life (e.g. severe arthritis, or fibromyalgia)
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
C0003864 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0016053 (UMLS CUI [3])
Comorbidity Impairing Vitamin D metabolism | Glomerular Filtration Rate | Liver Dysfunction
Item
co-morbidity that would negatively impact vitamin d metabolism (glomerular filtration rate-15-29%, significant liver dysfunction
boolean
C0009488 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1159433 (UMLS CUI [1,3])
C0017654 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
Pharmaceutical Preparation Lowering Serum vitamin D level | Glucocorticoids | Anticonvulsants
Item
on a pharmaceutical agent that could lower vitamin d levels (e.g. glucocorticoids, anticonvulsants)
boolean
C0013227 (UMLS CUI [1,1])
C2003888 (UMLS CUI [1,2])
C0428586 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
Intake Vitamin D IU per day | Cholecalciferol | Ergocalciferol
Item
taking >600 iu vitamin d (cholecalciferol or ergocalciferol) daily
boolean
C1512806 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
C0439465 (UMLS CUI [1,3])
C0008318 (UMLS CUI [2])
C0014695 (UMLS CUI [3])
Moderate cognitive impairment | Severe cognitive impairment
Item
moderate or severe cognitive impairment
boolean
C3839816 (UMLS CUI [1])
C3554639 (UMLS CUI [2])
Medical contraindication Vitamin D supplementation | Hypercalcemia | Condition At risk Hypercalcemia | Sarcoidosis | Tuberculosis | Lymphoma
Item
contraindication to vitamin d supplementation: history of hypercalcemia or conditions that increase the risk of hypercalcemia (sarcoidosis, tuberculosis or lymphoma)
boolean
C1301624 (UMLS CUI [1,1])
C4524013 (UMLS CUI [1,2])
C0020437 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0020437 (UMLS CUI [3,3])
C0036202 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
C0024299 (UMLS CUI [6])
WHEELCHAIR CONFINEMENT
Item
wheelchair bound (ambulation is a component of the qol questionnaire
boolean
C0241735 (UMLS CUI [1])
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