ID

36661

Descripción

Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00953225

Link

https://clinicaltrials.gov/show/NCT00953225

Palabras clave

Versiones (3)
  1. 17/1/19 17/1/19 -
  2. 27/5/19 27/5/19 -
  3. 29/5/19 29/5/19 -
Titular de derechos de autor

VA Office of Research and Development

Subido en

29 de mayo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Vitamin D Supplementation in Early-Stage Prostate Cancer NCT00953225

Inglés

Eligibility Criteria

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male veterans (> 18 years of age)
Descripción

Gender, age and veteran status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042610
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
recently diagnosed with low-risk pca (histologically documented adenocarcinoma of the prostate)
Descripción

recently diagnosed with histologically documented adenocarcinoma of the prostate, risk-assessed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0007112
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0086930
UMLS CUI [2,2]
C0007112
a serum psa value of up to 10.0 ng/ml, and a gleason score of six or less (three or less in either architectural pattern)
Descripción

PSA and Gleason Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C3203027
serum creatinine 2.0 mg/dl
Descripción

Serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dl
Descripción

serum phosphate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883013
serum calcium > 8.5 and < 10.5 mg/dl
Descripción

serum calcium

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0728876
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with any concurrent malignancy, except non-melanoma skin cancer
Descripción

concurrent malignancy except non-melanoma skin cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
subjects with a history of sarcoidosis
Descripción

history of sarcoidosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036202
subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
Descripción

history of vitamin D supplementation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4524013
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C4524013
subjects with a history of hypercalcemia
Descripción

history of hypercalcemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020437
subjects who use lithium as a medication
Descripción

use of lithium

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023870
UMLS CUI [1,2]
C0013216
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Similar models

Eligibility Criteria

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender, age and veteran status
Item
male veterans (> 18 years of age)
boolean
C0042610 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
recently diagnosed with histologically documented adenocarcinoma of the prostate, risk-assessed
Item
recently diagnosed with low-risk pca (histologically documented adenocarcinoma of the prostate)
boolean
C0019638 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0086930 (UMLS CUI [2,1])
C0007112 (UMLS CUI [2,2])
PSA and Gleason Score
Item
a serum psa value of up to 10.0 ng/ml, and a gleason score of six or less (three or less in either architectural pattern)
boolean
C0201544 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
Serum creatinine
Item
serum creatinine 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
serum phosphate
Item
serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dl
boolean
C1883013 (UMLS CUI [1])
serum calcium
Item
serum calcium > 8.5 and < 10.5 mg/dl
boolean
C0728876 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
concurrent malignancy except non-melanoma skin cancer
Item
subjects with any concurrent malignancy, except non-melanoma skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
history of sarcoidosis
Item
subjects with a history of sarcoidosis
boolean
C0262926 (UMLS CUI [1,1])
C0036202 (UMLS CUI [1,2])
history of vitamin D supplementation
Item
subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
boolean
C4524013 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C4524013 (UMLS CUI [2,2])
history of hypercalcemia
Item
subjects with a history of hypercalcemia
boolean
C0262926 (UMLS CUI [1,1])
C0020437 (UMLS CUI [1,2])
use of lithium
Item
subjects who use lithium as a medication
boolean
C0023870 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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