ID

30961

Descripción

Can Vitamin D Supplementation Prevent Bone Loss in Persons With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00785473

Link

https://clinicaltrials.gov/show/NCT00785473

Palabras clave

  1. 7/7/18 7/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 50 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
edss < 4.0 (able to walk without rest some 500 m)
Descripción

EDSS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451246
women have to be premenopausal
Descripción

Premenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232969
ms according to the mcdonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential)
Descripción

Multiple Sclerosis | Protocol Compliance | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
having given written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or unwillingness to use contraception; alcohol or drug abuse
Descripción

Pregnancy | Gender Contraceptive methods Unwilling | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0038586
use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
Descripción

Glucocorticoid therapy | Exception Methylprednisolone Intravenous Relapse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0744425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025815
UMLS CUI [2,3]
C1522726
UMLS CUI [2,4]
C0035020
known allergy to cholecalciferol or arachis oil (peanuts)
Descripción

Hypersensitivity Cholecalciferol | Arachis oil allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008318
UMLS CUI [2]
C0571231
therapy with digitalis, calcitonin, active vitamin d3 analogues, fluoride, or bisphosphonates during the previous 12 months
Descripción

Digitalis preparation | Calcitonin | Vitamin D3 Analogue | Fluorides | Diphosphonates

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304520
UMLS CUI [2]
C0006668
UMLS CUI [3]
C2917448
UMLS CUI [4]
C0016327
UMLS CUI [5]
C0012544
any condition predisposing to hypercalcaemia
Descripción

Condition predisposed Hypercalcemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0231203
UMLS CUI [1,3]
C0020437
nephrolithiasis or renal insufficiency
Descripción

Nephrolithiasis | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392525
UMLS CUI [2]
C1565489
presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
Descripción

Hyperparathyroidism, Primary | Hyperthyroidism | Hypothyroidism | Nephrolithiasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221002
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0392525

Similar models

Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 50 years
boolean
C0001779 (UMLS CUI [1])
EDSS
Item
edss < 4.0 (able to walk without rest some 500 m)
boolean
C0451246 (UMLS CUI [1])
Premenopausal state
Item
women have to be premenopausal
boolean
C0232969 (UMLS CUI [1])
Multiple Sclerosis | Protocol Compliance | Childbearing Potential Contraceptive methods
Item
ms according to the mcdonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential)
boolean
C0026769 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
having given written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Gender Contraceptive methods Unwilling | Substance Use Disorders
Item
pregnancy or unwillingness to use contraception; alcohol or drug abuse
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3])
Glucocorticoid therapy | Exception Methylprednisolone Intravenous Relapse
Item
use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
boolean
C0744425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025815 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C0035020 (UMLS CUI [2,4])
Hypersensitivity Cholecalciferol | Arachis oil allergy
Item
known allergy to cholecalciferol or arachis oil (peanuts)
boolean
C0020517 (UMLS CUI [1,1])
C0008318 (UMLS CUI [1,2])
C0571231 (UMLS CUI [2])
Digitalis preparation | Calcitonin | Vitamin D3 Analogue | Fluorides | Diphosphonates
Item
therapy with digitalis, calcitonin, active vitamin d3 analogues, fluoride, or bisphosphonates during the previous 12 months
boolean
C0304520 (UMLS CUI [1])
C0006668 (UMLS CUI [2])
C2917448 (UMLS CUI [3])
C0016327 (UMLS CUI [4])
C0012544 (UMLS CUI [5])
Condition predisposed Hypercalcemia
Item
any condition predisposing to hypercalcaemia
boolean
C0348080 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0020437 (UMLS CUI [1,3])
Nephrolithiasis | Renal Insufficiency
Item
nephrolithiasis or renal insufficiency
boolean
C0392525 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Hyperparathyroidism, Primary | Hyperthyroidism | Hypothyroidism | Nephrolithiasis
Item
presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
boolean
C0221002 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0392525 (UMLS CUI [4])

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