ID

30961

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00785473

Nyckelord

Versioner (1)
  1. 2018-07-07 2018-07-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

Engelsk

Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 50 years
Beskrivning

Age

Datatyp

boolean

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

EDSS

Datatyp

boolean

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

Premenopausal state

Datatyp

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)
Beskrivning

Multiple Sclerosis | Protocol Compliance | Childbearing Potential Contraceptive methods

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Pregnancy | Gender Contraceptive methods Unwilling | Substance Use Disorders

Datatyp

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
Beskrivning

Glucocorticoid therapy | Exception Methylprednisolone Intravenous Relapse

Datatyp

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)
Beskrivning

Hypersensitivity Cholecalciferol | Arachis oil allergy

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Condition predisposed Hypercalcemia

Datatyp

boolean

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

Nephrolithiasis | Renal Insufficiency

Datatyp

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.
Beskrivning

Hyperparathyroidism, Primary | Hyperthyroidism | Hypothyroidism | Nephrolithiasis

Datatyp

boolean

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

Eligibility Multiple Sclerosis, Osteoporosis NCT00785473

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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