ID

21982

Descrição

Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00492765

Link

https://clinicaltrials.gov/show/NCT00492765

Palavras-chave

Versões (1)
  1. 12/05/2017 12/05/2017 -
Transferido a

12 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00492765

Inglês

Eligibility Multiple Sclerosis NCT00492765

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
is between the age of 18 and 55 years (both included)
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
relapsing-remitting ms according to poser criteria (cdms or lsdms) 22 or definite ms according to mcdonald criteria 23
Descrição

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0026769
disability equivalent to an edss of 5.5 or less 21
Descrição

Disability Kurtzke multiple sclerosis rating scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0451246
clinical activity defined as at least one reported or documented relapse within the last year
Descrição

Relapse Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn
Descrição

Protocol Compliance | Treatment withdrawal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1701941
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition that might give rise to similar symptoms as ms
Descrição

Symptoms Multiple Sclerosis Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0026769
UMLS CUI [1,3]
C2348205
immunomodulatory or immunosuppressive treatment for ms prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
Descrição

Immunomodulation Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | Steroid therapy Intravenous High dose Recurrent disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0026769
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C1522726
UMLS CUI [3,3]
C0444956
UMLS CUI [3,4]
C0277556
treatment with glucocorticoids or acth later than one month prior to inclusion into the study, i.e. at the screening visit
Descrição

Glucocorticoids | Corticotropin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2]
C0001655
onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
Descrição

Recurrent disease Onset of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332162
history of major depression
Descrição

Major Depressive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
alcohol or drug dependency
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv)
Descrição

Heart failure | Cardiomyopathy | Cardiac Arrhythmia | Myocardial Ischemia Unstable New York Heart Association Classification | Myocardial Ischemia Advanced New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0878544
UMLS CUI [3]
C0003811
UMLS CUI [4,1]
C0151744
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C1275491
UMLS CUI [5,1]
C0151744
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C1275491
significant hypertension (bp > 180/110 mmhg)
Descrição

Hypertensive disease | Blood Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
Descrição

Renal Insufficiency | Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
total plasma cholesterol < 3.5 mmol/l
Descrição

Plasma total cholesterol level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1272107
any medical illness requiring treatment with systemic corticosteroids
Descrição

Illness Requirement CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
Descrição

Systemic disease Affecting Patient safety | Systemic disease Affecting Compliance behavior | Systemic disease Affecting Evaluation Disability

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0231170
women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. to avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
Descrição

Pregnancy | Breast Feeding | Childbearing Potential | Gender Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Sexual Abstinence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0232970
UMLS CUI [6]
C0015787
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0036899
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Similar models

Eligibility Multiple Sclerosis NCT00492765

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
is between the age of 18 and 55 years (both included)
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis
Item
relapsing-remitting ms according to poser criteria (cdms or lsdms) 22 or definite ms according to mcdonald criteria 23
boolean
C0751967 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Disability Kurtzke multiple sclerosis rating scale
Item
disability equivalent to an edss of 5.5 or less 21
boolean
C0231170 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Relapse Quantity
Item
clinical activity defined as at least one reported or documented relapse within the last year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Protocol Compliance | Treatment withdrawal
Item
patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn
boolean
C0525058 (UMLS CUI [1])
C1701941 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Symptoms Multiple Sclerosis Similar
Item
any condition that might give rise to similar symptoms as ms
boolean
C1457887 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
Immunomodulation Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | Steroid therapy Intravenous High dose Recurrent disease
Item
immunomodulatory or immunosuppressive treatment for ms prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
boolean
C1963758 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0444956 (UMLS CUI [3,3])
C0277556 (UMLS CUI [3,4])
Glucocorticoids | Corticotropin
Item
treatment with glucocorticoids or acth later than one month prior to inclusion into the study, i.e. at the screening visit
boolean
C0017710 (UMLS CUI [1])
C0001655 (UMLS CUI [2])
Recurrent disease Onset of
Item
onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
boolean
C0277556 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Major Depressive Disorder
Item
history of major depression
boolean
C1269683 (UMLS CUI [1])
Substance Dependence
Item
alcohol or drug dependency
boolean
C0038580 (UMLS CUI [1])
Heart failure | Cardiomyopathy | Cardiac Arrhythmia | Myocardial Ischemia Unstable New York Heart Association Classification | Myocardial Ischemia Advanced New York Heart Association Classification
Item
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv)
boolean
C0018801 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0151744 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
Hypertensive disease | Blood Pressure
Item
significant hypertension (bp > 180/110 mmhg)
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
Renal Insufficiency | Serum creatinine raised
Item
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Plasma total cholesterol level
Item
total plasma cholesterol < 3.5 mmol/l
boolean
C1272107 (UMLS CUI [1])
Illness Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
any medical illness requiring treatment with systemic corticosteroids
boolean
C0221423 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
Systemic disease Affecting Patient safety | Systemic disease Affecting Compliance behavior | Systemic disease Affecting Evaluation Disability
Item
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0442893 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0231170 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Childbearing Potential | Gender Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Sexual Abstinence
Item
women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. to avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0036899 (UMLS CUI [7,2])
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