ID

18269

Description

EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00137176

Lien

https://clinicaltrials.gov/show/NCT00137176

Mots-clés

Versions (1)
  1. 27/10/2016 27/10/2016 -
Téléchargé le

27 octobre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00137176

Anglais

Eligibility Multiple Sclerosis NCT00137176

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with isolated clinical syndrome suggestive of ms
Description

clinical syndrome Isolated Suggestive of Multiple Sclerosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221444
UMLS CUI [1,2]
C0205409
UMLS CUI [1,3]
C0332299
UMLS CUI [1,4]
C0026769
at least three out of four magnetic resonance imaging (mri) findings on the initial scan:
Description

Magnetic Resonance Imaging Quantity | MRI Scan Initial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0917711
UMLS CUI [2,2]
C0205265
one gd-enhancing lesion or nine t2 hyperintense lesions;
Description

Gadolinium-Enhancing Lesion Quantity | Focal T2 hyperintense brainstem lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C4022748
UMLS CUI [2,2]
C1265611
at least one infratentorial lesion;
Description

Lesion Infratentorial Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0441939
UMLS CUI [1,3]
C1265611
at least one juxtacortical lesion; and
Description

Lesion Cerebral cortex Adjacent Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0007776
UMLS CUI [1,3]
C0205117
UMLS CUI [1,4]
C1265611
at least three periventricular lesions.
Description

Lesion Periventricular Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C2675929
UMLS CUI [1,2]
C0228157
UMLS CUI [1,3]
C1265611
expanded disability status scale (edss) 0-5.5
Description

EDSS

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
18 to 60 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
at least one relapse in previous 12 months
Description

Relapse Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a diagnosis of clinically definitive relapsing-remitting (rr) ms, secondary progressive, or primary progressive ms.
Description

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Type de données

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0751964
patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (tli).
Description

Mitoxantrone | Cytoxan | Cyclophosphamide | Lymphatic Irradiation Total

Type de données

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2]
C0699319
UMLS CUI [3]
C0010583
UMLS CUI [4,1]
C0024230
UMLS CUI [4,2]
C0439810
patients treated with ifnb-1a, ifnb-1b, glatiramer acetate, intravenous immunoglobulins (ivig), plasma exchange, methotrexate, or azathioprine in the previous 3 months.
Description

Interferon beta-1a | interferon beta-1b | glatiramer acetate | Immunoglobulins, Intravenous | Plasma Exchange | Methotrexate | Azathioprine

Type de données

boolean

Alias
UMLS CUI [1]
C0254119
UMLS CUI [2]
C0244713
UMLS CUI [3]
C0289884
UMLS CUI [4]
C0085297
UMLS CUI [5]
C0032113
UMLS CUI [6]
C0025677
UMLS CUI [7]
C0004482
patients treated with intravenous or oral steroids within 30 days prior to baseline mri.
Description

Intravenous steroid injection | Steroids Oral

Type de données

boolean

Alias
UMLS CUI [1]
C0563322
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1527415
patients who have been treated with statins in the previous 3 months.
Description

Statins

Type de données

boolean

Alias
UMLS CUI [1]
C0360714
pregnant or breast-feeding women.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease.
Description

Heart Disease Severe | Liver disease Severe | Lung disease Severe | Gastrointestinal Disease Severe | Kidney Disease Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
abnormal baseline blood tests including alanine transaminase (alt) or aspartate transaminase (ast) greater than twice the upper limit of normal
Description

Hematologic Tests Abnormal | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
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Similar models

Eligibility Multiple Sclerosis NCT00137176

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
clinical syndrome Isolated Suggestive of Multiple Sclerosis
Item
patients with isolated clinical syndrome suggestive of ms
boolean
C0221444 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
Magnetic Resonance Imaging Quantity | MRI Scan Initial
Item
at least three out of four magnetic resonance imaging (mri) findings on the initial scan:
boolean
C0024485 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0917711 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
Gadolinium-Enhancing Lesion Quantity | Focal T2 hyperintense brainstem lesion Quantity
Item
one gd-enhancing lesion or nine t2 hyperintense lesions;
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4022748 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Lesion Infratentorial Quantity
Item
at least one infratentorial lesion;
boolean
C0221198 (UMLS CUI [1,1])
C0441939 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Lesion Cerebral cortex Adjacent Quantity
Item
at least one juxtacortical lesion; and
boolean
C0221198 (UMLS CUI [1,1])
C0007776 (UMLS CUI [1,2])
C0205117 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Lesion Periventricular Quantity
Item
at least three periventricular lesions.
boolean
C2675929 (UMLS CUI [1,1])
C0228157 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
EDSS
Item
expanded disability status scale (edss) 0-5.5
boolean
C0451246 (UMLS CUI [1])
Age
Item
18 to 60 years of age
boolean
C0001779 (UMLS CUI [1])
Relapse Quantity
Item
at least one relapse in previous 12 months
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive
Item
patients with a diagnosis of clinically definitive relapsing-remitting (rr) ms, secondary progressive, or primary progressive ms.
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0751964 (UMLS CUI [3])
Mitoxantrone | Cytoxan | Cyclophosphamide | Lymphatic Irradiation Total
Item
patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (tli).
boolean
C0026259 (UMLS CUI [1])
C0699319 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0024230 (UMLS CUI [4,1])
C0439810 (UMLS CUI [4,2])
Interferon beta-1a | interferon beta-1b | glatiramer acetate | Immunoglobulins, Intravenous | Plasma Exchange | Methotrexate | Azathioprine
Item
patients treated with ifnb-1a, ifnb-1b, glatiramer acetate, intravenous immunoglobulins (ivig), plasma exchange, methotrexate, or azathioprine in the previous 3 months.
boolean
C0254119 (UMLS CUI [1])
C0244713 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
C0032113 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0004482 (UMLS CUI [7])
Intravenous steroid injection | Steroids Oral
Item
patients treated with intravenous or oral steroids within 30 days prior to baseline mri.
boolean
C0563322 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Statins
Item
patients who have been treated with statins in the previous 3 months.
boolean
C0360714 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease Severe | Liver disease Severe | Lung disease Severe | Gastrointestinal Disease Severe | Kidney Disease Severe
Item
patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Hematologic Tests Abnormal | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
abnormal baseline blood tests including alanine transaminase (alt) or aspartate transaminase (ast) greater than twice the upper limit of normal
boolean
C0018941 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
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