ID

18257

Beschrijving

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00134563

Link

https://clinicaltrials.gov/show/NCT00134563

Trefwoorden

Versies (1)
  1. 27-10-16 27-10-16 -
Geüploaded op

27 oktober 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Multiple Sclerosis NCT00134563

Engels

Eligibility Multiple Sclerosis NCT00134563

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple sclerosis [ms] subject who was ambulatory (edss of ≤ 5.5)
Beschrijving

Multiple Sclerosis | Outpatient | EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0029921
UMLS CUI [3]
C0451246
exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
Beschrijving

Relapsing course Clinical | Disease Progression | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205336
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0751967
UMLS CUI [4]
C0751965
UMLS CUI [5]
C0393666
meeting mcdonald's criteria for ms diagnosis;
Beschrijving

Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
Beschrijving

Relapse Quantity Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1948053
no relapse onset in the preceding 60 days prior to randomization;
Beschrijving

Relapse Onset

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332162
clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [acth] or systemic steroid treatment.
Beschrijving

Stable status Clinical | Corticotropin | systemic steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0001655
UMLS CUI [3]
C2825233
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
Beschrijving

Cardiovascular Disease Relevant Clinical | Liver disease Relevant Clinical | nervous system disorder Relevant Clinical | Endocrine System Disease Relevant Clinical | Systemic disease Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205210
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C2347946
UMLS CUI [3,3]
C0205210
UMLS CUI [4,1]
C0014130
UMLS CUI [4,2]
C2347946
UMLS CUI [4,3]
C0205210
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205164
significantly impaired bone marrow function;
Beschrijving

Bone Marrow function Impaired Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0750502
pregnant or nursing woman;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol or drug abuse;
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
Beschrijving

Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | MYCOPHENOLATE

Datatype

boolean

Alias
UMLS CUI [1]
C0092801
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0025677
UMLS CUI [8]
C0883242
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
Beschrijving

Condition Preventing Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
Terug naar het begin van de pagina

Similar models

Eligibility Multiple Sclerosis NCT00134563

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis | Outpatient | EDSS
Item
multiple sclerosis [ms] subject who was ambulatory (edss of ≤ 5.5)
boolean
C0026769 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0451246 (UMLS CUI [3])
Relapsing course Clinical | Disease Progression | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
boolean
C0205336 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0751967 (UMLS CUI [3])
C0751965 (UMLS CUI [4])
C0393666 (UMLS CUI [5])
Multiple Sclerosis
Item
meeting mcdonald's criteria for ms diagnosis;
boolean
C0026769 (UMLS CUI [1])
Relapse Quantity Period
Item
experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Relapse Onset
Item
no relapse onset in the preceding 60 days prior to randomization;
boolean
C0035020 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Stable status Clinical | Corticotropin | systemic steroids
Item
clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [acth] or systemic steroid treatment.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0001655 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease Relevant Clinical | Liver disease Relevant Clinical | nervous system disorder Relevant Clinical | Endocrine System Disease Relevant Clinical | Systemic disease Major
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C0205210 (UMLS CUI [3,3])
C0014130 (UMLS CUI [4,1])
C2347946 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
C0442893 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
Bone Marrow function Impaired Significant
Item
significantly impaired bone marrow function;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
pregnant or nursing woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse;
boolean
C0038586 (UMLS CUI [1])
Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | MYCOPHENOLATE
Item
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
boolean
C0092801 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
Condition Preventing Protocol Compliance
Item
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial