ID

30936

Beschrijving

12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00616733

Link

https://clinicaltrials.gov/show/NCT00616733

Trefwoorden

Versies (2)
  1. 04-07-18 04-07-18 -
  2. 04-07-18 04-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 juli 2018

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 NCT00616733

Engels

Eligibility Multiple Sclerosis NCT00616733

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of clinically isolated syndrome or a relapsing form(s) of ms, based on poser or mcdonald criteria (may include patients with secondary progressive disease)
Beschrijving

Clinically isolated syndrome | Multiple Sclerosis, Acute Relapsing | Multiple Sclerosis, Secondary Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C2921627
UMLS CUI [2]
C0393664
UMLS CUI [3]
C0751965
clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain mri scan within the past 12 months
Beschrijving

Relapse Clinical | Gadolinium-Enhancing Lesion MRI scan brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C1333400
UMLS CUI [2,2]
C0412675
baseline edss score of 0 - 6.5
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
Beschrijving

Gender Sexually active Barrier Contraception Double | Exception Female Sterilization | Exception Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0004764
UMLS CUI [1,4]
C0205173
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015787
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0232970
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary progressive ms
Beschrijving

Multiple Sclerosis, Primary Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C0751964
any medical condition that predisposes to immunocompromise
Beschrijving

Medical condition predisposing Immunocompromised patient

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0231203
UMLS CUI [1,3]
C0085393
history of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
Beschrijving

Malignant Neoplasms | Tuberculosis | Invasive Fungal Infections | Herpes zoster disease | Opportunistic Infections | Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0041296
UMLS CUI [3]
C1262313
UMLS CUI [4]
C0019360
UMLS CUI [5]
C0029118
UMLS CUI [6]
C0009450
concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
Beschrijving

Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0409974
treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
Beschrijving

Cyclophosphamide | Mitoxantrone

Datatype

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2]
C0026259
treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
Beschrijving

Cyclosporine | Azathioprine | Methotrexate | Immunosuppressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0021081
treatment with interferon beta or glatiramer acetate within 2 months of study initiation
Beschrijving

Interferon-beta | Glatiramer acetate

Datatype

boolean

Alias
UMLS CUI [1]
C0015980
UMLS CUI [2]
C0289884
prior treatment with natalizumab or rituximab
Beschrijving

natalizumab | rituximab

Datatype

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C0393022
Terug naar het begin van de pagina

Similar models

Eligibility Multiple Sclerosis NCT00616733

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Clinically isolated syndrome | Multiple Sclerosis, Acute Relapsing | Multiple Sclerosis, Secondary Progressive
Item
diagnosis of clinically isolated syndrome or a relapsing form(s) of ms, based on poser or mcdonald criteria (may include patients with secondary progressive disease)
boolean
C2921627 (UMLS CUI [1])
C0393664 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
Relapse Clinical | Gadolinium-Enhancing Lesion MRI scan brain
Item
clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain mri scan within the past 12 months
boolean
C0035020 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2,1])
C0412675 (UMLS CUI [2,2])
EDSS
Item
baseline edss score of 0 - 6.5
boolean
C0451246 (UMLS CUI [1])
Gender Sexually active Barrier Contraception Double | Exception Female Sterilization | Exception Postmenopausal state
Item
female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C0205173 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0015787 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Primary Progressive
Item
primary progressive ms
boolean
C0751964 (UMLS CUI [1])
Medical condition predisposing Immunocompromised patient
Item
any medical condition that predisposes to immunocompromise
boolean
C3843040 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0085393 (UMLS CUI [1,3])
Malignant Neoplasms | Tuberculosis | Invasive Fungal Infections | Herpes zoster disease | Opportunistic Infections | Communicable Disease
Item
history of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
boolean
C0006826 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C1262313 (UMLS CUI [3])
C0019360 (UMLS CUI [4])
C0029118 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus
Item
concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
Cyclophosphamide | Mitoxantrone
Item
treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
boolean
C0010583 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
Cyclosporine | Azathioprine | Methotrexate | Immunosuppressive Agents
Item
treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
boolean
C0010592 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
Interferon-beta | Glatiramer acetate
Item
treatment with interferon beta or glatiramer acetate within 2 months of study initiation
boolean
C0015980 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
natalizumab | rituximab
Item
prior treatment with natalizumab or rituximab
boolean
C1172734 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
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