ID

22006

Beschreibung

Evaluation of Brain Atrophy in CIS Patients on Avonex; ODM derived from: https://clinicaltrials.gov/show/NCT01592474

Link

https://clinicaltrials.gov/show/NCT01592474

Stichworte

Versionen (2)
  1. 14.05.17 14.05.17 -
  2. 14.05.17 14.05.17 -
Hochgeladen am

14. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01592474

Englisch

Eligibility Multiple Sclerosis NCT01592474

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
mri findings must reveal at least 2 hyperintense lesions on t2-wi or flair images at first clinical onset
Beschreibung

Lesion High intensity Quantity T2/FLAIR MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C4081854
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C3897397
csf examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the csf taken before the treatment of attack starts)
Beschreibung

Oligoclonal Bands Cerebrospinal fluid examination | Therapeutic procedure Attack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4048246
UMLS CUI [1,2]
C0430067
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1304680
age 18 - 55 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
effective contraception in female patients of childbearing potential
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
kurtzke edss ≤ 3.5 at baseline
Beschreibung

Kurtzke multiple sclerosis rating scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
willingness to accept the plan of the study and compliance with the study
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
time from the beginning of first symptoms of cis to baseline visit should not exceed 4 months (baseline mri and baseline visit will be organized first 28 days after last steroid administration)
Beschreibung

Clinically isolated syndrome Symptoms First | Magnetic Resonance Imaging | Steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2921627
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205435
UMLS CUI [2]
C0024485
UMLS CUI [3]
C0038317
cis attack is treated by at least 3g of methylprednisolone without taper
Beschreibung

Clinically isolated syndrome Attack | Methylprednisolone Dose Without Medication taper

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2921627
UMLS CUI [1,2]
C1304680
UMLS CUI [2,1]
C0025815
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C1827449
in case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first mri and csf examination was done before treatment administered
Beschreibung

Attack Severe | Cyclophosphamide Dosage | Magnetic Resonance Imaging | Cerebrospinal fluid examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1304680
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0010583
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0430067
no active major organ disease especially of hepatic or thyroid origin
Beschreibung

Disease Organ Major Hepatic | Disease Organ Major Thyroid

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0205054
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0040132
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the clinical diagnosis of ms is definite (the second attack occurs before the baseline visit)
Beschreibung

Multiple Sclerosis | Attack second

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2,1]
C1304680
UMLS CUI [2,2]
C0205436
age less than 18 or more than 55
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
non-effective contraception method or pregnancy planning
Beschreibung

Contraceptive methods Inadequate | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0032992
active major organ disease, especially hepatic or endocrinologic
Beschreibung

Disease Organ Major Hepatic | Disease Organ Major endocrinologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0205054
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0694557
cooperation of the subject cannot be ensured
Beschreibung

Compliance behavior Unsure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0087130
kurtzke edss higher than 3.5 at baseline
Beschreibung

Kurtzke multiple sclerosis rating scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT01592474

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Lesion High intensity Quantity T2/FLAIR MRI
Item
mri findings must reveal at least 2 hyperintense lesions on t2-wi or flair images at first clinical onset
boolean
C0221198 (UMLS CUI [1,1])
C4081854 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3897397 (UMLS CUI [1,4])
Oligoclonal Bands Cerebrospinal fluid examination | Therapeutic procedure Attack
Item
csf examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the csf taken before the treatment of attack starts)
boolean
C4048246 (UMLS CUI [1,1])
C0430067 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1304680 (UMLS CUI [2,2])
Age
Item
age 18 - 55 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
effective contraception in female patients of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Kurtzke multiple sclerosis rating scale
Item
kurtzke edss ≤ 3.5 at baseline
boolean
C0451246 (UMLS CUI [1])
Protocol Compliance
Item
willingness to accept the plan of the study and compliance with the study
boolean
C0525058 (UMLS CUI [1])
Clinically isolated syndrome Symptoms First | Magnetic Resonance Imaging | Steroids
Item
time from the beginning of first symptoms of cis to baseline visit should not exceed 4 months (baseline mri and baseline visit will be organized first 28 days after last steroid administration)
boolean
C2921627 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Clinically isolated syndrome Attack | Methylprednisolone Dose Without Medication taper
Item
cis attack is treated by at least 3g of methylprednisolone without taper
boolean
C2921627 (UMLS CUI [1,1])
C1304680 (UMLS CUI [1,2])
C0025815 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C1827449 (UMLS CUI [2,4])
Attack Severe | Cyclophosphamide Dosage | Magnetic Resonance Imaging | Cerebrospinal fluid examination
Item
in case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first mri and csf examination was done before treatment administered
boolean
C1304680 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0010583 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3])
C0430067 (UMLS CUI [4])
Disease Organ Major Hepatic | Disease Organ Major Thyroid
Item
no active major organ disease especially of hepatic or thyroid origin
boolean
C0012634 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0205054 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0040132 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis | Attack second
Item
the clinical diagnosis of ms is definite (the second attack occurs before the baseline visit)
boolean
C0026769 (UMLS CUI [1])
C1304680 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Age
Item
age less than 18 or more than 55
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Inadequate | Pregnancy, Planned
Item
non-effective contraception method or pregnancy planning
boolean
C0700589 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2])
Disease Organ Major Hepatic | Disease Organ Major endocrinologic
Item
active major organ disease, especially hepatic or endocrinologic
boolean
C0012634 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0205054 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0694557 (UMLS CUI [2,4])
Compliance behavior Unsure
Item
cooperation of the subject cannot be ensured
boolean
C1321605 (UMLS CUI [1,1])
C0087130 (UMLS CUI [1,2])
Kurtzke multiple sclerosis rating scale
Item
kurtzke edss higher than 3.5 at baseline
boolean
C0451246 (UMLS CUI [1])
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