ID

18300

Beskrivning

Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00493077

Länk

https://clinicaltrials.gov/show/NCT00493077

Nyckelord

Versioner (1)
  1. 2016-10-28 2016-10-28 -
Uppladdad den

28 oktober 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Multiple Sclerosis NCT00493077

Engelsk

Eligibility Multiple Sclerosis NCT00493077

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing-remitting ms according to poser criteria(cdms or lsdms)30 or ms according to mcdonald criteria
Beskrivning

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0026769
disability equivalent to an edss of 6.0 or less at screening
Beskrivning

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
neutralizing antibody titre > 20 and <500 in two consecutive nab tests. one must be from before screening
Beskrivning

Neutralizing Antibodies Titer | Neutralizing Antibodies Tests Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C0475208
UMLS CUI [2,1]
C0475463
UMLS CUI [2,2]
C0392366
UMLS CUI [2,3]
C1265611
previous treatment with either subcutaneous administered interferon-b-1b (betaferon®) or interferon-b-1a (rebif tm) prior to enrolment
Beskrivning

interferon beta-1b Subcutaneous | Betaferon | Interferon beta-1a Subcutaneous | Rebif

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0244713
UMLS CUI [1,2]
C1522438
UMLS CUI [2]
C0592527
UMLS CUI [3,1]
C0254119
UMLS CUI [3,2]
C1522438
UMLS CUI [4]
C0752980
a priori has been decided to be treated with avonex
Beskrivning

Avonex

Datatyp

boolean

Alias
UMLS CUI [1]
C0594372
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
is nab positive on avonex
Beskrivning

Neutralizing Antibodies Positive Avonex

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0594372
history of major depression
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv), or significant hypertension (bp > 180/110 mmhg)
Beskrivning

Heart failure | Cardiomyopathies | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable | Myocardial Ischemia Advanced | New York Heart Association Classification | Hypertensive disease Significant | Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0151744
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0151744
UMLS CUI [5,2]
C0205179
UMLS CUI [6]
C1275491
UMLS CUI [7,1]
C0020538
UMLS CUI [7,2]
C0750502
UMLS CUI [8]
C0005823
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
Beskrivning

Systemic disease Affecting patient safety | Systemic disease Compliance behavior Limited | Systemic disease Affecting Disability Evaluation

Datatyp

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]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0231170
UMLS CUI [3,4]
C1261322
women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0700589
Tillbaka till toppen

Similar models

Eligibility Multiple Sclerosis NCT00493077

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis
Item
relapsing-remitting ms according to poser criteria(cdms or lsdms)30 or ms according to mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
EDSS
Item
disability equivalent to an edss of 6.0 or less at screening
boolean
C0451246 (UMLS CUI [1])
Neutralizing Antibodies Titer | Neutralizing Antibodies Tests Quantity
Item
neutralizing antibody titre > 20 and <500 in two consecutive nab tests. one must be from before screening
boolean
C0475463 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C0475463 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
interferon beta-1b Subcutaneous | Betaferon | Interferon beta-1a Subcutaneous | Rebif
Item
previous treatment with either subcutaneous administered interferon-b-1b (betaferon®) or interferon-b-1a (rebif tm) prior to enrolment
boolean
C0244713 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0592527 (UMLS CUI [2])
C0254119 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
C0752980 (UMLS CUI [4])
Avonex
Item
a priori has been decided to be treated with avonex
boolean
C0594372 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neutralizing Antibodies Positive Avonex
Item
is nab positive on avonex
boolean
C0475463 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0594372 (UMLS CUI [1,3])
Major Depressive Disorder
Item
history of major depression
boolean
C1269683 (UMLS CUI [1])
Heart failure | Cardiomyopathies | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable | Myocardial Ischemia Advanced | New York Heart Association Classification | Hypertensive disease Significant | Blood Pressure
Item
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv), or significant hypertension (bp > 180/110 mmhg)
boolean
C0018801 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0151744 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1275491 (UMLS CUI [6])
C0020538 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
C0005823 (UMLS CUI [8])
Renal Insufficiency | Creatinine measurement, serum
Item
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Systemic disease Affecting patient safety | Systemic disease Compliance behavior Limited | Systemic disease Affecting Disability Evaluation
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])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0442893 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0231170 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods
Item
women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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