ID

11914

Beschreibung

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients https://clinicaltrials.gov/ct2/show/NCT00099502 The purpose of this study is to determine - whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms - whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Link

https://clinicaltrials.gov/ct2/show/NCT00099502

Stichworte

Versionen (2)
  1. 11.12.13 11.12.13 - Martin Dugas
  2. 21.08.15 21.08.15 - Martin Dugas
Hochgeladen am

21. August 2015

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

Deutsch Englisch

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 Formulare  
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Female and male patients
Beschreibung

Female and male patients

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Aged 18-55 years
Beschreibung

Aged 18-55 years

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
Beschreibung

Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
EDSS score of 0 to 5.0
Beschreibung

EDSS score of 0 to 5.0

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
Treatment-naive to IFNB or Copaxone
Beschreibung

Treatment

Datentyp

boolean

Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Neurological progression at disease onset or between relapses
Beschreibung

Neurological progression at disease onset or between relapses

Datentyp

boolean

Serious or acute heart diseases
Beschreibung

Serious or acute heart diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
History of severe depression or suicide attempt
Beschreibung

History of severe depression or suicide attempt

Datentyp

boolean

Alias
UMLS CUI [1]
C0588008
Serious or acute liver, renal or bone marrow dysfunction
Beschreibung

dysfunctions

Datentyp

boolean

Monoclonal gammopathy
Beschreibung

Monoclonal gammopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C1136085
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
Beschreibung

Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
Pregnancy or lactation
Beschreibung

Pregnancy or lactation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Medical Concepts
Beschreibung

Medical Concepts

Betaferon
Beschreibung

Betaferon

Datentyp

string

Alias
UMLS CUI
C0244714
Copaxone
Beschreibung

Copaxone

Datentyp

string

Alias
UMLS CUI
C0528175
Depression
Beschreibung

Depression

Datentyp

string

Alias
UMLS CUI
C0011581
SNOMEDCT
35489007
MDR
10012399
ICD10CM
F34.1
Suicide attempt
Beschreibung

Suicide attempt

Datentyp

string

Alias
UMLS CUI
C0038663
SNOMEDCT
82313006
MDR
10042464
ICD10CM
T14.91
CTCAE
E12969
Red blood cell count
Beschreibung

RBC

Datentyp

string

Alias
UMLS CUI
C0362910
LNC
789-8
White blood cell count
Beschreibung

WBC

Datentyp

string

Alias
UMLS CUI
C0023508
SNOMEDCT
767002
MDR
10047939
LNC
6690-2
Platelet count - finding
Beschreibung

Platelet count - finding

Datentyp

string

Alias
UMLS CUI
C1287267
SNOMEDCT
365632008
LNC
777-3
Creatinine
Beschreibung

Creatinine

Datentyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Liver Dysfunction
Beschreibung

Liver Dysfunction

Datentyp

string

Alias
UMLS CUI
C0086565
SNOMEDCT
75183008
MDR
10019670
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
Beschreibung

AST

Datentyp

string

Alias
UMLS CUI
C0004002
SNOMEDCT
26091008
LNC
MTHU004883
Aspartate aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Beschreibung

AST Measurement in Serum/Plasma

Datentyp

string

Alias
UMLS CUI
C0364055
LNC
1920-8
Glutamate Pyruvate Transaminase (GPT) = Alanine Transaminase (ALT)
Beschreibung

ALT

Datentyp

string

Alias
UMLS CUI
C0001899
SNOMEDCT
56935002
LNC
MTHU006766
Alanine aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Beschreibung

ALT Measurement in Serum/Plasma

Datentyp

string

Alias
UMLS CUI
C0363876
LNC
1742-6
Gamma-glutamyl transferase
Beschreibung

Gamma GT

Datentyp

string

Alias
UMLS CUI
C0017040
SNOMEDCT
60153001
LNC
MTHU001941
Gamma glutamyl transferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Beschreibung

Gamma GT Measurement

Datentyp

string

Alias
UMLS CUI
C0364459
LNC
2324-2
Glutamate Dehydrogenase
Beschreibung

GLDH

Datentyp

string

Alias
UMLS CUI
C0017786
SNOMEDCT
75284005
LNC
MTHU011411
Glutamate dehydrogenase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Beschreibung

GLDH Measurement

Datentyp

string

Alias
UMLS CUI
C0364507
LNC
2367-1
Monoclonal Gammapathies
Beschreibung

Monoclonal Gammapathy

Datentyp

string

Alias
UMLS CUI
C1136085
SNOMEDCT
109983007
MDR
10060880
ICD10CM
D47.2
Hypersensitivity
Beschreibung

Allergy

Datentyp

string

Alias
UMLS CUI
C0020517
SNOMEDCT
418634005
ICD10CM
T78.40
Magnetic resonance imaging contrast media allergy
Beschreibung

Magnetic resonance imaging contrast media allergy

Datentyp

string

Alias
UMLS CUI
C0570564
SNOMEDCT
293639009
Interferons allergy
Beschreibung

Interferons allergy

Datentyp

string

Alias
UMLS CUI
C0571288
SNOMEDCT
294375008
Drug Allergy
Beschreibung

Drug Allergy

Datentyp

string

Alias
UMLS CUI
C0013182
SNOMEDCT
416098002
MDR
10013700
ICD10CM
T88.7
HL7V3.0
DALG
Albumin solution allergy
Beschreibung

Albumin solution allergy

Datentyp

string

Alias
UMLS CUI
C0571759
SNOMEDCT
294854007
Mannitol (substance)
Beschreibung

Mannitol (substance)

Datentyp

string

Alias
UMLS CUI
C0024730
SNOMEDCT
387168006
LNC
MTHU015736
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender
Item
Female and male patients
boolean
C0079399 (UMLS CUI [1])
Age
Item
Aged 18-55 years
boolean
C0001779 (UMLS CUI [1])
RRMS
Item
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
boolean
C0751967 (UMLS CUI [1])
EDSS score
Item
EDSS score of 0 to 5.0
boolean
C0451246 (UMLS CUI [1])
Treatment
Item
Treatment-naive to IFNB or Copaxone
boolean
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Neurological progression
Item
Neurological progression at disease onset or between relapses
boolean
heart diseases
Item
Serious or acute heart diseases
boolean
C0018799 (UMLS CUI [1])
Severe depression
Item
History of severe depression or suicide attempt
boolean
C0588008 (UMLS CUI [1])
dysfunctions
Item
Serious or acute liver, renal or bone marrow dysfunction
boolean
Monoclonal gammopathy
Item
Monoclonal gammopathy
boolean
C1136085 (UMLS CUI [1])
Allergies
Item
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
boolean
C0020517 (UMLS CUI [1])
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Item Group
Medical Concepts
Betaferon
Item
Betaferon
string
C0244714 (UMLS CUI)
Copaxone
Item
Copaxone
string
C0528175 (UMLS CUI)
Depression
Item
Depression
string
C0011581 (UMLS CUI)
35489007 (SNOMEDCT)
10012399 (MDR)
F34.1 (ICD10CM)
Suicide attempt
Item
Suicide attempt
string
C0038663 (UMLS CUI)
82313006 (SNOMEDCT)
10042464 (MDR)
T14.91 (ICD10CM)
E12969 (CTCAE)
RBC
Item
Red blood cell count
string
C0362910 (UMLS CUI)
789-8 (LNC)
WBC
Item
White blood cell count
string
C0023508 (UMLS CUI)
767002 (SNOMEDCT)
10047939 (MDR)
6690-2 (LNC)
Platelet count - finding
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMEDCT)
777-3 (LNC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
75183008 (SNOMEDCT)
10019670 (MDR)
AST
Item
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
string
C0004002 (UMLS CUI)
26091008 (SNOMEDCT)
MTHU004883 (LNC)
AST Measurement in Serum/Plasma
Item
Aspartate aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364055 (UMLS CUI)
1920-8 (LNC)
ALT
Item
Glutamate Pyruvate Transaminase (GPT) = Alanine Transaminase (ALT)
string
C0001899 (UMLS CUI)
56935002 (SNOMEDCT)
MTHU006766 (LNC)
ALT Measurement in Serum/Plasma
Item
Alanine aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0363876 (UMLS CUI)
1742-6 (LNC)
Gamma GT
Item
Gamma-glutamyl transferase
string
C0017040 (UMLS CUI)
60153001 (SNOMEDCT)
MTHU001941 (LNC)
Gamma GT Measurement
Item
Gamma glutamyl transferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364459 (UMLS CUI)
2324-2 (LNC)
GLDH
Item
Glutamate Dehydrogenase
string
C0017786 (UMLS CUI)
75284005 (SNOMEDCT)
MTHU011411 (LNC)
GLDH Measurement
Item
Glutamate dehydrogenase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364507 (UMLS CUI)
2367-1 (LNC)
Monoclonal Gammapathy
Item
Monoclonal Gammapathies
string
C1136085 (UMLS CUI)
109983007 (SNOMEDCT)
10060880 (MDR)
D47.2 (ICD10CM)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
418634005 (SNOMEDCT)
T78.40 (ICD10CM)
Magnetic resonance imaging contrast media allergy
Item
Magnetic resonance imaging contrast media allergy
string
C0570564 (UMLS CUI)
293639009 (SNOMEDCT)
Interferons allergy
Item
Interferons allergy
string
C0571288 (UMLS CUI)
294375008 (SNOMEDCT)
Drug Allergy
Item
Drug Allergy
string
C0013182 (UMLS CUI)
416098002 (SNOMEDCT)
10013700 (MDR)
T88.7 (ICD10CM)
DALG (HL7V3.0)
Albumin solution allergy
Item
Albumin solution allergy
string
C0571759 (UMLS CUI)
294854007 (SNOMEDCT)
Mannitol (substance)
Item
Mannitol (substance)
string
C0024730 (UMLS CUI)
387168006 (SNOMEDCT)
MTHU015736 (LNC)
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