ID

43469

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00820105

Link

http://clinicaltrials.gov/show/NCT00820105

Stichworte

Versionen (4)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 16.04.14 16.04.14 - Julian Varghese
  3. 16.04.14 16.04.14 - Julian Varghese
  4. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Eligibility NCT00820105 Migraine

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter zwischen 18 und 65 Jahrens
Beschreibung

Age between 18 and 65 years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
History of migraine
Beschreibung

History of migraine

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0149931
SNOMED CT 2011_0131
37796009
MedDRA 14.1
10027599
ICD-10-CM Version 2010
G43
ICD-9-CM Version 2011
346
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Aged <= 50 years at onset of migraine history
Beschreibung

Aged <= 50 years at onset of migraine history

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0149931
SNOMED CT 2011_0131
37796009
MedDRA 14.1
10027599
ICD-10-CM Version 2010
G43
ICD-9-CM Version 2011
346
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Cluster headache or chronic migraine headaches
Beschreibung

Cluster headache or chronic migraine headaches

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0009088
SNOMED CT 2011_0131
193031009
MedDRA 14.1
10059133
ICD-10-CM Version 2010
G44.00
ICD-9-CM Version 2011
339.00
UMLS CUI 2011AA
C1960870
MedDRA 14.1
10066636
Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
Beschreibung

Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0037567
SNOMED CT 2011_0131
387481005
UMLS CUI 2011AA
C0076829
SNOMED CT 2011_0131
108400009
LOINC Version 232
MTHU007741
UMLS CUI 2011AA
C0355642
SNOMED CT 2011_0131
322837006
UMLS CUI 2011AA
C0001645
SNOMED CT 2011_0131
33252009
LOINC Version 232
MTHU003324
UMLS CUI 2011AA
C0006684
SNOMED CT 2011_0131
373304005
UMLS CUI 2011AA
C0003290
SNOMED CT 2011_0131
373253007
LOINC Version 232
MTHU001920
UMLS CUI 2011AA
C0360105
SNOMED CT 2011_0131
349854005
Unable to distinguish migraine headache from tension and other types of headache
Beschreibung

Unable to distinguish migraine headache from tension and other types of headache

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0205235
SNOMED CT 2011_0131
43147006
UMLS CUI 2011AA
C0149931
SNOMED CT 2011_0131
37796009
MedDRA 14.1
10027599
ICD-10-CM Version 2010
G43
ICD-9-CM Version 2011
346
UMLS CUI 2011AA
C0033893
SNOMED CT 2011_0131
398057008
MedDRA 14.1
10043269
ICD-10-CM Version 2010
G44.2
ICD-9-CM Version 2011
307.81
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0018681
SNOMED CT 2011_0131
25064002
MedDRA 14.1
10019211
LOINC Version 232
MTHU020860
ICD-10-CM Version 2010
R51
ICD-9-CM Version 2011
784.0
CTCAE 1105E
E12678
Current history of psychiatric disorder requiring regular medication
Beschreibung

Current history of psychiatric disorder requiring regular medication

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0260462
ICD-9-CM Version 2011
V11.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0013227
History of alcohol abuse
Beschreibung

Known history of alcohol abuse

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0221628
SNOMED CT 2011_0131
371434005
Known clinically significant allergy or known hypersensitivity to drugs
Beschreibung

Known clinically significant allergy or known hypersensitivity to drugs

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0013182
LOINC Version 232
MTHU002637
History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
Beschreibung

History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Pregnant or breast-feeding
Beschreibung

Pregnant or breast-feeding

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
Age between 18 and 65 years
Item
Alter zwischen 18 und 65 Jahrens
boolean
C0001779 (UMLS CUI 2011AA)
History of migraine
Item
History of migraine
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Aged <= 50 years at onset of migraine history
Item
Aged <= 50 years at onset of migraine history
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Cluster headache or chronic migraine headaches
Item
Cluster headache or chronic migraine headaches
boolean
C0009088 (UMLS CUI 2011AA)
193031009 (SNOMED CT 2011_0131)
10059133 (MedDRA 14.1)
G44.00 (ICD-10-CM Version 2010)
339.00 (ICD-9-CM Version 2011)
C1960870 (UMLS CUI 2011AA)
10066636 (MedDRA 14.1)
Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
Item
Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0037567 (UMLS CUI 2011AA)
387481005 (SNOMED CT 2011_0131)
C0076829 (UMLS CUI 2011AA)
108400009 (SNOMED CT 2011_0131)
MTHU007741 (LOINC Version 232)
C0355642 (UMLS CUI 2011AA)
322837006 (SNOMED CT 2011_0131)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
C0006684 (UMLS CUI 2011AA)
373304005 (SNOMED CT 2011_0131)
C0003290 (UMLS CUI 2011AA)
373253007 (SNOMED CT 2011_0131)
MTHU001920 (LOINC Version 232)
C0360105 (UMLS CUI 2011AA)
349854005 (SNOMED CT 2011_0131)
Unable to distinguish migraine headache from tension and other types of headache
Item
Unable to distinguish migraine headache from tension and other types of headache
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0205235 (UMLS CUI 2011AA)
43147006 (SNOMED CT 2011_0131)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0033893 (UMLS CUI 2011AA)
398057008 (SNOMED CT 2011_0131)
10043269 (MedDRA 14.1)
G44.2 (ICD-10-CM Version 2010)
307.81 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0018681 (UMLS CUI 2011AA)
25064002 (SNOMED CT 2011_0131)
10019211 (MedDRA 14.1)
MTHU020860 (LOINC Version 232)
R51 (ICD-10-CM Version 2010)
784.0 (ICD-9-CM Version 2011)
E12678 (CTCAE 1105E)
Current history of psychiatric disorder requiring regular medication
Item
Current history of psychiatric disorder requiring regular medication
boolean
C0260462 (UMLS CUI 2011AA)
V11.9 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Known history of alcohol abuse
Item
History of alcohol abuse
boolean
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
Known clinically significant allergy or known hypersensitivity to drugs
Item
Known clinically significant allergy or known hypersensitivity to drugs
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0013182 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
Item
History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C1113679 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Pregnant or breast-feeding
Item
Pregnant or breast-feeding
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
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