ID
4395
Description
ODM derived from http://clinicaltrials.gov/show/NCT00883051
Lien
http://clinicaltrials.gov/show/NCT00883051
Mots-clés
Versions (3)
- 09/12/2013 09/12/2013 - Martin Dugas
- 17/04/2014 17/04/2014 - Julian Varghese
- 20/09/2021 20/09/2021 -
Téléchargé le
9 décembre 2013
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00883051 Migraine Disorders
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
History of life threatening or intolerable adverse reaction to any triptan
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1744706
- UMLS CUI 2011AA
- C2826244
- UMLS CUI 2011AA
- C0041755
- SNOMED CT 2011_0131
- 62014003
- MedDRA 14.1
- 10061623
- ICD-10-CM Version 2010
- T88.7
- UMLS CUI 2011AA
- C1567966
Description
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1521941
- LOINC Version 232
- MTHU034709
- 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
- C0420172
- SNOMED CT 2011_0131
- 33572000
Description
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0949854
- UMLS CUI 2011AA
- C0376266
- UMLS CUI 2011AA
- C0937904
- SNOMED CT 2011_0131
- 417382006
- UMLS CUI 2011AA
- C1142085
- SNOMED CT 2011_0131
- 408381007
- MedDRA 14.1
- 10058734
Description
Using 5-HT reuptake inhibitors
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2911696
Description
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C2962191
Description
Pregnant or breast-feeding women
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
Description
Women of child-bearing potential not using highly effective contraception
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
Description
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0948008
- SNOMED CT 2011_0131
- 422504002
- MedDRA 14.1
- 10055221
- UMLS CUI 2011AA
- C0553692
- SNOMED CT 2011_0131
- 230706003
- MedDRA 14.1
- 10019016
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
History of hypertension (controlled or uncontrolled)
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0020538
- SNOMED CT 2011_0131
- 38341003
- MedDRA 14.1
- 10020772
- LOINC Version 232
- MTHU020789
- ICD-10-CM Version 2010
- I10
- ICD-9-CM Version 2011
- 997.91
- CTCAE 1105E
- E13785
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
Description
History of orthostatic hypotension
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0020651
- SNOMED CT 2011_0131
- 28651003
- MedDRA 14.1
- 10031127
- ICD-10-CM Version 2010
- I95.1
- ICD-9-CM Version 2011
- 458.0
Description
Current use of hemodynamically active cardiovascular drugs
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0019010
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0007220
- SNOMED CT 2011_0131
- 14833006
Description
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
Description
Significant renal or hepatic impairment
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0341697
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- UMLS CUI 2011AA
- C0948807
- MedDRA 14.1
- 10052254
Description
Previous participation in this clinical trial
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
Description
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0587081
- SNOMED CT 2011_0131
- 118246004
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1548788
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Known Hepatitis B or C or HIV infection
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- C0019693
- SNOMED CT 2011_0131
- 86406008
- MedDRA 14.1
- 10020161
- LOINC Version 232
- MTHU020829
- ICD-10-CM Version 2010
- B20
- ICD-9-CM Version 2011
- 042
Description
Patients who are employees of the sponsor
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0599987
- SNOMED CT 2011_0131
- 224528001
- UMLS CUI 2011AA
- C2347796
Description
Relatives of, or staff directly reporting to, the investigator
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0080103
- SNOMED CT 2011_0131
- 125677006
- UMLS CUI 2011AA
- C0851286
- UMLS CUI 2011AA
- C0700287
- SNOMED CT 2011_0131
- 223458004
- LOINC Version 232
- MTHU002737
- UMLS CUI 2011AA
- CL102947
Description
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C2974932
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
- UMLS CUI 2011AA
- C0534690
- UMLS CUI 2011AA
- C0243192
Description
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C2974932
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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)
C0154723 (UMLS CUI 2011AA)
4473006 (SNOMED CT 2011_0131)
10027607 (MedDRA 14.1)
G43.1 (ICD-10-CM Version 2010)
C0338480 (UMLS CUI 2011AA)
56097005 (SNOMED CT 2011_0131)
10052787 (MedDRA 14.1)
G43.0 (ICD-10-CM Version 2010)
346.1 (ICD-9-CM Version 2011)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1512888 (UMLS CUI 2011AA)
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)
C0037459 (UMLS CUI 2011AA)
C0679228 (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)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
392521001 (SNOMED CT 2011_0131)
CL415096 (UMLS CUI 2011AA)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0439507 (UMLS CUI 2011AA)
259036001 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
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)
C0376660 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1744706 (UMLS CUI 2011AA)
C2826244 (UMLS CUI 2011AA)
C0041755 (UMLS CUI 2011AA)
62014003 (SNOMED CT 2011_0131)
10061623 (MedDRA 14.1)
T88.7 (ICD-10-CM Version 2010)
C1567966 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
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)
C0420172 (UMLS CUI 2011AA)
33572000 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
C0949854 (UMLS CUI 2011AA)
C0376266 (UMLS CUI 2011AA)
C0937904 (UMLS CUI 2011AA)
417382006 (SNOMED CT 2011_0131)
C1142085 (UMLS CUI 2011AA)
408381007 (SNOMED CT 2011_0131)
10058734 (MedDRA 14.1)
260676000 (SNOMED CT 2011_0131)
C2911696 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2962191 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C0553692 (UMLS CUI 2011AA)
230706003 (SNOMED CT 2011_0131)
10019016 (MedDRA 14.1)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
392521001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
C0020651 (UMLS CUI 2011AA)
28651003 (SNOMED CT 2011_0131)
10031127 (MedDRA 14.1)
I95.1 (ICD-10-CM Version 2010)
458.0 (ICD-9-CM Version 2011)
260676000 (SNOMED CT 2011_0131)
C0019010 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0007220 (UMLS CUI 2011AA)
14833006 (SNOMED CT 2011_0131)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
224528001 (SNOMED CT 2011_0131)
C2347796 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
C0851286 (UMLS CUI 2011AA)
C0700287 (UMLS CUI 2011AA)
223458004 (SNOMED CT 2011_0131)
MTHU002737 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C2974932 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0534690 (UMLS CUI 2011AA)
C0243192 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C2974932 (UMLS CUI 2011AA)