ID
4359
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01206647
Länk
http://clinicaltrials.gov/show/NCT01206647
Nyckelord
Versioner (3)
- 2013-12-07 2013-12-07 - Martin Dugas
- 2014-04-19 2014-04-19 - Julian Varghese
- 2021-09-27 2021-09-27 -
Uppladdad den
7 december 2013
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01206647 Diabetes Mellitus, Type 2
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
Type 1 Diabetes mellitus
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Beskrivning
History of drug or alcohol abuse within the last five years prior to screening
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1299544
- SNOMED CT 2011_0131
- 371435006
- UMLS CUI 2011AA
- C0221628
- SNOMED CT 2011_0131
- 371434005
Beskrivning
History of severe or multiple allergies
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
Beskrivning
Progressive fatal disease
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1302234
- SNOMED CT 2011_0131
- 399166001
- UMLS CUI 2011AA
- C1335499
Beskrivning
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0007222
- SNOMED CT 2011_0131
- 105980002
- MedDRA 14.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
- UMLS CUI 2011AA
- C0035204
- SNOMED CT 2011_0131
- 50043002
- MedDRA 14.1
- 10038683
- ICD-10-CM Version 2010
- J98.9
- ICD-9-CM Version 2011
- 519.9
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C0023895
- SNOMED CT 2011_0131
- 235856003
- MedDRA 14.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0018939
- SNOMED CT 2011_0131
- 191124002
- MedDRA 14.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
Beskrivning
Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
Beskrivning
Contra-indications for study drugs including contraindications for the rescue drugs
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C0175673
- SNOMED CT 2011_0131
- 25876001
- UMLS CUI 2011AA
- C0013227
Beskrivning
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0021055
- SNOMED CT 2011_0131
- 940000
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0220807
Beskrivning
Pregnancy or breast feeding
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0032961
- SNOMED CT 2011_0131
- 289908002
- MedDRA 14.1
- 10036556
- LOINC Version 232
- MTHU035048
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Beskrivning
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
- 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
- UMLS CUI 2011AA
- CL424925
- UMLS CUI 2011AA
- C1262153
- MedDRA 14.1
- 10062577
- UMLS CUI 2011AA
- C0457572
- SNOMED CT 2011_0131
- 268458002
- UMLS CUI 2011AA
- C3164761
- SNOMED CT 2011_0131
- 449038007
- UMLS CUI 2011AA
- C0036899
- SNOMED CT 2011_0131
- 47037006
- MedDRA 14.1
- 10029805
- UMLS CUI 2011AA
- C0420842
- SNOMED CT 2011_0131
- 268457007
Beskrivning
Treatment with any other investigational drug within 3 months prior to screening
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
Beskrivning
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0392360
- SNOMED CT 2011_0131
- 410666004 230165009
- LOINC Version 232
- MTHU008862
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C1272703
- SNOMED CT 2011_0131
- 385669000
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0650607 (UMLS CUI 2011AA)
416303005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
161649006 (SNOMED CT 2011_0131)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0439453 (UMLS CUI 2011AA)
258997004 (SNOMED CT 2011_0131)
C0439505 (UMLS CUI 2011AA)
259032004 (SNOMED CT 2011_0131)
FAST (HL7 V3 2006_05)
C0006558 (UMLS CUI 2011AA)
39973008 (SNOMED CT 2011_0131)
MTHU003747 (LOINC Version 232)
R73.01 (ICD-10-CM Version 2010)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
MTHU035862 (LOINC Version 232)
C0033131, C0017319 (UMLS CUI 2011AA)
446050000, 59058001 (SNOMED CT 2011_0131)
C1522154 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
371435006 (SNOMED CT 2011_0131)
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
MTHU001065 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
399166001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
10038474 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
397745006 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0175673 (UMLS CUI 2011AA)
25876001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
940000 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C2348205 (UMLS CUI 2011AA)
C0220807 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C3164761 (UMLS CUI 2011AA)
449038007 (SNOMED CT 2011_0131)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C2348205 (UMLS CUI 2011AA)
C0392360 (UMLS CUI 2011AA)
410666004 230165009 (SNOMED CT 2011_0131)
MTHU008862 (LOINC Version 232)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)