ID
5064
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT00993473
Link
http://clinicaltrials.gov/show/NCT00993473
Palavras-chave
Versões (2)
- 07/12/2013 07/12/2013 - Martin Dugas
- 17/04/2014 17/04/2014 - Julian Varghese
Transferido a
17 de abril de 2014
DOI
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Licença
Creative Commons BY 4.0
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Eligibility NCT00993473 Type 1 Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Descrição
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descrição
Diagnosis of type 1 diabetes for < one year
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Descrição
HbA1c at screening >12% or <6%
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0019018
Descrição
Diabetes other than type 1 diabetes
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Descrição
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C1276391
- SNOMED CT 2011_0131
- 359772000
- UMLS CUI 2011AA
- C0785704
- SNOMED CT 2011_0131
- 354068006
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
- UMLS CUI 2011AA
- C0332173
- SNOMED CT 2011_0131
- 69620002
- UMLS CUI 2011AA
- C0586328
- SNOMED CT 2011_0131
- 308755006
Descrição
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1301820
- SNOMED CT 2011_0131
- 398092000
- UMLS CUI 2011AA
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
- UMLS CUI 2011AA
- C0205197
- SNOMED CT 2011_0131
- 255594003
- UMLS CUI 2011AA
- C0872182
- UMLS CUI 2011AA
- C0449913
- SNOMED CT 2011_0131
- 246333005
- LOINC Version 232
- MTHU025766
- UMLS CUI 2011AA
- C1511726
Descrição
Patients treated with insulin pump therapy during the two months prior to screening
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1140609
- SNOMED CT 2011_0131
- 69805005
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descrição
History of primary seizure disorder
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- CL414904
- UMLS CUI 2011AA
- C0852425
- MedDRA 14.1
- 10039912
Descrição
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0020615
- SNOMED CT 2011_0131
- 302866003
- MedDRA 14.1
- 10020993
- ICD-10-CM Version 2010
- E16.2
- ICD-9-CM Version 2011
- 251.2
- CTCAE 1105E
- E12322
- UMLS CUI 2011AA
- C0332189
- SNOMED CT 2011_0131
- 272128006
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- C0009421
- SNOMED CT 2011_0131
- 371632003
- MedDRA 14.1
- 10010071
- LOINC Version 232
- MTHU020645
- ICD-10-CM Version 2010
- R40.20
- ICD-9-CM Version 2011
- 780.01
- UMLS CUI 2011AA
- C0011880
- SNOMED CT 2011_0131
- 420422005
- MedDRA 14.1
- 10012671
- ICD-9-CM Version 2011
- 250.1
Descrição
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0686904
- SNOMED CT 2011_0131
- 103325001
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0000970
- SNOMED CT 2011_0131
- 387517004
- LOINC Version 232
- MTHU003399
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0013227
Descrição
Serum creatinine > 2.0mg/dL at screening
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1409616
Descrição
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
Tipo de dados
boolean
Alias
- 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
- C1519815
- UMLS CUI 2011AA
- C1409616
Descrição
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0019046
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- LOINC Version 232
- 777-3
- UMLS CUI 2011AA
- C1409616
Descrição
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205464
- SNOMED CT 2011_0131
- 56183000
- UMLS CUI 2011AA
- C0359086
- SNOMED CT 2011_0131
- 346597008
- LOINC Version 232
- MTHU003326
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Descrição
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C2825234
- UMLS CUI 2011AA
- C1174780
- SNOMED CT 2011_0131
- 427360000
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Descrição
Treatment with systemic glucocorticoids within the month prior to screening
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- CL428886
- MedDRA 14.1
- 10071104
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1519316 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
191044006 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
225465005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1276391 (UMLS CUI 2011AA)
359772000 (SNOMED CT 2011_0131)
C0785704 (UMLS CUI 2011AA)
354068006 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0586328 (UMLS CUI 2011AA)
308755006 (SNOMED CT 2011_0131)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0872182 (UMLS CUI 2011AA)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C1511726 (UMLS CUI 2011AA)
69805005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
103325001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0000970 (UMLS CUI 2011AA)
387517004 (SNOMED CT 2011_0131)
MTHU003399 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1409616 (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)
C1519815 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
C0205464 (UMLS CUI 2011AA)
56183000 (SNOMED CT 2011_0131)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2825234 (UMLS CUI 2011AA)
C1174780 (UMLS CUI 2011AA)
427360000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)