ID

4972

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00717457

Link

http://clinicaltrials.gov/show/NCT00717457

Palavras-chave

Versões (2)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 16/04/2014 16/04/2014 - Julian Varghese
Transferido a

16 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00717457 Diabetes Mellitus, Type 2

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 75 Jahre
Descrição

age 18 Years to 75 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Erwachsener, erwachsen
Descrição

adult patients, 18-75 years of age

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks
Descrição

type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0071097
SNOMED CT 2011_0131
395828009
UMLS CUI 2011AA
C0289313
SNOMED CT 2011_0131
395869000
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
HbA1c >=7.0% and <=10% at screening
Descrição

HbA1c >=7.0% and <=10% at screening

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening
Descrição

BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
UMLS CUI 2011AA
C0078988
SNOMED CT 2011_0131
413582008
HL7 V3 2006_05
2028-9
UMLS CUI 2011AA
C1409616
stable weight +/- 5% for at least 12 weeks prior to screening.
Descrição

stable weight +/- 5% for at least 12 weeks prior to screening.

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0424657
SNOMED CT 2011_0131
271398006
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Ausschlusskriterien
Descrição

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
Descrição

history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0273163
SNOMED CT 2011_0131
61823004
MedDRA 14.1
10033627
ICD-10-CM Version 2010
S36.2
UMLS CUI 2011AA
C0271640
SNOMED CT 2011_0131
8801005
ICD-9-CM Version 2011
249
history of acute metabolic diabetic complications within the previous 6 months
Descrição

history of acute metabolic diabetic complications within the previous 6 months

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0311400
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
evidence of clinically significant diabetic complications
Descrição

evidence of clinically significant diabetic complications

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
Proliferative diabetic retinopathy
Descrição

known proliferative diabetic retinopathy

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0154830
SNOMED CT 2011_0131
59276001
MedDRA 14.1
10036857
ICD-9-CM Version 2011
362.02
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months
Descrição

myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
CL411823
SNOMED CT 2011_0131
85898001
MedDRA 14.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator
Descrição

any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
known hemoglobinopathy or chronic anemia
Descrição

known hemoglobinopathy or chronic anemia

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0019045
SNOMED CT 2011_0131
80141007
MedDRA 14.1
10060892
LOINC Version 232
MTHU029621
ICD-10-CM Version 2010
D58.2
UMLS CUI 2011AA
C0581384
SNOMED CT 2011_0131
191268006
ICD-10-CM Version 2010
D53.9
clinically significant gastrointestinal disease.
Descrição

clinically significant gastrointestinal disease.

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
Alter 18 bis 75 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
adult patients, 18-75 years of age
Item
Erwachsener, erwachsen
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks
Item
type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks
boolean
C0011860 (UMLS CUI 2011AA)
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)
C1514756 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0071097 (UMLS CUI 2011AA)
395828009 (SNOMED CT 2011_0131)
C0289313 (UMLS CUI 2011AA)
395869000 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
HbA1c >=7.0% and <=10% at screening
Item
HbA1c >=7.0% and <=10% at screening
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening
Item
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0078988 (UMLS CUI 2011AA)
413582008 (SNOMED CT 2011_0131)
2028-9 (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
stable weight +/- 5% for at least 12 weeks prior to screening.
Item
stable weight +/- 5% for at least 12 weeks prior to screening.
boolean
C0424657 (UMLS CUI 2011AA)
271398006 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
Item
history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (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)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0273163 (UMLS CUI 2011AA)
61823004 (SNOMED CT 2011_0131)
10033627 (MedDRA 14.1)
S36.2 (ICD-10-CM Version 2010)
C0271640 (UMLS CUI 2011AA)
8801005 (SNOMED CT 2011_0131)
249 (ICD-9-CM Version 2011)
history of acute metabolic diabetic complications within the previous 6 months
Item
history of acute metabolic diabetic complications within the previous 6 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0311400 (UMLS CUI 2011AA)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
evidence of clinically significant diabetic complications
Item
evidence of clinically significant diabetic complications
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
known proliferative diabetic retinopathy
Item
Proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI 2011AA)
59276001 (SNOMED CT 2011_0131)
10036857 (MedDRA 14.1)
362.02 (ICD-9-CM Version 2011)
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months
Item
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months
boolean
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator
Item
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator
boolean
C1704258 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
known hemoglobinopathy or chronic anemia
Item
known hemoglobinopathy or chronic anemia
boolean
C0019045 (UMLS CUI 2011AA)
80141007 (SNOMED CT 2011_0131)
10060892 (MedDRA 14.1)
MTHU029621 (LOINC Version 232)
D58.2 (ICD-10-CM Version 2010)
C0581384 (UMLS CUI 2011AA)
191268006 (SNOMED CT 2011_0131)
D53.9 (ICD-10-CM Version 2010)
clinically significant gastrointestinal disease.
Item
clinically significant gastrointestinal disease.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
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