ID

4947

Description

ODM derived from http://clinicaltrials.gov/show/NCT00662714

Link

http://clinicaltrials.gov/show/NCT00662714

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
Uploaded on

April 15, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00662714 Cystic Fibrosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 10 Years
Description

age at least 10 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosed cystic fibrosis
Description

Diagnosed cystic fibrosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
Newly diagnosed Diabetes mellitus in the screening
Description

Newly diagnosed Diabetes mellitus in the screening

Data type

boolean

Alias
UMLS CUI 2011AA
C2585997
SNOMED CT 2011_0131
441308009
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1409616
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)
Description

Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011880
SNOMED CT 2011_0131
420422005
MedDRA 14.1
10012671
ICD-9-CM Version 2011
250.1
UMLS CUI 2011AA
C0392201
SNOMED CT 2011_0131
33747003
MedDRA 14.1
10005553
UMLS CUI 2011AA
C0428199
SNOMED CT 2011_0131
27051004
MedDRA 14.1
10063590
Already treated Diabetes mellitus by oral antidiabetic medication or insulin
Description

Already treated Diabetes mellitus by oral antidiabetic medication or insulin

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Systemic steroid therapy during the last 3 months
Description

Systemic steroid therapy during the last 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
CL383594
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Transplantation (status post TX or on the waiting list for TX)
Description

Transplantation (status post TX or on the waiting list for TX)

Data type

boolean

Alias
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0422768
SNOMED CT 2011_0131
270459005
Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition
Description

Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0439659
SNOMED CT 2011_0131
246062003
LOINC Version 232
MTHU026300
UMLS CUI 2011AA
CL355398
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C0024119
SNOMED CT 2011_0131
23426006
MedDRA 14.1
10025099
LOINC Version 232
MTHU029811
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Already diagnosed and treated diabetes mellitus
Description

Already diagnosed and treated diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma
Description

Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma

Data type

boolean

Alias
UMLS CUI 2011AA
C0011880
SNOMED CT 2011_0131
420422005
MedDRA 14.1
10012671
ICD-9-CM Version 2011
250.1
UMLS CUI 2011AA
C0392201
SNOMED CT 2011_0131
33747003
MedDRA 14.1
10005553
UMLS CUI 2011AA
C0428199
SNOMED CT 2011_0131
27051004
MedDRA 14.1
10063590
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1263960
SNOMED CT 2011_0131
26298008
MedDRA 14.1
10012650
Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)
Description

Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1306571
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10056542
UMLS CUI 2011AA
C0524909
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
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
C1948050
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0086890
MedDRA 14.1
10050994
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0246689
SNOMED CT 2011_0131
386964000
LOINC Version 232
MTHU017515
Treatment with an indispensable important drug which contraindicates Repaglinide
Description

Treatment with an indispensable important drug which contraindicates Repaglinide

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205224
SNOMED CT 2011_0131
34325006
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0246689
SNOMED CT 2011_0131
386964000
LOINC Version 232
MTHU017515
PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
Description

PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0176751
SNOMED CT 2011_0131
235159007
ICD-9-CM Version 2011
43.11
UMLS CUI 2011AA
CL382941
UMLS CUI 2011AA
C0030548
SNOMED CT 2011_0131
225372007
MedDRA 14.1
10044107
LOINC Version 232
MTHU014331
ICD-9-CM Version 2011
99.15
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
CF-patients with type 1 diabetes
Description

CF-patients with type 1 diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
Not patient's consent to randomisation and therapeutic trial
Description

Not patient's consent to randomisation and therapeutic trial

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C1515364
Participation on other medical trial
Description

Participation in other medical trial

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 10 Years
Item
age at least 10 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosed cystic fibrosis
Item
Diagnosed cystic fibrosis
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
Newly diagnosed Diabetes mellitus in the screening
Item
Newly diagnosed Diabetes mellitus in the screening
boolean
C2585997 (UMLS CUI 2011AA)
441308009 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)
Item
Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)
boolean
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0428199 (UMLS CUI 2011AA)
27051004 (SNOMED CT 2011_0131)
10063590 (MedDRA 14.1)
Already treated Diabetes mellitus by oral antidiabetic medication or insulin
Item
Already treated Diabetes mellitus by oral antidiabetic medication or insulin
boolean
CL415147 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Systemic steroid therapy during the last 3 months
Item
Systemic steroid therapy during the last 3 months
boolean
CL383594 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Transplantation (status post TX or on the waiting list for TX)
Item
Transplantation (status post TX or on the waiting list for TX)
boolean
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C0422768 (UMLS CUI 2011AA)
270459005 (SNOMED CT 2011_0131)
Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition
Item
Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition
boolean
C0439659 (UMLS CUI 2011AA)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
CL355398 (UMLS CUI 2011AA)
CL414841 (UMLS CUI 2011AA)
C0024119 (UMLS CUI 2011AA)
23426006 (SNOMED CT 2011_0131)
10025099 (MedDRA 14.1)
MTHU029811 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Already diagnosed and treated diabetes mellitus
Item
Already diagnosed and treated diabetes mellitus
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL415147 (UMLS CUI 2011AA)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma
Item
Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma
boolean
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0428199 (UMLS CUI 2011AA)
27051004 (SNOMED CT 2011_0131)
10063590 (MedDRA 14.1)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1263960 (UMLS CUI 2011AA)
26298008 (SNOMED CT 2011_0131)
10012650 (MedDRA 14.1)
Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)
Item
Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C0524909 (UMLS CUI 2011AA)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
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)
C1948050 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
C0086890 (UMLS CUI 2011AA)
10050994 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0246689 (UMLS CUI 2011AA)
386964000 (SNOMED CT 2011_0131)
MTHU017515 (LOINC Version 232)
Treatment with an indispensable important drug which contraindicates Repaglinide
Item
Treatment with an indispensable important drug which contraindicates Repaglinide
boolean
C0039798 (UMLS CUI 2011AA)
C0205224 (UMLS CUI 2011AA)
34325006 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0246689 (UMLS CUI 2011AA)
386964000 (SNOMED CT 2011_0131)
MTHU017515 (LOINC Version 232)
PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
Item
PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
boolean
C0176751 (UMLS CUI 2011AA)
235159007 (SNOMED CT 2011_0131)
43.11 (ICD-9-CM Version 2011)
CL382941 (UMLS CUI 2011AA)
C0030548 (UMLS CUI 2011AA)
225372007 (SNOMED CT 2011_0131)
10044107 (MedDRA 14.1)
MTHU014331 (LOINC Version 232)
99.15 (ICD-9-CM Version 2011)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
CF-patients with type 1 diabetes
Item
CF-patients with type 1 diabetes
boolean
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0030705 (UMLS CUI 2011AA)
116154003 (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)
Not patient's consent to randomisation and therapeutic trial
Item
Not patient's consent to randomisation and therapeutic trial
boolean
C1518422 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
C1515364 (UMLS CUI 2011AA)
Participation in other medical trial
Item
Participation on other medical trial
boolean
C2348568 (UMLS CUI 2011AA)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial