ID

5116

Description

ODM derived from http://clinicaltrials.gov/show/NCT01282294

Link

http://clinicaltrials.gov/show/NCT01282294

Keywords

Versions (2)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01282294 Tibial Fractures

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

Adult patients aged 18 years or more

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Open or closed tibia fracture according to the surgical technique
Description

Open or closed tibia fracture according to the surgical technique

Data type

boolean

Alias
UMLS CUI 2011AA
C0749492
SNOMED CT 2011_0131
446979005
MedDRA 14.1
10010211
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0159870
SNOMED CT 2011_0131
447139008
MedDRA 14.1
10009621
ICD-9-CM Version 2011
823.80
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0449851
SNOMED CT 2011_0131
246501002
Exclusion Criteria
Description

Exclusion Criteria

Women who are pregnant or breast-feeding or are planning to become pregnant during the study
Description

Women who are pregnant or breast-feeding or are planning to become pregnant during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
Description

Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0277554
SNOMED CT 2011_0131
56416009
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Patients with a known allergy to aminoglycosides
Description

Patients with a known allergy to aminoglycosides

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002556
SNOMED CT 2011_0131
324116004
Physical or mental incapacity, which makes it impossible to obtain informed consent
Description

Physical or mental incapacity, which makes it impossible to obtain informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C1306341
SNOMED CT 2011_0131
47437004
MedDRA 14.1
10027374
ICD-10-CM Version 2010
F79
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
History of drug and alcohol abuse
Description

History of drug and alcohol abuse

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
371435006
SNOMED CT 2011_0131
371434005
Patient unlikely to cooperate
Description

Patient unlikely to cooperate

Data type

boolean

Alias
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C0392337
Legal incompetence
Description

Legal incompetence

Data type

boolean

Alias
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C0231189
SNOMED CT 2011_0131
41204007
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients aged 18 years or more
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Open or closed tibia fracture according to the surgical technique
Item
Open or closed tibia fracture according to the surgical technique
boolean
C0749492 (UMLS CUI 2011AA)
446979005 (SNOMED CT 2011_0131)
10010211 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0159870 (UMLS CUI 2011AA)
447139008 (SNOMED CT 2011_0131)
10009621 (MedDRA 14.1)
823.80 (ICD-9-CM Version 2011)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0449851 (UMLS CUI 2011AA)
246501002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Women who are pregnant or breast-feeding or are planning to become pregnant during the study
Item
Women who are pregnant or breast-feeding or are planning to become pregnant during the study
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
Item
Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
boolean
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0277554 (UMLS CUI 2011AA)
56416009 (SNOMED CT 2011_0131)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (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)
Patients with a known allergy to aminoglycosides
Item
Patients with a known allergy to aminoglycosides
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0002556 (UMLS CUI 2011AA)
324116004 (SNOMED CT 2011_0131)
Physical or mental incapacity, which makes it impossible to obtain informed consent
Item
Physical or mental incapacity, which makes it impossible to obtain informed consent
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1306341 (UMLS CUI 2011AA)
47437004 (SNOMED CT 2011_0131)
10027374 (MedDRA 14.1)
F79 (ICD-10-CM Version 2010)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
History of drug and alcohol abuse
Item
History of drug and alcohol abuse
boolean
C0085762 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
371434005 (SNOMED CT 2011_0131)
Patient unlikely to cooperate
Item
Patient unlikely to cooperate
boolean
C0750558 (UMLS CUI 2011AA)
C0392337 (UMLS CUI 2011AA)
Legal incompetence
Item
Legal incompetence
boolean
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C0231189 (UMLS CUI 2011AA)
41204007 (SNOMED CT 2011_0131)
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