ID

5011

Description

ODM derived from http://clinicaltrials.gov/show/NCT00822159

Link

http://clinicaltrials.gov/show/NCT00822159

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00822159 Femoral Fractures

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 50 Years
Description

age at least 50 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
Description

Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3

Data type

boolean

Alias
UMLS CUI 2011AA
C0162387
UMLS CUI 2011AA
C0015806
SNOMED CT 2011_0131
5913000
MedDRA 14.1
10016450
ICD-10-CM Version 2010
S72.00
ICD-9-CM Version 2011
820
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0559822
SNOMED CT 2011_0131
281959004
Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
Description

Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)

Data type

boolean

Alias
UMLS CUI 2011AA
C0185023
SNOMED CT 2011_0131
129371009
UMLS CUI 2011AA
C0441261
SNOMED CT 2011_0131
257327003
UMLS CUI 2011AA
C0086510
SNOMED CT 2011_0131
257301003
Patients willing to participate in the study according to the clinical investigation plan
Description

Patients willing to participate in the study according to the clinical investigation plan

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C2697496
Patients able to understand and read country national language at an elementary level
Description

Patients able to understand and read country national language at an elementary level

Data type

boolean

Alias
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0586740
SNOMED CT 2011_0131
309251006
UMLS CUI 2011AA
C0454664
SNOMED CT 2011_0131
223369002
UMLS CUI 2011AA
CL415062
UMLS CUI 2011AA
C0023008
SNOMED CT 2011_0131
61909002
LOINC Version 232
MTHU021113
Signed written informed consent by the patient or legal guardian
Description

Signed written informed consent by the patient or legal guardian

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Bilateral hip fractures (at present or in the past)
Description

Bilateral hip fractures (at present or in the past)

Data type

boolean

Alias
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C0019557
SNOMED CT 2011_0131
263225007
MedDRA 14.1
10020100
LOINC Version 232
MTHU020794
ICD-10-CM Version 2010
S72.00
CTCAE 1105E
E11726
Open hip fracture
Description

Open hip fracture

Data type

boolean

Alias
UMLS CUI 2011AA
C0016662
SNOMED CT 2011_0131
52329006
MedDRA 14.1
10030527
ICD-9-CM Version 2011
829.1
UMLS CUI 2011AA
C0019552
SNOMED CT 2011_0131
24136001
LOINC Version 232
MTHU002686
Any previous surgical procedures of the hip (ipsilateral / contralateral)
Description

Any previous surgical procedures of the hip (ipsilateral / contralateral)

Data type

boolean

Alias
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0019552
SNOMED CT 2011_0131
24136001
LOINC Version 232
MTHU002686
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0441988
SNOMED CT 2011_0131
255209002
More than 7 days between injury and surgery
Description

More than 7 days between injury and surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205453
SNOMED CT 2011_0131
65607009
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0038895
Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
Description

Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)

Data type

boolean

Alias
UMLS CUI 2011AA
C0026771
SNOMED CT 2011_0131
262519004
MedDRA 14.1
10028224
ICD-10-CM Version 2010
T07
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C2826244
Patients being pregnant or breast-feeding
Description

Patients being pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Pathological fracture
Description

Pathologic fractures

Data type

boolean

Alias
UMLS CUI 2011AA
C0016663
SNOMED CT 2011_0131
268029009
MedDRA 14.1
10034156
ICD-10-CM Version 2010
M84.4
ICD-9-CM Version 2011
733.10
Active malignancy
Description

Active malignancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
Description

Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)

Data type

boolean

Alias
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
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006
Drug or alcohol abuse
Description

Drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI 2011AA
C0237123
Patients having participated in any other device or drug related clinical trial within the previous month
Description

Patients having participated in any other device or drug related clinical trial within the previous month

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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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
CL425202 (UMLS CUI 2011AA)
age at least 50 Years
Item
age at least 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
Item
Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
boolean
C0162387 (UMLS CUI 2011AA)
C0015806 (UMLS CUI 2011AA)
5913000 (SNOMED CT 2011_0131)
10016450 (MedDRA 14.1)
S72.00 (ICD-10-CM Version 2010)
820 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0559822 (UMLS CUI 2011AA)
281959004 (SNOMED CT 2011_0131)
Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
Item
Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
boolean
C0185023 (UMLS CUI 2011AA)
129371009 (SNOMED CT 2011_0131)
C0441261 (UMLS CUI 2011AA)
257327003 (SNOMED CT 2011_0131)
C0086510 (UMLS CUI 2011AA)
257301003 (SNOMED CT 2011_0131)
Patients willing to participate in the study according to the clinical investigation plan
Item
Patients willing to participate in the study according to the clinical investigation plan
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C2697496 (UMLS CUI 2011AA)
Patients able to understand and read country national language at an elementary level
Item
Patients able to understand and read country national language at an elementary level
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0586740 (UMLS CUI 2011AA)
309251006 (SNOMED CT 2011_0131)
C0454664 (UMLS CUI 2011AA)
223369002 (SNOMED CT 2011_0131)
CL415062 (UMLS CUI 2011AA)
C0023008 (UMLS CUI 2011AA)
61909002 (SNOMED CT 2011_0131)
MTHU021113 (LOINC Version 232)
Signed written informed consent by the patient or legal guardian
Item
Signed written informed consent by the patient or legal guardian
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Bilateral hip fractures (at present or in the past)
Item
Bilateral hip fractures (at present or in the past)
boolean
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0019557 (UMLS CUI 2011AA)
263225007 (SNOMED CT 2011_0131)
10020100 (MedDRA 14.1)
MTHU020794 (LOINC Version 232)
S72.00 (ICD-10-CM Version 2010)
E11726 (CTCAE 1105E)
Open hip fracture
Item
Open hip fracture
boolean
C0016662 (UMLS CUI 2011AA)
52329006 (SNOMED CT 2011_0131)
10030527 (MedDRA 14.1)
829.1 (ICD-9-CM Version 2011)
C0019552 (UMLS CUI 2011AA)
24136001 (SNOMED CT 2011_0131)
MTHU002686 (LOINC Version 232)
Any previous surgical procedures of the hip (ipsilateral / contralateral)
Item
Any previous surgical procedures of the hip (ipsilateral / contralateral)
boolean
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0019552 (UMLS CUI 2011AA)
24136001 (SNOMED CT 2011_0131)
MTHU002686 (LOINC Version 232)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
More than 7 days between injury and surgery
Item
More than 7 days between injury and surgery
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL426201 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0038895 (UMLS CUI 2011AA)
Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
Item
Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
boolean
C0026771 (UMLS CUI 2011AA)
262519004 (SNOMED CT 2011_0131)
10028224 (MedDRA 14.1)
T07 (ICD-10-CM Version 2010)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1947911 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C2826244 (UMLS CUI 2011AA)
Patients being pregnant or breast-feeding
Item
Patients being pregnant or breast-feeding
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Pathologic fractures
Item
Pathological fracture
boolean
C0016663 (UMLS CUI 2011AA)
268029009 (SNOMED CT 2011_0131)
10034156 (MedDRA 14.1)
M84.4 (ICD-10-CM Version 2010)
733.10 (ICD-9-CM Version 2011)
Active malignancy
Item
Active malignancy
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
Item
Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
boolean
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)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)
Drug or alcohol abuse
Item
Drug or alcohol abuse
boolean
C0237123 (UMLS CUI 2011AA)
Patients having participated in any other device or drug related clinical trial within the previous month
Item
Patients having participated in any other device or drug related clinical trial within the previous month
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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