ID

43482

Description

ODM derived from http://clinicaltrials.gov/show/NCT00832039

Link

http://clinicaltrials.gov/show/NCT00832039

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00832039 Severe Sepsis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Severe sepsis or septic shock according to ACCP/SCCM criteria
Description

Severe sepsis or septic shock according to ACCP/SCCM criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C1719672
ICD-10-CM Version 2010
R65.2
ICD-9-CM Version 2011
995.92
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0036983
SNOMED CT 2011_0131
76571007
MedDRA 14.1
10040070
ICD-9-CM Version 2011
785.52
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0586857
SNOMED CT 2011_0131
309345004
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C1319411
SNOMED CT 2011_0131
408478003
UMLS CUI 2011AA
CL414621
Onset of severe sepsis or septic shock <24 h
Description

Onset of severe sepsis or septic shock <24 h

Data type

boolean

Alias
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C1719672
ICD-10-CM Version 2010
R65.2
ICD-9-CM Version 2011
995.92
UMLS CUI 2011AA
C0036983
SNOMED CT 2011_0131
76571007
MedDRA 14.1
10040070
ICD-9-CM Version 2011
785.52
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
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Informed Consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Pregnant or breast-feeding women
Description

Pregnant or breast-feeding women

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Fertile female women without effective contraception
Description

Fertile female women without effective contraception

Data type

boolean

Alias
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Participation in interventional clinical trial within the last 30 days
Description

Participation in interventional clinical trial within the last 30 days

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
CL432484
Current participation in any study
Description

Current participation in any study

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Former participation in this trial
Description

Former participation in this trial

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Selenium intoxication
Description

Selenium intoxication

Data type

boolean

Alias
UMLS CUI 2011AA
C0036581
SNOMED CT 2011_0131
22038003
LOINC Version 232
MTHU007657
UMLS CUI 2011AA
C0728899
SNOMED CT 2011_0131
75478009
MedDRA 14.1
10022727
No commitment to full patient support (i.e. DNR order)
Description

No commitment to full patient support (i.e. DNR order)

Data type

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
C0079252
Patient's death is considered imminent due to coexisting disease
Description

Patient's death is considered imminent due to coexisting disease

Data type

boolean

Alias
UMLS CUI 2011AA
C2363727
MedDRA 14.1
10068311
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0243087
Relationship of the patient to study team member (i.e. colleague, relative)
Description

Relationship of the patient to study team member (i.e. colleague, relative)

Data type

boolean

Alias
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1552089
HL7 V3 2006_05
STF
UMLS CUI 2011AA
C0681088
UMLS CUI 2011AA
C0080103
SNOMED CT 2011_0131
125677006
Infection where guidelines recommend a longer duration of antimicrobial therapy (i.e. endocarditis, tuberculosis, malaria etc)
Description

Infection where guidelines recommend a longer duration of antimicrobial therapy (i.e. endocarditis, tuberculosis, malaria etc)

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0014118
SNOMED CT 2011_0131
56819008
MedDRA 14.1
10014665
ICD-9-CM Version 2011
424.90
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
C0024530
SNOMED CT 2011_0131
61462000
MedDRA 14.1
10025487
ICD-10-CM Version 2010
B54
ICD-9-CM Version 2011
084.6
Patient immunocompromised
Description

Immunocompromised patients

Data type

boolean

Alias
UMLS CUI 2011AA
C0085393
SNOMED CT 2011_0131
370388006
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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 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Severe sepsis or septic shock according to ACCP/SCCM criteria
Item
Severe sepsis or septic shock according to ACCP/SCCM criteria
boolean
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0586857 (UMLS CUI 2011AA)
309345004 (SNOMED CT 2011_0131)
C0037459 (UMLS CUI 2011AA)
C1319411 (UMLS CUI 2011AA)
408478003 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Onset of severe sepsis or septic shock <24 h
Item
Onset of severe sepsis or septic shock <24 h
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Informed consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Pregnant or breast-feeding women
Item
Pregnant or breast-feeding women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Fertile female women without effective contraception
Item
Fertile female women without effective contraception
boolean
CL426012 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Participation in interventional clinical trial within the last 30 days
Item
Participation in interventional clinical trial within the last 30 days
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
CL432484 (UMLS CUI 2011AA)
Current participation in any study
Item
Current participation in any study
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
CL407060 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Former participation in this trial
Item
Former participation in this trial
boolean
C2348568 (UMLS CUI 2011AA)
Selenium intoxication
Item
Selenium intoxication
boolean
C0036581 (UMLS CUI 2011AA)
22038003 (SNOMED CT 2011_0131)
MTHU007657 (LOINC Version 232)
C0728899 (UMLS CUI 2011AA)
75478009 (SNOMED CT 2011_0131)
10022727 (MedDRA 14.1)
No commitment to full patient support (i.e. DNR order)
Item
No commitment to full patient support (i.e. DNR order)
boolean
C1705492 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1521721 (UMLS CUI 2011AA)
C0079252 (UMLS CUI 2011AA)
Patient's death is considered imminent due to coexisting disease
Item
Patient's death is considered imminent due to coexisting disease
boolean
C2363727 (UMLS CUI 2011AA)
10068311 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0243087 (UMLS CUI 2011AA)
Relationship of the patient to study team member (i.e. colleague, relative)
Item
Relationship of the patient to study team member (i.e. colleague, relative)
boolean
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1552089 (UMLS CUI 2011AA)
STF (HL7 V3 2006_05)
C0681088 (UMLS CUI 2011AA)
C0080103 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
Infection where guidelines recommend a longer duration of antimicrobial therapy (i.e. endocarditis, tuberculosis, malaria etc)
Item
Infection where guidelines recommend a longer duration of antimicrobial therapy (i.e. endocarditis, tuberculosis, malaria etc)
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
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)
C0024530 (UMLS CUI 2011AA)
61462000 (SNOMED CT 2011_0131)
10025487 (MedDRA 14.1)
B54 (ICD-10-CM Version 2010)
084.6 (ICD-9-CM Version 2011)
Immunocompromised patients
Item
Patient immunocompromised
boolean
C0085393 (UMLS CUI 2011AA)
370388006 (SNOMED CT 2011_0131)
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