ID

246

Description

ODM derived from http://clinicaltrials.gov/show/NCT00303589

Link

http://clinicaltrials.gov/show/NCT00303589

Keywords

  1. 3/16/12 3/16/12 -
  2. 6/9/17 6/9/17 - Martin Dugas
Uploaded on

March 16, 2012

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility NCT00303589 Soft Tissue Infections

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age adult patients, >=18 years of age
Description

Age

Data type

boolean

skin or skin structure infection requiring hospitalization
Description

skin infection requiring hospitalization

Data type

boolean

clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment
Description

skin infection caused by bacteria susceptible to the study treatment

Data type

boolean

material from site of infection is clinically purulent or seropurulent
Description

infection material is purulent or sero-purulent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation)
Description

presenting with sustained shock

Data type

boolean

known or suspected concomitant bacterial infection requiring antibiotic treatment
Description

concomitant bacterial infection requiring antibiotic treatment

Data type

boolean

skin infection or chronic non-healing ulcer of > 2 weeks duration
Description

skin infection or non-healing ulcer

Data type

boolean

patients in whom surgery is the primary treatment
Description

surgery as primary treatment

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Adult disease
Description

Adult Illness

Data type

string

Alias
UMLS CUI
C0277562
SNOMED CT 2010_0731
64342008
Skin Infection
Description

Skin Infection

Data type

string

Alias
UMLS CUI
C0037278
SNOMED CT 2010_0731
108365000
MedDRA 13.1
10040872
CTCAE Version 4.03
E11568
Inpatient care (regime/therapy)
Description

Hospitalization

Data type

string

Alias
UMLS CUI
C0019993
SNOMED CT 2010_0731
394656005
MedDRA 13.1
10054112
Clinical Diagnosis (contextual qualifier)
Description

Clinical Diagnosis

Data type

string

Alias
UMLS CUI
C0332140
SNOMED CT 2010_0731
39154008
Integument
Description

Skin

Data type

string

Alias
UMLS CUI
C1123023
SNOMED CT 2010_0731
39937001
LOINC Version 232
MTHU001414
Bacterium
Description

Bacteria

Data type

string

Alias
UMLS CUI
C0004611
SNOMED CT 2010_0731
409822003
LOINC Version 232
MTHU002404
Randomized Clinical Trial
Description

Randomized Clinical Trial

Data type

string

Alias
UMLS CUI
C0206034
Purulent
Description

Purulent

Data type

string

Alias
UMLS CUI
C0439665
SNOMED CT 2010_0731
255316004
SKIN LESION, SEROPURULENT
Description

SKIN LESION, SEROPURULENT

Data type

string

Alias
UMLS CUI
C0241117
Circulatory collapse
Description

Shock

Data type

string

Alias
UMLS CUI
C0036974
SNOMED CT 2010_0731
27942005
MedDRA 13.1
10040560
ICD-10-CM Version 2010
R57.9
ICD-9-CM Version 2011
785.50
Sustained (qualifier value)
Description

Sustained

Data type

string

Alias
UMLS CUI
C0443318
SNOMED CT 2010_0731
263892007
Systolic Blood Pressure
Description

Systolic Pressure

Data type

string

Alias
UMLS CUI
C0871470
SNOMED CT 2010_0731
271649006
Resuscitation procedure
Description

Resuscitation

Data type

string

Alias
UMLS CUI
C0035273
SNOMED CT 2010_0731
439569004
MedDRA 13.1
10038749
Body Fluid or Substance
Description

Body Fluid or Substance

Data type

string

Alias
UMLS CUI
CL427986
Bacterial infectious disease
Description

Bacterial Infections

Data type

string

Alias
UMLS CUI
C0004623
SNOMED CT 2010_0731
87628006
MedDRA 13.1
10060945
ICD-10-CM Version 2010
A49.9
Concomitant
Description

Concomitant

Data type

string

Alias
UMLS CUI
CL415222
Antibiotic Therapy (procedure)
Description

Antibiotic Therapy

Data type

string

Alias
UMLS CUI
C0338237
SNOMED CT 2010_0731
281789004
MedDRA 13.1
10067768
non-healing ulcer of skin
Description

non-healing ulcer of skin

Data type

string

Alias
UMLS CUI
C0748826
ICD-10-CM Version 2010
L97
chronic
Description

chronic

Data type

string

Alias
UMLS CUI
C0205191
SNOMED CT 2010_0731
90734009
operative procedures
Description

surgery

Data type

string

Alias
UMLS CUI
C0038895
First-Line Therapy
Description

primary treatment

Data type

string

Alias
UMLS CUI
C1708063

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age adult patients, >=18 years of age
boolean
skin infection requiring hospitalization
Item
skin or skin structure infection requiring hospitalization
boolean
skin infection caused by bacteria susceptible to the study treatment
Item
clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment
boolean
infection material is purulent or sero-purulent
Item
material from site of infection is clinically purulent or seropurulent
boolean
Item Group
Exclusion Criteria
presenting with sustained shock
Item
presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation)
boolean
concomitant bacterial infection requiring antibiotic treatment
Item
known or suspected concomitant bacterial infection requiring antibiotic treatment
boolean
skin infection or non-healing ulcer
Item
skin infection or chronic non-healing ulcer of > 2 weeks duration
boolean
surgery as primary treatment
Item
patients in whom surgery is the primary treatment
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Adult Illness
Item
Adult disease
string
C0277562 (UMLS CUI)
64342008 (SNOMED CT 2010_0731)
Skin Infection
Item
Skin Infection
string
C0037278 (UMLS CUI)
108365000 (SNOMED CT 2010_0731)
10040872 (MedDRA 13.1)
E11568 (CTCAE Version 4.03)
Hospitalization
Item
Inpatient care (regime/therapy)
string
C0019993 (UMLS CUI)
394656005 (SNOMED CT 2010_0731)
10054112 (MedDRA 13.1)
Clinical Diagnosis
Item
Clinical Diagnosis (contextual qualifier)
string
C0332140 (UMLS CUI)
39154008 (SNOMED CT 2010_0731)
Skin
Item
Integument
string
C1123023 (UMLS CUI)
39937001 (SNOMED CT 2010_0731)
MTHU001414 (LOINC Version 232)
Bacteria
Item
Bacterium
string
C0004611 (UMLS CUI)
409822003 (SNOMED CT 2010_0731)
MTHU002404 (LOINC Version 232)
Randomized Clinical Trial
Item
Randomized Clinical Trial
string
C0206034 (UMLS CUI)
Purulent
Item
Purulent
string
C0439665 (UMLS CUI)
255316004 (SNOMED CT 2010_0731)
SKIN LESION, SEROPURULENT
Item
SKIN LESION, SEROPURULENT
string
C0241117 (UMLS CUI)
Shock
Item
Circulatory collapse
string
C0036974 (UMLS CUI)
27942005 (SNOMED CT 2010_0731)
10040560 (MedDRA 13.1)
R57.9 (ICD-10-CM Version 2010)
785.50 (ICD-9-CM Version 2011)
Sustained
Item
Sustained (qualifier value)
string
C0443318 (UMLS CUI)
263892007 (SNOMED CT 2010_0731)
Systolic Pressure
Item
Systolic Blood Pressure
string
C0871470 (UMLS CUI)
271649006 (SNOMED CT 2010_0731)
Resuscitation
Item
Resuscitation procedure
string
C0035273 (UMLS CUI)
439569004 (SNOMED CT 2010_0731)
10038749 (MedDRA 13.1)
Body Fluid or Substance
Item
Body Fluid or Substance
string
CL427986 (UMLS CUI)
Bacterial Infections
Item
Bacterial infectious disease
string
C0004623 (UMLS CUI)
87628006 (SNOMED CT 2010_0731)
10060945 (MedDRA 13.1)
A49.9 (ICD-10-CM Version 2010)
Concomitant
Item
Concomitant
string
CL415222 (UMLS CUI)
Antibiotic Therapy
Item
Antibiotic Therapy (procedure)
string
C0338237 (UMLS CUI)
281789004 (SNOMED CT 2010_0731)
10067768 (MedDRA 13.1)
non-healing ulcer of skin
Item
non-healing ulcer of skin
string
C0748826 (UMLS CUI)
L97 (ICD-10-CM Version 2010)
chronic
Item
chronic
string
C0205191 (UMLS CUI)
90734009 (SNOMED CT 2010_0731)
surgery
Item
operative procedures
string
C0038895 (UMLS CUI)
primary treatment
Item
First-Line Therapy
string
C1708063 (UMLS CUI)

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