ID

246

Description

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

Lien

http://clinicaltrials.gov/show/NCT00303589

Mots-clés

  1. 16/03/2012 16/03/2012 -
  2. 09/06/2017 09/06/2017 - Martin Dugas
Téléchargé le

16 mars 2012

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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Eligibility NCT00303589 Soft Tissue Infections

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alter >=18 Jahre
Description

Age

Type de données

boolean

skin or skin structure infection requiring hospitalization
Description

skin infection requiring hospitalization

Type de données

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

Type de données

boolean

material from site of infection is clinically purulent or seropurulent
Description

infection material is purulent or sero-purulent

Type de données

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

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

presenting with sustained shock

Type de données

boolean

known or suspected concomitant bacterial infection requiring antibiotic treatment
Description

concomitant bacterial infection requiring antibiotic treatment

Type de données

boolean

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

skin infection or non-healing ulcer

Type de données

boolean

patients in whom surgery is the primary treatment
Description

surgery as primary treatment

Type de données

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Alter
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnose
Description

Diagnosis

Type de données

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Erkrankung im Erwachsenenalter
Description

Adult Illness

Type de données

string

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

Skin Infection

Type de données

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

Type de données

string

Alias
UMLS CUI
C0019993
SNOMED CT 2010_0731
394656005
MedDRA 13.1
10054112
klinische Diagnose
Description

Clinical Diagnosis

Type de données

string

Alias
UMLS CUI
C0332140
SNOMED CT 2010_0731
39154008
Haut
Description

Skin

Type de données

string

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

Bacteria

Type de données

string

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

Randomized Clinical Trial

Type de données

string

Alias
UMLS CUI
C0206034
purulent
Description

Purulent

Type de données

string

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

SKIN LESION, SEROPURULENT

Type de données

string

Alias
UMLS CUI
C0241117
Circulatory collapse
Description

Shock

Type de données

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

Type de données

string

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

Systolic Pressure

Type de données

string

Alias
UMLS CUI
C0871470
SNOMED CT 2010_0731
271649006
Reanimation
Description

Resuscitation

Type de données

string

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

Body Fluid or Substance

Type de données

string

Alias
UMLS CUI
CL427986
bakterielle Infektion
Description

Bacterial Infections

Type de données

string

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

Concomitant

Type de données

string

Alias
UMLS CUI
CL415222
Antibiotikatherapie
Description

Antibiotic Therapy

Type de données

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

Type de données

string

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

chronic

Type de données

string

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

surgery

Type de données

string

Alias
UMLS CUI
C0038895
First-Line Therapy
Description

primary treatment

Type de données

string

Alias
UMLS CUI
C1708063

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
Age
Item
Alter >=18 Jahre
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
Ausschlusskriterien
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
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Adult Illness
Item
Erkrankung im Erwachsenenalter
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
klinische Diagnose
string
C0332140 (UMLS CUI)
39154008 (SNOMED CT 2010_0731)
Skin
Item
Haut
string
C1123023 (UMLS CUI)
39937001 (SNOMED CT 2010_0731)
MTHU001414 (LOINC Version 232)
Bacteria
Item
Bakterium
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
Reanimation
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
bakterielle Infektion
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
Antibiotikatherapie
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
chronisch
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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