ID

44077

Description

Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Keywords

Versions (3)
  1. 11/2/15 11/2/15 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

German ( localization.languageCode.DE ) English

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

1 forms  
Outpatient Department Visit
Description

Outpatient Department Visit

Alias
UMLS CUI-1
C3845562
Center number:
Description

Center number

Data type

integer

Patient number:
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date of the visit to the outpatient department:
Description

Date of the visit to the outpatient department

Data type

date

Alias
UMLS CUI [1]
C0011008
Reason of the visit:
Description

Reason of the visit

Data type

text

Alias
UMLS CUI [1]
C0945727
Outpatient department visit number:
Description

Outpatient department visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Diseases
Description

Diseases

Alias
UMLS CUI-1
C0012634
Pancreatic insufficiency:
Description

Pancreatic insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0030293
When yes, please mention the date the disease began:
Description

When yes, please mention the date the disease began

Data type

date

Therapy requiring diabetic metabolism:
Description

Therapy requiring diabetic metabolism

Data type

boolean

Alias
UMLS CUI [1]
C0011849
When yes, please mention the date the disease began:
Description

When yes, please mention the date the disease began:

Data type

date

Alias
UMLS CUI [1]
C0011008
Allergic bronchopulmonary aspergillosis (ABPA) with cortisone therapy since the last outpatient visit:
Description

Allergic bronchopulmonary aspergillosis (ABPA) with cortisone therapy since the last outpatient visit

Data type

boolean

Alias
UMLS CUI [1]
C0004031
When yes, please mention the date the disease began:
Description

When yes, please mention the date the disease began:

Data type

date

Alias
UMLS CUI [1]
C0011008
Chronic P. aeruginosa colonization / infection (> 6 months) in the past:
Description

Chronic P. aeruginosa colonization / infection (> 6 months) in the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0033809
UMLS CUI [1,2]
C0151317
Vital signs/ Lung function
Description

Vital signs/ Lung function

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0024119
Height:
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight:
Description

Weight

Data type

float

Measurement units
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
FEV1
Description

PULMONARY FUNCTION TEST

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0748133
%
MEF25:
Description

Maximum expiratory flow rate at 25% of vital capacity

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0429717
%
VC:
Description

Vital capacity

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0042834
%
Clinical status
Description

Clinical status

Alias
UMLS CUI-1
C0449440
Malaise, fatigue:
Description

Malaise, fatigue

Data type

text

Alias
UMLS CUI [1]
C0231218
Sinusitis:
Description

Sinusitis

Data type

boolean

Alias
UMLS CUI [1]
C0037199
Headache:
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Nasal secretion:
Description

Nasal secretion

Data type

text

Alias
UMLS CUI [1]
C1546724
Increased productive cough
Description

Increased productive cough

Data type

boolean

Alias
UMLS CUI [1]
C0239134
Hemoptysis:
Description

Hemoptysis

Data type

boolean

Alias
UMLS CUI [1]
C0019079
Sputum:
Description

Sputum

Data type

boolean

Alias
UMLS CUI [1]
C0038056
Sputum volume:
Description

Sputum volume

Data type

text

Alias
UMLS CUI [1]
C0425514
Physical signs of infection:
Description

Physical signs of infection

Data type

boolean

Alias
UMLS CUI [1]
C3714514
Progressive obstructive breath noise:
Description

Progressive obstructive breath noise

Data type

boolean

Alias
UMLS CUI [1]
C0231856
Progressive rales :
Description

Progressive rales

Data type

boolean

Alias
UMLS CUI [1]
C0034642
Number of days absent (school or job) since the last clinic visit:
Description

Number of days absent (school or job) since the last clinic visit

Data type

integer

Alias
UMLS CUI [1]
C0332197
UMLS CUI [2]
C0439228
Chest x-ray carried out?
Description

Chest x-ray carried out

Data type

boolean

Alias
UMLS CUI [1]
C0039985
When chest x-ray carried out, signs of fresh infection?
Description

When chest x-ray carried out, signs of fresh infection?

Data type

boolean

Alias
UMLS CUI [1]
C3714514
Increased pleural effusion compared to earlier studies?
Description

Increased pleural effusion compared to earlier studies

Data type

boolean

Alias
UMLS CUI [1]
C1253943
Increased atelectasis compared to earlier studies?
Description

Increased atelectasis compared to earlier studies?

Data type

boolean

Alias
UMLS CUI [1]
C0004144
Increased infiltrate compared to earlier studies?
Description

Increased infiltrate compared to earlier studies?

Data type

boolean

Alias
UMLS CUI [1]
C0332448
Infection present (assessed by investigator)?
Description

Infection present (assessed by investigator)?

Data type

text

Alias
UMLS CUI [1]
C3714514
Anti-staphylococcal therapy
Description

Anti-staphylococcal therapy

Alias
UMLS CUI-1
C0003232
Cotrimoxazol:
Description

Cotrimoxazol

Data type

boolean

Alias
UMLS CUI [1]
C0041044
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy end date:
Description

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Indication:
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Flucloxacillin:
Description

Flucloxacillin

Data type

boolean

Alias
UMLS CUI [1]
C0016267
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy end date:
Description

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Indication:
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Cefaclor:
Description

Cefaclor

Data type

boolean

Alias
UMLS CUI [1]
C0007537
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy end date:
Description

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Indication:
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
When other, please mention:
Description

When other, please mention

Data type

text

Alias
UMLS CUI [1]
C0205394
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy end date:
Description

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Indication:
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Therapy with Azithromycin
Description

Therapy with Azithromycin

Alias
UMLS CUI-1
C0052796
UMLS CUI-2
C0039798
Therapy with Azithromycin:
Description

Therapy with Azithromycin

Data type

boolean

Alias
UMLS CUI [1,1]
C0052796
UMLS CUI [1,2]
C0039798
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy end date:
Description

Therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
Inhaled antibiotic therapy (since the last outpatient department visit)
Description

Inhaled antibiotic therapy (since the last outpatient department visit)

Alias
UMLS CUI-1
C0003232
UMLS CUI-2
C0556393
Polymyxin:
Description

Polymyxin

Data type

boolean

Alias
UMLS CUI [1]
C0032539
Number of cycles:
Description

number of cycles

Data type

integer

Mean duration of therapy per cycle:
Description

Mean duration of therapy per cycle

Data type

text

Alias
UMLS CUI [1]
C0444921
Tobramycin:
Description

Tobramycin

Data type

boolean

Alias
UMLS CUI [1]
C0040341
Number of cycles:
Description

Number of cycles

Data type

integer

Mean duration of therapy per cycle:
Description

Mean duration of therapy per cycle

Data type

text

Alias
UMLS CUI [1]
C0444921
Further antibiotics (since the last outpatient department visit)
Description

Further antibiotics (since the last outpatient department visit)

Alias
UMLS CUI-1
C0003232
Medication name:
Description

Medication name

Data type

text

Alias
UMLS CUI [1]
C0013227
Route of administration:
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Therapy start date:
Description

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Duration of therapy:
Description

Duration of therapy

Data type

integer

Measurement units
  • Tage
Alias
UMLS CUI [1]
C0444921
Tage
Sample material collection
Description

Sample material collection

Alias
UMLS CUI-1
C0200345
Outpatient visit Friday or before a holiday? (When yes, sampling material must be omitted because they can not be preserved for many days)
Description

Outpatient visit Friday or before a holiday? (When yes, sampling material must be omitted because they can not be preserved for many days)

Data type

boolean

Alias
UMLS CUI [1]
C0557824
Sputum:
Description

Sputum

Data type

boolean

Alias
UMLS CUI [1]
C0038056
Nasal swab
Description

nasal swab

Data type

boolean

Alias
UMLS CUI [1]
C3669207
Throat swab sample
Description

Throat swab sample

Data type

boolean

Alias
UMLS CUI [1]
C0439056
Serum vacutainer
Description

Serum vacutainer

Data type

boolean

Alias
UMLS CUI [1,1]
C1883522
UMLS CUI [1,2]
C0229671
Blood specimen with EDTA:
Description

Blood specimen with EDTA

Data type

boolean

Alias
UMLS CUI [1]
C2919842
Dispatch
Description

Dispatch

Alias
UMLS CUI-1
C0200368
Dispatch of the specimen and the case report form of the Outpatient department visit and Basic data
Description

Dispatch of the specimen and the case report form of the Outpatient department visit and Basic data

Data type

text

Alias
UMLS CUI [1]
C0200368
UMLS CUI [2]
C0370003
UMLS CUI [3]
C1516308
Please mention when other reasons chosen:
Description

Please mention when other reasons chosen

Data type

text

Alias
UMLS CUI [1]
C0205394
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Similar models

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Outpatient Department Visit
C3845562 (UMLS CUI-1)
Center number
Item
Center number:
integer
Patient number
Item
Patient number:
integer
C1830427 (UMLS CUI [1])
date
Item
Date of the visit to the outpatient department:
date
C0011008 (UMLS CUI [1])
Item
Reason of the visit:
text
C0945727 (UMLS CUI [1])
Reason of the visit
Code List
Reason of the visit:
CL Item
Routine visit (1)
CL Item
Exacerbation (2)
Visit number
Item
Outpatient department visit number:
integer
C1549755 (UMLS CUI [1])
Item Group
Diseases
C0012634 (UMLS CUI-1)
pancreatic insufficiency
Item
Pancreatic insufficiency:
boolean
C0030293 (UMLS CUI [1])
date
Item
When yes, please mention the date the disease began:
date
diabetes mellitus
Item
Therapy requiring diabetic metabolism:
boolean
C0011849 (UMLS CUI [1])
date
Item
When yes, please mention the date the disease began:
date
C0011008 (UMLS CUI [1])
Allergic bronchopulmonary aspergillosis
Item
Allergic bronchopulmonary aspergillosis (ABPA) with cortisone therapy since the last outpatient visit:
boolean
C0004031 (UMLS CUI [1])
date
Item
When yes, please mention the date the disease began:
date
C0011008 (UMLS CUI [1])
P. aeruginosa, chronic infection
Item
Chronic P. aeruginosa colonization / infection (> 6 months) in the past:
boolean
C0033809 (UMLS CUI [1,1])
C0151317 (UMLS CUI [1,2])
Item Group
Vital signs/ Lung function
C0518766 (UMLS CUI-1)
C0024119 (UMLS CUI-2)
Height
Item
Height:
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight:
float
C0005910 (UMLS CUI [1])
FEV1
Item
FEV1
integer
C0748133 (UMLS CUI [1])
MEF25
Item
MEF25:
integer
C0429717 (UMLS CUI [1])
Vital capacity
Item
VC:
integer
C0042834 (UMLS CUI [1])
Item Group
Clinical status
C0449440 (UMLS CUI-1)
Item
Malaise, fatigue:
text
C0231218 (UMLS CUI [1])
malaise
Code List
Malaise, fatigue:
CL Item
No (1)
CL Item
Slight (2)
CL Item
Intermediate (3)
CL Item
Severe (4)
Sinusitis
Item
Sinusitis:
boolean
C0037199 (UMLS CUI [1])
headache
Item
Headache:
boolean
C0018681 (UMLS CUI [1])
Item
Nasal secretion:
text
C1546724 (UMLS CUI [1])
Nasal secretion
Code List
Nasal secretion:
CL Item
Clear (1)
CL Item
Green/ Yellow (2)
CL Item
No (3)
productive cough
Item
Increased productive cough
boolean
C0239134 (UMLS CUI [1])
Hemoptysis
Item
Hemoptysis:
boolean
C0019079 (UMLS CUI [1])
Sputum
Item
Sputum:
boolean
C0038056 (UMLS CUI [1])
Item
Sputum volume:
text
C0425514 (UMLS CUI [1])
Sputum volume
Code List
Sputum volume:
CL Item
Little (1)
CL Item
A lot (2)
infection
Item
Physical signs of infection:
boolean
C3714514 (UMLS CUI [1])
Abnormal breath sounds
Item
Progressive obstructive breath noise:
boolean
C0231856 (UMLS CUI [1])
rales
Item
Progressive rales :
boolean
C0034642 (UMLS CUI [1])
Absent; day
Item
Number of days absent (school or job) since the last clinic visit:
integer
C0332197 (UMLS CUI [1])
C0439228 (UMLS CUI [2])
chest x-ray
Item
Chest x-ray carried out?
boolean
C0039985 (UMLS CUI [1])
infection
Item
When chest x-ray carried out, signs of fresh infection?
boolean
C3714514 (UMLS CUI [1])
Pleural effusion
Item
Increased pleural effusion compared to earlier studies?
boolean
C1253943 (UMLS CUI [1])
Atelectasis
Item
Increased atelectasis compared to earlier studies?
boolean
C0004144 (UMLS CUI [1])
Infiltration
Item
Increased infiltrate compared to earlier studies?
boolean
C0332448 (UMLS CUI [1])
Item
Infection present (assessed by investigator)?
text
C3714514 (UMLS CUI [1])
Infection
Code List
Infection present (assessed by investigator)?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Can not be assessed certainly. (3)
Item Group
Anti-staphylococcal therapy
C0003232 (UMLS CUI-1)
Trimethoprim-Sulfamethoxazole Combination
Item
Cotrimoxazol:
boolean
C0041044 (UMLS CUI [1])
therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Therapy end date
Item
Therapy end date:
date
C1531784 (UMLS CUI [1])
Item
Indication:
text
C3146298 (UMLS CUI [1])
indication
Code List
Indication:
CL Item
prophylaxis (1)
CL Item
by proof of S. aureus (2)
CL Item
clinical indication (3)
Floxacillin
Item
Flucloxacillin:
boolean
C0016267 (UMLS CUI [1])
Therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Therapy end date
Item
Therapy end date:
date
C1531784 (UMLS CUI [1])
Item
Indication:
text
C3146298 (UMLS CUI [1])
Indication
Code List
Indication:
CL Item
prophylaxis (1)
CL Item
by proof of S. aureus (2)
CL Item
clinical indication (3)
Cefaclor
Item
Cefaclor:
boolean
C0007537 (UMLS CUI [1])
Therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Therapy end date
Item
Therapy end date:
date
C1531784 (UMLS CUI [1])
Item
Indication:
text
C3146298 (UMLS CUI [1])
Indication
Code List
Indication:
CL Item
prophylaxis (1)
CL Item
by proof of S. aureus (2)
CL Item
clinical indication (3)
Other
Item
When other, please mention:
text
C0205394 (UMLS CUI [1])
Therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Therapy end date
Item
Therapy end date:
date
C1531784 (UMLS CUI [1])
Item
Indication:
text
C3146298 (UMLS CUI [1])
Indication
Code List
Indication:
CL Item
prophylaxis (1)
CL Item
by proof of S. aureus (2)
CL Item
clinical indication (3)
Item Group
Therapy with Azithromycin
C0052796 (UMLS CUI-1)
C0039798 (UMLS CUI-2)
Azithromycin, therapy
Item
Therapy with Azithromycin:
boolean
C0052796 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
Therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Therapy end date
Item
Therapy end date:
date
C1531784 (UMLS CUI [1])
Item Group
Inhaled antibiotic therapy (since the last outpatient department visit)
C0003232 (UMLS CUI-1)
C0556393 (UMLS CUI-2)
Polymyxin
Item
Polymyxin:
boolean
C0032539 (UMLS CUI [1])
number of cycles
Item
Number of cycles:
integer
Therapy duration
Item
Mean duration of therapy per cycle:
text
C0444921 (UMLS CUI [1])
Tobramycin
Item
Tobramycin:
boolean
C0040341 (UMLS CUI [1])
Number of cycles
Item
Number of cycles:
integer
Duration of therapy
Item
Mean duration of therapy per cycle:
text
C0444921 (UMLS CUI [1])
Item Group
Further antibiotics (since the last outpatient department visit)
C0003232 (UMLS CUI-1)
medication
Item
Medication name:
text
C0013227 (UMLS CUI [1])
Item
Route of administration:
text
C0013153 (UMLS CUI [1])
Route of administration
Code List
Route of administration:
CL Item
oral (1)
CL Item
intravenous (2)
Therapy start date
Item
Therapy start date:
date
C3173309 (UMLS CUI [1])
Duration of therapy
Item
Duration of therapy:
integer
C0444921 (UMLS CUI [1])
Item Group
Sample material collection
C0200345 (UMLS CUI-1)
outpatient department
Item
Outpatient visit Friday or before a holiday? (When yes, sampling material must be omitted because they can not be preserved for many days)
boolean
C0557824 (UMLS CUI [1])
Sputum
Item
Sputum:
boolean
C0038056 (UMLS CUI [1])
nasal swab
Item
Nasal swab
boolean
C3669207 (UMLS CUI [1])
Throat swab sample
Item
Throat swab sample
boolean
C0439056 (UMLS CUI [1])
Vacutainer Serum
Item
Serum vacutainer
boolean
C1883522 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Blood specimen with EDTA
Item
Blood specimen with EDTA:
boolean
C2919842 (UMLS CUI [1])
Item Group
Dispatch
C0200368 (UMLS CUI-1)
Item
Dispatch of the specimen and the case report form of the Outpatient department visit and Basic data
text
C0200368 (UMLS CUI [1])
C0370003 (UMLS CUI [2])
C1516308 (UMLS CUI [3])
dispatch; specimen; case report form
Code List
Dispatch of the specimen and the case report form of the Outpatient department visit and Basic data
CL Item
No, due to friday or holiday (1)
CL Item
No, due to other reasons (2)
CL Item
Yes (3)
CL Item
Dispatch of the CRF pages only (4)
other
Item
Please mention when other reasons chosen:
text
C0205394 (UMLS CUI [1])
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