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ID
42057
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)
- 11/2/15 11/2/15 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Uploaded on
March 15, 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
Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8
Similar models
Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
CL Item
Routine visit (1)
CL Item
Exacerbation (2)
Visit number
Item
Outpatient department visit number:
integer
C1549755 (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])
C0151317 (UMLS CUI [1,2])
Item Group
Vital signs/ Lung function
C0518766 (UMLS CUI-1)
C0024119 (UMLS CUI-2)
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])
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])
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])
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])
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])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Can not be assessed certainly. (3)
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])
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])
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])
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])
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)
C0039798 (UMLS CUI-2)
Azithromycin, therapy
Item
Therapy with Azithromycin:
boolean
C0052796 (UMLS CUI [1,1])
C0039798 (UMLS CUI [1,2])
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)
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
C0444917 (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
C0444917 (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])
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
C0444917 (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])
C0229671 (UMLS CUI [1,2])
Blood specimen with EDTA
Item
Blood specimen with EDTA:
boolean
C2919842 (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])
C0370003 (UMLS CUI [2])
C1516308 (UMLS CUI [3])
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])