ID

26515

Description

Original CRFs from: K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor. Further details on: http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html https://clinicaltrials.gov/ct2/show/NCT03151603 Worksheet Source Data

Link

http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html

Keywords

Versions (2)
  1. 10/18/17 10/18/17 -
  2. 11/1/17 11/1/17 -
Copyright Holder

K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor

Uploaded on

October 18, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0
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Worksheet Source Data REGATTA NCT03151603

English

Worksheet Source Data REGATTA NCT03151603

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient-ID
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Day 0 Baseline
Description

Day 0 Baseline

Alias
UMLS CUI-1
C1442488
Written Informed Consent (REGATA)
Description

Written Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Date of Informed Consent
Description

Informed Consent Date

Data type

text

Alias
UMLS CUI [1]
C2985782
Written Informed Consent: Observational Study
Description

Informed Consent: Observational Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1518527
Written Informed Consent: Observational Study
Description

Informed Consent Date: Observational Study

Data type

date

Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C1518527
Inclusion Criteria - Mark with a cross where applicable.
Description

Inclusion Criteria - Mark with a cross where applicable.

Alias
UMLS CUI-1
C1512693
Women (18 - 75 y/o) with suspected Urinary Tract Infection:
Description

Gender, Age, Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0042029
Dysuria
Description

The female patient has following symptoms of a urinary tract infection: (at least two symptoms to be included)

Data type

boolean

Alias
UMLS CUI [1]
C0013428
Frequent Urination
Description

The female patient has following symptoms of a urinary tract infection: (at least two symptoms to be included)

Data type

boolean

Alias
UMLS CUI [1]
C2584336
Urge to urinate
Description

The female patient has following symptoms of a urinary tract infection: (at least two symptoms to be included)

Data type

boolean

Alias
UMLS CUI [1]
C0085606
Lower abdominal pain
Description

The female patient has following symptoms of a urinary tract infection: (at least two symptoms to be included)

Data type

boolean

Alias
UMLS CUI [1]
C0232495
Exlusion Criteria - Mark with a cross where applicable.
Description

Exlusion Criteria - Mark with a cross where applicable.

Alias
UMLS CUI-1
C0680251
Symptoms of Kidney Infection (Complicated Urinary Tract Infection) (e.g. body temperature > 38°C, flank pain)
Description

Kidney Infection

Data type

boolean

Alias
UMLS CUI [1]
C0021313
Conditions which may lead to a Kidney Infection
Description

At Risk for Kidney Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0021313
Known Pregnancy or Lactation
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Existing Pain Medication with Uva Ursi-preparations, e.g. Cystinol, Uvalysat, Arctuvan.
Description

Analgesics

Data type

boolean

Alias
UMLS CUI [1]
C0002771
Intake of antibiotics in the last 7 days.
Description

Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0003232
Previous Urinary Tract Infection in the last two weeks.
Description

Previous Urinary Tract Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0042029
Anamnestic known pyelonephritis.
Description

Pyelonephritis

Data type

boolean

Alias
UMLS CUI [1]
C0034186
Contraindication to Study Drug following Study Instruction.
Description

Contraindication to Study Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
Serious Illness
Description

Serious Illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
Incapacity to understand nature and scope as well as possible consequences of clinical examination.
Description

Incapacity

Data type

boolean

Alias
UMLS CUI [1]
C3176592
Actual Participation in another study or participation in another study in the last 4 weeks.
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Patient Data
Description

Patient Data

Alias
UMLS CUI-1
C2707520
Serving and explanation of intake of Study Medication.
Description

Study Medication

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Serving and explanation of intake of Study Medication. If NO, please specify the reason for not doing so:
Description

Study Medication: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348235
Patient Birth Year
Description

Birth Year

Data type

date

Alias
UMLS CUI [1]
C2826771
Body Temperature (measured in ear or mouth):
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pregnancy Test performed?
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Pregnancy Test performed? If NO, specify reason:
Description

Pregnancy Test: Reason

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0566251
Pregnancy Test Finding:
Description

Pregnancy Test Finding

Data type

text

Alias
UMLS CUI [1]
C0427777
Comorbidity:
Description

Comorbidity

Data type

text

Alias
UMLS CUI [1]
C0009488
Comorbidity: ICD-10 Code
Description

Comorbidity: ICD-10 Code

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2598420
Concomitant Medication (Substance)
Description

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Concomitant Medication (Substance): Intake
Description

Concomitant Medication: Intake

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1512806
Urine Dipstick Test
Description

Urine Dipstick Test

Alias
UMLS CUI-1
C0430370
Urine Dipstick Test performed?
Description

Urine Dipstick Test

Data type

boolean

Alias
UMLS CUI [1]
C0430056
Urine Dipstick Test performed? If NO, specify reason:
Description

Urine Dipstick Test: Reason

Data type

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0392360
Date of Urine Dipstick Test:
Description

Urine Dipstick Test Date

Data type

date

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0011008
Leukocytes
Description

Urine Dipstick Test: Leukocytes

Data type

text

Alias
UMLS CUI [1]
C1256582
Erythrocytes
Description

Urine Dipstick Test: Erythrocytes

Data type

text

Alias
UMLS CUI [1]
C2188659
Nitrite
Description

Urine Dipstick Test: Nitrite

Data type

text

Alias
UMLS CUI [1]
C0580333
Urine Culture
Description

Urine Culture

Alias
UMLS CUI-1
C0848716
Urine Culture performed?
Description

Urine Culture

Data type

boolean

Alias
UMLS CUI [1]
C0848716
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator's Name
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date of Report

Data type

date

Alias
UMLS CUI [1]
C1302584
Investigator's Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Worksheet Source Data REGATTA NCT03151603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient ID
Item
Patient-ID
text
C2348585 (UMLS CUI [1])
Item Group
Day 0 Baseline
C1442488 (UMLS CUI-1)
Written Informed Consent
Item
Written Informed Consent (REGATA)
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Date of Informed Consent
text
C2985782 (UMLS CUI [1])
Informed Consent: Observational Study
Item
Written Informed Consent: Observational Study
boolean
C0021430 (UMLS CUI [1,1])
C1518527 (UMLS CUI [1,2])
Informed Consent Date: Observational Study
Item
Written Informed Consent: Observational Study
date
C2985782 (UMLS CUI [1,1])
C1518527 (UMLS CUI [1,2])
Item Group
Inclusion Criteria - Mark with a cross where applicable.
C1512693 (UMLS CUI-1)
Gender, Age, Urinary Tract Infection
Item
Women (18 - 75 y/o) with suspected Urinary Tract Infection:
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0042029 (UMLS CUI [3])
Dysuria
Item
Dysuria
boolean
C0013428 (UMLS CUI [1])
Urinary Frequency
Item
Frequent Urination
boolean
C2584336 (UMLS CUI [1])
Urge to urinate
Item
Urge to urinate
boolean
C0085606 (UMLS CUI [1])
Lower abdominal pain
Item
Lower abdominal pain
boolean
C0232495 (UMLS CUI [1])
Item Group
Exlusion Criteria - Mark with a cross where applicable.
C0680251 (UMLS CUI-1)
Kidney Infection
Item
Symptoms of Kidney Infection (Complicated Urinary Tract Infection) (e.g. body temperature > 38°C, flank pain)
boolean
C0021313 (UMLS CUI [1])
At Risk for Kidney Infection
Item
Conditions which may lead to a Kidney Infection
boolean
C1444641 (UMLS CUI [1,1])
C0021313 (UMLS CUI [1,2])
Gynaecological Status
Item
Known Pregnancy or Lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Analgesics
Item
Existing Pain Medication with Uva Ursi-preparations, e.g. Cystinol, Uvalysat, Arctuvan.
boolean
C0002771 (UMLS CUI [1])
Antibiotics
Item
Intake of antibiotics in the last 7 days.
boolean
C0003232 (UMLS CUI [1])
Previous Urinary Tract Infection
Item
Previous Urinary Tract Infection in the last two weeks.
boolean
C0205156 (UMLS CUI [1,1])
C0042029 (UMLS CUI [1,2])
Pyelonephritis
Item
Anamnestic known pyelonephritis.
boolean
C0034186 (UMLS CUI [1])
Contraindication to Study Drug
Item
Contraindication to Study Drug following Study Instruction.
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Serious Illness
Item
Serious Illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Incapacity
Item
Incapacity to understand nature and scope as well as possible consequences of clinical examination.
boolean
C3176592 (UMLS CUI [1])
Study Participation Status
Item
Actual Participation in another study or participation in another study in the last 4 weeks.
boolean
C2348568 (UMLS CUI [1])
Item Group
Patient Data
C2707520 (UMLS CUI-1)
Study Medication
Item
Serving and explanation of intake of Study Medication.
boolean
C0304229 (UMLS CUI [1])
Study Medication: Specification
Item
Serving and explanation of intake of Study Medication. If NO, please specify the reason for not doing so:
text
C0304229 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Birth Year
Item
Patient Birth Year
date
C2826771 (UMLS CUI [1])
Body Temperature
Item
Body Temperature (measured in ear or mouth):
float
C0005903 (UMLS CUI [1])
Pregnancy Test
Item
Pregnancy Test performed?
boolean
C0032976 (UMLS CUI [1])
Pregnancy Test: Reason
Item
Pregnancy Test performed? If NO, specify reason:
text
C0032976 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item
Pregnancy Test Finding:
text
C0427777 (UMLS CUI [1])
Pregnancy Test Finding
Code List
Pregnancy Test Finding:
CL Item
positive (positive)
CL Item
negative (negative)
Comorbidity
Item
Comorbidity:
text
C0009488 (UMLS CUI [1])
Comorbidity: ICD-10 Code
Item
Comorbidity: ICD-10 Code
text
C0009488 (UMLS CUI [1,1])
C2598420 (UMLS CUI [1,2])
Concomitant Medication
Item
Concomitant Medication (Substance)
text
C2347852 (UMLS CUI [1])
Item
Concomitant Medication (Substance): Intake
text
C2347852 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
Concomitant Medication: Intake
Code List
Concomitant Medication (Substance): Intake
CL Item
if required (if required)
CL Item
temporary (temporary)
CL Item
long-term (long-term)
Item Group
Urine Dipstick Test
C0430370 (UMLS CUI-1)
Urine Dipstick Test
Item
Urine Dipstick Test performed?
boolean
C0430056 (UMLS CUI [1])
Urine Dipstick Test: Reason
Item
Urine Dipstick Test performed? If NO, specify reason:
text
C0430056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Urine Dipstick Test Date
Item
Date of Urine Dipstick Test:
date
C0430370 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Leukocytes
text
C1256582 (UMLS CUI [1])
Urine Dipstick Test: Leukocytes
Code List
Leukocytes
CL Item
- (-)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
Item
Erythrocytes
text
C2188659 (UMLS CUI [1])
Urine Dipstick Test: Erythrocytes
Code List
Erythrocytes
CL Item
- (-)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
Item
Nitrite
text
C0580333 (UMLS CUI [1])
Urine Dipstick Test: Nitrite
Code List
Nitrite
CL Item
positive (positive)
CL Item
negative (negative)
Item Group
Urine Culture
C0848716 (UMLS CUI-1)
Urine Culture
Item
Urine Culture performed?
boolean
C0848716 (UMLS CUI [1])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Date of Report
Item
Date
date
C1302584 (UMLS CUI [1])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
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