ID

27113

Beschreibung

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

Stichworte

Versionen (2)
  1. 18.10.17 18.10.17 -
  2. 01.11.17 01.11.17 -
Rechteinhaber

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

Hochgeladen am

1. November 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC-ND 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Worksheet Source Data REGATTA NCT03151603

Deutsch Englisch

Worksheet Source Data REGATTA NCT03151603

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient-ID
Beschreibung

Patient ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Day 0 Baseline
Beschreibung

Day 0 Baseline

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

Written Informed Consent

Datentyp

boolean

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

Informed Consent Date

Datentyp

text

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

Informed Consent: Observational Study

Datentyp

boolean

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

Informed Consent Date: Observational Study

Datentyp

date

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

Inclusion Criteria - Mark with a cross where applicable.

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

Gender, Age, Urinary Tract Infection

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0013428
Frequent Urination
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C2584336
Urge to urinate
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0085606
Lower abdominal pain
Beschreibung

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

Datentyp

boolean

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

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)
Beschreibung

Kidney Infection

Datentyp

boolean

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

At Risk for Kidney Infection

Datentyp

boolean

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

Gynaecological Status

Datentyp

boolean

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

Analgesics

Datentyp

boolean

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

Antibiotics

Datentyp

boolean

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

Previous Urinary Tract Infection

Datentyp

boolean

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

Pyelonephritis

Datentyp

boolean

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

Contraindication to Study Drug

Datentyp

boolean

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

Serious Illness

Datentyp

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.
Beschreibung

Incapacity

Datentyp

boolean

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

Study Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Patient Data
Beschreibung

Patient Data

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

Study Medication

Datentyp

boolean

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

Study Medication: Specification

Datentyp

text

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

Birth Year

Datentyp

date

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

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pregnancy Test performed?
Beschreibung

Pregnancy Test

Datentyp

boolean

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

Pregnancy Test: Reason

Datentyp

text

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

Pregnancy Test Finding

Datentyp

text

Alias
UMLS CUI [1]
C0427777
Comorbidity:
Beschreibung

Comorbidity

Datentyp

text

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

Comorbidity: ICD-10 Code

Datentyp

text

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

Concomitant Medication

Datentyp

text

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

Concomitant Medication: Intake

Datentyp

text

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

Urine Dipstick Test

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

Urine Dipstick Test

Datentyp

boolean

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

Urine Dipstick Test: Reason

Datentyp

text

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

Urine Dipstick Test Date

Datentyp

date

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

Urine Dipstick Test: Leukocytes

Datentyp

text

Alias
UMLS CUI [1]
C1256582
Erythrocytes
Beschreibung

Urine Dipstick Test: Erythrocytes

Datentyp

text

Alias
UMLS CUI [1]
C2188659
Nitrite
Beschreibung

Urine Dipstick Test: Nitrite

Datentyp

text

Alias
UMLS CUI [1]
C0580333
Urine Culture
Beschreibung

Urine Culture

Alias
UMLS CUI-1
C0848716
Urine Culture performed?
Beschreibung

Urine Culture

Datentyp

boolean

Alias
UMLS CUI [1]
C0848716
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator's Name
Beschreibung

Investigator's Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date of Report

Datentyp

date

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

Investigator's Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Worksheet Source Data REGATTA NCT03151603

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
 (positiv)
CL Item
 (negativ)
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
 (bei Bedarf)
CL Item
 (vorübergehend)
CL Item
 (Dauermedikation)
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video