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Informações:
Falhas:
ID
26515
Descrição
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
Palavras-chave
Versões (2)
- 18/10/2017 18/10/2017 -
- 01/11/2017 01/11/2017 -
Titular dos direitos
K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor
Transferido a
18 de outubro de 2017
DOI
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Licença
Creative Commons BY-NC-ND 3.0
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Worksheet Source Data REGATTA NCT03151603
Worksheet Source Data REGATTA NCT03151603
- StudyEvent: ODM
Similar models
Worksheet Source Data REGATTA NCT03151603
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Patient ID
Item
Patient-ID
text
C2348585 (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])
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])
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])
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])
C0021313 (UMLS CUI [1,2])
Gynaecological Status
Item
Known Pregnancy or Lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
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])
C0013230 (UMLS CUI [1,2])
Serious Illness
Item
Serious Illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
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])
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])
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])
C0566251 (UMLS CUI [1,2])
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])
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])
C1512806 (UMLS CUI [1,2])
CL Item
if required (if required)
CL Item
temporary (temporary)
CL Item
long-term (long-term)
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])
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])
C0011008 (UMLS CUI [1,2])
CL Item
- (-)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
- (-)
CL Item
+ (+)
CL Item
++ (++)
CL Item
+++ (+++)
CL Item
positive (positive)
CL Item
negative (negative)
Urine Culture
Item
Urine Culture performed?
boolean
C0848716 (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])