Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

ID

23709

Descrizione

Responsible Party: Stephan Ehrhardt, Lead investigator, Bernhard Nocht Institute for Tropical Medicine ClinicalTrials.gov Identifier: NCT01143272 History of Changes Other Study ID Numbers: BNI-2009-01 2009-017374 [Titel anhand dieser ISBN in Citavi-Projekt übernehmen] -20 ( EudraCT Number ) ISRCTN01005546 ( Registry Identifier: ISRCTN, http://www.controlled-trials.com/ISRCTN01005546 ) DRKS00000084 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: June 11, 2010 Results First Received: March 17, 2016 Last Updated: June 7, 2016 Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea (SacBo) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01143272

collegamento

http://www.controlled-trials.com/ISRCTN01005546

Keywords

Diarrhea

Antibiose

Eligibility Determination

Gastroenterologie

11/07/2017 11/07/2017 -

Caricato su

11 de julho de 2017

DOI

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Licenza

Creative Commons BY 4.0

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1 moduli

StudyEvent: ODM
1. Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Age

Item

Adult patient (≥ 18 years)

boolean

C0001779 (UMLS CUI [1])

Hospitalization

Item

Patient hospitalized

boolean

C0019993 (UMLS CUI [1])

Systemic antibiotic treatment

Item

Patient receives systemic antibiotic treatment

boolean

C3540704 (UMLS CUI [1])

Legal competency

Item

Patient contractually capable

boolean

C0680554 (UMLS CUI [1])

Compliance

Item

Patient able to follow study procedures

boolean

C1321605 (UMLS CUI [1])

Informed consent

Item

Informed consent of patient

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Control Group

Item

Healthy Volunteers

boolean

C0009932 (UMLS CUI [1])

Hypersensitivity

Item

allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.

boolean

C0020517 (UMLS CUI [1])

Central venous catheter

Item

Central venous catheter

boolean

C1145640 (UMLS CUI [1])

Immunosuppression

Item

Immunosuppression

boolean

C0021079 (UMLS CUI [1])

Diarrhea

Item

Diarrhoea and/or chronic diarrhoea

boolean

C0011991 (UMLS CUI [1])

Pharmacotherapy

Item

Regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study

boolean

C0013216 (UMLS CUI [1])

Systemic antimycotic treatment

Item

Systemic antimycotic treatment

boolean

C3653762 (UMLS CUI [1])

Prior Antibiotic Treatment

Item

Systemic antibiotic treatment within the last 6 weeks

boolean

C0003232 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])

Gynaecological Status

Item

No protection against conception, pregnancy, or lactation

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])

Study Participation Status

Item

Simultaneous participation in other clinical trials

boolean

C2348568 (UMLS CUI [1])

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Keywords

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Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084