ID

43054

Description

ODM derived from http://clinicaltrials.gov/ct2/show/NCT00343161?term=NCT00343161&rank=1

Link

http://clinicaltrials.gov/ct2/show/NCT00343161?term=NCT00343161&rank=1

Keywords

Versions (3)
  1. 2/24/12 2/24/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00343161 Gastroesophageal Reflux Disease

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

18 Years to 55 Years
Description

Age

Data type

boolean

Signed informed consent
Description

Signed informed consent

Data type

boolean

Patients who seek medical advice in primary care for symptoms thought to be GERD-related
Description

GERD-related symptoms

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

Clinical GERD diagnosis/treatment within last 3 month
Description

Clinical GERD diagnosis/treatment

Data type

boolean

History of severe esophagitis (i.e. LA grade C or D)
Description

History of severe esophagitis

Data type

boolean

Previous anti-reflux surgery
Description

Previous anti-reflux surgery

Data type

boolean

History of drug abuse
Description

History of drug abuse

Data type

boolean

Female patients who are pregnant or lactating or at risk of pregnancy
Description

pregnancy/lactation

Data type

boolean

Medical Concepts
Description

Medical Concepts

age
Description

age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
diagnosis
Description

diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Gastroesophageal reflux disease
Description

GERD

Data type

string

Alias
UMLS CUI
C0017168
SNOMED CT 2010_0731
235595009
MedDRA 13.1
10066874
ICD-10-CM Version 2010
K21
ICD-9-CM Version 2011
530.81
CTCAE Version 4.03
E10739
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Esophagitis
Description

Esophagitis

Data type

string

Alias
UMLS CUI
C0014868
SNOMED CT 2010_0731
16761005
MedDRA 13.1
10015461
ICD-10-CM Version 2010
K20.9
ICD-9-CM Version 2011
530.10
CTCAE Version 4.03
E10687
Anti-reflux surgery
Description

Anti-reflux surgery

Data type

string

Alias
UMLS CUI
C0399651
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
treatment
Description

Therapy

Data type

string

Alias
UMLS CUI
C0087111
Drug abuse
Description

Drug abuse

Data type

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 55 Years
boolean
Signed informed consent
Item
Signed informed consent
boolean
GERD-related symptoms
Item
Patients who seek medical advice in primary care for symptoms thought to be GERD-related
boolean
Item Group
Exclusion criteria
Clinical GERD diagnosis/treatment
Item
Clinical GERD diagnosis/treatment within last 3 month
boolean
History of severe esophagitis
Item
History of severe esophagitis (i.e. LA grade C or D)
boolean
Previous anti-reflux surgery
Item
Previous anti-reflux surgery
boolean
History of drug abuse
Item
History of drug abuse
boolean
pregnancy/lactation
Item
Female patients who are pregnant or lactating or at risk of pregnancy
boolean
Item Group
Medical Concepts
age
Item
age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
diagnosis
Item
diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
GERD
Item
Gastroesophageal reflux disease
string
C0017168 (UMLS CUI)
235595009 (SNOMED CT 2010_0731)
10066874 (MedDRA 13.1)
K21 (ICD-10-CM Version 2010)
530.81 (ICD-9-CM Version 2011)
E10739 (CTCAE Version 4.03)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Esophagitis
Item
Esophagitis
string
C0014868 (UMLS CUI)
16761005 (SNOMED CT 2010_0731)
10015461 (MedDRA 13.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE Version 4.03)
Anti-reflux surgery
Item
Anti-reflux surgery
string
C0399651 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Therapy
Item
treatment
string
C0087111 (UMLS CUI)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
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