ID

24792

Beschrijving

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury; ODM derived from: https://clinicaltrials.gov/show/NCT00597818

Link

https://clinicaltrials.gov/show/NCT00597818

Trefwoorden

Versies (2)
  1. 17-08-17 17-08-17 -
  2. 17-08-17 17-08-17 -
Geüploaded op

17 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

Engels

Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is more than 40 and less than 70 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient has confirmed osteoarthritis (oa) and/or rheumatoid arthritis (ra) and could benefit from nsaid therapy.
Beschrijving

Osteoarthritis | Rheumatoid Arthritis | Benefit Due to NSAID treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0814225
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0746950
no current gastrointestinal h. pylori infection.
Beschrijving

Helicobacter pylori gastrointestinal tract infection Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585625
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy or hypersensitivity to nsaids, or has any other contraindicated condition(s) to nsaid therapy.
Beschrijving

Allergy to nonsteroidal anti-inflammatory agents | Medical contraindication NSAID treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0746949
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0746950
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
Beschrijving

Gastrointestinal Surgical Procedure | Abdominal operation | Bowel resection

Datatype

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2]
C0198482
UMLS CUI [3]
C0741614
medical history includes prior or active gi complications and/or disorders, including but not limited to barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (ibs), or inflammatory bowel disease (ibd).
Beschrijving

Gastrointestinal complication | Gastrointestinal Diseases | Barrett Esophagus | Erosive esophagitis | Esophageal Stenosis | Esophageal ring | Obstruction gastric | Irritable Bowel Syndrome | Inflammatory Bowel Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0161819
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0004763
UMLS CUI [4]
C0267055
UMLS CUI [5]
C0014866
UMLS CUI [6]
C0267081
UMLS CUI [7]
C0149700
UMLS CUI [8]
C0022104
UMLS CUI [9]
C0021390
active symptomatic peptic ulcer disease or gi bleeding.
Beschrijving

Peptic Ulcer Symptomatic | Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0017181
patient has received cobiprostone (spi-8811; ru-8811) or amitiza (lubiprostone, spi-0211, or ru-0211) at any time prior to participation in this study.
Beschrijving

cobiprostone | SPI-8811 | Amitiza | lubiprostone | SPI 0211 | RU 0211

Datatype

boolean

Alias
UMLS CUI [1]
C2699393
UMLS CUI [2]
C2703103
UMLS CUI [3]
C1699150
UMLS CUI [4]
C1684405
UMLS CUI [5]
C1681887
UMLS CUI [6]
C1683269
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Similar models

Eligibility NSAID-induced Gastroduodenal Injury NCT00597818

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is more than 40 and less than 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis | Rheumatoid Arthritis | Benefit Due to NSAID treatment
Item
patient has confirmed osteoarthritis (oa) and/or rheumatoid arthritis (ra) and could benefit from nsaid therapy.
boolean
C0029408 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0814225 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0746950 (UMLS CUI [3,3])
Helicobacter pylori gastrointestinal tract infection Absent
Item
no current gastrointestinal h. pylori infection.
boolean
C0585625 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergy to nonsteroidal anti-inflammatory agents | Medical contraindication NSAID treatment
Item
known allergy or hypersensitivity to nsaids, or has any other contraindicated condition(s) to nsaid therapy.
boolean
C0746949 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0746950 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure | Abdominal operation | Bowel resection
Item
patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
boolean
C0524722 (UMLS CUI [1])
C0198482 (UMLS CUI [2])
C0741614 (UMLS CUI [3])
Gastrointestinal complication | Gastrointestinal Diseases | Barrett Esophagus | Erosive esophagitis | Esophageal Stenosis | Esophageal ring | Obstruction gastric | Irritable Bowel Syndrome | Inflammatory Bowel Disease
Item
medical history includes prior or active gi complications and/or disorders, including but not limited to barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (ibs), or inflammatory bowel disease (ibd).
boolean
C0161819 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0004763 (UMLS CUI [3])
C0267055 (UMLS CUI [4])
C0014866 (UMLS CUI [5])
C0267081 (UMLS CUI [6])
C0149700 (UMLS CUI [7])
C0022104 (UMLS CUI [8])
C0021390 (UMLS CUI [9])
Peptic Ulcer Symptomatic | Gastrointestinal Hemorrhage
Item
active symptomatic peptic ulcer disease or gi bleeding.
boolean
C0030920 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2])
cobiprostone | SPI-8811 | Amitiza | lubiprostone | SPI 0211 | RU 0211
Item
patient has received cobiprostone (spi-8811; ru-8811) or amitiza (lubiprostone, spi-0211, or ru-0211) at any time prior to participation in this study.
boolean
C2699393 (UMLS CUI [1])
C2703103 (UMLS CUI [2])
C1699150 (UMLS CUI [3])
C1684405 (UMLS CUI [4])
C1681887 (UMLS CUI [5])
C1683269 (UMLS CUI [6])
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