ID

35195

Descrição

Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs; ODM derived from: https://clinicaltrials.gov/show/NCT02202967

Link

https://clinicaltrials.gov/show/NCT02202967

Palavras-chave

Versões (1)
  1. 23/02/2019 23/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

23 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Arthritis NCT02202967

Inglês

Eligibility Chronic Arthritis NCT02202967

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
obscure occult gastrointestinal bleeding:
Descrição

Obscure gastrointestinal hemorrhage Occult

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4302233
UMLS CUI [1,2]
C0205262
iron deficiency anemia (ferritin <100 ug/l, hemoglobin [hb] 7-12 g/dl [female] or 7-13 g/dl [male])
Descrição

Iron deficiency anemia | Ferritin measurement | Hemoglobin measurement | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0162316
UMLS CUI [2]
C0373607
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
absence of bleeding lesions on upper gastrointestinal endoscopy and colonoscopy
Descrição

Lesion bleeding absent | Upper Gastrointestinal Tract Endoscopy | Upper Gastrointestinal Tract Colonoscopy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3203348
UMLS CUI [2,2]
C0014245
UMLS CUI [3,1]
C3203348
UMLS CUI [3,2]
C0009378
taking low-dose aspirin (75-325m/ day) or nsaids
Descrição

Aspirin Low Dose | Anti-Inflammatory Agents, Non-Steroidal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2608320
UMLS CUI [2]
C0003211
drop in hemoglobin, > 2gm/dl from baseline, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy
Descrição

Hemoglobin low | Lesion bleeding absent | Upper Gastrointestinal Tract Endoscopy | Upper Gastrointestinal Tract Colonoscopy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0162119
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3203348
UMLS CUI [3,2]
C0014245
UMLS CUI [4,1]
C3203348
UMLS CUI [4,2]
C0009378
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
• systemic disease that is unstable at the time of randomisation (unstable vital signs; ongoing non-gastrointestinal investigations; frequent modifications to treatment)
Descrição

Systemic disease Unstable | Unstable vital signs | Investigation | Exception Investigation gastrointestinal | Treatment modification Frequent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C2188217
UMLS CUI [3]
C1261322
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1261322
UMLS CUI [4,3]
C0521362
UMLS CUI [5,1]
C1299575
UMLS CUI [5,2]
C0332183
intake of certain drugs: high-dose steroids (>7.5-mg prednisolone/ day), cytotoxic drugs, or warfarin.
Descrição

Steroids High dose | Prednisolone U/day | Cytotoxic agent | Warfarin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0444956
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0304497
UMLS CUI [4]
C0043031
upper gastrointestinal lesions: esophageal varices; esophageal stricture; esophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
Descrição

Lesion Upper Gastrointestinal Tract | Esophageal Varices | Esophageal Stenosis | Esophageal Neoplasms | Stomach Neoplasms | Pyloric Stenosis | Peptic Ulcer | Vascular anomaly

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3203348
UMLS CUI [2]
C0014867
UMLS CUI [3]
C0014866
UMLS CUI [4]
C0014859
UMLS CUI [5]
C0038356
UMLS CUI [6]
C0034194
UMLS CUI [7]
C0030920
UMLS CUI [8]
C0158570
colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
Descrição

Colonic Diseases | Colonic Neoplasms | Adenomatous polyp of colon | Inflammatory Bowel Diseases | Vascular anomaly | Diverticular Bleeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009373
UMLS CUI [2]
C0009375
UMLS CUI [3]
C0850572
UMLS CUI [4]
C0021390
UMLS CUI [5]
C0158570
UMLS CUI [6]
C4505353
women planning pregnancy, pregnancy or women of child-bearing potential not using two highly effective contraceptive methods [implants, injectables, combined oral contraceptives, some intrauterine devices (iuds), sexual abstinence or vasectomised partner]
Descrição

Pregnancy, Planned | Pregnancy | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C1657106
UMLS CUI [5]
C1262153
UMLS CUI [6]
C0009906
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0036899
UMLS CUI [9]
C0420842
hypotension: systolic blood pressure <100-mm hg.
Descrição

Hypotension | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
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Similar models

Eligibility Chronic Arthritis NCT02202967

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Obscure gastrointestinal hemorrhage Occult
Item
obscure occult gastrointestinal bleeding:
boolean
C4302233 (UMLS CUI [1,1])
C0205262 (UMLS CUI [1,2])
Iron deficiency anemia | Ferritin measurement | Hemoglobin measurement | Gender
Item
iron deficiency anemia (ferritin <100 ug/l, hemoglobin [hb] 7-12 g/dl [female] or 7-13 g/dl [male])
boolean
C0162316 (UMLS CUI [1])
C0373607 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Lesion bleeding absent | Upper Gastrointestinal Tract Endoscopy | Upper Gastrointestinal Tract Colonoscopy
Item
absence of bleeding lesions on upper gastrointestinal endoscopy and colonoscopy
boolean
C0221198 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3203348 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
C3203348 (UMLS CUI [3,1])
C0009378 (UMLS CUI [3,2])
Aspirin Low Dose | Anti-Inflammatory Agents, Non-Steroidal
Item
taking low-dose aspirin (75-325m/ day) or nsaids
boolean
C2608320 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
Hemoglobin low | Lesion bleeding absent | Upper Gastrointestinal Tract Endoscopy | Upper Gastrointestinal Tract Colonoscopy
Item
drop in hemoglobin, > 2gm/dl from baseline, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy
boolean
C0162119 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3203348 (UMLS CUI [3,1])
C0014245 (UMLS CUI [3,2])
C3203348 (UMLS CUI [4,1])
C0009378 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Unstable vital signs | Investigation | Exception Investigation gastrointestinal | Treatment modification Frequent
Item
• systemic disease that is unstable at the time of randomisation (unstable vital signs; ongoing non-gastrointestinal investigations; frequent modifications to treatment)
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2188217 (UMLS CUI [2])
C1261322 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
C0521362 (UMLS CUI [4,3])
C1299575 (UMLS CUI [5,1])
C0332183 (UMLS CUI [5,2])
Steroids High dose | Prednisolone U/day | Cytotoxic agent | Warfarin
Item
intake of certain drugs: high-dose steroids (>7.5-mg prednisolone/ day), cytotoxic drugs, or warfarin.
boolean
C0038317 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0304497 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
Lesion Upper Gastrointestinal Tract | Esophageal Varices | Esophageal Stenosis | Esophageal Neoplasms | Stomach Neoplasms | Pyloric Stenosis | Peptic Ulcer | Vascular anomaly
Item
upper gastrointestinal lesions: esophageal varices; esophageal stricture; esophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
boolean
C0221198 (UMLS CUI [1,1])
C3203348 (UMLS CUI [1,2])
C0014867 (UMLS CUI [2])
C0014866 (UMLS CUI [3])
C0014859 (UMLS CUI [4])
C0038356 (UMLS CUI [5])
C0034194 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
C0158570 (UMLS CUI [8])
Colonic Diseases | Colonic Neoplasms | Adenomatous polyp of colon | Inflammatory Bowel Diseases | Vascular anomaly | Diverticular Bleeding
Item
colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
boolean
C0009373 (UMLS CUI [1])
C0009375 (UMLS CUI [2])
C0850572 (UMLS CUI [3])
C0021390 (UMLS CUI [4])
C0158570 (UMLS CUI [5])
C4505353 (UMLS CUI [6])
Pregnancy, Planned | Pregnancy | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy
Item
women planning pregnancy, pregnancy or women of child-bearing potential not using two highly effective contraceptive methods [implants, injectables, combined oral contraceptives, some intrauterine devices (iuds), sexual abstinence or vasectomised partner]
boolean
C0032992 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1657106 (UMLS CUI [4])
C1262153 (UMLS CUI [5])
C0009906 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
C0420842 (UMLS CUI [9])
Hypotension | Systolic Pressure
Item
hypotension: systolic blood pressure <100-mm hg.
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
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