ID

22064

Description

Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH); ODM derived from: https://clinicaltrials.gov/show/NCT01000779

Lien

https://clinicaltrials.gov/show/NCT01000779

Mots-clés

Versions (1)
  1. 17/05/2017 17/05/2017 -
Téléchargé le

17 mai 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Non Cirrhotic Portal Hypertension NCT01000779

Anglais

Eligibility Non Cirrhotic Portal Hypertension NCT01000779

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with non cirrhotic portal hypertension (ncph) presenting to our liver diseases follow-up clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper gi endoscopy
Description

Non-cirrhotic Portal Hypertension | Hematemesis | Melena | Esophageal Varices Upper gastrointestinal endoscopy | Hemorrhage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020541
UMLS CUI [1,2]
C0439687
UMLS CUI [2]
C0018926
UMLS CUI [3]
C0025222
UMLS CUI [4,1]
C0014867
UMLS CUI [4,2]
C2095643
UMLS CUI [5]
C0019080
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of surgery for portal hypertension
Description

Operative Surgical Procedures Portal Hypertension

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0020541
patients already on a est, evl, or glue injection program before presenting to our hospital
Description

Sclerotherapy Endoscopic | Ligation of esophageal varices Endoscopic | Fibrin glue Injection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036435
UMLS CUI [1,2]
C0442418
UMLS CUI [2,1]
C0192331
UMLS CUI [2,2]
C0442418
UMLS CUI [3,1]
C0016004
UMLS CUI [3,2]
C1533685
patients already on beta blockers for primary prophylaxis of variceal bleed
Description

Adrenergic beta-1 Receptor Antagonists | Prophylactic treatment Primary Bleeding varices

Type de données

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0333106
severe cardiopulmonary or renal disease
Description

Cor pulmonale Severe | Kidney Disease Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034072
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
Description

Bradycardia | heart rate | Complete atrioventricular block

Type de données

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0018810
UMLS CUI [3]
C0151517
a history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm hg)
Description

Adrenergic beta-1 Receptor Antagonists Adverse effects Severe | Medical contraindication Adrenergic beta-1 Receptor Antagonists | Asthma | Diabetes Mellitus | Heart failure | Peripheral Vascular Diseases | Prostatic Hypertrophy | Hypotension | Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0304516
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0304516
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0085096
UMLS CUI [7]
C1739363
UMLS CUI [8]
C0020649
UMLS CUI [9]
C0871470
refusal to give informed written consent to participate in the trial
Description

Informed Consent Refused

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
patients bleeding from gastric varices or portal hypertensive gastropathy (phg).
Description

Hemorrhage Due to Gastric Varices | Hemorrhage Due to Portal hypertensive gastropathy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0017145
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0580174
patients who had a failure of primary hemostasis during acute bleed were also excluded.
Description

Hemorrhage | Hemostasis Primary failed

Type de données

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C0740166
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0231175
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Similar models

Eligibility Non Cirrhotic Portal Hypertension NCT01000779

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-cirrhotic Portal Hypertension | Hematemesis | Melena | Esophageal Varices Upper gastrointestinal endoscopy | Hemorrhage
Item
patients with non cirrhotic portal hypertension (ncph) presenting to our liver diseases follow-up clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper gi endoscopy
boolean
C0020541 (UMLS CUI [1,1])
C0439687 (UMLS CUI [1,2])
C0018926 (UMLS CUI [2])
C0025222 (UMLS CUI [3])
C0014867 (UMLS CUI [4,1])
C2095643 (UMLS CUI [4,2])
C0019080 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures Portal Hypertension
Item
a history of surgery for portal hypertension
boolean
C0543467 (UMLS CUI [1,1])
C0020541 (UMLS CUI [1,2])
Sclerotherapy Endoscopic | Ligation of esophageal varices Endoscopic | Fibrin glue Injection
Item
patients already on a est, evl, or glue injection program before presenting to our hospital
boolean
C0036435 (UMLS CUI [1,1])
C0442418 (UMLS CUI [1,2])
C0192331 (UMLS CUI [2,1])
C0442418 (UMLS CUI [2,2])
C0016004 (UMLS CUI [3,1])
C1533685 (UMLS CUI [3,2])
Adrenergic beta-1 Receptor Antagonists | Prophylactic treatment Primary Bleeding varices
Item
patients already on beta blockers for primary prophylaxis of variceal bleed
boolean
C0304516 (UMLS CUI [1])
C0199176 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0333106 (UMLS CUI [2,3])
Cor pulmonale Severe | Kidney Disease Severe
Item
severe cardiopulmonary or renal disease
boolean
C0034072 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Bradycardia | heart rate | Complete atrioventricular block
Item
bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
boolean
C0428977 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Adrenergic beta-1 Receptor Antagonists Adverse effects Severe | Medical contraindication Adrenergic beta-1 Receptor Antagonists | Asthma | Diabetes Mellitus | Heart failure | Peripheral Vascular Diseases | Prostatic Hypertrophy | Hypotension | Systolic Pressure
Item
a history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm hg)
boolean
C0304516 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
C1739363 (UMLS CUI [7])
C0020649 (UMLS CUI [8])
C0871470 (UMLS CUI [9])
Informed Consent Refused
Item
refusal to give informed written consent to participate in the trial
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Hemorrhage Due to Gastric Varices | Hemorrhage Due to Portal hypertensive gastropathy
Item
patients bleeding from gastric varices or portal hypertensive gastropathy (phg).
boolean
C0019080 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0017145 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0580174 (UMLS CUI [2,3])
Hemorrhage | Hemostasis Primary failed
Item
patients who had a failure of primary hemostasis during acute bleed were also excluded.
boolean
C0019080 (UMLS CUI [1])
C0740166 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
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