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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

Link

https://clinicaltrials.gov/show/NCT01000779

Keywords

Versions (1)
  1. 5/17/17 5/17/17 -
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May 17, 2017

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Creative Commons BY 4.0
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    Eligibility Non Cirrhotic Portal Hypertension NCT01000779

    English

    Eligibility Non Cirrhotic Portal Hypertension NCT01000779

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020541 (Portal Hypertension)
    SNOMED
    34742003
    UMLS CUI [1,2]
    C0439687 (Non-cirrhotic)
    SNOMED
    255436002
    UMLS CUI [2]
    C0018926 (Hematemesis)
    SNOMED
    8765009
    UMLS CUI [3]
    C0025222 (Melena)
    SNOMED
    2901004
    UMLS CUI [4,1]
    C0014867 (Esophageal Varices)
    SNOMED
    28670008
    UMLS CUI [4,2]
    C2095643 (Diagnostic upper gastrointestinal endoscopy)
    UMLS CUI [5]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    a history of surgery for portal hypertension
    Description

    Operative Surgical Procedures Portal Hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [1,2]
    C0020541 (Portal Hypertension)
    SNOMED
    34742003
    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036435 (Sclerotherapy)
    SNOMED
    82579001
    UMLS CUI [1,2]
    C0442418 (Endoscopic approach - access)
    UMLS CUI [2,1]
    C0192331 (Ligation of esophageal varices)
    SNOMED
    67364009
    UMLS CUI [2,2]
    C0442418 (Endoscopic approach - access)
    UMLS CUI [3,1]
    C0016004 (Fibrin Tissue Adhesive)
    UMLS CUI [3,2]
    C1533685 (Injection procedure)
    SNOMED
    59108006
    LOINC
    LP35021-2
    patients already on beta blockers for primary prophylaxis of variceal bleed
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304516 (Adrenergic beta-1 Receptor Antagonists)
    SNOMED
    372661004
    UMLS CUI [2,1]
    C0199176 (Prophylactic treatment)
    SNOMED
    360271000
    UMLS CUI [2,2]
    C0205225 (Primary)
    SNOMED
    63161005
    LOINC
    LA21208-6
    UMLS CUI [2,3]
    C0333106 (Bleeding varices)
    SNOMED
    57052009
    severe cardiopulmonary or renal disease
    Description

    Cor pulmonale Severe | Kidney Disease Severe

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034072 (Cor pulmonale)
    SNOMED
    83291003
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,1]
    C0022658 (Kidney Diseases)
    SNOMED
    90708001
    UMLS CUI [2,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
    Description

    Bradycardia | heart rate | Complete atrioventricular block

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428977 (Bradycardia)
    SNOMED
    48867003
    LOINC
    LA17394-0
    UMLS CUI [2]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [3]
    C0151517 (Complete atrioventricular block)
    SNOMED
    27885002
    LOINC
    LA17089-6
    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304516 (Adrenergic beta-1 Receptor Antagonists)
    SNOMED
    372661004
    UMLS CUI [1,2]
    C0879626 (Adverse effects)
    UMLS CUI [1,3]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,1]
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI [2,2]
    C0304516 (Adrenergic beta-1 Receptor Antagonists)
    SNOMED
    372661004
    UMLS CUI [3]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [4]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [5]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [6]
    C0085096 (Peripheral Vascular Diseases)
    SNOMED
    400047006
    UMLS CUI [7]
    C1739363 (Prostatic Hypertrophy)
    SNOMED
    266569009
    UMLS CUI [8]
    C0020649 (Hypotension)
    SNOMED
    45007003
    LOINC
    MTHU020790
    UMLS CUI [9]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    refusal to give informed written consent to participate in the trial
    Description

    Informed Consent Refused

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C1705116 (Refused)
    SNOMED
    443390004
    LOINC
    LA4389-8
    patients bleeding from gastric varices or portal hypertensive gastropathy (phg).
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI [1,2]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [1,3]
    C0017145 (Gastric Varix)
    SNOMED
    91109007
    UMLS CUI [2,1]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI [2,2]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [2,3]
    C0580174 (Portal hypertensive gastropathy)
    SNOMED
    303082009
    patients who had a failure of primary hemostasis during acute bleed were also excluded.
    Description

    Hemorrhage | Hemostasis Primary failed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI [2,1]
    C0740166 (Hemostasis procedure)
    UMLS CUI [2,2]
    C0205225 (Primary)
    SNOMED
    63161005
    LOINC
    LA21208-6
    UMLS CUI [2,3]
    C0231175 (Failed)
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    Similar models

    Eligibility Non Cirrhotic Portal Hypertension NCT01000779

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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