ID

40361

Beskrivning

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01407809

Länk

https://clinicaltrials.gov/show/NCT01407809

Nyckelord

Versioner (1)
  1. 2020-04-13 2020-04-13 -
Rättsinnehavare

See clinicaltrials.gov

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13 april 2020

DOI

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Creative Commons BY 4.0
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Eligibility Idiopathic Intracranial Hypertension (IIH) NCT01407809

Engelsk

Eligibility Idiopathic Intracranial Hypertension (IIH) NCT01407809

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 21 year-old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
established diagnosis of idiopathic intracranial hypertension according to the criteria of the 2004 international classification of headache disorders
Beskrivning

Idiopathic intracranial hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0033845
severe visual function loss, defined as grades 4 and 5 on the humphrey visual field analyzer sita standard 24-2 test grading scale
Beskrivning

Visual Impairment Grade Humphrey Visual Field Analyzer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C2721095
failure of treatment with acetazolamide (diamox) given at efficient dose (2g/d or maximum tolerated dose). failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
Beskrivning

Acetazolamide Dose failed | Diamox Dose failed | Acetazolamide Maximum Tolerated Dose failed | Diamox Maximum Tolerated Dose failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0000981
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0591362
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0000981
UMLS CUI [3,2]
C0752079
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C0591362
UMLS CUI [4,2]
C0752079
UMLS CUI [4,3]
C0231175
failure of treatment with topiramate (topamax) given at efficient dose (maximum 150mg daily). failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
Beskrivning

Topiramate Dose U/day failed | Topamax Dose U/day failed | Intolerance to Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0076829
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0723778
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [2,4]
C0231175
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0013227
magnetic resonance venography (mrv) or computed tomography venography (ctv) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. at least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
Beskrivning

MRI venography | Computed tomography venography | Sinus Transverse Stenosis Bilateral | Sinus Transverse Stenosis Unilateral | Sinus Transverse Hypoplasia Contralateral | Sinus Transverse Atresia Contralateral | Sinus Lumen Diameter Reduction

Datatyp

boolean

Alias
UMLS CUI [1]
C1690005
UMLS CUI [2]
C2317140
UMLS CUI [3,1]
C0226504
UMLS CUI [3,2]
C0205106
UMLS CUI [3,3]
C1261287
UMLS CUI [3,4]
C0238767
UMLS CUI [4,1]
C0226504
UMLS CUI [4,2]
C0205106
UMLS CUI [4,3]
C1261287
UMLS CUI [4,4]
C0205092
UMLS CUI [5,1]
C0226504
UMLS CUI [5,2]
C0205106
UMLS CUI [5,3]
C0243069
UMLS CUI [5,4]
C0441988
UMLS CUI [6,1]
C0226504
UMLS CUI [6,2]
C0205106
UMLS CUI [6,3]
C0243066
UMLS CUI [6,4]
C0441988
UMLS CUI [7,1]
C0226504
UMLS CUI [7,2]
C1301906
UMLS CUI [7,3]
C1301886
UMLS CUI [7,4]
C0392756
signed informed consent obtained from the patient.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe allergic reaction to iodine contrast despite pre-medication with steroids.
Beskrivning

Iodine contrast allergy Severe | Premedication Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4022917
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0033045
UMLS CUI [2,2]
C0038317
renal function impairment:creatinine >1.5 mg/dl, and/or creatinine clearance <60 ml/min
Beskrivning

Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
contraindication to general anesthesia.
Beskrivning

Medical contraindication General Anesthesia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002915
contraindication to aspirin, clopidogrel (plavix®) or anticoagulants.
Beskrivning

Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Plavix | Medical contraindication Anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0633084
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0003280
patients with thrombophilic disorders and anti-cardiolipin syndrome will be excluded from the study. patients using tetracycline, oral contraceptives or vitamin a, can only be included 3 months after discontinuing these agents.
Beskrivning

Thrombophilia | Antiphospholipid Syndrome | Tetracycline To be stopped | Oral Contraceptives To be stopped | Vitamin A To be stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C0398623
UMLS CUI [2]
C0085278
UMLS CUI [3,1]
C0039644
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C0009905
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C0042839
UMLS CUI [5,2]
C1272691
patients with dural arteriovenous fistula (davf) or other arteriovenous lesion affecting cortical venous flow will be excluded from the protocol.
Beskrivning

Dural Arteriovenous Fistula | Lesion Arteriovenous | Involvement with Cortical flow in veins

Datatyp

boolean

Alias
UMLS CUI [1]
C0752156
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0450109
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0425705
UMLS CUI [3,3]
C0007776
acute shunt dysfunction in patients with prior csf diversion procedure.
Beskrivning

Shunt malfunction | Cerebrospinal Fluid Diversion

Datatyp

boolean

Alias
UMLS CUI [1]
C0948276
UMLS CUI [2,1]
C0007806
UMLS CUI [2,2]
C0185033
pregnancy or absence of contraception in woman of childbearing potential.
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Idiopathic Intracranial Hypertension (IIH) NCT01407809

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 21 year-old
boolean
C0001779 (UMLS CUI [1])
Idiopathic intracranial hypertension
Item
established diagnosis of idiopathic intracranial hypertension according to the criteria of the 2004 international classification of headache disorders
boolean
C0033845 (UMLS CUI [1])
Visual Impairment Grade Humphrey Visual Field Analyzer
Item
severe visual function loss, defined as grades 4 and 5 on the humphrey visual field analyzer sita standard 24-2 test grading scale
boolean
C3665347 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C2721095 (UMLS CUI [1,3])
Acetazolamide Dose failed | Diamox Dose failed | Acetazolamide Maximum Tolerated Dose failed | Diamox Maximum Tolerated Dose failed
Item
failure of treatment with acetazolamide (diamox) given at efficient dose (2g/d or maximum tolerated dose). failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
boolean
C0000981 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0591362 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0000981 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0591362 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Topiramate Dose U/day failed | Topamax Dose U/day failed | Intolerance to Pharmaceutical Preparations
Item
failure of treatment with topiramate (topamax) given at efficient dose (maximum 150mg daily). failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
boolean
C0076829 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0723778 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
C1744706 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
MRI venography | Computed tomography venography | Sinus Transverse Stenosis Bilateral | Sinus Transverse Stenosis Unilateral | Sinus Transverse Hypoplasia Contralateral | Sinus Transverse Atresia Contralateral | Sinus Lumen Diameter Reduction
Item
magnetic resonance venography (mrv) or computed tomography venography (ctv) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. at least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
boolean
C1690005 (UMLS CUI [1])
C2317140 (UMLS CUI [2])
C0226504 (UMLS CUI [3,1])
C0205106 (UMLS CUI [3,2])
C1261287 (UMLS CUI [3,3])
C0238767 (UMLS CUI [3,4])
C0226504 (UMLS CUI [4,1])
C0205106 (UMLS CUI [4,2])
C1261287 (UMLS CUI [4,3])
C0205092 (UMLS CUI [4,4])
C0226504 (UMLS CUI [5,1])
C0205106 (UMLS CUI [5,2])
C0243069 (UMLS CUI [5,3])
C0441988 (UMLS CUI [5,4])
C0226504 (UMLS CUI [6,1])
C0205106 (UMLS CUI [6,2])
C0243066 (UMLS CUI [6,3])
C0441988 (UMLS CUI [6,4])
C0226504 (UMLS CUI [7,1])
C1301906 (UMLS CUI [7,2])
C1301886 (UMLS CUI [7,3])
C0392756 (UMLS CUI [7,4])
Informed Consent
Item
signed informed consent obtained from the patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Iodine contrast allergy Severe | Premedication Steroids
Item
severe allergic reaction to iodine contrast despite pre-medication with steroids.
boolean
C4022917 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0033045 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal function impairment:creatinine >1.5 mg/dl, and/or creatinine clearance <60 ml/min
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Medical contraindication General Anesthesia
Item
contraindication to general anesthesia.
boolean
C1301624 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Plavix | Medical contraindication Anticoagulants
Item
contraindication to aspirin, clopidogrel (plavix®) or anticoagulants.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0633084 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0003280 (UMLS CUI [4,2])
Thrombophilia | Antiphospholipid Syndrome | Tetracycline To be stopped | Oral Contraceptives To be stopped | Vitamin A To be stopped
Item
patients with thrombophilic disorders and anti-cardiolipin syndrome will be excluded from the study. patients using tetracycline, oral contraceptives or vitamin a, can only be included 3 months after discontinuing these agents.
boolean
C0398623 (UMLS CUI [1])
C0085278 (UMLS CUI [2])
C0039644 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0042839 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Dural Arteriovenous Fistula | Lesion Arteriovenous | Involvement with Cortical flow in veins
Item
patients with dural arteriovenous fistula (davf) or other arteriovenous lesion affecting cortical venous flow will be excluded from the protocol.
boolean
C0752156 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0450109 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0425705 (UMLS CUI [3,2])
C0007776 (UMLS CUI [3,3])
Shunt malfunction | Cerebrospinal Fluid Diversion
Item
acute shunt dysfunction in patients with prior csf diversion procedure.
boolean
C0948276 (UMLS CUI [1])
C0007806 (UMLS CUI [2,1])
C0185033 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or absence of contraception in woman of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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