ID

41019

Description

Idiopathic Intracranial Hypertension Treatment Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01003639

Link

https://clinicaltrials.gov/show/NCT01003639

Keywords

  1. 6/13/20 6/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 13, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Idiopathic Intracranial Hypertension NCT01003639

Eligibility Idiopathic Intracranial Hypertension NCT01003639

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of iih by modified dandy criteria signs and symptoms of increased intracranial pressure absence of localizing findings on neurologic examination absence of deformity, displacement, or obstruction of the ventricular system and otherwise normal neurodiagnostic studies, except for evidence of increased cerebrospinal fluid pressure (>200 mm water). abnormal neuroimaging except for empty sella turcica, optic nerve sheath enlargement, and smooth-walled non flow-related venous sinus stenosis or collapse106 should lead to another diagnosis awake and alert no other cause of increased intracranial pressure present
Description

Idiopathic intracranial hypertension | Signs and Symptoms Intracranial Hypertension | Absence Finding Localized Neurologic Examination | Absence Deformity Cerebral Ventricles | Absence Displacement Cerebral Ventricles | Absence Obstruction Cerebral Ventricles | Neurologic Examination Normal | Exception Raised cerebrospinal fluid pressure | Neuroimaging Abnormal | Exception Empty Sella turcica | Exception Optic nerve sheath Enlargement | Exception Venous sinus Stenosis | Exception Venous sinus Collapse

Data type

boolean

Alias
UMLS CUI [1]
C0033845
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0151740
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0243095
UMLS CUI [3,3]
C0392752
UMLS CUI [3,4]
C0027853
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0302142
UMLS CUI [4,3]
C0007799
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0012727
UMLS CUI [5,3]
C0007799
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0028778
UMLS CUI [6,3]
C0007799
UMLS CUI [7,1]
C0027853
UMLS CUI [7,2]
C0205307
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0428711
UMLS CUI [9,1]
C0679575
UMLS CUI [9,2]
C0205161
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0014008
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0228673
UMLS CUI [11,3]
C2711450
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0226504
UMLS CUI [12,3]
C1261287
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0226504
UMLS CUI [13,3]
C0344329
2. diagnosis of iih for 6 weeks or less
Description

Idiopathic intracranial hypertension Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0033845
UMLS CUI [1,2]
C0872146
3. age 18 to 60 years at time of diagnosis
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. reproducible visual loss present on automated perimetry (in eye with greatest loss)
Description

Reproducibility Visual loss Perimetry

Data type

boolean

Alias
UMLS CUI [1,1]
C1514863
UMLS CUI [1,2]
C3665346
UMLS CUI [1,3]
C0031061
5. average pmd -2 db up to -5 db in the worst eye
Description

Average Pellucid marginal corneal degeneration

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0339288
6. presence of bilateral papilledema
Description

Papilledema Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0030353
UMLS CUI [1,2]
C0238767
7. able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
8. women of child-bearing potential must use an acceptable form of birth control during the intervention phase of the study. acceptable forms include oral contraceptives, transdermal contraceptives,
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Transdermal contraceptive

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1456475
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. total treatment of iih of more than two weeks (except for acetazolamide which is limited to 1 week). for every day on treatment there must be a one-day washout period.
Description

Treatment Total Idiopathic intracranial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0033845
2. previous surgery for iih including optic nerve sheath fenestration, csf shunting procedures, subtemporal decompression and venous stenting
Description

Prior surgery Idiopathic intracranial hypertension | Optic nerve sheath Fenestration | Cerebrospinal fluid shunts procedure | Subtemporal decompression | Insertion of stent into vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0033845
UMLS CUI [2,1]
C0228673
UMLS CUI [2,2]
C0337280
UMLS CUI [3]
C0007812
UMLS CUI [4]
C0844214
UMLS CUI [5]
C0398136
3. previous gastric bypass surgery
Description

Gastric Bypass

Data type

boolean

Alias
UMLS CUI [1]
C0017125
4. abnormalities on neurologic examination aside from papilledema and its related visual loss or vi nerve paresis
Description

Abnormality Neurologic Examination | Exception Papilledema | Exception Abnormal vision Related | Exception VIth nerve paresis

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030353
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3665386
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3160842
5. abnormal ct or mri scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, unfolded optic nerve sheaths, flattened sclera, or smooth- walled venous stenosis
Description

CT result abnormal | MRI scan abnormal | Intracranial mass | Hydrocephalus | Dural sinus Thrombus | Arteriovenous malformation | Exception Empty Sella | Other Coding | Exception Sclera Flattened | Exception Venous stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0436539
UMLS CUI [2]
C0436540
UMLS CUI [3]
C0270614
UMLS CUI [4]
C0020255
UMLS CUI [5,1]
C4512343
UMLS CUI [5,2]
C0087086
UMLS CUI [6]
C0003857
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0014008
UMLS CUI [8]
C3846158
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0036410
UMLS CUI [9,3]
C0016203
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0340753
6. csf pressure less than 200 mm water (patients may have repeat csf pressure measurements if the first is normal or no opening pressure obtained)
Description

Cerebrospinal Fluid Pressure Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0007809
UMLS CUI [1,2]
C0242485
7. abnormal csf contents: increased cells: > 5 cells, elevated protein:
Description

CSF cell content Abnormal | Cells Increased | protein elevated

Data type

boolean

Alias
UMLS CUI [1,1]
C1304682
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0205217
UMLS CUI [3]
C0748024
> 45 mg%, low glucose: < 30 mg% (if the lumbar puncture produces a cell count compatible with a traumatic needle insertion, the patient does not need to be excluded if the csf wbc after correction is 5 wbc/mm3 or less- see operations manual for calculation) 8. intraocular pressure currently > 28 mm hg or > 30 mm hg at any time in the past 9. refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye with the following exceptions: subjects with myopia of >-6.00 d sphere but less than or equal to - 8.00 d sphere are eligible if 1)there are no abnormalities on ophthalmoscopy or fundus photos related to myopia that are associated with visual loss (such as staphyloma, retinal thinning in the posterior pole or more than mild optic disc tilt), and 2) the subject wears a contact lens for all perimetry examinations with the appropriate correction. if either the site investigator or the prc director (or his designate) decides there are optic fundus abnormalities of myopia that are associated with visual loss, then 9. subjects with hyperopia of > +6.00 d but less than or equal to
Description

Glucose low | Cerebrospinal fluid white blood cell count | Intraocular pressure | Refractive Errors | Hyperopia

Data type

boolean

Alias
UMLS CUI [1]
C0860801
UMLS CUI [2]
C0855357
UMLS CUI [3]
C0578862
UMLS CUI [4]
C0034951
UMLS CUI [5]
C0020490
8.00 d sphere are eligible if 1) there is an unambiguous characteristic halo of peripapillary edema as opposed to features of a small crowded disc or other hyperopic change related to visual loss determined by the site investigator or the prc director (or his designate) and 2) the subject wears a contact le 10. other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis 11. optic disc drusen on exam or in previous history 12. presence of diagnosed untreated obstructive sleep apnea 13. inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors) 14. abnormal blood work-up indicating a medical or systemic condition associated with raised icp 15. study blood results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the site investigator's judgment 16. type i diabetes or the presence of diabetic retinopathy 17. exposure to a drug, substance or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin a, various cyclines (see table in operations manual for conditions and drugs) 18. other condition requiring diuretics, oral, i.v. or injectable steroids or other pressure lowering agents including topiramate (nasal, inhaled, or topical steroids are allowed since the systemic effects are small) 19. presence of a medical condition such as renal stones that would contraindicate use of the study drug (acetazolamide) 20. pregnancy or unwillingness for subject of childbearing potential to use contraception during the first year of the study 21. breastfeeding mothers are excluded from participation unless willing to discontinue breastfeeding by the baseline visit 22. presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless) 23. anticipation of a move from the site area within six months and unwillingness to return for follow-up at an iihtt study site 24. allergy to pupil dilating drops or narrow angles precluding safe dilation
Description

Disease Causing Abnormal vision | Exception Refractive Errors | Exception Amblyopia | Optic Disk Drusen | Obstructive Sleep Apnea Untreated | Peripheral visual field examination Unable | Blood work up Abnormal | Anemia, severe | Leukopenia | Thrombocytopenia | Kidney Failure | Liver diseases | Diabetes Mellitus, Insulin-Dependent | Diabetic Retinopathy | Exposure to Lithium | Exposure to Vitamin A | Exposure to Cyclins | Condition Requirement Diuretics | Condition Requirement Oral steroid therapy | Condition Requirement Intravenous steroid injection | Condition Requirement Injection of steroid | Condition Requirement Antihypertensive Agents | Condition Requirement Topiramate | Medical condition Contraindicated Acetazolamide | Kidney Calculi | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Breast Feeding | Drug Dependence | Terminal illness | Telephone Lacking | Homelessness | Relocation of home | Hypersensitivity Pupil dilation procedure | Narrow angles Exclude Pupil dilation procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C3665386
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0034951
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002418
UMLS CUI [4]
C0029128
UMLS CUI [5,1]
C0520679
UMLS CUI [5,2]
C0332155
UMLS CUI [6,1]
C0522797
UMLS CUI [6,2]
C1299582
UMLS CUI [7,1]
C0005767
UMLS CUI [7,2]
C0750430
UMLS CUI [7,3]
C0205161
UMLS CUI [8]
C0238644
UMLS CUI [9]
C0023530
UMLS CUI [10]
C0040034
UMLS CUI [11]
C0035078
UMLS CUI [12]
C0023895
UMLS CUI [13]
C0011854
UMLS CUI [14]
C0011884
UMLS CUI [15,1]
C0332157
UMLS CUI [15,2]
C0023870
UMLS CUI [16,1]
C0332157
UMLS CUI [16,2]
C0042839
UMLS CUI [17,1]
C0332157
UMLS CUI [17,2]
C0079183
UMLS CUI [18,1]
C0348080
UMLS CUI [18,2]
C1514873
UMLS CUI [18,3]
C0012798
UMLS CUI [19,1]
C0348080
UMLS CUI [19,2]
C1514873
UMLS CUI [19,3]
C0574135
UMLS CUI [20,1]
C0348080
UMLS CUI [20,2]
C1514873
UMLS CUI [20,3]
C0563322
UMLS CUI [21,1]
C0348080
UMLS CUI [21,2]
C1514873
UMLS CUI [21,3]
C1261311
UMLS CUI [22,1]
C0348080
UMLS CUI [22,2]
C1514873
UMLS CUI [22,3]
C0003364
UMLS CUI [23,1]
C0348080
UMLS CUI [23,2]
C1514873
UMLS CUI [23,3]
C0076829
UMLS CUI [24,1]
C3843040
UMLS CUI [24,2]
C1444657
UMLS CUI [24,3]
C0000981
UMLS CUI [25]
C0022650
UMLS CUI [26]
C0032961
UMLS CUI [27,1]
C3831118
UMLS CUI [27,2]
C0700589
UMLS CUI [27,3]
C0558080
UMLS CUI [28]
C0006147
UMLS CUI [29]
C1510472
UMLS CUI [30]
C0679247
UMLS CUI [31,1]
C0039457
UMLS CUI [31,2]
C0332268
UMLS CUI [32]
C0237154
UMLS CUI [33]
C2699029
UMLS CUI [34,1]
C0020517
UMLS CUI [34,2]
C3267125
UMLS CUI [35,1]
C1410927
UMLS CUI [35,2]
C0332196
UMLS CUI [35,3]
C3267125

Similar models

Eligibility Idiopathic Intracranial Hypertension NCT01003639

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic intracranial hypertension | Signs and Symptoms Intracranial Hypertension | Absence Finding Localized Neurologic Examination | Absence Deformity Cerebral Ventricles | Absence Displacement Cerebral Ventricles | Absence Obstruction Cerebral Ventricles | Neurologic Examination Normal | Exception Raised cerebrospinal fluid pressure | Neuroimaging Abnormal | Exception Empty Sella turcica | Exception Optic nerve sheath Enlargement | Exception Venous sinus Stenosis | Exception Venous sinus Collapse
Item
1. diagnosis of iih by modified dandy criteria signs and symptoms of increased intracranial pressure absence of localizing findings on neurologic examination absence of deformity, displacement, or obstruction of the ventricular system and otherwise normal neurodiagnostic studies, except for evidence of increased cerebrospinal fluid pressure (>200 mm water). abnormal neuroimaging except for empty sella turcica, optic nerve sheath enlargement, and smooth-walled non flow-related venous sinus stenosis or collapse106 should lead to another diagnosis awake and alert no other cause of increased intracranial pressure present
boolean
C0033845 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0151740 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C0027853 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0302142 (UMLS CUI [4,2])
C0007799 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0012727 (UMLS CUI [5,2])
C0007799 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0028778 (UMLS CUI [6,2])
C0007799 (UMLS CUI [6,3])
C0027853 (UMLS CUI [7,1])
C0205307 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0428711 (UMLS CUI [8,2])
C0679575 (UMLS CUI [9,1])
C0205161 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0014008 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0228673 (UMLS CUI [11,2])
C2711450 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0226504 (UMLS CUI [12,2])
C1261287 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0226504 (UMLS CUI [13,2])
C0344329 (UMLS CUI [13,3])
Idiopathic intracranial hypertension Disease length
Item
2. diagnosis of iih for 6 weeks or less
boolean
C0033845 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. age 18 to 60 years at time of diagnosis
boolean
C0001779 (UMLS CUI [1])
Reproducibility Visual loss Perimetry
Item
4. reproducible visual loss present on automated perimetry (in eye with greatest loss)
boolean
C1514863 (UMLS CUI [1,1])
C3665346 (UMLS CUI [1,2])
C0031061 (UMLS CUI [1,3])
Average Pellucid marginal corneal degeneration
Item
5. average pmd -2 db up to -5 db in the worst eye
boolean
C1510992 (UMLS CUI [1,1])
C0339288 (UMLS CUI [1,2])
Papilledema Bilateral
Item
6. presence of bilateral papilledema
boolean
C0030353 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Informed Consent
Item
7. able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Transdermal contraceptive
Item
8. women of child-bearing potential must use an acceptable form of birth control during the intervention phase of the study. acceptable forms include oral contraceptives, transdermal contraceptives,
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1456475 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Treatment Total Idiopathic intracranial hypertension
Item
1. total treatment of iih of more than two weeks (except for acetazolamide which is limited to 1 week). for every day on treatment there must be a one-day washout period.
boolean
C0087111 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0033845 (UMLS CUI [1,3])
Prior surgery Idiopathic intracranial hypertension | Optic nerve sheath Fenestration | Cerebrospinal fluid shunts procedure | Subtemporal decompression | Insertion of stent into vein
Item
2. previous surgery for iih including optic nerve sheath fenestration, csf shunting procedures, subtemporal decompression and venous stenting
boolean
C0455610 (UMLS CUI [1,1])
C0033845 (UMLS CUI [1,2])
C0228673 (UMLS CUI [2,1])
C0337280 (UMLS CUI [2,2])
C0007812 (UMLS CUI [3])
C0844214 (UMLS CUI [4])
C0398136 (UMLS CUI [5])
Gastric Bypass
Item
3. previous gastric bypass surgery
boolean
C0017125 (UMLS CUI [1])
Abnormality Neurologic Examination | Exception Papilledema | Exception Abnormal vision Related | Exception VIth nerve paresis
Item
4. abnormalities on neurologic examination aside from papilledema and its related visual loss or vi nerve paresis
boolean
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0030353 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3665386 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3160842 (UMLS CUI [4,2])
CT result abnormal | MRI scan abnormal | Intracranial mass | Hydrocephalus | Dural sinus Thrombus | Arteriovenous malformation | Exception Empty Sella | Other Coding | Exception Sclera Flattened | Exception Venous stenosis
Item
5. abnormal ct or mri scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, unfolded optic nerve sheaths, flattened sclera, or smooth- walled venous stenosis
boolean
C0436539 (UMLS CUI [1])
C0436540 (UMLS CUI [2])
C0270614 (UMLS CUI [3])
C0020255 (UMLS CUI [4])
C4512343 (UMLS CUI [5,1])
C0087086 (UMLS CUI [5,2])
C0003857 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0014008 (UMLS CUI [7,2])
C3846158 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0036410 (UMLS CUI [9,2])
C0016203 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0340753 (UMLS CUI [10,2])
Cerebrospinal Fluid Pressure Measurement
Item
6. csf pressure less than 200 mm water (patients may have repeat csf pressure measurements if the first is normal or no opening pressure obtained)
boolean
C0007809 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
CSF cell content Abnormal | Cells Increased | protein elevated
Item
7. abnormal csf contents: increased cells: > 5 cells, elevated protein:
boolean
C1304682 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0007634 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0748024 (UMLS CUI [3])
Glucose low | Cerebrospinal fluid white blood cell count | Intraocular pressure | Refractive Errors | Hyperopia
Item
> 45 mg%, low glucose: < 30 mg% (if the lumbar puncture produces a cell count compatible with a traumatic needle insertion, the patient does not need to be excluded if the csf wbc after correction is 5 wbc/mm3 or less- see operations manual for calculation) 8. intraocular pressure currently > 28 mm hg or > 30 mm hg at any time in the past 9. refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye with the following exceptions: subjects with myopia of >-6.00 d sphere but less than or equal to - 8.00 d sphere are eligible if 1)there are no abnormalities on ophthalmoscopy or fundus photos related to myopia that are associated with visual loss (such as staphyloma, retinal thinning in the posterior pole or more than mild optic disc tilt), and 2) the subject wears a contact lens for all perimetry examinations with the appropriate correction. if either the site investigator or the prc director (or his designate) decides there are optic fundus abnormalities of myopia that are associated with visual loss, then 9. subjects with hyperopia of > +6.00 d but less than or equal to
boolean
C0860801 (UMLS CUI [1])
C0855357 (UMLS CUI [2])
C0578862 (UMLS CUI [3])
C0034951 (UMLS CUI [4])
C0020490 (UMLS CUI [5])
Disease Causing Abnormal vision | Exception Refractive Errors | Exception Amblyopia | Optic Disk Drusen | Obstructive Sleep Apnea Untreated | Peripheral visual field examination Unable | Blood work up Abnormal | Anemia, severe | Leukopenia | Thrombocytopenia | Kidney Failure | Liver diseases | Diabetes Mellitus, Insulin-Dependent | Diabetic Retinopathy | Exposure to Lithium | Exposure to Vitamin A | Exposure to Cyclins | Condition Requirement Diuretics | Condition Requirement Oral steroid therapy | Condition Requirement Intravenous steroid injection | Condition Requirement Injection of steroid | Condition Requirement Antihypertensive Agents | Condition Requirement Topiramate | Medical condition Contraindicated Acetazolamide | Kidney Calculi | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Breast Feeding | Drug Dependence | Terminal illness | Telephone Lacking | Homelessness | Relocation of home | Hypersensitivity Pupil dilation procedure | Narrow angles Exclude Pupil dilation procedure
Item
8.00 d sphere are eligible if 1) there is an unambiguous characteristic halo of peripapillary edema as opposed to features of a small crowded disc or other hyperopic change related to visual loss determined by the site investigator or the prc director (or his designate) and 2) the subject wears a contact le 10. other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis 11. optic disc drusen on exam or in previous history 12. presence of diagnosed untreated obstructive sleep apnea 13. inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors) 14. abnormal blood work-up indicating a medical or systemic condition associated with raised icp 15. study blood results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the site investigator's judgment 16. type i diabetes or the presence of diabetic retinopathy 17. exposure to a drug, substance or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin a, various cyclines (see table in operations manual for conditions and drugs) 18. other condition requiring diuretics, oral, i.v. or injectable steroids or other pressure lowering agents including topiramate (nasal, inhaled, or topical steroids are allowed since the systemic effects are small) 19. presence of a medical condition such as renal stones that would contraindicate use of the study drug (acetazolamide) 20. pregnancy or unwillingness for subject of childbearing potential to use contraception during the first year of the study 21. breastfeeding mothers are excluded from participation unless willing to discontinue breastfeeding by the baseline visit 22. presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless) 23. anticipation of a move from the site area within six months and unwillingness to return for follow-up at an iihtt study site 24. allergy to pupil dilating drops or narrow angles precluding safe dilation
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C3665386 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0034951 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002418 (UMLS CUI [3,2])
C0029128 (UMLS CUI [4])
C0520679 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C0522797 (UMLS CUI [6,1])
C1299582 (UMLS CUI [6,2])
C0005767 (UMLS CUI [7,1])
C0750430 (UMLS CUI [7,2])
C0205161 (UMLS CUI [7,3])
C0238644 (UMLS CUI [8])
C0023530 (UMLS CUI [9])
C0040034 (UMLS CUI [10])
C0035078 (UMLS CUI [11])
C0023895 (UMLS CUI [12])
C0011854 (UMLS CUI [13])
C0011884 (UMLS CUI [14])
C0332157 (UMLS CUI [15,1])
C0023870 (UMLS CUI [15,2])
C0332157 (UMLS CUI [16,1])
C0042839 (UMLS CUI [16,2])
C0332157 (UMLS CUI [17,1])
C0079183 (UMLS CUI [17,2])
C0348080 (UMLS CUI [18,1])
C1514873 (UMLS CUI [18,2])
C0012798 (UMLS CUI [18,3])
C0348080 (UMLS CUI [19,1])
C1514873 (UMLS CUI [19,2])
C0574135 (UMLS CUI [19,3])
C0348080 (UMLS CUI [20,1])
C1514873 (UMLS CUI [20,2])
C0563322 (UMLS CUI [20,3])
C0348080 (UMLS CUI [21,1])
C1514873 (UMLS CUI [21,2])
C1261311 (UMLS CUI [21,3])
C0348080 (UMLS CUI [22,1])
C1514873 (UMLS CUI [22,2])
C0003364 (UMLS CUI [22,3])
C0348080 (UMLS CUI [23,1])
C1514873 (UMLS CUI [23,2])
C0076829 (UMLS CUI [23,3])
C3843040 (UMLS CUI [24,1])
C1444657 (UMLS CUI [24,2])
C0000981 (UMLS CUI [24,3])
C0022650 (UMLS CUI [25])
C0032961 (UMLS CUI [26])
C3831118 (UMLS CUI [27,1])
C0700589 (UMLS CUI [27,2])
C0558080 (UMLS CUI [27,3])
C0006147 (UMLS CUI [28])
C1510472 (UMLS CUI [29])
C0679247 (UMLS CUI [30])
C0039457 (UMLS CUI [31,1])
C0332268 (UMLS CUI [31,2])
C0237154 (UMLS CUI [32])
C2699029 (UMLS CUI [33])
C0020517 (UMLS CUI [34,1])
C3267125 (UMLS CUI [34,2])
C1410927 (UMLS CUI [35,1])
C0332196 (UMLS CUI [35,2])
C3267125 (UMLS CUI [35,3])

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