ID

40362

Beschrijving

An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH; ODM derived from: https://clinicaltrials.gov/show/NCT02124486

Link

https://clinicaltrials.gov/show/NCT02124486

Trefwoorden

Versies (2)
  1. 13-04-20 13-04-20 -
  2. 13-04-20 13-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 april 2020

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Idiopathic Intracranial Hypertension NCT02124486

Engels

Eligibility Idiopathic Intracranial Hypertension NCT02124486

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female iih patients aged between 18 and 55 years, diagnosed according to the modified dandy criteria who have chronic (> 6 months duration), active disease (papilloedema [frisen grade ≥ 1], significantly raised icp > 25cmh2o) and no evidence of venous sinus thrombosis (magnetic resonance or ct imaging and venography as noted at diagnosis).
Beschrijving

Gender | Pseudotumor Cerebri Duration | Age | Papilledema Grade | Raised intracranial pressure | Thrombosis of venous sinuses Absent Magnetic Resonance Imaging | Thrombosis of venous sinuses Absent Computed Tomography | Thrombosis of venous sinuses Absent Venography

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0033845
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0030353
UMLS CUI [4,2]
C0441800
UMLS CUI [5]
C0437215
UMLS CUI [6,1]
C0740384
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0024485
UMLS CUI [7,1]
C0740384
UMLS CUI [7,2]
C0332197
UMLS CUI [7,3]
C0040405
UMLS CUI [8,1]
C0740384
UMLS CUI [8,2]
C0332197
UMLS CUI [8,3]
C0031545
2. bmi >35kg/m2.
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
3. tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
Beschrijving

Weight reduction regimen failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0311130
UMLS CUI [1,2]
C0231175
4. able to give informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age less than 18 or older than 55 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. pregnant or planning to conceive during the first 18 months of the trial .
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
3. significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
Beschrijving

Comorbidity | Endocrine System Diseases | Hormone Modulating Pharmaceutical Preparations | Exception Contraceptive methods | Exception Topical steroids | Exception Inhaled steroids

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0014130
UMLS CUI [3,1]
C0019932
UMLS CUI [3,2]
C0443264
UMLS CUI [3,3]
C0013227
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2064827
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2065041
4. undergone optic nerve sheath fenestration.
Beschrijving

Optic nerve sheath Fenestration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0228673
UMLS CUI [1,2]
C0337280
5. definite indication for or contraindication against surgery or dieting.
Beschrijving

Indication Operative Surgical Procedures | Medical contraindication Operative Surgical Procedures | Indication Dieting | Medical contraindication Dieting

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C2945766
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C2945766
6. have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months).
Beschrijving

Medical contraindication Operative Surgical Procedures | Drug abuse | Eating Disorders | Major Depressive Disorder | Feeling suicidal | Drug Overdose | Patient Admission Psychological

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0013473
UMLS CUI [4]
C1269683
UMLS CUI [5]
C0424000
UMLS CUI [6]
C0029944
UMLS CUI [7,1]
C0030673
UMLS CUI [7,2]
C0205486
7. previous bariatric surgery.
Beschrijving

Bariatric Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
8. taken azd4017 within the last four months .
Beschrijving

AZD4017

Datatype

boolean

Alias
UMLS CUI [1]
C3501337
9. inability to give informed consent e.g. due to cognitive impairment.
Beschrijving

Informed Consent Unable | Etiology Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0338656
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Similar models

Eligibility Idiopathic Intracranial Hypertension NCT02124486

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pseudotumor Cerebri Duration | Age | Papilledema Grade | Raised intracranial pressure | Thrombosis of venous sinuses Absent Magnetic Resonance Imaging | Thrombosis of venous sinuses Absent Computed Tomography | Thrombosis of venous sinuses Absent Venography
Item
1. female iih patients aged between 18 and 55 years, diagnosed according to the modified dandy criteria who have chronic (> 6 months duration), active disease (papilloedema [frisen grade ≥ 1], significantly raised icp > 25cmh2o) and no evidence of venous sinus thrombosis (magnetic resonance or ct imaging and venography as noted at diagnosis).
boolean
C0079399 (UMLS CUI [1])
C0033845 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0030353 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0437215 (UMLS CUI [5])
C0740384 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0024485 (UMLS CUI [6,3])
C0740384 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0040405 (UMLS CUI [7,3])
C0740384 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0031545 (UMLS CUI [8,3])
Body mass index
Item
2. bmi >35kg/m2.
boolean
C1305855 (UMLS CUI [1])
Weight reduction regimen failed
Item
3. tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
boolean
C0311130 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Informed Consent
Item
4. able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age less than 18 or older than 55 years.
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
2. pregnant or planning to conceive during the first 18 months of the trial .
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Comorbidity | Endocrine System Diseases | Hormone Modulating Pharmaceutical Preparations | Exception Contraceptive methods | Exception Topical steroids | Exception Inhaled steroids
Item
3. significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
boolean
C0009488 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0019932 (UMLS CUI [3,1])
C0443264 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2064827 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C2065041 (UMLS CUI [6,2])
Optic nerve sheath Fenestration
Item
4. undergone optic nerve sheath fenestration.
boolean
C0228673 (UMLS CUI [1,1])
C0337280 (UMLS CUI [1,2])
Indication Operative Surgical Procedures | Medical contraindication Operative Surgical Procedures | Indication Dieting | Medical contraindication Dieting
Item
5. definite indication for or contraindication against surgery or dieting.
boolean
C3146298 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C2945766 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C2945766 (UMLS CUI [4,2])
Medical contraindication Operative Surgical Procedures | Drug abuse | Eating Disorders | Major Depressive Disorder | Feeling suicidal | Drug Overdose | Patient Admission Psychological
Item
6. have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months).
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0013146 (UMLS CUI [2])
C0013473 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0424000 (UMLS CUI [5])
C0029944 (UMLS CUI [6])
C0030673 (UMLS CUI [7,1])
C0205486 (UMLS CUI [7,2])
Bariatric Surgery
Item
7. previous bariatric surgery.
boolean
C1456587 (UMLS CUI [1])
AZD4017
Item
8. taken azd4017 within the last four months .
boolean
C3501337 (UMLS CUI [1])
Informed Consent Unable | Etiology Impaired cognition
Item
9. inability to give informed consent e.g. due to cognitive impairment.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0338656 (UMLS CUI [2,2])
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