ID

16669

Beschrijving

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT00324376

Link

https://clinicaltrials.gov/show/NCT00324376

Trefwoorden

  1. 31-07-16 31-07-16 -
Geüploaded op

31 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Kidney Disease NCT00324376

Eligibility Chronic Kidney Disease NCT00324376

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy of at least 12 months,
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patients have received hemodialysis three times per week for 3 months or longer,
Beschrijving

Hemodialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0019004
patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
Beschrijving

sevelamer | Phosphate Binder | serum phosphorus measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0718050
UMLS CUI [2]
C2267031
UMLS CUI [3]
C2229833
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bowel obstruction,
Beschrijving

Intestinal Obstruction

Datatype

boolean

Alias
UMLS CUI [1]
C0021843
dysphagia,
Beschrijving

Deglutition Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0011168
wallowing dsisorders,
Beschrijving

swallowing disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0011168
severe gastrointestinal motility disorders,
Beschrijving

Gastrointestinal motility disorder Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0854121
UMLS CUI [1,2]
C0205082
active ethanol or drug abuse (excluding tobacco),
Beschrijving

Substance Use Disorders | Tobacco Use Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0040336
need for antidysrhythmic or antiseizure medications used to control these conditions,
Beschrijving

Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0003811
UMLS CUI [1,4]
C0027552
UMLS CUI [2,1]
C0521306
UMLS CUI [2,2]
C0027552
poorly controlled diabetes mellitus or hypertension,
Beschrijving

poorly controlled diabetes mellitus | Poor hypertension control

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0421190
active vasculitis,
Beschrijving

Vasculitis

Datatype

boolean

Alias
UMLS CUI [1]
C0042384
active malignancy other than basal-cell carcinoma,
Beschrijving

Malignant Neoplasms | Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
hiv infection,
Beschrijving

HIV Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
any clinically significant unstable medical condition as judged by the investigator.
Beschrijving

medical condition Unstable Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2826293

Similar models

Eligibility Chronic Kidney Disease NCT00324376

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy of at least 12 months,
boolean
C0023671 (UMLS CUI [1])
Hemodialysis
Item
patients have received hemodialysis three times per week for 3 months or longer,
boolean
C0019004 (UMLS CUI [1])
sevelamer | Phosphate Binder | serum phosphorus measurement
Item
patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
boolean
C0718050 (UMLS CUI [1])
C2267031 (UMLS CUI [2])
C2229833 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Intestinal Obstruction
Item
active bowel obstruction,
boolean
C0021843 (UMLS CUI [1])
Deglutition Disorders
Item
dysphagia,
boolean
C0011168 (UMLS CUI [1])
swallowing disorder
Item
wallowing dsisorders,
boolean
C0011168 (UMLS CUI [1])
Gastrointestinal motility disorder Severe
Item
severe gastrointestinal motility disorders,
boolean
C0854121 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Substance Use Disorders | Tobacco Use Disorder
Item
active ethanol or drug abuse (excluding tobacco),
boolean
C0038586 (UMLS CUI [1])
C0040336 (UMLS CUI [2])
Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed
Item
need for antidysrhythmic or antiseizure medications used to control these conditions,
boolean
C0013227 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0027552 (UMLS CUI [1,4])
C0521306 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
poorly controlled diabetes mellitus | Poor hypertension control
Item
poorly controlled diabetes mellitus or hypertension,
boolean
C0554876 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Vasculitis
Item
active vasculitis,
boolean
C0042384 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma
Item
active malignancy other than basal-cell carcinoma,
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
HIV Infections
Item
hiv infection,
boolean
C0019693 (UMLS CUI [1])
medical condition Unstable Clinical Significance
Item
any clinically significant unstable medical condition as judged by the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])

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