ID

16669

Descrição

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

Palavras-chave

  1. 31/07/2016 31/07/2016 -
Transferido a

31 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Chronic Kidney Disease NCT00324376

Eligibility Chronic Kidney Disease NCT00324376

Inclusion Criteria
Descrição

Inclusion Criteria

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

Life Expectancy

Tipo de dados

boolean

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

Hemodialysis

Tipo de dados

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).
Descrição

sevelamer | Phosphate Binder | serum phosphorus measurement

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bowel obstruction,
Descrição

Intestinal Obstruction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021843
dysphagia,
Descrição

Deglutition Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011168
wallowing dsisorders,
Descrição

swallowing disorder

Tipo de dados

boolean

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

Gastrointestinal motility disorder Severe

Tipo de dados

boolean

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

Substance Use Disorders | Tobacco Use Disorder

Tipo de dados

boolean

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

Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed

Tipo de dados

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,
Descrição

poorly controlled diabetes mellitus | Poor hypertension control

Tipo de dados

boolean

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

Vasculitis

Tipo de dados

boolean

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

Malignant Neoplasms | Basal cell carcinoma

Tipo de dados

boolean

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

HIV Infections

Tipo de dados

boolean

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

medical condition Unstable Clinical Significance

Tipo de dados

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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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