ID

44269

Beskrivning

Analysis of Calcium Balance in Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00974532

Länk

https://clinicaltrials.gov/show/NCT00974532

Nyckelord

Versioner (2)
  1. 2017-12-10 2017-12-10 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00974532

Engelsk

Eligibility Chronic Kidney Disease NCT00974532

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women 18 years of age or greater and able to comply with the study protocol.
Beskrivning

Age | Protocol Compliance Ability

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0085732
egfr within appropriate target ranges (15-40 ml/min/m² for late stage ckd stage 3 stage 4, and egfr > 60 ml/min/m² for normal subjects)
Beskrivning

Estimated Glomerular Filtration Rate | Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate Study Subject Normal

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C2074731
UMLS CUI [3,1]
C3811844
UMLS CUI [3,2]
C0681850
UMLS CUI [3,3]
C0205307
stable kidney function defined as an egfr which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. this will be determined from historical laboratory data.
Beskrivning

Renal function Stable | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C3811844
willing to follow study protocol
Beskrivning

Protocol Compliance Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0600109
have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
Beskrivning

Comprehension Study Protocol | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C1321605
overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods
Beskrivning

Patient's condition stable | Absence Condition Protocol Compliance Difficult | Absence Malignant Neoplasms | Absence Metabolic Diseases | Absence Gastrointestinal Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1282982
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0332218
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0025517
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0017178
able to read the consent form and provide informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
serum calcium and phosphorus within the normal range off of vitamin d analogues, calcium supplements, and phosphate binders for 1 month.
Beskrivning

Serum calcium normal | Normal serum phosphorus | Vitamin D Analog Absent | Calcium supplement Absent | Phosphate Binder Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0858094
UMLS CUI [2]
C1859276
UMLS CUI [3,1]
C2917444
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3540037
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C2267031
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age less than 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female.
Beskrivning

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
patient declines participation.
Beskrivning

Refusal to Participate

Datatyp

boolean

Alias
UMLS CUI [1]
C1136454
gi malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis.
Beskrivning

Malabsorption gastrointestinal | Short Bowel Syndrome | Frequent vomiting | Gastroparesis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714745
UMLS CUI [1,2]
C0521362
UMLS CUI [2]
C0036992
UMLS CUI [3]
C1857202
UMLS CUI [4]
C0152020
subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates.
Beskrivning

Parathyroid Hormone synthetic | Glucocorticoids | Calcitonin | Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030520
UMLS CUI [1,2]
C1883254
UMLS CUI [2]
C0017710
UMLS CUI [3]
C0006668
UMLS CUI [4]
C0012544
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Similar models

Eligibility Chronic Kidney Disease NCT00974532

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Protocol Compliance Ability
Item
men and women 18 years of age or greater and able to comply with the study protocol.
boolean
C0001779 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Estimated Glomerular Filtration Rate | Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate Study Subject Normal
Item
egfr within appropriate target ranges (15-40 ml/min/m² for late stage ckd stage 3 stage 4, and egfr > 60 ml/min/m² for normal subjects)
boolean
C3811844 (UMLS CUI [1])
C1561643 (UMLS CUI [2,1])
C2074731 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C0205307 (UMLS CUI [3,3])
Renal function Stable | Estimated Glomerular Filtration Rate
Item
stable kidney function defined as an egfr which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. this will be determined from historical laboratory data.
boolean
C0232804 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Protocol Compliance Willing
Item
willing to follow study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Comprehension Study Protocol | Compliance behavior
Item
have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
Patient's condition stable | Absence Condition Protocol Compliance Difficult | Absence Malignant Neoplasms | Absence Metabolic Diseases | Absence Gastrointestinal Disease
Item
overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods
boolean
C1282982 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0332218 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0025517 (UMLS CUI [4,2])
C0332197 (UMLS CUI [5,1])
C0017178 (UMLS CUI [5,2])
Informed Consent
Item
able to read the consent form and provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Serum calcium normal | Normal serum phosphorus | Vitamin D Analog Absent | Calcium supplement Absent | Phosphate Binder Absent
Item
serum calcium and phosphorus within the normal range off of vitamin d analogues, calcium supplements, and phosphate binders for 1 month.
boolean
C0858094 (UMLS CUI [1])
C1859276 (UMLS CUI [2])
C2917444 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3540037 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2267031 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age less than 18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Refusal to Participate
Item
patient declines participation.
boolean
C1136454 (UMLS CUI [1])
Malabsorption gastrointestinal | Short Bowel Syndrome | Frequent vomiting | Gastroparesis
Item
gi malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis.
boolean
C3714745 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
C0036992 (UMLS CUI [2])
C1857202 (UMLS CUI [3])
C0152020 (UMLS CUI [4])
Parathyroid Hormone synthetic | Glucocorticoids | Calcitonin | Diphosphonates
Item
subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates.
boolean
C0030520 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2])
C0006668 (UMLS CUI [3])
C0012544 (UMLS CUI [4])
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