ID

30049

Beskrivning

Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients; ODM derived from: https://clinicaltrials.gov/show/NCT01007994

Länk

https://clinicaltrials.gov/show/NCT01007994

Nyckelord

Versioner (1)
  1. 2018-05-05 2018-05-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension Secondary to Kidney Transplant NCT01007994

Engelsk

Eligibility Hypertension Secondary to Kidney Transplant NCT01007994

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects age 5-21 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
stable kidney transplant recipients (<30% change in egfr in past 3 months)
Beskrivning

Kidney Transplant Recipient Stable | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1709854
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C3811844
egfr > 30 ml/min/1.73 m2
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
>6 months since kidney transplant
Beskrivning

Kidney Transplantation Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205156
abpm: non-dipper status defined as <10% decline in systolic or diastolic blood pressure from daytime to night-time
Beskrivning

Blood Pressure Monitoring, Ambulatory | Other Coding | Daytime Decreased systolic arterial pressure Night time | Daytime Decreased diastolic arterial pressure Night time

Datatyp

boolean

Alias
UMLS CUI [1]
C0242876
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0332169
UMLS CUI [3,2]
C0277885
UMLS CUI [3,3]
C0240526
UMLS CUI [4,1]
C0332169
UMLS CUI [4,2]
C0277890
UMLS CUI [4,3]
C0240526
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
abpm: subjects with daytime mean blood pressure > 95% for height and sex
Beskrivning

Blood Pressure Monitoring, Ambulatory | Mean blood pressure Daytime | Body Height | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0242876
UMLS CUI [2,1]
C0428886
UMLS CUI [2,2]
C0332169
UMLS CUI [3]
C0005890
UMLS CUI [4]
C0079399
subjects on diuretic monotherapy will not be eligible for the time change group (to avoid discomfort of nocturnal enuresis)
Beskrivning

Diuretics | Avoidance Discomfort Nocturnal enuresis

Datatyp

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0231218
UMLS CUI [2,3]
C0270327
subjects with nephrotic range proteinuria
Beskrivning

Nephrotic range proteinuria

Datatyp

boolean

Alias
UMLS CUI [1]
C0445118
subjects with major co-morbid conditions such as cardiac disease, pulmonary disease and diabetes mellitus
Beskrivning

Comorbidity Major | Heart Diseases | Lung diseases | Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0011849
subjects/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Beskrivning

Guardian Protocol Compliance Lacking | Protocol Compliance Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1274041
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332268
subjects who are pregnant will not be eligible for the new medication group
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Hypertension Secondary to Kidney Transplant NCT01007994

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects age 5-21 years
boolean
C0001779 (UMLS CUI [1])
Kidney Transplant Recipient Stable | Estimated Glomerular Filtration Rate
Item
stable kidney transplant recipients (<30% change in egfr in past 3 months)
boolean
C0022671 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C3811844 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
egfr > 30 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Kidney Transplantation Previous
Item
>6 months since kidney transplant
boolean
C0022671 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Blood Pressure Monitoring, Ambulatory | Other Coding | Daytime Decreased systolic arterial pressure Night time | Daytime Decreased diastolic arterial pressure Night time
Item
abpm: non-dipper status defined as <10% decline in systolic or diastolic blood pressure from daytime to night-time
boolean
C0242876 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0332169 (UMLS CUI [3,1])
C0277885 (UMLS CUI [3,2])
C0240526 (UMLS CUI [3,3])
C0332169 (UMLS CUI [4,1])
C0277890 (UMLS CUI [4,2])
C0240526 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Blood Pressure Monitoring, Ambulatory | Mean blood pressure Daytime | Body Height | Gender
Item
abpm: subjects with daytime mean blood pressure > 95% for height and sex
boolean
C0242876 (UMLS CUI [1])
C0428886 (UMLS CUI [2,1])
C0332169 (UMLS CUI [2,2])
C0005890 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Diuretics | Avoidance Discomfort Nocturnal enuresis
Item
subjects on diuretic monotherapy will not be eligible for the time change group (to avoid discomfort of nocturnal enuresis)
boolean
C0012798 (UMLS CUI [1])
C0870186 (UMLS CUI [2,1])
C0231218 (UMLS CUI [2,2])
C0270327 (UMLS CUI [2,3])
Nephrotic range proteinuria
Item
subjects with nephrotic range proteinuria
boolean
C0445118 (UMLS CUI [1])
Comorbidity Major | Heart Diseases | Lung diseases | Diabetes Mellitus
Item
subjects with major co-morbid conditions such as cardiac disease, pulmonary disease and diabetes mellitus
boolean
C0009488 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
Guardian Protocol Compliance Lacking | Protocol Compliance Lacking
Item
subjects/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
boolean
C1274041 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Pregnancy
Item
subjects who are pregnant will not be eligible for the new medication group
boolean
C0032961 (UMLS CUI [1])
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