ID

14250

Beskrivning

ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00140907

Länk

https://clinicaltrials.gov/show/NCT00140907

Nyckelord

Versioner (2)
  1. 2016-04-04 2016-04-04 -
  2. 2016-04-05 2016-04-05 - Julian Varghese
Uppladdad den

5 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility High Blood Pressure NCT00140907

Engelsk

Eligibility High Blood Pressure NCT00140907

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with end stage chronic renal failure, four to eight week after receiving a first or a second renal transplant from a dead donor. in the case of a second transplant the survival of the first graft must has been 6 month or more
Beskrivning

Renal failure: renal transplant from a dead donor

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0973442
UMLS CUI [3]
C0022671
patients must have a serum creatinine * 2 at visit 1 and 2. results must be within 25% of each other. the baseline period may be extended until four more weeks to obtain an additional serum creatinine if one of the first two serum creatinine results do not qualify
Beskrivning

Serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
patients with hypertension must have a sitting blood pressure < 200/110 mmhg at the time of randomization
Beskrivning

Sitting blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0580946
normotensive patients must have a sitting systolic blood pressure >100 mmhg at the time of randomization
Beskrivning

Sitting systolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1319893
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hyperimmunized patients at the transplant time or in the previous 6 month, with a pra of 50 %
Beskrivning

Hyperimmunized patients and Panel-reactive antibody

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0301877
UMLS CUI [1,2]
C1141951
patients with evidence of advanced liver disease
Beskrivning

Liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
serum potassium <3.5 or >5.5 meq/l
Beskrivning

Serum potassium

Datatyp

boolean

Alias
UMLS CUI [1]
C0202194
history of allergy to losartan
Beskrivning

Allergy to losartan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0126174
other factors which may affect participation (e.g., significant concurrent or life limiting disease such as cancer in the last five year except skin neoplasias, mental or legal incapacitation, drug or alcohol abuse within the last 2 years, extensive travel planned in the next 3 years, investigative drug trial within the last 4 weeks)
Beskrivning

Factors affecting participation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0679823
patients with disseminated or localized active infectious disease, at the time of transplant
Beskrivning

Disseminated or localized active infectious disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205221
UMLS CUI [1,2]
C3262321
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C3262321
acute graft rejection in the grade iii of banff classification
Beskrivning

acute graft rejection

Datatyp

boolean

Alias
UMLS CUI [1]
C1736177
patients with double-transplant (reno-pancreatic)
Beskrivning

Reno-pancreatic transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030275
UMLS CUI [1,2]
C0022671
patients with heart failure or history of myocardial infarction requiring ace inhibitor or aiia therapies. presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy
Beskrivning

Cardiovascular status

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003015
UMLS CUI [4]
C1384985
UMLS CUI [5]
C0007194
renal graft artery stenosis. an eco-doppler test must be performed in order to exclude a graft artery stenosis
Beskrivning

Eco-doppler test: renal graft artery stenosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0022671
UMLS CUI [1,3]
C0162481
pregnant or nursing women
Beskrivning

Gynaecological status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
chronic use of nsaids
Beskrivning

Chronic use of nsaids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1398175
major psychotropic agents such as phenothiazines are not permitted, use of lithium is not permitted
Beskrivning

Phenothiazines or lithium

Datatyp

boolean

Alias
UMLS CUI [1]
C0031436
UMLS CUI [2]
C3540800
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Similar models

Eligibility High Blood Pressure NCT00140907

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Renal failure: renal transplant from a dead donor
Item
patients with end stage chronic renal failure, four to eight week after receiving a first or a second renal transplant from a dead donor. in the case of a second transplant the survival of the first graft must has been 6 month or more
boolean
C0022661 (UMLS CUI [1])
C0973442 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Serum creatinine
Item
patients must have a serum creatinine * 2 at visit 1 and 2. results must be within 25% of each other. the baseline period may be extended until four more weeks to obtain an additional serum creatinine if one of the first two serum creatinine results do not qualify
boolean
C0201976 (UMLS CUI [1])
Sitting blood pressure
Item
patients with hypertension must have a sitting blood pressure < 200/110 mmhg at the time of randomization
boolean
C0580946 (UMLS CUI [1])
Sitting systolic blood pressure
Item
normotensive patients must have a sitting systolic blood pressure >100 mmhg at the time of randomization
boolean
C1319893 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperimmunized patients and Panel-reactive antibody
Item
hyperimmunized patients at the transplant time or in the previous 6 month, with a pra of 50 %
boolean
C0301877 (UMLS CUI [1,1])
C1141951 (UMLS CUI [1,2])
Liver disease
Item
patients with evidence of advanced liver disease
boolean
C0023895 (UMLS CUI [1])
Serum potassium
Item
serum potassium <3.5 or >5.5 meq/l
boolean
C0202194 (UMLS CUI [1])
Allergy to losartan
Item
history of allergy to losartan
boolean
C0020517 (UMLS CUI [1,1])
C0126174 (UMLS CUI [1,2])
Factors affecting participation
Item
other factors which may affect participation (e.g., significant concurrent or life limiting disease such as cancer in the last five year except skin neoplasias, mental or legal incapacitation, drug or alcohol abuse within the last 2 years, extensive travel planned in the next 3 years, investigative drug trial within the last 4 weeks)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
Disseminated or localized active infectious disease
Item
patients with disseminated or localized active infectious disease, at the time of transplant
boolean
C0205221 (UMLS CUI [1,1])
C3262321 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C3262321 (UMLS CUI [2,2])
acute graft rejection
Item
acute graft rejection in the grade iii of banff classification
boolean
C1736177 (UMLS CUI [1])
Reno-pancreatic transplant
Item
patients with double-transplant (reno-pancreatic)
boolean
C0030275 (UMLS CUI [1,1])
C0022671 (UMLS CUI [1,2])
Cardiovascular status
Item
patients with heart failure or history of myocardial infarction requiring ace inhibitor or aiia therapies. presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy
boolean
C0018801 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C1384985 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
Eco-doppler test: renal graft artery stenosis
Item
renal graft artery stenosis. an eco-doppler test must be performed in order to exclude a graft artery stenosis
boolean
C0035067 (UMLS CUI [1,1])
C0022671 (UMLS CUI [1,2])
C0162481 (UMLS CUI [1,3])
Gynaecological status
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Chronic use of nsaids
Item
chronic use of nsaids
boolean
C0003211 (UMLS CUI [1,1])
C1398175 (UMLS CUI [1,2])
Phenothiazines or lithium
Item
major psychotropic agents such as phenothiazines are not permitted, use of lithium is not permitted
boolean
C0031436 (UMLS CUI [1])
C3540800 (UMLS CUI [2])
Tillbaka till toppen 

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