ID

21530

Beschrijving

DILIPO (DILutIonal HyPOnatremia); ODM derived from: https://clinicaltrials.gov/show/NCT00274326

Link

https://clinicaltrials.gov/show/NCT00274326

Trefwoorden

Versies (1)
  1. 26-04-17 26-04-17 -
Geüploaded op

26 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00274326

Engels

Eligibility Congestive Heart Failure NCT00274326

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged 18 higher
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
dilutional hyponatremia with serum sodium between 115 and 132 mmol/l
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585109
UMLS CUI [1,2]
C0523891
ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of known or untreated adrenal insufficiency, siadh or cirrhosis, or hyperthyroidism
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001623
UMLS CUI [1,2]
C0021141
UMLS CUI [1,3]
C0020550
presence of signs of hypovolemia
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0546884
administration of other v2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162829
UMLS CUI [1,2]
C0003139
UMLS CUI [2]
C0011276
UMLS CUI [3]
C0023870
presence of uncontrolled diabetes with fasting glycemia ³ 200 mg/dl (³ 11.09 mmol/l)
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1,1]
C0810250
UMLS CUI [1,2]
C0005802
patients considered by the investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious)
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1,1]
C3839996
UMLS CUI [1,2]
C0013230
administration of inducers of cyp3a4 (phenobarbital, phenytoin, rifampin, saint john's wort) or potent and moderate inhibitors of cyp3a4 within two weeks prior to study drug administration
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1,1]
C3830625
UMLS CUI [1,2]
C3830624
presence or history of allergic reaction to sr121463b8
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C3530089
previous study with sr121463b
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1,1]
C3530089
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205156
inadequate hematological, renal, and hepatic functions: hemoglobin (hb) < 9 g/dl, neutrophils < 1,500/mm3, platelets < 100,000/mm3, serum creatinine > 175 mol/l (or clearance of creatinine < 30 ml/min for sites where ethics committees require this parameter), serum alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) > 2 x upper limit of normal (uln)
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019046
UMLS CUI [1,2]
C0948762
UMLS CUI [1,3]
C0005821
UMLS CUI [1,4]
C0201976
UMLS CUI [1,5]
C0201836
UMLS CUI [1,6]
C0201899
qtcb 500 ³ ms
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C2984919
positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C3831118
pregnancy or breast-feeding
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
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Similar models

Eligibility Congestive Heart Failure NCT00274326

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female patients aged 18 higher
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
dilutional hyponatremia with serum sodium between 115 and 132 mmol/l
boolean
C0585109 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
ID.3
Item
ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.4
Item
presence of known or untreated adrenal insufficiency, siadh or cirrhosis, or hyperthyroidism
boolean
C0001623 (UMLS CUI [1,1])
C0021141 (UMLS CUI [1,2])
C0020550 (UMLS CUI [1,3])
ID.5
Item
presence of signs of hypovolemia
boolean
C0546884 (UMLS CUI [1])
ID.6
Item
administration of other v2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration
boolean
C0162829 (UMLS CUI [1,1])
C0003139 (UMLS CUI [1,2])
C0011276 (UMLS CUI [2])
C0023870 (UMLS CUI [3])
ID.7
Item
presence of uncontrolled diabetes with fasting glycemia ³ 200 mg/dl (³ 11.09 mmol/l)
boolean
C0810250 (UMLS CUI [1,1])
C0005802 (UMLS CUI [1,2])
ID.8
Item
patients considered by the investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious)
boolean
C3839996 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
ID.9
Item
administration of inducers of cyp3a4 (phenobarbital, phenytoin, rifampin, saint john's wort) or potent and moderate inhibitors of cyp3a4 within two weeks prior to study drug administration
boolean
C3830625 (UMLS CUI [1,1])
C3830624 (UMLS CUI [1,2])
ID.10
Item
presence or history of allergic reaction to sr121463b8
boolean
C1527304 (UMLS CUI [1,1])
C3530089 (UMLS CUI [1,2])
ID.11
Item
previous study with sr121463b
boolean
C3530089 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
ID.12
Item
inadequate hematological, renal, and hepatic functions: hemoglobin (hb) < 9 g/dl, neutrophils < 1,500/mm3, platelets < 100,000/mm3, serum creatinine > 175 mol/l (or clearance of creatinine < 30 ml/min for sites where ethics committees require this parameter), serum alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) > 2 x upper limit of normal (uln)
boolean
C0019046 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,3])
C0201976 (UMLS CUI [1,4])
C0201836 (UMLS CUI [1,5])
C0201899 (UMLS CUI [1,6])
ID.13
Item
qtcb 500 ³ ms
boolean
C2984919 (UMLS CUI [1])
ID.14
Item
positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
ID.15
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
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