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])
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])