Primary Insomnia
Item
diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
boolean
C0033139 (UMLS CUI [1])
Sleep Initiation and Maintenance Disorders | Patient Sleep pattern
Item
disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
boolean
C0021603 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0474396 (UMLS CUI [2,2])
Clinical Trial Part
Item
sub-study :
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable
Item
patients will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening)
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Breast Feeding | Pregnancy
Item
females who are lactating or who are pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Night shift worker | Nap Frequency
Item
night shift workers, and individuals who nap 3 or more times per week over the preceding month
boolean
C0555008 (UMLS CUI [1])
C0870935 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink
Item
consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
boolean
C0005329 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0043315 (UMLS CUI [1,3])
C0039400 (UMLS CUI [2,1])
C0560654 (UMLS CUI [2,2])
C0009237 (UMLS CUI [3,1])
C0560654 (UMLS CUI [3,2])
C0452444 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another trial having received study medication within 1 month before the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Body mass index
Item
body mass index ≥ 33
boolean
C1305855 (UMLS CUI [1])
Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents
Item
use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
boolean
C0013231 (UMLS CUI [1])
C0041249 (UMLS CUI [2])
C0795674 (UMLS CUI [3])
C0939882 (UMLS CUI [4])
C0025219 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
C4020625 (UMLS CUI [7])
Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake
Item
use of any substance with psychotropic effects or properties know to affect sleep/wake
boolean
C0033978 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0033978 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0442696 (UMLS CUI [2,3])
Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias
Item
history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
boolean
C0033138 (UMLS CUI [1])
C0027404 (UMLS CUI [2])
C0236845 (UMLS CUI [3])
C0877792 (UMLS CUI [4])
C0030508 (UMLS CUI [5])
C0700201 (UMLS CUI [6])
Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures
Item
clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C1335499 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
Urine drug screen positive | Opiates | Cocaine | Amphetamine
Item
positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
boolean
C0743300 (UMLS CUI [1])
C0376196 (UMLS CUI [2])
C0009170 (UMLS CUI [3])
C0002658 (UMLS CUI [4])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])