ID

25348

Beschrijving

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00464061

Link

https://clinicaltrials.gov/show/NCT00464061

Trefwoorden

Versies (1)
  1. 01-09-17 01-09-17 -
Geüploaded op

1 september 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

Engels

Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria
Beschrijving

Primary Insomnia

Datatype

boolean

Alias
UMLS CUI [1]
C0033139
disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
Beschrijving

Sleep Initiation and Maintenance Disorders | Patient Sleep pattern

Datatype

boolean

Alias
UMLS CUI [1]
C0021603
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0474396
sub-study :
Beschrijving

Clinical Trial Part

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
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)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Dose Stable | Insulin Dose Stable

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are lactating or who are pregnant
Beschrijving

Breast Feeding | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
night shift workers, and individuals who nap 3 or more times per week over the preceding month
Beschrijving

Night shift worker | Nap Frequency

Datatype

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2,1]
C0870935
UMLS CUI [2,2]
C0439603
consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
Beschrijving

Beverages Containing Xanthine or xanthine derivative | Tea cups/day | Coffee cups/day | Cola drink

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005329
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0043315
UMLS CUI [2,1]
C0039400
UMLS CUI [2,2]
C0560654
UMLS CUI [3,1]
C0009237
UMLS CUI [3,2]
C0560654
UMLS CUI [4]
C0452444
participation in another trial having received study medication within 1 month before the screening visit
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
body mass index ≥ 33
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication
Beschrijving

Drugs, Non-Prescription | Tryptophan | valerian root extract | Kava preparation | Melatonin | ST. JOHN'S WORT EXTRACT | Sleep Disorder Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0041249
UMLS CUI [3]
C0795674
UMLS CUI [4]
C0939882
UMLS CUI [5]
C0025219
UMLS CUI [6]
C0813171
UMLS CUI [7]
C4020625
use of any substance with psychotropic effects or properties know to affect sleep/wake
Beschrijving

Psychotropic Drugs Affecting Sleep | Psychotropic Drugs Affecting Wake

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0037313
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0442696
history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
Beschrijving

Primary Hypersomnia | Narcolepsy | Breathing-related sleep disorder | Sleep Disorders, Circadian Rhythm | Parasomnia | Dyssomnias

Datatype

boolean

Alias
UMLS CUI [1]
C0033138
UMLS CUI [2]
C0027404
UMLS CUI [3]
C0236845
UMLS CUI [4]
C0877792
UMLS CUI [5]
C0030508
UMLS CUI [6]
C0700201
clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
Beschrijving

Disease Severe | Disease Unstable | Progressive Disease | Progressive Disease chronic | Disease Due to Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C1335499
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0543467
positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
Beschrijving

Urine drug screen positive | Opiates | Cocaine | Amphetamine

Datatype

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0376196
UMLS CUI [3]
C0009170
UMLS CUI [4]
C0002658
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Sleep Initiation and Maintenance Disorders NCT00464061

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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