ID
185
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00247390
Link
http://clinicaltrials.gov/show/NCT00247390
Trefwoorden
Versies (3)
- 17-02-12 17-02-12 -
- 06-06-17 06-06-17 - Martin Dugas
- 27-09-21 27-09-21 -
Geüploaded op
17 februari 2012
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Eligibility NCT00247390 Chronic Insomnia
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Beschrijving
hypersensitivity to ramelteon or related compounds
Datatype
boolean
Beschrijving
Participated in any other investigational study and/or taken any investigational drug
Datatype
boolean
Beschrijving
Sleep schedule changes required by employment
Datatype
boolean
Beschrijving
Flown across greater than three time zones
Datatype
boolean
Beschrijving
Participated in a weight loss program or has substantially altered their exercise routine
Datatype
boolean
Beschrijving
history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
Datatype
boolean
Beschrijving
History of psychiatric disorder
Datatype
boolean
Beschrijving
History of alcohol abuse
Datatype
boolean
Beschrijving
History of drug abuse
Datatype
boolean
Beschrijving
Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease
Datatype
boolean
Beschrijving
Apnea hypopnea index (per hour of sleep) greater than 10
Datatype
boolean
Beschrijving
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10
Datatype
boolean
Beschrijving
Positive urine drug screen
Datatype
boolean
Beschrijving
Positive breathalyzer test
Datatype
boolean
Beschrijving
Uses tobacco products or any other products that may interfere with the sleep wake cycle
Datatype
boolean
Beschrijving
Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function
Datatype
boolean
Beschrijving
Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function
Datatype
boolean
Beschrijving
taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication
Datatype
boolean
Beschrijving
Anxiolytics
Datatype
boolean
Beschrijving
Sedatives
Datatype
boolean
Beschrijving
Hypnotics
Datatype
boolean
Beschrijving
CNS active drugs (including herbal)
Datatype
boolean
Beschrijving
Antidepressants
Datatype
boolean
Beschrijving
Narcotic analgesics
Datatype
boolean
Beschrijving
Anticonvulsants
Datatype
boolean
Beschrijving
Beta blockers
Datatype
boolean
Beschrijving
Sedating H1 antihistamines
Datatype
boolean
Beschrijving
St. John's Wort
Datatype
boolean
Beschrijving
Systemic steroids
Datatype
boolean
Beschrijving
Kava-kava
Datatype
boolean
Beschrijving
Respiratory stimulants
Datatype
boolean
Beschrijving
Ginkgo-biloba
Datatype
boolean
Beschrijving
Decongestants
Datatype
boolean
Beschrijving
Over-the-counter and prescription stimulants
Datatype
boolean
Beschrijving
Antipsychotics
Datatype
boolean
Beschrijving
Over-the-counter and prescription diet aids
Datatype
boolean
Beschrijving
Muscle Relaxants
Datatype
boolean
Beschrijving
Melatonin and all other drugs or supplements known to affect sleep/wake function
Datatype
boolean
Beschrijving
additional condition(s)
Datatype
boolean
Beschrijving
History of hepatitis B or hepatitis C
Datatype
boolean
Beschrijving
Medical Concepts
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschrijving
Diagnosis
Datatype
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
- LOINC Version 232
- MTHU008876
Beschrijving
Contraception
Datatype
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beschrijving
Lactation
Datatype
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschrijving
pregnant
Datatype
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschrijving
BMI
Datatype
string
Alias
- UMLS CUI
- C1305855
- SNOMED CT 2010_0731
- 140075008
- MedDRA 13.1
- 10005894
- LOINC Version 232
- LP35925-4
Beschrijving
Chronic Insomnia
Datatype
string
Alias
- UMLS CUI
- C0751249
- MedDRA 13.1
- 10053851
Beschrijving
Reduced sleep latency
Datatype
string
Alias
- UMLS CUI
- C2674747
Beschrijving
Hour of sleep
Datatype
string
Alias
- UMLS CUI
- C0521112
- SNOMED CT 2010_0731
- 21029003
Beschrijving
Hypersensitivity
Datatype
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 418634005
- ICD-10-CM Version 2010
- T78.40
Beschrijving
Ramelteon
Datatype
string
Alias
- UMLS CUI
- C1565316
- SNOMED CT 2010_0731
- 419878007
- LOINC Version 232
- MTHU035868
Beschrijving
Melatonin
Datatype
string
Alias
- UMLS CUI
- C0025219
- SNOMED CT 2010_0731
- 41199001
- LOINC Version 232
- MTHU002350
Beschrijving
Blinded clinical study
Datatype
string
Alias
- UMLS CUI
- C0681870
Beschrijving
Pharmaceutical Preparations
Datatype
string
Alias
- UMLS CUI
- C0013227
Beschrijving
Time zone
Datatype
string
Alias
- UMLS CUI
- C2825194
Beschrijving
Screening
Datatype
string
Alias
- UMLS CUI
- C1409616
Beschrijving
Weight loss advised
Datatype
string
Alias
- UMLS CUI
- C0555962
- SNOMED CT 2010_0731
- 275919002
Beschrijving
Seizures
Datatype
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Beschrijving
Sleep apnea syndromes
Datatype
string
Alias
- UMLS CUI
- C0037315
- SNOMED CT 2010_0731
- 73430006
- MedDRA 13.1
- 10040979
- ICD-10-CM Version 2010
- G47.30
- ICD-9-CM Version 2011
- 780.57
- CTCAE Version 4.03
- E13566
Beschrijving
Restless legs syndrome
Datatype
string
Alias
- UMLS CUI
- C0035258
- SNOMED CT 2010_0731
- 32914008
- MedDRA 13.1
- 10058920
- ICD-10-CM Version 2010
- G25.81
- ICD-9-CM Version 2011
- 333.94
Beschrijving
Periodic leg movements of sleep
Datatype
string
Alias
- UMLS CUI
- C2919187
- SNOMED CT 2010_0731
- 445140006
Beschrijving
COPD
Datatype
string
Alias
- UMLS CUI
- C0024117
- SNOMED CT 2010_0731
- 13645005
- MedDRA 13.1
- 10009033
- ICD-10-CM Version 2010
- J44.9
- ICD-9-CM Version 2011
- 496
Beschrijving
Fibromyalgia
Datatype
string
Alias
- UMLS CUI
- C0016053
- SNOMED CT 2010_0731
- 24693007
- MedDRA 13.1
- 10048439
- ICD-10-CM Version 2010
- M79.7
Beschrijving
Mental disorders
Datatype
string
Alias
- UMLS CUI
- C0004936
- SNOMED CT 2010_0731
- 74732009
- MedDRA 13.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
Beschrijving
Alcohol abuse
Datatype
string
Alias
- UMLS CUI
- C0085762
- SNOMED CT 2010_0731
- 15167005
- MedDRA 13.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
Beschrijving
Drug abuse
Datatype
string
Alias
- UMLS CUI
- C0013146
- SNOMED CT 2010_0731
- 26416006
- MedDRA 13.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
Beschrijving
Liver disorder
Datatype
string
Alias
- UMLS CUI
- C0023895
- SNOMED CT 2010_0731
- 235856003
- MedDRA 13.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
Beschrijving
Renal disease
Datatype
string
Alias
- UMLS CUI
- C0022658
- SNOMED CT 2010_0731
- 90708001
- MedDRA 13.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
Beschrijving
Endocrine system diseases
Datatype
string
Alias
- UMLS CUI
- C0014130
- SNOMED CT 2010_0731
- 362969004
- MedDRA 13.1
- 10014695
- LOINC Version 232
- MTHU021570
- ICD-10-CM Version 2010
- E34.9
- ICD-9-CM Version 2011
- 259.9
Beschrijving
Cardiovascular diseases
Datatype
string
Alias
- UMLS CUI
- C0007222
- SNOMED CT 2010_0731
- 105980002
- MedDRA 13.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
Beschrijving
Gastrointestinal diseases
Datatype
string
Alias
- UMLS CUI
- C0017178
- SNOMED CT 2010_0731
- 119292006
- MedDRA 13.1
- 10017944
Beschrijving
Pulmonary disease
Datatype
string
Alias
- UMLS CUI
- C0024115
- SNOMED CT 2010_0731
- 19829001
- MedDRA 13.1
- 10025082
- ICD-10-CM Version 2010
- J98.4
Beschrijving
Hematological disease
Datatype
string
Alias
- UMLS CUI
- C0018939
- SNOMED CT 2010_0731
- 191124002
- MedDRA 13.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
Beschrijving
Nervous system disorder
Datatype
string
Alias
- UMLS CUI
- C0027765
- SNOMED CT 2010_0731
- 118940003
- MedDRA 13.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
Beschrijving
Metabolic disorder
Datatype
string
Alias
- UMLS CUI
- C0025517
- SNOMED CT 2010_0731
- 30390004
- MedDRA 13.1
- 10058097
- ICD-10-CM Version 2010
- E88.9
- ICD-9-CM Version 2011
- 277.9
Beschrijving
Nocturnal myoclonus syndrome
Datatype
string
Alias
- UMLS CUI
- C0751774
- SNOMED CT 2010_0731
- 418763003
- MedDRA 13.1
- 10064600
- ICD-10-CM Version 2010
- G47.61
- ICD-9-CM Version 2011
- 327.51
Beschrijving
Urine drug screen positive
Datatype
string
Alias
- UMLS CUI
- C0743300
- MedDRA 13.1
- 10051105
Beschrijving
Polysomnography
Datatype
string
Alias
- UMLS CUI
- C0162701
- SNOMED CT 2010_0731
- 60554003
- MedDRA 13.1
- 10053319
- ICD-9-CM Version 2011
- 89.17
Beschrijving
Breathalyzer test
Datatype
string
Alias
- UMLS CUI
- C0085924
- SNOMED CT 2010_0731
- D001944
Beschrijving
positive
Datatype
string
Alias
- UMLS CUI
- CL415097
Beschrijving
Use of tobacco products at least daily
Datatype
string
Alias
- UMLS CUI
- C1976668
- LOINC Version 232
- MTHU026131
Beschrijving
Nicotine gum
Datatype
string
Alias
- UMLS CUI
- C0068722
- SNOMED CT 2010_0731
- 346593007
Beschrijving
Nicotine patch
Datatype
string
Alias
- UMLS CUI
- C0358855
- SNOMED CT 2010_0731
- 346594001
Beschrijving
Organic disorder of sleep wake cycle
Datatype
string
Alias
- UMLS CUI
- C1561880
Beschrijving
CNS agents
Datatype
string
Alias
- UMLS CUI
- C0007680
- SNOMED CT 2010_0731
- 372752008
Beschrijving
Single blind study
Datatype
string
Alias
- UMLS CUI
- C0242570
Beschrijving
Misuse of over-the-counter medications
Datatype
string
Alias
- UMLS CUI
- C1827845
- SNOMED CT 2010_0731
- 424626006
Beschrijving
Herbal drugs
Datatype
string
Alias
- UMLS CUI
- C1360419
Beschrijving
Anti-Anxiety Agents
Datatype
string
Alias
- UMLS CUI
- C0040616
- SNOMED CT 2010_0731
- 373282008
Beschrijving
Sedative
Datatype
string
Alias
- UMLS CUI
- C0036557
- SNOMED CT 2010_0731
- 372614000
Beschrijving
Hypnotics
Datatype
string
Alias
- UMLS CUI
- C0020591
- SNOMED CT 2010_0731
- 372585002
- LOINC Version 232
- MTHU015316
Beschrijving
Antidepressants
Datatype
string
Alias
- UMLS CUI
- C0003289
- SNOMED CT 2010_0731
- 372720008
- LOINC Version 232
- MTHU006782
Beschrijving
Analgesics, Narcotic
Datatype
string
Alias
- UMLS CUI
- C0027409
- SNOMED CT 2010_0731
- 360204007
Beschrijving
Antiepileptic Agents
Datatype
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Beschrijving
Beta Blocker
Datatype
string
Alias
- UMLS CUI
- C0001645
- SNOMED CT 2010_0731
- 33252009
- LOINC Version 232
- MTHU003324
Beschrijving
Histamine H1 Antagonists
Datatype
string
Alias
- UMLS CUI
- C0019592
- SNOMED CT 2010_0731
- 373228009
Beschrijving
Hypericum perforatum
Datatype
string
Alias
- UMLS CUI
- C0936242
- SNOMED CT 2010_0731
- 51621002
Beschrijving
systemic steroids
Datatype
string
Alias
- UMLS CUI
- C2911187
- ICD-10-CM Version 2010
- Z79.52
Beschrijving
Kava preparation
Datatype
string
Alias
- UMLS CUI
- C0939882
- SNOMED CT 2010_0731
- 412231002
Beschrijving
Stimulants, Respiratory
Datatype
string
Alias
- UMLS CUI
- C0282685
- SNOMED CT 2010_0731
- 418760000
Beschrijving
Ginkgo biloba
Datatype
string
Alias
- UMLS CUI
- C0772125
- SNOMED CT 2010_0731
- 412394005
Beschrijving
Decongestants
Datatype
string
Alias
- UMLS CUI
- C0282374
- SNOMED CT 2010_0731
- 96328007
Beschrijving
Stimulant
Datatype
string
Alias
- UMLS CUI
- C0304402
- SNOMED CT 2010_0731
- 373333006
- LOINC Version 232
- MTHU003469
Beschrijving
Prescriptions
Datatype
string
Alias
- UMLS CUI
- C0033080
- SNOMED CT 2010_0731
- 16076005
Beschrijving
Antipsychotic Agent
Datatype
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 372482001
- LOINC Version 232
- MTHU003337
Beschrijving
Diet Aid
Datatype
string
Alias
- UMLS CUI
- C0719894
Beschrijving
Muscle relaxants
Datatype
string
Alias
- UMLS CUI
- C0358430
Beschrijving
Hepatitis B
Datatype
string
Alias
- UMLS CUI
- C0019163
- SNOMED CT 2010_0731
- 66071002
- MedDRA 13.1
- 10019731
Beschrijving
Hepatitis C
Datatype
string
Alias
- UMLS CUI
- C0019196
- SNOMED CT 2010_0731
- 50711007
- MedDRA 13.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
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Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
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429.2 (ICD-9-CM Version 2011)
119292006 (SNOMED CT 2010_0731)
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289.9 (ICD-9-CM Version 2011)
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G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
30390004 (SNOMED CT 2010_0731)
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E88.9 (ICD-10-CM Version 2010)
277.9 (ICD-9-CM Version 2011)
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16076005 (SNOMED CT 2010_0731)
66071002 (SNOMED CT 2010_0731)
10019731 (MedDRA 13.1)
50711007 (SNOMED CT 2010_0731)
10019744 (MedDRA 13.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)