ID
185
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00247390
Länk
http://clinicaltrials.gov/show/NCT00247390
Nyckelord
Versioner (3)
- 2012-02-17 2012-02-17 -
- 2017-06-06 2017-06-06 - Martin Dugas
- 2021-09-27 2021-09-27 -
Uppladdad den
17 februari 2012
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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Eligibility NCT00247390 Chronic Insomnia
Eligibility
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Beskrivning
hypersensitivity to ramelteon or related compounds
Datatyp
boolean
Beskrivning
Participated in any other investigational study and/or taken any investigational drug
Datatyp
boolean
Beskrivning
Sleep schedule changes required by employment
Datatyp
boolean
Beskrivning
Flown across greater than three time zones
Datatyp
boolean
Beskrivning
Participated in a weight loss program or has substantially altered their exercise routine
Datatyp
boolean
Beskrivning
history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
Datatyp
boolean
Beskrivning
History of psychiatric disorder
Datatyp
boolean
Beskrivning
History of alcohol abuse
Datatyp
boolean
Beskrivning
History of drug abuse
Datatyp
boolean
Beskrivning
Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease
Datatyp
boolean
Beskrivning
Apnea hypopnea index (per hour of sleep) greater than 10
Datatyp
boolean
Beskrivning
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10
Datatyp
boolean
Beskrivning
Positive urine drug screen
Datatyp
boolean
Beskrivning
Positive breathalyzer test
Datatyp
boolean
Beskrivning
Uses tobacco products or any other products that may interfere with the sleep wake cycle
Datatyp
boolean
Beskrivning
Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function
Datatyp
boolean
Beskrivning
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
Datatyp
boolean
Beskrivning
taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication
Datatyp
boolean
Beskrivning
Anxiolytics
Datatyp
boolean
Beskrivning
Sedatives
Datatyp
boolean
Beskrivning
Hypnotics
Datatyp
boolean
Beskrivning
CNS active drugs (including herbal)
Datatyp
boolean
Beskrivning
Antidepressants
Datatyp
boolean
Beskrivning
Narcotic analgesics
Datatyp
boolean
Beskrivning
Anticonvulsants
Datatyp
boolean
Beskrivning
Beta blockers
Datatyp
boolean
Beskrivning
Sedating H1 antihistamines
Datatyp
boolean
Beskrivning
St. John's Wort
Datatyp
boolean
Beskrivning
Systemic steroids
Datatyp
boolean
Beskrivning
Kava-kava
Datatyp
boolean
Beskrivning
Respiratory stimulants
Datatyp
boolean
Beskrivning
Ginkgo-biloba
Datatyp
boolean
Beskrivning
Decongestants
Datatyp
boolean
Beskrivning
Over-the-counter and prescription stimulants
Datatyp
boolean
Beskrivning
Antipsychotics
Datatyp
boolean
Beskrivning
Over-the-counter and prescription diet aids
Datatyp
boolean
Beskrivning
Muscle Relaxants
Datatyp
boolean
Beskrivning
Melatonin and all other drugs or supplements known to affect sleep/wake function
Datatyp
boolean
Beskrivning
additional condition(s)
Datatyp
boolean
Beskrivning
History of hepatitis B or hepatitis C
Datatyp
boolean
Beskrivning
Medical Concepts
Beskrivning
Age
Datatyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beskrivning
Diagnosis
Datatyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
- LOINC Version 232
- MTHU008876
Beskrivning
Contraception
Datatyp
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beskrivning
Lactation
Datatyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beskrivning
pregnant
Datatyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beskrivning
BMI
Datatyp
string
Alias
- UMLS CUI
- C1305855
- SNOMED CT 2010_0731
- 140075008
- MedDRA 13.1
- 10005894
- LOINC Version 232
- LP35925-4
Beskrivning
Chronic Insomnia
Datatyp
string
Alias
- UMLS CUI
- C0751249
- MedDRA 13.1
- 10053851
Beskrivning
Reduced sleep latency
Datatyp
string
Alias
- UMLS CUI
- C2674747
Beskrivning
Hour of sleep
Datatyp
string
Alias
- UMLS CUI
- C0521112
- SNOMED CT 2010_0731
- 21029003
Beskrivning
Hypersensitivity
Datatyp
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 418634005
- ICD-10-CM Version 2010
- T78.40
Beskrivning
Ramelteon
Datatyp
string
Alias
- UMLS CUI
- C1565316
- SNOMED CT 2010_0731
- 419878007
- LOINC Version 232
- MTHU035868
Beskrivning
Melatonin
Datatyp
string
Alias
- UMLS CUI
- C0025219
- SNOMED CT 2010_0731
- 41199001
- LOINC Version 232
- MTHU002350
Beskrivning
Blinded clinical study
Datatyp
string
Alias
- UMLS CUI
- C0681870
Beskrivning
Pharmaceutical Preparations
Datatyp
string
Alias
- UMLS CUI
- C0013227
Beskrivning
Time zone
Datatyp
string
Alias
- UMLS CUI
- C2825194
Beskrivning
Screening
Datatyp
string
Alias
- UMLS CUI
- C1409616
Beskrivning
Weight loss advised
Datatyp
string
Alias
- UMLS CUI
- C0555962
- SNOMED CT 2010_0731
- 275919002
Beskrivning
Seizures
Datatyp
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Beskrivning
Sleep apnea syndromes
Datatyp
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
Beskrivning
Restless legs syndrome
Datatyp
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
Beskrivning
Periodic leg movements of sleep
Datatyp
string
Alias
- UMLS CUI
- C2919187
- SNOMED CT 2010_0731
- 445140006
Beskrivning
COPD
Datatyp
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
Beskrivning
Fibromyalgia
Datatyp
string
Alias
- UMLS CUI
- C0016053
- SNOMED CT 2010_0731
- 24693007
- MedDRA 13.1
- 10048439
- ICD-10-CM Version 2010
- M79.7
Beskrivning
Mental disorders
Datatyp
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
Beskrivning
Alcohol abuse
Datatyp
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
Beskrivning
Drug abuse
Datatyp
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
Beskrivning
Liver disorder
Datatyp
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
Beskrivning
Renal disease
Datatyp
string
Alias
- UMLS CUI
- C0022658
- SNOMED CT 2010_0731
- 90708001
- MedDRA 13.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
Beskrivning
Endocrine system diseases
Datatyp
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
Beskrivning
Cardiovascular diseases
Datatyp
string
Alias
- UMLS CUI
- C0007222
- SNOMED CT 2010_0731
- 105980002
- MedDRA 13.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
Beskrivning
Gastrointestinal diseases
Datatyp
string
Alias
- UMLS CUI
- C0017178
- SNOMED CT 2010_0731
- 119292006
- MedDRA 13.1
- 10017944
Beskrivning
Pulmonary disease
Datatyp
string
Alias
- UMLS CUI
- C0024115
- SNOMED CT 2010_0731
- 19829001
- MedDRA 13.1
- 10025082
- ICD-10-CM Version 2010
- J98.4
Beskrivning
Hematological disease
Datatyp
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
Beskrivning
Nervous system disorder
Datatyp
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
Beskrivning
Metabolic disorder
Datatyp
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
Beskrivning
Nocturnal myoclonus syndrome
Datatyp
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
Beskrivning
Urine drug screen positive
Datatyp
string
Alias
- UMLS CUI
- C0743300
- MedDRA 13.1
- 10051105
Beskrivning
Polysomnography
Datatyp
string
Alias
- UMLS CUI
- C0162701
- SNOMED CT 2010_0731
- 60554003
- MedDRA 13.1
- 10053319
- ICD-9-CM Version 2011
- 89.17
Beskrivning
Breathalyzer test
Datatyp
string
Alias
- UMLS CUI
- C0085924
- SNOMED CT 2010_0731
- D001944
Beskrivning
positive
Datatyp
string
Alias
- UMLS CUI
- CL415097
Beskrivning
Use of tobacco products at least daily
Datatyp
string
Alias
- UMLS CUI
- C1976668
- LOINC Version 232
- MTHU026131
Beskrivning
Nicotine gum
Datatyp
string
Alias
- UMLS CUI
- C0068722
- SNOMED CT 2010_0731
- 346593007
Beskrivning
Nicotine patch
Datatyp
string
Alias
- UMLS CUI
- C0358855
- SNOMED CT 2010_0731
- 346594001
Beskrivning
Organic disorder of sleep wake cycle
Datatyp
string
Alias
- UMLS CUI
- C1561880
Beskrivning
CNS agents
Datatyp
string
Alias
- UMLS CUI
- C0007680
- SNOMED CT 2010_0731
- 372752008
Beskrivning
Single blind study
Datatyp
string
Alias
- UMLS CUI
- C0242570
Beskrivning
Misuse of over-the-counter medications
Datatyp
string
Alias
- UMLS CUI
- C1827845
- SNOMED CT 2010_0731
- 424626006
Beskrivning
Herbal drugs
Datatyp
string
Alias
- UMLS CUI
- C1360419
Beskrivning
Anti-Anxiety Agents
Datatyp
string
Alias
- UMLS CUI
- C0040616
- SNOMED CT 2010_0731
- 373282008
Beskrivning
Sedative
Datatyp
string
Alias
- UMLS CUI
- C0036557
- SNOMED CT 2010_0731
- 372614000
Beskrivning
Hypnotics
Datatyp
string
Alias
- UMLS CUI
- C0020591
- SNOMED CT 2010_0731
- 372585002
- LOINC Version 232
- MTHU015316
Beskrivning
Antidepressants
Datatyp
string
Alias
- UMLS CUI
- C0003289
- SNOMED CT 2010_0731
- 372720008
- LOINC Version 232
- MTHU006782
Beskrivning
Analgesics, Narcotic
Datatyp
string
Alias
- UMLS CUI
- C0027409
- SNOMED CT 2010_0731
- 360204007
Beskrivning
Antiepileptic Agents
Datatyp
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Beskrivning
Beta Blocker
Datatyp
string
Alias
- UMLS CUI
- C0001645
- SNOMED CT 2010_0731
- 33252009
- LOINC Version 232
- MTHU003324
Beskrivning
Histamine H1 Antagonists
Datatyp
string
Alias
- UMLS CUI
- C0019592
- SNOMED CT 2010_0731
- 373228009
Beskrivning
Hypericum perforatum
Datatyp
string
Alias
- UMLS CUI
- C0936242
- SNOMED CT 2010_0731
- 51621002
Beskrivning
systemic steroids
Datatyp
string
Alias
- UMLS CUI
- C2911187
- ICD-10-CM Version 2010
- Z79.52
Beskrivning
Kava preparation
Datatyp
string
Alias
- UMLS CUI
- C0939882
- SNOMED CT 2010_0731
- 412231002
Beskrivning
Stimulants, Respiratory
Datatyp
string
Alias
- UMLS CUI
- C0282685
- SNOMED CT 2010_0731
- 418760000
Beskrivning
Ginkgo biloba
Datatyp
string
Alias
- UMLS CUI
- C0772125
- SNOMED CT 2010_0731
- 412394005
Beskrivning
Decongestants
Datatyp
string
Alias
- UMLS CUI
- C0282374
- SNOMED CT 2010_0731
- 96328007
Beskrivning
Stimulant
Datatyp
string
Alias
- UMLS CUI
- C0304402
- SNOMED CT 2010_0731
- 373333006
- LOINC Version 232
- MTHU003469
Beskrivning
Prescriptions
Datatyp
string
Alias
- UMLS CUI
- C0033080
- SNOMED CT 2010_0731
- 16076005
Beskrivning
Antipsychotic Agent
Datatyp
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 372482001
- LOINC Version 232
- MTHU003337
Beskrivning
Diet Aid
Datatyp
string
Alias
- UMLS CUI
- C0719894
Beskrivning
Muscle relaxants
Datatyp
string
Alias
- UMLS CUI
- C0358430
Beskrivning
Hepatitis B
Datatyp
string
Alias
- UMLS CUI
- C0019163
- SNOMED CT 2010_0731
- 66071002
- MedDRA 13.1
- 10019731
Beskrivning
Hepatitis C
Datatyp
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
Similar models
Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
10006247 (MedDRA 13.1)
10036586 (MedDRA 13.1)
140075008 (SNOMED CT 2010_0731)
10005894 (MedDRA 13.1)
LP35925-4 (LOINC Version 232)
10053851 (MedDRA 13.1)
21029003 (SNOMED CT 2010_0731)
418634005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
275919002 (SNOMED CT 2010_0731)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
73430006 (SNOMED CT 2010_0731)
10040979 (MedDRA 13.1)
G47.30 (ICD-10-CM Version 2010)
780.57 (ICD-9-CM Version 2011)
E13566 (CTCAE Version 4.03)
32914008 (SNOMED CT 2010_0731)
10058920 (MedDRA 13.1)
G25.81 (ICD-10-CM Version 2010)
333.94 (ICD-9-CM Version 2011)
445140006 (SNOMED CT 2010_0731)
13645005 (SNOMED CT 2010_0731)
10009033 (MedDRA 13.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
24693007 (SNOMED CT 2010_0731)
10048439 (MedDRA 13.1)
M79.7 (ICD-10-CM Version 2010)
74732009 (SNOMED CT 2010_0731)
10037174 (MedDRA 13.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
90708001 (SNOMED CT 2010_0731)
10029151 (MedDRA 13.1)
N18.9 (ICD-10-CM Version 2010)
362969004 (SNOMED CT 2010_0731)
10014695 (MedDRA 13.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
105980002 (SNOMED CT 2010_0731)
10007649 (MedDRA 13.1)
429.2 (ICD-9-CM Version 2011)
119292006 (SNOMED CT 2010_0731)
10017944 (MedDRA 13.1)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
191124002 (SNOMED CT 2010_0731)
10061590 (MedDRA 13.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
118940003 (SNOMED CT 2010_0731)
10029202 (MedDRA 13.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
30390004 (SNOMED CT 2010_0731)
10058097 (MedDRA 13.1)
E88.9 (ICD-10-CM Version 2010)
277.9 (ICD-9-CM Version 2011)
418763003 (SNOMED CT 2010_0731)
10064600 (MedDRA 13.1)
G47.61 (ICD-10-CM Version 2010)
327.51 (ICD-9-CM Version 2011)
10051105 (MedDRA 13.1)
60554003 (SNOMED CT 2010_0731)
10053319 (MedDRA 13.1)
89.17 (ICD-9-CM Version 2011)
D001944 (SNOMED CT 2010_0731)
346593007 (SNOMED CT 2010_0731)
346594001 (SNOMED CT 2010_0731)
372752008 (SNOMED CT 2010_0731)
424626006 (SNOMED CT 2010_0731)
373282008 (SNOMED CT 2010_0731)
372614000 (SNOMED CT 2010_0731)
360204007 (SNOMED CT 2010_0731)
373228009 (SNOMED CT 2010_0731)
51621002 (SNOMED CT 2010_0731)
Z79.52 (ICD-10-CM Version 2010)
412231002 (SNOMED CT 2010_0731)
418760000 (SNOMED CT 2010_0731)
412394005 (SNOMED CT 2010_0731)
96328007 (SNOMED CT 2010_0731)
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)