ID
185
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT00247390
Link
http://clinicaltrials.gov/show/NCT00247390
Stichworte
Versionen (3)
- 17.02.12 17.02.12 -
- 06.06.17 06.06.17 - Martin Dugas
- 27.09.21 27.09.21 -
Hochgeladen am
17. Februar 2012
DOI
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Lizenz
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Eligibility NCT00247390 Chronic Insomnia
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Beschreibung
hypersensitivity to ramelteon or related compounds
Datentyp
boolean
Beschreibung
Participated in any other investigational study and/or taken any investigational drug
Datentyp
boolean
Beschreibung
Sleep schedule changes required by employment
Datentyp
boolean
Beschreibung
Flown across greater than three time zones
Datentyp
boolean
Beschreibung
Participated in a weight loss program or has substantially altered their exercise routine
Datentyp
boolean
Beschreibung
history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia
Datentyp
boolean
Beschreibung
History of psychiatric disorder
Datentyp
boolean
Beschreibung
History of alcohol abuse
Datentyp
boolean
Beschreibung
History of drug abuse
Datentyp
boolean
Beschreibung
Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease
Datentyp
boolean
Beschreibung
Apnea hypopnea index (per hour of sleep) greater than 10
Datentyp
boolean
Beschreibung
Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10
Datentyp
boolean
Beschreibung
Positive urine drug screen
Datentyp
boolean
Beschreibung
Positive breathalyzer test
Datentyp
boolean
Beschreibung
Uses tobacco products or any other products that may interfere with the sleep wake cycle
Datentyp
boolean
Beschreibung
Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function
Datentyp
boolean
Beschreibung
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
Datentyp
boolean
Beschreibung
taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication
Datentyp
boolean
Beschreibung
Anxiolytics
Datentyp
boolean
Beschreibung
Sedatives
Datentyp
boolean
Beschreibung
Hypnotics
Datentyp
boolean
Beschreibung
CNS active drugs (including herbal)
Datentyp
boolean
Beschreibung
Antidepressants
Datentyp
boolean
Beschreibung
Narcotic analgesics
Datentyp
boolean
Beschreibung
Anticonvulsants
Datentyp
boolean
Beschreibung
Beta blockers
Datentyp
boolean
Beschreibung
Sedating H1 antihistamines
Datentyp
boolean
Beschreibung
St. John's Wort
Datentyp
boolean
Beschreibung
Systemic steroids
Datentyp
boolean
Beschreibung
Kava-kava
Datentyp
boolean
Beschreibung
Respiratory stimulants
Datentyp
boolean
Beschreibung
Ginkgo-biloba
Datentyp
boolean
Beschreibung
Decongestants
Datentyp
boolean
Beschreibung
Over-the-counter and prescription stimulants
Datentyp
boolean
Beschreibung
Antipsychotics
Datentyp
boolean
Beschreibung
Over-the-counter and prescription diet aids
Datentyp
boolean
Beschreibung
Muscle Relaxants
Datentyp
boolean
Beschreibung
Melatonin and all other drugs or supplements known to affect sleep/wake function
Datentyp
boolean
Beschreibung
additional condition(s)
Datentyp
boolean
Beschreibung
History of hepatitis B or hepatitis C
Datentyp
boolean
Beschreibung
Medical Concepts
Beschreibung
Age
Datentyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschreibung
Diagnosis
Datentyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
- LOINC Version 232
- MTHU008876
Beschreibung
Contraception
Datentyp
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beschreibung
Lactation
Datentyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschreibung
pregnant
Datentyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschreibung
BMI
Datentyp
string
Alias
- UMLS CUI
- C1305855
- SNOMED CT 2010_0731
- 140075008
- MedDRA 13.1
- 10005894
- LOINC Version 232
- LP35925-4
Beschreibung
Chronic Insomnia
Datentyp
string
Alias
- UMLS CUI
- C0751249
- MedDRA 13.1
- 10053851
Beschreibung
Reduced sleep latency
Datentyp
string
Alias
- UMLS CUI
- C2674747
Beschreibung
Hour of sleep
Datentyp
string
Alias
- UMLS CUI
- C0521112
- SNOMED CT 2010_0731
- 21029003
Beschreibung
Hypersensitivity
Datentyp
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 418634005
- ICD-10-CM Version 2010
- T78.40
Beschreibung
Ramelteon
Datentyp
string
Alias
- UMLS CUI
- C1565316
- SNOMED CT 2010_0731
- 419878007
- LOINC Version 232
- MTHU035868
Beschreibung
Melatonin
Datentyp
string
Alias
- UMLS CUI
- C0025219
- SNOMED CT 2010_0731
- 41199001
- LOINC Version 232
- MTHU002350
Beschreibung
Blinded clinical study
Datentyp
string
Alias
- UMLS CUI
- C0681870
Beschreibung
Pharmaceutical Preparations
Datentyp
string
Alias
- UMLS CUI
- C0013227
Beschreibung
Time zone
Datentyp
string
Alias
- UMLS CUI
- C2825194
Beschreibung
Screening
Datentyp
string
Alias
- UMLS CUI
- C1409616
Beschreibung
Weight loss advised
Datentyp
string
Alias
- UMLS CUI
- C0555962
- SNOMED CT 2010_0731
- 275919002
Beschreibung
Seizures
Datentyp
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Beschreibung
Sleep apnea syndromes
Datentyp
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
Beschreibung
Restless legs syndrome
Datentyp
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
Beschreibung
Periodic leg movements of sleep
Datentyp
string
Alias
- UMLS CUI
- C2919187
- SNOMED CT 2010_0731
- 445140006
Beschreibung
COPD
Datentyp
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
Beschreibung
Fibromyalgia
Datentyp
string
Alias
- UMLS CUI
- C0016053
- SNOMED CT 2010_0731
- 24693007
- MedDRA 13.1
- 10048439
- ICD-10-CM Version 2010
- M79.7
Beschreibung
Mental disorders
Datentyp
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
Beschreibung
Alcohol abuse
Datentyp
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
Beschreibung
Drug abuse
Datentyp
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
Beschreibung
Liver disorder
Datentyp
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
Beschreibung
Renal disease
Datentyp
string
Alias
- UMLS CUI
- C0022658
- SNOMED CT 2010_0731
- 90708001
- MedDRA 13.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
Beschreibung
Endocrine system diseases
Datentyp
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
Beschreibung
Cardiovascular diseases
Datentyp
string
Alias
- UMLS CUI
- C0007222
- SNOMED CT 2010_0731
- 105980002
- MedDRA 13.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
Beschreibung
Gastrointestinal diseases
Datentyp
string
Alias
- UMLS CUI
- C0017178
- SNOMED CT 2010_0731
- 119292006
- MedDRA 13.1
- 10017944
Beschreibung
Pulmonary disease
Datentyp
string
Alias
- UMLS CUI
- C0024115
- SNOMED CT 2010_0731
- 19829001
- MedDRA 13.1
- 10025082
- ICD-10-CM Version 2010
- J98.4
Beschreibung
Hematological disease
Datentyp
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
Beschreibung
Nervous system disorder
Datentyp
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
Beschreibung
Metabolic disorder
Datentyp
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
Beschreibung
Nocturnal myoclonus syndrome
Datentyp
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
Beschreibung
Urine drug screen positive
Datentyp
string
Alias
- UMLS CUI
- C0743300
- MedDRA 13.1
- 10051105
Beschreibung
Polysomnography
Datentyp
string
Alias
- UMLS CUI
- C0162701
- SNOMED CT 2010_0731
- 60554003
- MedDRA 13.1
- 10053319
- ICD-9-CM Version 2011
- 89.17
Beschreibung
Breathalyzer test
Datentyp
string
Alias
- UMLS CUI
- C0085924
- SNOMED CT 2010_0731
- D001944
Beschreibung
positive
Datentyp
string
Alias
- UMLS CUI
- CL415097
Beschreibung
Use of tobacco products at least daily
Datentyp
string
Alias
- UMLS CUI
- C1976668
- LOINC Version 232
- MTHU026131
Beschreibung
Nicotine gum
Datentyp
string
Alias
- UMLS CUI
- C0068722
- SNOMED CT 2010_0731
- 346593007
Beschreibung
Nicotine patch
Datentyp
string
Alias
- UMLS CUI
- C0358855
- SNOMED CT 2010_0731
- 346594001
Beschreibung
Organic disorder of sleep wake cycle
Datentyp
string
Alias
- UMLS CUI
- C1561880
Beschreibung
CNS agents
Datentyp
string
Alias
- UMLS CUI
- C0007680
- SNOMED CT 2010_0731
- 372752008
Beschreibung
Single blind study
Datentyp
string
Alias
- UMLS CUI
- C0242570
Beschreibung
Misuse of over-the-counter medications
Datentyp
string
Alias
- UMLS CUI
- C1827845
- SNOMED CT 2010_0731
- 424626006
Beschreibung
Herbal drugs
Datentyp
string
Alias
- UMLS CUI
- C1360419
Beschreibung
Anti-Anxiety Agents
Datentyp
string
Alias
- UMLS CUI
- C0040616
- SNOMED CT 2010_0731
- 373282008
Beschreibung
Sedative
Datentyp
string
Alias
- UMLS CUI
- C0036557
- SNOMED CT 2010_0731
- 372614000
Beschreibung
Hypnotics
Datentyp
string
Alias
- UMLS CUI
- C0020591
- SNOMED CT 2010_0731
- 372585002
- LOINC Version 232
- MTHU015316
Beschreibung
Antidepressants
Datentyp
string
Alias
- UMLS CUI
- C0003289
- SNOMED CT 2010_0731
- 372720008
- LOINC Version 232
- MTHU006782
Beschreibung
Analgesics, Narcotic
Datentyp
string
Alias
- UMLS CUI
- C0027409
- SNOMED CT 2010_0731
- 360204007
Beschreibung
Antiepileptic Agents
Datentyp
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Beschreibung
Beta Blocker
Datentyp
string
Alias
- UMLS CUI
- C0001645
- SNOMED CT 2010_0731
- 33252009
- LOINC Version 232
- MTHU003324
Beschreibung
Histamine H1 Antagonists
Datentyp
string
Alias
- UMLS CUI
- C0019592
- SNOMED CT 2010_0731
- 373228009
Beschreibung
Hypericum perforatum
Datentyp
string
Alias
- UMLS CUI
- C0936242
- SNOMED CT 2010_0731
- 51621002
Beschreibung
systemic steroids
Datentyp
string
Alias
- UMLS CUI
- C2911187
- ICD-10-CM Version 2010
- Z79.52
Beschreibung
Kava preparation
Datentyp
string
Alias
- UMLS CUI
- C0939882
- SNOMED CT 2010_0731
- 412231002
Beschreibung
Stimulants, Respiratory
Datentyp
string
Alias
- UMLS CUI
- C0282685
- SNOMED CT 2010_0731
- 418760000
Beschreibung
Ginkgo biloba
Datentyp
string
Alias
- UMLS CUI
- C0772125
- SNOMED CT 2010_0731
- 412394005
Beschreibung
Decongestants
Datentyp
string
Alias
- UMLS CUI
- C0282374
- SNOMED CT 2010_0731
- 96328007
Beschreibung
Stimulant
Datentyp
string
Alias
- UMLS CUI
- C0304402
- SNOMED CT 2010_0731
- 373333006
- LOINC Version 232
- MTHU003469
Beschreibung
Prescriptions
Datentyp
string
Alias
- UMLS CUI
- C0033080
- SNOMED CT 2010_0731
- 16076005
Beschreibung
Antipsychotic Agent
Datentyp
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 372482001
- LOINC Version 232
- MTHU003337
Beschreibung
Diet Aid
Datentyp
string
Alias
- UMLS CUI
- C0719894
Beschreibung
Muscle relaxants
Datentyp
string
Alias
- UMLS CUI
- C0358430
Beschreibung
Hepatitis B
Datentyp
string
Alias
- UMLS CUI
- C0019163
- SNOMED CT 2010_0731
- 66071002
- MedDRA 13.1
- 10019731
Beschreibung
Hepatitis C
Datentyp
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
Ähnliche Modelle
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)