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