ID
3738
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01294644
Länk
http://clinicaltrials.gov/show/NCT01294644
Nyckelord
Versioner (2)
- 2013-02-28 2013-02-28 - Martin Dugas
- 2021-09-20 2021-09-20 -
Uppladdad den
28 februari 2013
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT01294644 Healthy
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1948041
- SNOMED CT 2011_0131
- 71388002
- MedDRA 14.1
- 10042613
- LOINC Version 232
- MTHU006237
- ICD-9-CM Version 2011
- 00-99.99
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0542339
- SNOMED CT 2011_0131
- 351726001, 261089000
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- CL429588
- UMLS CUI 2011AA
- C0038640
- SNOMED CT 2011_0131
- 302441008
- MedDRA 14.1
- 10048701
- UMLS CUI 2011AA
- C0038895
- UMLS CUI 2011AA
- C0023796
- SNOMED CT 2011_0131
- 34785007
- UMLS CUI 2011AA
- C1254351
- UMLS CUI 2011AA
- C0175677
- SNOMED CT 2011_0131
- 417746004
- MedDRA 14.1
- 10022116
- ICD-10-CM Version 2010
- T14.9
- UMLS CUI 2011AA
- C0332281
- SNOMED CT 2011_0131
- 47429007
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- C0027530
- SNOMED CT 2011_0131
- 45048000
- LOINC Version 232
- MTHU002688
- UMLS CUI 2011AA
- C0205146
- SNOMED CT 2011_0131
- 42798000
- LOINC Version 232
- MTHU009059
Beskrivning
Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0010495
- SNOMED CT 2011_0131
- 58588007
- MedDRA 14.1
- 10011692
- ICD-10-CM Version 2010
- Q82.8
- UMLS CUI 2011AA
- C0027530
- SNOMED CT 2011_0131
- 45048000
- LOINC Version 232
- MTHU002688
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- C0205146
- SNOMED CT 2011_0131
- 42798000
- LOINC Version 232
- MTHU009059
- UMLS CUI 2011AA
- C0449820
- SNOMED CT 2011_0131
- 246262008
- LOINC Version 232
- MTHU024701
- UMLS CUI 2011AA
- C0205450
- SNOMED CT 2011_0131
- 9362000
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0681889
Beskrivning
Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205402
- SNOMED CT 2011_0131
- 4657009
- UMLS CUI 2011AA
- C0224176
- SNOMED CT 2011_0131
- 18252004
- UMLS CUI 2011AA
- CL419362
- UMLS CUI 2011AA
- C0443144
- SNOMED CT 2011_0131
- 263678003
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0502371
- SNOMED CT 2011_0131
- 91805003
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0220825
- UMLS CUI 2011AA
- C0542339
- SNOMED CT 2011_0131
- 351726001, 261089000
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- CL429588
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C1274040
- SNOMED CT 2011_0131
- 79409006
Beskrivning
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL406656
- UMLS CUI 2011AA
- C0542339
- SNOMED CT 2011_0131
- 351726001, 261089000
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- C0205146
- SNOMED CT 2011_0131
- 42798000
- LOINC Version 232
- MTHU009059
- UMLS CUI 2011AA
- C0018021
- SNOMED CT 2011_0131
- 3716002
- MedDRA 14.1
- 10018498
- ICD-10-CM Version 2010
- E04.9
- ICD-9-CM Version 2011
- 240.9
- UMLS CUI 2011AA
- C0235592
- SNOMED CT 2011_0131
- 127086001
- MedDRA 14.1
- 10025200
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0392752
- SNOMED CT 2011_0131
- 255471002
- UMLS CUI 2011AA
- C0542339
- SNOMED CT 2011_0131
- 351726001, 261089000
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- CL429588
Beskrivning
Body mass index (BMI) > 30 (Appendix B1).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1305855
- SNOMED CT 2011_0131
- 140075008
- MedDRA 14.1
- 10005894
- LOINC Version 232
- LP35925-4
Beskrivning
Currently on or considering starting a weight reduction regimen.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C0311130
- SNOMED CT 2011_0131
- 388976009
Beskrivning
Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0035204
- SNOMED CT 2011_0131
- 50043002
- MedDRA 14.1
- 10038683
- ICD-10-CM Version 2010
- J98.9
- ICD-9-CM Version 2011
- 519.9
- UMLS CUI 2011AA
- C0007222
- SNOMED CT 2011_0131
- 105980002
- MedDRA 14.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
- UMLS CUI 2011AA
- C0023895
- SNOMED CT 2011_0131
- 235856003
- MedDRA 14.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
- UMLS CUI 2011AA
- C0348024
- SNOMED CT 2011_0131
- 264580006
- MedDRA 14.1
- 10013907
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C0184704
- SNOMED CT 2011_0131
- 55149002
Beskrivning
Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0034547
- SNOMED CT 2011_0131
- 52799000
- UMLS CUI 2011AA
- C1562720
- SNOMED CT 2011_0131
- 416376001
- UMLS CUI 2011AA
- C0007979
- SNOMED CT 2011_0131
- 31459005
- MedDRA 14.1
- 10064840
- UMLS CUI 2011AA
- C2958948
- MedDRA 14.1
- 10072349
- UMLS CUI 2011AA
- C0006055
- SNOMED CT 2011_0131
- 11894001
- LOINC Version 232
- MTHU002713
- UMLS CUI 2011AA
- C1533685
- SNOMED CT 2011_0131
- 59108006
- MedDRA 14.1
- 10052995
- UMLS CUI 2011AA
- C0027530
- SNOMED CT 2011_0131
- 45048000
- LOINC Version 232
- MTHU002688
- UMLS CUI 2011AA
- C0008114
- SNOMED CT 2011_0131
- 30291003
- UMLS CUI 2011AA
- C0205146
- SNOMED CT 2011_0131
- 42798000
- LOINC Version 232
- MTHU009059
Beskrivning
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0036667
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C2985618
- UMLS CUI 2011AA
- C0040464
- SNOMED CT 2011_0131
- 373520001
- UMLS CUI 2011AA
- C0002934
- SNOMED CT 2011_0131
- 373477003
- UMLS CUI 2011AA
- C0023660
- SNOMED CT 2011_0131
- 387480006
- LOINC Version 232
- MTHU005009
- UMLS CUI 2011AA
- C0005059
- SNOMED CT 2011_0131
- 387357002
- UMLS CUI 2011AA
- C0358490
- SNOMED CT 2011_0131
- 73444000
Beskrivning
Previous randomization into this study or previous treatment with ATX-101.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0034656
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
Beskrivning
Treatment with an investigational device or agent within 30 days of randomization.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C2346570
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0034656
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C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)