ID
43289
Description
ODM derived from http://clinicaltrials.gov/show/NCT01294644
Link
http://clinicaltrials.gov/show/NCT01294644
Keywords
Versions (2)
- 2/28/13 2/28/13 - Martin Dugas
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01294644 Healthy
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
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.
Data type
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
Description
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).
Data type
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
Description
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.
Data type
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
Description
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
Data type
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
Description
Body mass index (BMI) > 30 (Appendix B1).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1305855
- SNOMED CT 2011_0131
- 140075008
- MedDRA 14.1
- 10005894
- LOINC Version 232
- LP35925-4
Description
Currently on or considering starting a weight reduction regimen.
Data type
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
Description
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.
Data type
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
Description
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.
Data type
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
Description
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
Data type
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
Description
Previous randomization into this study or previous treatment with ATX-101.
Data type
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
Description
Treatment with an investigational device or agent within 30 days of randomization.
Data type
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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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)