ID

4416

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT00878293

collegamento

http://clinicaltrials.gov/show/NCT00878293

Keywords

versioni (2)
  1. 09/12/13 09/12/13 - Martin Dugas
  2. 17/09/21 17/09/21 -
Caricato su

9 dicembre 2013

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility NCT00878293 Diabetic Polyneuropathy

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Descrizione

age 18 Years to 75 Years

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
Descrizione

Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0030193
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
UMLS CUI 2011AA
C1504479
MedDRA 14.1
10063374
UMLS CUI 2011AA
CL414713
UMLS CUI 2011AA
C0271680
SNOMED CT 2011_0131
49455004
MedDRA 14.1
10012685
ICD-9-CM Version 2011
357.2
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
Descrizione

Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0026549
SNOMED CT 2011_0131
373529000
LOINC Version 232
MTHU004293
UMLS CUI 2011AA
C0591423
SNOMED CT 2011_0131
373492002
LOINC Version 232
MTHU002556
UMLS CUI 2011AA
C0020264
SNOMED CT 2011_0131
372671002
LOINC Version 232
MTHU003226
UMLS CUI 2011AA
C0000970
SNOMED CT 2011_0131
387517004
LOINC Version 232
MTHU003399
UMLS CUI 2011AA
C0019134
SNOMED CT 2011_0131
372877000
LOINC Version 232
MTHU003766
UMLS CUI 2011AA
C0032478
UMLS CUI 2011AA
C1706444
UMLS CUI 2011AA
C0282300
non Caucasian or Hispanic.
Descrizione

non Caucasian or Hispanic.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0007457
SNOMED CT 2011_0131
14045001
UMLS CUI 2011AA
C0086409
LOINC Version 232
MTHU010274
HL7 V3 2006_05
2135-2
Concomitant painful disease.
Descrizione

Concomitant painful disease.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0391976
Life-long history of seizure disorder or epilepsy.
Descrizione

Life-long history of seizure disorder or epilepsy.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0376558
LOINC Version 232
MTHU029989
UMLS CUI 2011AA
C0205166
SNOMED CT 2011_0131
255511005
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0852425
MedDRA 14.1
10039912
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Subjects with clinical relevant cardiac and vascular diseases.
Descrizione

Subjects with clinical relevant cardiac and vascular diseases.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0042373
SNOMED CT 2011_0131
27550009
MedDRA 14.1
10047062
Renal dysfunction
Descrizione

Subjects with impaired renal function

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1848822
Abnormal hepatic function
Descrizione

Subjects with impaired hepatic function

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
Female subjects who are pregnant or breastfeeding.
Descrizione

Female subjects who are pregnant or breastfeeding.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
Item
Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C1504479 (UMLS CUI 2011AA)
10063374 (MedDRA 14.1)
CL414713 (UMLS CUI 2011AA)
C0271680 (UMLS CUI 2011AA)
49455004 (SNOMED CT 2011_0131)
10012685 (MedDRA 14.1)
357.2 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
Item
Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0026549 (UMLS CUI 2011AA)
373529000 (SNOMED CT 2011_0131)
MTHU004293 (LOINC Version 232)
C0591423 (UMLS CUI 2011AA)
373492002 (SNOMED CT 2011_0131)
MTHU002556 (LOINC Version 232)
C0020264 (UMLS CUI 2011AA)
372671002 (SNOMED CT 2011_0131)
MTHU003226 (LOINC Version 232)
C0000970 (UMLS CUI 2011AA)
387517004 (SNOMED CT 2011_0131)
MTHU003399 (LOINC Version 232)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0032478 (UMLS CUI 2011AA)
C1706444 (UMLS CUI 2011AA)
C0282300 (UMLS CUI 2011AA)
non Caucasian or Hispanic.
Item
non Caucasian or Hispanic.
boolean
C0007457 (UMLS CUI 2011AA)
14045001 (SNOMED CT 2011_0131)
C0086409 (UMLS CUI 2011AA)
MTHU010274 (LOINC Version 232)
2135-2 (HL7 V3 2006_05)
Concomitant painful disease.
Item
Concomitant painful disease.
boolean
CL415222 (UMLS CUI 2011AA)
C0391976 (UMLS CUI 2011AA)
Life-long history of seizure disorder or epilepsy.
Item
Life-long history of seizure disorder or epilepsy.
boolean
C0376558 (UMLS CUI 2011AA)
MTHU029989 (LOINC Version 232)
C0205166 (UMLS CUI 2011AA)
255511005 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Subjects with clinical relevant cardiac and vascular diseases.
Item
Subjects with clinical relevant cardiac and vascular diseases.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0042373 (UMLS CUI 2011AA)
27550009 (SNOMED CT 2011_0131)
10047062 (MedDRA 14.1)
Subjects with impaired renal function
Item
Renal dysfunction
boolean
C1848822 (UMLS CUI 2011AA)
Subjects with impaired hepatic function
Item
Abnormal hepatic function
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
Female subjects who are pregnant or breastfeeding.
Item
Female subjects who are pregnant or breastfeeding.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Ritorna all'inizio della pagina 

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