ID
42809
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00630864
Link
http://clinicaltrials.gov/show/NCT00630864
Palabras clave
Versiones (2)
- 10/12/13 10/12/13 - Martin Dugas
- 17/9/21 17/9/21 -
Subido en
17 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00630864 Transthyretin-associated Amyloidosis With Polyneuropathy
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3-4 times/month (ibuprofen and nimesulide will be permitted).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005
- UMLS CUI 2011AA
- C1704788
- UMLS CUI 2011AA
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C1524004
- UMLS CUI 2011AA
- C0593507
- SNOMED CT 2011_0131
- 387207008
- LOINC Version 232
- MTHU004262
- UMLS CUI 2011AA
- C0132515
Descripción
Patient has primary or secondary amyloidosis.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0268381
- SNOMED CT 2011_0131
- 23132008
- MedDRA 14.1
- 10036673
- UMLS CUI 2011AA
- C0221014
- SNOMED CT 2011_0131
- 281034005
- MedDRA 14.1
- 10039811
- ICD-10-CM Version 2010
- E85.3
Descripción
Patient has TTR-associated amyloidosis with V30M mutation.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0032923
- SNOMED CT 2011_0131
- 37959007
- LOINC Version 232
- MTHU004200
- UMLS CUI 2011AA
- C0332281
- SNOMED CT 2011_0131
- 47429007
- UMLS CUI 2011AA
- C0002726
- SNOMED CT 2011_0131
- 17602002
- MedDRA 14.1
- 10002022
- LOINC Version 232
- E85
- ICD-10-CM Version 2010
- 277.3
- UMLS CUI 2011AA
- C1867806
- UMLS CUI 2011AA
- C0026882
- SNOMED CT 2011_0131
- 55446002
Descripción
If female, patient is pregnant or breast feeding.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0086287
- 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
Descripción
Patient has received prior liver transplantation.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0023911
- SNOMED CT 2011_0131
- 18027006
- MedDRA 14.1
- 10024714
- ICD-9-CM Version 2011
- 50.5
Descripción
Patient is expected to undergo liver transplantation within 12 months after enrollment.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1517001
- UMLS CUI 2011AA
- C0023911
- SNOMED CT 2011_0131
- 18027006
- MedDRA 14.1
- 10024714
- ICD-9-CM Version 2011
- 50.5
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
- UMLS CUI 2011AA
- C1516879
Descripción
Patient with positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C0281863
- MedDRA 14.1
- 10019747
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
Descripción
Patient has renal insufficiency (creatinine clearance < 30 ml/min).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Descripción
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) > 2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0151766
- SNOMED CT 2011_0131
- 166603001
- MedDRA 14.1
- 10024690
- ICD-10-CM Version 2010
- R94.5
- ICD-9-CM Version 2011
- 794.8
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0392756
- SNOMED CT 2011_0131
- 260400001
- UMLS CUI 2011AA
- C0232741
- SNOMED CT 2011_0131
- 79036002
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- 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
Descripción
Patient has a New York Heart Association (NYHA) Functional Classification >= III.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
Descripción
Patient has other causes of sensorimotor neuropathy (B12 deficiency, Diabetes Mellitus, HIV treated with retroviral medications, thyroid disorders, alcohol abuse, and chronic inflammatory diseases).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1112256
- MedDRA 14.1
- 10056673
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- C0042847
- SNOMED CT 2011_0131
- 190634004
- MedDRA 14.1
- 10047609
- ICD-10-CM Version 2010
- E53.8
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- CL106887
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0040128
- SNOMED CT 2011_0131
- 14304000
- MedDRA 14.1
- 10043709
- ICD-10-CM Version 2010
- E00-E07
- ICD-9-CM Version 2011
- 240-246.99
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
- UMLS CUI 2011AA
- C1290886
- SNOMED CT 2011_0131
- 128294001
Descripción
Patient has prior non-amyloid cardiac disease such as: myocardial infarction due to obstructive coronary artery disease, active non-amyloid cardiomyopathy (e.g., symptomatic left ventricular dysfunction from any cause other than amyloid, patients with a primary diagnosis of symptomatic valvular heart disease)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0028778
- SNOMED CT 2011_0131
- 26036001
- MedDRA 14.1
- 10061876
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- CL411823
- SNOMED CT 2011_0131
- 85898001
- MedDRA 14.1
- 10007636
- ICD-10-CM Version 2010
- I42.9
- ICD-9-CM Version 2011
- 425
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0242698
- MedDRA 14.1
- 10049694
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- C0801658
- LOINC Version 232
- 18630-4
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0026265
- SNOMED CT 2011_0131
- 11851006
- MedDRA 14.1
- 10061532
- ICD-9-CM Version 2011
- 424.0
- CTCAE 1105E
- E10134
Descripción
Patient has a co-morbidity anticipated to limit survival to < 12 months.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0009488
- UMLS CUI 2011AA
- C0679106
- UMLS CUI 2011AA
- C2349209
- UMLS CUI 2011AA
- C0220921
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Descripción
Patient has received an investigational drug/device and/or participated in another clinical investigational study within 60 days before Baseline (Day 0).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1442488
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
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10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
10056673 (MedDRA 14.1)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0042847 (UMLS CUI 2011AA)
190634004 (SNOMED CT 2011_0131)
10047609 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
CL106887 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0040128 (UMLS CUI 2011AA)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C1290886 (UMLS CUI 2011AA)
128294001 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0028778 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10061876 (MedDRA 14.1)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0242698 (UMLS CUI 2011AA)
10049694 (MedDRA 14.1)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
C0679106 (UMLS CUI 2011AA)
C2349209 (UMLS CUI 2011AA)
C0220921 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)