ID
43364
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00508664
Link
http://clinicaltrials.gov/show/NCT00508664
Palabras clave
Versiones (3)
- 10/12/13 10/12/13 - Martin Dugas
- 14/4/14 14/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility DRKS00005561 NCT00508664 Squamous Cell Carcinoma of the Hypopharynx
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
primary cancer treatable by operational larynx-conserving procedures
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1306459
- SNOMED CT 2011_0131
- 372087000
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0189204
- SNOMED CT 2011_0131
- 387636004
- MedDRA 14.1
- 10062034
- UMLS CUI 2011AA
- C0459914
- SNOMED CT 2011_0131
- 281131004
Descripción
distant metastases (M1-Status)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL278860
- UMLS CUI 2011AA
- C0441971
- SNOMED CT 2011_0131
- 55440008
Descripción
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0475276
- SNOMED CT 2011_0131
- 258261001
- UMLS CUI 2011AA
- C0023078
- SNOMED CT 2011_0131
- 4596009
- LOINC Version 232
- MTHU015048
- UMLS CUI 2011AA
- C0521324
- UMLS CUI 2011AA
- C0332448
- SNOMED CT 2011_0131
- 47351003
- UMLS CUI 2011AA
- C0225317
- SNOMED CT 2011_0131
- 87784001
- LOINC Version 232
- MTHU016974
- UMLS CUI 2011AA
- C1522619
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0007301
- SNOMED CT 2011_0131
- 309312004
- UMLS CUI 2011AA
- C0332448
- SNOMED CT 2011_0131
- 47351003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- CL425201
Descripción
tumor-specific prior chemo- or radiotherapy
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C1552740
- HL7 V3 2006_05
- INSTANCE
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0034619
Descripción
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1334703
- UMLS CUI 2011AA
- C0027663
- UMLS CUI 2011AA
- C1554961
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- CL425202
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0475264
- SNOMED CT 2011_0131
- 257880008
Descripción
life expectancy < 3 month
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0023671
- LOINC Version 232
- LP75025-4
Descripción
Karnofsky performance status < 70%
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0206065
- SNOMED CT 2011_0131
- 273546003
Descripción
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0034072
- SNOMED CT 2011_0131
- 83291003, 274096000
- MedDRA 14.1
- 10010971
- ICD-10-CM Version 2010
- I27.81
- UMLS CUI 2011AA
- C0018801
- SNOMED CT 2011_0131
- 155374007
- MedDRA 14.1
- 10019279
- ICD-9-CM Version 2011
- 428
- CTCAE 1105E
- E10124
- 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
- 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
- C0002962
- SNOMED CT 2011_0131
- 194828000
- MedDRA 14.1
- 10002383
- ICD-10-CM Version 2010
- I20
- ICD-9-CM Version 2011
- 413
- UMLS CUI 2011AA
- C2348867
- UMLS CUI 2011AA
- C0035229
- SNOMED CT 2011_0131
- 409623005
- MedDRA 14.1
- 10038701
Descripción
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0008679
- SNOMED CT 2011_0131
- 27624003
- UMLS CUI 2011AA
- C0205355
- SNOMED CT 2011_0131
- 6934004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0003873
- SNOMED CT 2011_0131
- 69896004
- MedDRA 14.1
- 10039073
- ICD-10-CM Version 2010
- M06.9
- ICD-9-CM Version 2011
- 714.0
Descripción
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0694550
- MedDRA 14.1
- 10066727
- UMLS CUI 2011AA
- C0024117
- SNOMED CT 2011_0131
- 13645005
- MedDRA 14.1
- 10009033
- ICD-10-CM Version 2010
- J44.9
- ICD-9-CM Version 2011
- 496
- UMLS CUI 2011AA
- C1856359
- UMLS CUI 2011AA
- C0243087
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- CL415098
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- C0031831
- SNOMED CT 2011_0131
- 309343006
- LOINC Version 232
- MTHU010489
- HL7 V3 2006_05
- PHYS
Descripción
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- MedDRA 14.1
- 10010833
- UMLS CUI 2011AA
- C0699967
- SNOMED CT 2011_0131
- 386918005
- UMLS CUI 2011AA
- C0008838
- SNOMED CT 2011_0131
- 387318005
- LOINC Version 232
- MTHU016242
- UMLS CUI 2011AA
- C0016360
- SNOMED CT 2011_0131
- 387172005
- LOINC Version 232
- MTHU016749
- UMLS CUI 2011AA
- C0995188
- SNOMED CT 2011_0131
- 409400001
- UMLS CUI 2011AA
- C0034619
Descripción
Expected absent patient compliance
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1321605
Descripción
Periodic follow-up not possible (for example address outside germany)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1522577
Descripción
Pregnant or breast-feeding woman
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Descripción
Absent or constricted legal capacity
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0443288
- SNOMED CT 2011_0131
- 263856008
- UMLS CUI 2011AA
- C0683673
Descripción
Participation to another clinical trial with any investigational study within 30 days prior to study screening
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1409616
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CL415098 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
10010833 (MedDRA 14.1)
C0699967 (UMLS CUI 2011AA)
386918005 (SNOMED CT 2011_0131)
C0008838 (UMLS CUI 2011AA)
387318005 (SNOMED CT 2011_0131)
MTHU016242 (LOINC Version 232)
C0016360 (UMLS CUI 2011AA)
387172005 (SNOMED CT 2011_0131)
MTHU016749 (LOINC Version 232)
C0995188 (UMLS CUI 2011AA)
409400001 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
2667000 (SNOMED CT 2011_0131)
C0443288 (UMLS CUI 2011AA)
263856008 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)