ID

37989

Beschreibung

Prediction of Pain After Breast Cancer Surgery With EEG; ODM derived from: https://clinicaltrials.gov/show/NCT01392248

Link

https://clinicaltrials.gov/show/NCT01392248

Stichworte

Versionen (1)
  1. 05.09.19 05.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01392248

Englisch

Eligibility Breast Cancer NCT01392248

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 - 65 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
asa 1-2.
Beschreibung

ASA physical status classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0450990
sufficient comprehension of the dutch spoken and written language.
Beschreibung

Comprehension Spoken Dutch Language | Comprehension Written Dutch Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0424919
UMLS CUI [1,3]
C0376241
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0681288
UMLS CUI [2,3]
C0376241
elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
Beschreibung

Breast Carcinoma Curative Surgery elective | Mastectomy | Breast-conserving therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1511562
UMLS CUI [1,3]
C0439608
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0024885
stage i and ii breast cancer.
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
written informed consent is obtained
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous breast surgery, both ipsilateral and contralateral.
Beschreibung

Previous breast surgery Ipsilateral | Previous breast surgery Contralateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4062914
UMLS CUI [1,2]
C0441989
UMLS CUI [2,1]
C4062914
UMLS CUI [2,2]
C0441988
stage iii-iv breast cancer.
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
chronic pain (>3months) with an average severity of at least a vas score 4 during the last two weeks.
Beschreibung

Chronic pain Average Severity Visual Analog Pain Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0150055
UMLS CUI [1,2]
C3641836
UMLS CUI [1,3]
C0042815
chronic pain for which invasive treatment is needed.
Beschreibung

Chronic pain | Invasive treatment Needed

Datentyp

boolean

Alias
UMLS CUI [1]
C0150055
UMLS CUI [2,1]
C0683468
UMLS CUI [2,2]
C0027552
use of (weak / strong) opioids in the last week.
Beschreibung

Use of Opioids Weak | Use of Opioids Strong

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0242402
UMLS CUI [1,3]
C1762617
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0242402
UMLS CUI [2,3]
C0442821
a history of opioid addiction.
Beschreibung

Opioid Addiction

Datentyp

boolean

Alias
UMLS CUI [1]
C0524662
regular use of the following medications in the last year:
Beschreibung

Pharmaceutical Preparations Specified Regular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205272
antiepileptics,antipsychotics and anxiolytics.
Beschreibung

Antiepileptic Agents | Antipsychotic Agents | Anti-Anxiety Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003299
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0040616
asa 3 or higher.
Beschreibung

ASA physical status classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0450990
consumption of alcohol (>4 units) and / or drugs the evening before.
Beschreibung

Alcohol consumption Units Quantity Recently | Drug consumption Recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0556604
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332185
UMLS CUI [2,1]
C0678263
UMLS CUI [2,2]
C0332185
alcohol consumption (>= 5 units/day).
Beschreibung

Alcohol consumption units/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560578
illiteracy, problems with self expression, language barrier.
Beschreibung

Illiteracy | Difficulty using self-expression | Language Barriers

Datentyp

boolean

Alias
UMLS CUI [1]
C0020899
UMLS CUI [2]
C0566165
UMLS CUI [3]
C0237167
serious vision and / or hearing problems, interfering the performance of the experimental tasks.
Beschreibung

Visual Impairment Serious | Hearing problem Serious | Interference Performance Task Experimental

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0260662
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0597198
UMLS CUI [3,3]
C3540678
UMLS CUI [3,4]
C1517586
a history of psychiatric complaints and/or epilepsy .
Beschreibung

Complaints Psychiatric | Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277786
UMLS CUI [1,2]
C0205487
UMLS CUI [2]
C0014544
a medical history of cva or tia.
Beschreibung

Medical History Cerebrovascular accident | Medical History Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0038454
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0007787
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Ähnliche Modelle

Eligibility Breast Cancer NCT01392248

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 - 65 years.
boolean
C0001779 (UMLS CUI [1])
ASA physical status classification
Item
asa 1-2.
boolean
C0450990 (UMLS CUI [1])
Comprehension Spoken Dutch Language | Comprehension Written Dutch Language
Item
sufficient comprehension of the dutch spoken and written language.
boolean
C0233733 (UMLS CUI [1,1])
C0424919 (UMLS CUI [1,2])
C0376241 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0681288 (UMLS CUI [2,2])
C0376241 (UMLS CUI [2,3])
Breast Carcinoma Curative Surgery elective | Mastectomy | Breast-conserving therapy
Item
elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
boolean
C0678222 (UMLS CUI [1,1])
C1511562 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0024881 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
Breast Carcinoma TNM Breast tumor staging
Item
stage i and ii breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent is obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Previous breast surgery Ipsilateral | Previous breast surgery Contralateral
Item
previous breast surgery, both ipsilateral and contralateral.
boolean
C4062914 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C4062914 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Breast Carcinoma TNM Breast tumor staging
Item
stage iii-iv breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chronic pain Average Severity Visual Analog Pain Scale
Item
chronic pain (>3months) with an average severity of at least a vas score 4 during the last two weeks.
boolean
C0150055 (UMLS CUI [1,1])
C3641836 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
Chronic pain | Invasive treatment Needed
Item
chronic pain for which invasive treatment is needed.
boolean
C0150055 (UMLS CUI [1])
C0683468 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
Use of Opioids Weak | Use of Opioids Strong
Item
use of (weak / strong) opioids in the last week.
boolean
C1524063 (UMLS CUI [1,1])
C0242402 (UMLS CUI [1,2])
C1762617 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0242402 (UMLS CUI [2,2])
C0442821 (UMLS CUI [2,3])
Opioid Addiction
Item
a history of opioid addiction.
boolean
C0524662 (UMLS CUI [1])
Pharmaceutical Preparations Specified Regular
Item
regular use of the following medications in the last year:
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Antiepileptic Agents | Antipsychotic Agents | Anti-Anxiety Agents
Item
antiepileptics,antipsychotics and anxiolytics.
boolean
C0003299 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
ASA physical status classification
Item
asa 3 or higher.
boolean
C0450990 (UMLS CUI [1])
Alcohol consumption Units Quantity Recently | Drug consumption Recently
Item
consumption of alcohol (>4 units) and / or drugs the evening before.
boolean
C0001948 (UMLS CUI [1,1])
C0556604 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0678263 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Alcohol consumption units/day
Item
alcohol consumption (>= 5 units/day).
boolean
C0001948 (UMLS CUI [1,1])
C0560578 (UMLS CUI [1,2])
Illiteracy | Difficulty using self-expression | Language Barriers
Item
illiteracy, problems with self expression, language barrier.
boolean
C0020899 (UMLS CUI [1])
C0566165 (UMLS CUI [2])
C0237167 (UMLS CUI [3])
Visual Impairment Serious | Hearing problem Serious | Interference Performance Task Experimental
Item
serious vision and / or hearing problems, interfering the performance of the experimental tasks.
boolean
C3665347 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0260662 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0597198 (UMLS CUI [3,2])
C3540678 (UMLS CUI [3,3])
C1517586 (UMLS CUI [3,4])
Complaints Psychiatric | Epilepsy
Item
a history of psychiatric complaints and/or epilepsy .
boolean
C0277786 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
Medical History Cerebrovascular accident | Medical History Transient Ischemic Attack
Item
a medical history of cva or tia.
boolean
C0262926 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0007787 (UMLS CUI [2,2])
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