ID

43226

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00274573

Länk

http://clinicaltrials.gov/show/NCT00274573

Nyckelord

  1. 2012-02-28 2012-02-28 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
  3. 2014-08-11 2014-08-11 - Martin Dugas
  4. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility NCT00274573 Pulmonary Disease, Chronic Obstructive

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
Alter 40 Jahre oder älter
Beskrivning

Age 40 years or older

Datatyp

boolean

All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %. Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
Beskrivning

COPD

Datatyp

boolean

Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
Beskrivning

Smoking

Datatyp

boolean

Alias
UMLS CUI-1
C1519386
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol
Beskrivning

Study related tests

Datatyp

boolean

Patients must be able to inhale medication from the HandiHaler
Beskrivning

inhale medication

Datatyp

boolean

All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications
Beskrivning

consent

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI-1
C0680251
Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
Beskrivning

significant diseases

Datatyp

boolean

Patients with a recent history (i.e., one year or less) of myocardial infarction.
Beskrivning

Myocardial Infarction

Datatyp

boolean

Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
Beskrivning

Cardiac Arrhythmia

Datatyp

boolean

Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
Beskrivning

daytime oxygen

Datatyp

boolean

Patients with known active tuberculosis.
Beskrivning

tuberculosis

Datatyp

boolean

Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
Beskrivning

Cancer

Datatyp

boolean

Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
Beskrivning

major pulmonary Diseases

Datatyp

boolean

Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
Beskrivning

Thoracotomy

Datatyp

boolean

Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
Beskrivning

Respiratory Infections

Datatyp

boolean

Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
Beskrivning

pulmonary rehabilitation program

Datatyp

boolean

Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Beskrivning

Allergies

Datatyp

boolean

Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
Beskrivning

prostate hypertrophy or bladder neck obstruction

Datatyp

boolean

Patients with known narrow-angle glaucoma.
Beskrivning

narrow-angle glaucoma

Datatyp

boolean

Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
Beskrivning

oral corticosteroids

Datatyp

boolean

Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
Beskrivning

pregnant

Datatyp

boolean

Patients with a history of asthma, allergic rhinitis or atopy.
Beskrivning

history of asthma, allergic rhinitis or atopy.

Datatyp

boolean

Patients with a history of and/or active significant alcohol or drug abuse.
Beskrivning

alcohol or drug abuse

Datatyp

boolean

Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
Beskrivning

other trial

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Alter
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Beskrivning

Disease

Datatyp

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
COPD
Beskrivning

COPD

Datatyp

string

Alias
UMLS CUI
C0024117
SNOMED CT 2010_0731
13645005
MedDRA 13.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
Spirometrie
Beskrivning

Spirometry

Datatyp

string

Alias
UMLS CUI
C0037981
SNOMED CT 2010_0731
127783003
MedDRA 13.1
10041629
Atemwegsobstruktion
Beskrivning

Airway Obstruction

Datatyp

string

Alias
UMLS CUI
C0001883
SNOMED CT 2010_0731
79688008
MedDRA 13.1
10001539
Forced expired volume in one second/vital capacity ratio
Beskrivning

FEV1/VC

Datatyp

string

Alias
UMLS CUI
C0429744
SNOMED CT 2010_0731
251943006
European Coal and Steel Community
Beskrivning

ECCS

Datatyp

string

Alias
UMLS CUI
C0524592
Pack years (assessment scale)
Beskrivning

Pack Year

Datatyp

string

Alias
UMLS CUI
C1277691
SNOMED CT 2010_0731
315609007
Test
Beskrivning

Test

Datatyp

string

Alias
UMLS CUI
C0392366
SNOMED CT 2010_0731
C47891
Lungenfunktionstest
Beskrivning

Pulmonary function tests

Datatyp

string

Alias
UMLS CUI
C0024119
SNOMED CT 2010_0731
23426006
MedDRA 13.1
10025099
LOINC Version 232
MTHU029811
Peak expiratory flow rate measurement
Beskrivning

PEFR

Datatyp

string

Alias
UMLS CUI
C0030735
MedDRA 13.1
10034192
Peak expiratory flow rate monitoring using diary
Beskrivning

PEFR monitoring using diary

Datatyp

string

Alias
UMLS CUI
C1276011
SNOMED CT 2010_0731
401011001
Home Medications
Beskrivning

Home Medications

Datatyp

string

Alias
UMLS CUI
C0013227
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Subject Participation Status in Clinical Study
Beskrivning

Study Subject Participation Status

Datatyp

string

Alias
UMLS CUI
C2348568
disease risk
Beskrivning

disorder risk

Datatyp

string

Alias
UMLS CUI
C1281905
Herzinfarkt
Beskrivning

Myocardial Infarction (MI)

Datatyp

string

Alias
UMLS CUI
C0027051
SNOMED CT 2010_0731
22298006
MedDRA 13.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE Version 4.03
E10152
Herzrhythmusstörung
Beskrivning

Cardiac Arrhythmia

Datatyp

string

Alias
UMLS CUI
C0003811
SNOMED CT 2010_0731
44808001
MedDRA 13.1
10003119
ICD-9-CM Version 2011
427.9
medikamentöse Therapie
Beskrivning

Drug Therapy

Datatyp

string

Alias
UMLS CUI
CL428482
Heart failure
Beskrivning

Heart failure

Datatyp

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
ICD-9-CM Version 2011
428
CTCAE Version 4.03
E10124
Sauerstofftherapie
Beskrivning

Oxygen Therapy

Datatyp

string

Alias
UMLS CUI
CL426373
Aktive Tuberkulose
Beskrivning

Active tuberculosis

Datatyp

string

Alias
UMLS CUI
C0151332
SNOMED CT 2010_0731
427099000
MedDRA 13.1
10071157
Krebs
Beskrivning

Cancer

Datatyp

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Basalzellenkarzinom
Beskrivning

Basal cell carcinoma

Datatyp

string

Alias
UMLS CUI
C0007117
SNOMED CT 2010_0731
1338007
MedDRA 13.1
10004146
Lunge
Beskrivning

Lung

Datatyp

string

Alias
UMLS CUI
C0024109
SNOMED CT 2010_0731
39607008
LOINC Version 232
MTHU008683
Obstruktion
Beskrivning

Obstruction

Datatyp

string

Alias
UMLS CUI
C0028778
SNOMED CT 2010_0731
26036001
MedDRA 13.1
10061876
Mukoviszidose
Beskrivning

Cystic Fibrosis (CF)

Datatyp

string

Alias
UMLS CUI
C0010674
SNOMED CT 2010_0731
190905008
MedDRA 13.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
Bronchiectasis
Beskrivning

Bronchiectasis

Datatyp

string

Alias
UMLS CUI
C0006267
SNOMED CT 2010_0731
12295008
MedDRA 13.1
10006445
ICD-10-CM Version 2010
J47.9
ICD-9-CM Version 2011
494
Thorakotomie
Beskrivning

Thoracotomy

Datatyp

string

Alias
UMLS CUI
C0039991
SNOMED CT 2010_0731
177765008
MedDRA 13.1
10043491
ICD-9-CM Version 2011
34.01
Pulmonary resection
Beskrivning

Lung excision

Datatyp

string

Alias
UMLS CUI
C0396565
SNOMED CT 2010_0731
119746007
Atemweginfektion
Beskrivning

Respiratory Infections

Datatyp

string

Alias
UMLS CUI
C0035243
SNOMED CT 2010_0731
275498002
MedDRA 13.1
10062352
LOINC Version 232
MTHU026191
Screening
Beskrivning

Screening

Datatyp

string

Alias
UMLS CUI
C1409616
Pulmonary rehabilitation programme completed
Beskrivning

Pulmonary rehabilitation program completed

Datatyp

string

Alias
UMLS CUI
C1272303
SNOMED CT 2010_0731
391130000
Anticholinergic allergy
Beskrivning

Anticholinergic allergy

Datatyp

string

Alias
UMLS CUI
C0570982
SNOMED CT 2010_0731
294065003
Laktoseintoleranz
Beskrivning

Lactose Intolerance

Datatyp

string

Alias
UMLS CUI
C0022951
SNOMED CT 2010_0731
267425008
MedDRA 13.1
10023681
ICD-10-CM Version 2010
E73.9
Medikamenteninhalation
Beskrivning

Inhalation Drug Administration

Datatyp

string

Alias
UMLS CUI
C0001559
SNOMED CT 2010_0731
243132000
Prostatahypertrophie
Beskrivning

Prostatic Hypertrophy

Datatyp

string

Alias
UMLS CUI
C1739363
MedDRA 13.1
10036962
ICD-10-CM Version 2010
N40
Blasenhalsobstruktion
Beskrivning

Bladder obstruction

Datatyp

string

Alias
UMLS CUI
C0005694
SNOMED CT 2010_0731
399072004
MedDRA 13.1
10005060
ICD-10-CM Version 2010
N32.0
ICD-9-CM Version 2011
596.0
Engwinkelglaukom
Beskrivning

Anatomical narrow angle glaucoma

Datatyp

string

Alias
UMLS CUI
C0154947
SNOMED CT 2010_0731
33647009
MedDRA 13.1
10008833
ICD-10-CM Version 2010
H40.22
ICD-9-CM Version 2011
365.23
Corticosteroide
Beskrivning

Corticosteroids

Datatyp

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Prednisolon
Beskrivning

prednisolone

Datatyp

string

Alias
UMLS CUI
C0032950
SNOMED CT 2010_0731
116601002
LOINC Version 232
MTHU003522
schwanger
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillzeit
Beskrivning

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Kontrazeption
Beskrivning

Contraception

Datatyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
orales Kontrazeptivum
Beskrivning

Contraceptives, Oral

Datatyp

string

Alias
UMLS CUI
C0009905
SNOMED CT 2010_0731
59261009
Intrauterine contraceptive device
Beskrivning

Intrauterine Devices

Datatyp

string

Alias
UMLS CUI
C0021900
SNOMED CT 2010_0731
268460000
MedDRA 13.1
10022745
Subdermal implantation of progesterone
Beskrivning

Subdermal implantation of progesterone

Datatyp

string

Alias
UMLS CUI
C0864560
Implant, device
Beskrivning

Implant

Datatyp

string

Alias
UMLS CUI
C0021102
SNOMED CT 2010_0731
40388003
subkutan
Beskrivning

subdermal

Datatyp

string

Alias
UMLS CUI
C1522438
SNOMED CT 2010_0731
34206005
HL7 V3 02-34
SubcutaneousRoute
Vaginal contraceptive diaphragm (device)
Beskrivning

Contraceptive diaphragm

Datatyp

string

Alias
UMLS CUI
C0042241
SNOMED CT 2010_0731
20359006
Asthma
Beskrivning

Bronchial Asthma

Datatyp

string

Alias
UMLS CUI
C0004096
SNOMED CT 2010_0731
195967001
MedDRA 13.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Rhinitis allergica
Beskrivning

Allergic rhinitis

Datatyp

string

Alias
UMLS CUI
C2607914
SNOMED CT 2010_0731
61582004
MedDRA 13.1
10039085
ICD-10-CM Version 2010
J30.9
ICD-9-CM Version 2011
477.9
CTCAE Version 4.03
E13303
Atopie
Beskrivning

Atopy

Datatyp

string

Alias
UMLS CUI
C0392707
SNOMED CT 2010_0731
115665000
MedDRA 13.1
10003645
Alkohol-Abusus
Beskrivning

Alcohol abuse

Datatyp

string

Alias
UMLS CUI
C0085762
SNOMED CT 2010_0731
15167005
MedDRA 13.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Drug abuse
Beskrivning

Drug abuse

Datatyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Investigational New Drug
Beskrivning

Investigational Drug

Datatyp

string

Alias
UMLS CUI
C0013230
Screening
Beskrivning

Screening

Datatyp

string

Alias
UMLS CUI
C1409616
patient encounter
Beskrivning

visit

Datatyp

string

Alias
UMLS CUI
C1512346
HL7 V3 02-34
ENC
Random Allocation
Beskrivning

Randomization

Datatyp

string

Alias
UMLS CUI
C0034656

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
Age 40 years or older
Item
Alter 40 Jahre oder älter
boolean
COPD
Item
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %. Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
boolean
Smoking
Item
Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
boolean
C1519386 (UMLS CUI-1)
Study related tests
Item
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol
boolean
inhale medication
Item
Patients must be able to inhale medication from the HandiHaler
boolean
consent
Item
All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications
boolean
Item Group
Ausschlusskriterien
C0680251 (UMLS CUI-1)
significant diseases
Item
Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
boolean
Myocardial Infarction
Item
Patients with a recent history (i.e., one year or less) of myocardial infarction.
boolean
Cardiac Arrhythmia
Item
Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
boolean
daytime oxygen
Item
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
boolean
tuberculosis
Item
Patients with known active tuberculosis.
boolean
Cancer
Item
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
boolean
major pulmonary Diseases
Item
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
boolean
Thoracotomy
Item
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
boolean
Respiratory Infections
Item
Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
boolean
pulmonary rehabilitation program
Item
Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
boolean
Allergies
Item
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
boolean
prostate hypertrophy or bladder neck obstruction
Item
Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
boolean
narrow-angle glaucoma
Item
Patients with known narrow-angle glaucoma.
boolean
oral corticosteroids
Item
Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
boolean
pregnant
Item
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
boolean
history of asthma, allergic rhinitis or atopy.
Item
Patients with a history of asthma, allergic rhinitis or atopy.
boolean
alcohol or drug abuse
Item
Patients with a history of and/or active significant alcohol or drug abuse.
boolean
other trial
Item
Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
COPD
Item
COPD
string
C0024117 (UMLS CUI)
13645005 (SNOMED CT 2010_0731)
10009033 (MedDRA 13.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
Spirometry
Item
Spirometrie
string
C0037981 (UMLS CUI)
127783003 (SNOMED CT 2010_0731)
10041629 (MedDRA 13.1)
Airway Obstruction
Item
Atemwegsobstruktion
string
C0001883 (UMLS CUI)
79688008 (SNOMED CT 2010_0731)
10001539 (MedDRA 13.1)
FEV1/VC
Item
Forced expired volume in one second/vital capacity ratio
string
C0429744 (UMLS CUI)
251943006 (SNOMED CT 2010_0731)
ECCS
Item
European Coal and Steel Community
string
C0524592 (UMLS CUI)
Pack Year
Item
Pack years (assessment scale)
string
C1277691 (UMLS CUI)
315609007 (SNOMED CT 2010_0731)
Test
Item
Test
string
C0392366 (UMLS CUI)
C47891 (SNOMED CT 2010_0731)
Pulmonary function tests
Item
Lungenfunktionstest
string
C0024119 (UMLS CUI)
23426006 (SNOMED CT 2010_0731)
10025099 (MedDRA 13.1)
MTHU029811 (LOINC Version 232)
PEFR
Item
Peak expiratory flow rate measurement
string
C0030735 (UMLS CUI)
10034192 (MedDRA 13.1)
PEFR monitoring using diary
Item
Peak expiratory flow rate monitoring using diary
string
C1276011 (UMLS CUI)
401011001 (SNOMED CT 2010_0731)
Home Medications
Item
Home Medications
string
C0013227 (UMLS CUI)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study
string
C2348568 (UMLS CUI)
disorder risk
Item
disease risk
string
C1281905 (UMLS CUI)
Myocardial Infarction (MI)
Item
Herzinfarkt
string
C0027051 (UMLS CUI)
22298006 (SNOMED CT 2010_0731)
10028596 (MedDRA 13.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE Version 4.03)
Cardiac Arrhythmia
Item
Herzrhythmusstörung
string
C0003811 (UMLS CUI)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
427.9 (ICD-9-CM Version 2011)
Drug Therapy
Item
medikamentöse Therapie
string
CL428482 (UMLS CUI)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
Oxygen Therapy
Item
Sauerstofftherapie
string
CL426373 (UMLS CUI)
Active tuberculosis
Item
Aktive Tuberkulose
string
C0151332 (UMLS CUI)
427099000 (SNOMED CT 2010_0731)
10071157 (MedDRA 13.1)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Basal cell carcinoma
Item
Basalzellenkarzinom
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Lung
Item
Lunge
string
C0024109 (UMLS CUI)
39607008 (SNOMED CT 2010_0731)
MTHU008683 (LOINC Version 232)
Obstruction
Item
Obstruktion
string
C0028778 (UMLS CUI)
26036001 (SNOMED CT 2010_0731)
10061876 (MedDRA 13.1)
Cystic Fibrosis (CF)
Item
Mukoviszidose
string
C0010674 (UMLS CUI)
190905008 (SNOMED CT 2010_0731)
10011762 (MedDRA 13.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
Bronchiectasis
Item
Bronchiectasis
string
C0006267 (UMLS CUI)
12295008 (SNOMED CT 2010_0731)
10006445 (MedDRA 13.1)
J47.9 (ICD-10-CM Version 2010)
494 (ICD-9-CM Version 2011)
Thoracotomy
Item
Thorakotomie
string
C0039991 (UMLS CUI)
177765008 (SNOMED CT 2010_0731)
10043491 (MedDRA 13.1)
34.01 (ICD-9-CM Version 2011)
Lung excision
Item
Pulmonary resection
string
C0396565 (UMLS CUI)
119746007 (SNOMED CT 2010_0731)
Respiratory Infections
Item
Atemweginfektion
string
C0035243 (UMLS CUI)
275498002 (SNOMED CT 2010_0731)
10062352 (MedDRA 13.1)
MTHU026191 (LOINC Version 232)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
Pulmonary rehabilitation program completed
Item
Pulmonary rehabilitation programme completed
string
C1272303 (UMLS CUI)
391130000 (SNOMED CT 2010_0731)
Anticholinergic allergy
Item
Anticholinergic allergy
string
C0570982 (UMLS CUI)
294065003 (SNOMED CT 2010_0731)
Lactose Intolerance
Item
Laktoseintoleranz
string
C0022951 (UMLS CUI)
267425008 (SNOMED CT 2010_0731)
10023681 (MedDRA 13.1)
E73.9 (ICD-10-CM Version 2010)
Inhalation Drug Administration
Item
Medikamenteninhalation
string
C0001559 (UMLS CUI)
243132000 (SNOMED CT 2010_0731)
Prostatic Hypertrophy
Item
Prostatahypertrophie
string
C1739363 (UMLS CUI)
10036962 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
Bladder obstruction
Item
Blasenhalsobstruktion
string
C0005694 (UMLS CUI)
399072004 (SNOMED CT 2010_0731)
10005060 (MedDRA 13.1)
N32.0 (ICD-10-CM Version 2010)
596.0 (ICD-9-CM Version 2011)
Anatomical narrow angle glaucoma
Item
Engwinkelglaukom
string
C0154947 (UMLS CUI)
33647009 (SNOMED CT 2010_0731)
10008833 (MedDRA 13.1)
H40.22 (ICD-10-CM Version 2010)
365.23 (ICD-9-CM Version 2011)
Corticosteroids
Item
Corticosteroide
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
prednisolone
Item
Prednisolon
string
C0032950 (UMLS CUI)
116601002 (SNOMED CT 2010_0731)
MTHU003522 (LOINC Version 232)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraceptives, Oral
Item
orales Kontrazeptivum
string
C0009905 (UMLS CUI)
59261009 (SNOMED CT 2010_0731)
Intrauterine Devices
Item
Intrauterine contraceptive device
string
C0021900 (UMLS CUI)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
Subdermal implantation of progesterone
Item
Subdermal implantation of progesterone
string
C0864560 (UMLS CUI)
Implant
Item
Implant, device
string
C0021102 (UMLS CUI)
40388003 (SNOMED CT 2010_0731)
subdermal
Item
subkutan
string
C1522438 (UMLS CUI)
34206005 (SNOMED CT 2010_0731)
SubcutaneousRoute (HL7 V3 02-34)
Contraceptive diaphragm
Item
Vaginal contraceptive diaphragm (device)
string
C0042241 (UMLS CUI)
20359006 (SNOMED CT 2010_0731)
Bronchial Asthma
Item
Asthma
string
C0004096 (UMLS CUI)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Allergic rhinitis
Item
Rhinitis allergica
string
C2607914 (UMLS CUI)
61582004 (SNOMED CT 2010_0731)
10039085 (MedDRA 13.1)
J30.9 (ICD-10-CM Version 2010)
477.9 (ICD-9-CM Version 2011)
E13303 (CTCAE Version 4.03)
Atopy
Item
Atopie
string
C0392707 (UMLS CUI)
115665000 (SNOMED CT 2010_0731)
10003645 (MedDRA 13.1)
Alcohol abuse
Item
Alkohol-Abusus
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Investigational Drug
Item
Investigational New Drug
string
C0013230 (UMLS CUI)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
visit
Item
patient encounter
string
C1512346 (UMLS CUI)
ENC (HL7 V3 02-34)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)

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