ID

43226

Descripción

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

Link

http://clinicaltrials.gov/show/NCT00274573

Palabras clave

  1. 28/2/12 28/2/12 -
  2. 13/4/14 13/4/14 - Julian Varghese
  3. 11/8/14 11/8/14 - Martin Dugas
  4. 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 NCT00274573 Pulmonary Disease, Chronic Obstructive

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descripción

Einschlusskriterien

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

Age 40 years or older

Tipo de datos

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.
Descripción

COPD

Tipo de datos

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)
Descripción

Smoking

Tipo de datos

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
Descripción

Study related tests

Tipo de datos

boolean

Patients must be able to inhale medication from the HandiHaler
Descripción

inhale medication

Tipo de datos

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
Descripción

consent

Tipo de datos

boolean

Ausschlusskriterien
Descripción

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.
Descripción

significant diseases

Tipo de datos

boolean

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

Myocardial Infarction

Tipo de datos

boolean

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

Cardiac Arrhythmia

Tipo de datos

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.
Descripción

daytime oxygen

Tipo de datos

boolean

Patients with known active tuberculosis.
Descripción

tuberculosis

Tipo de datos

boolean

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

Cancer

Tipo de datos

boolean

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

major pulmonary Diseases

Tipo de datos

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.
Descripción

Thoracotomy

Tipo de datos

boolean

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

Respiratory Infections

Tipo de datos

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).
Descripción

pulmonary rehabilitation program

Tipo de datos

boolean

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

Allergies

Tipo de datos

boolean

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

prostate hypertrophy or bladder neck obstruction

Tipo de datos

boolean

Patients with known narrow-angle glaucoma.
Descripción

narrow-angle glaucoma

Tipo de datos

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.
Descripción

oral corticosteroids

Tipo de datos

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).
Descripción

pregnant

Tipo de datos

boolean

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

history of asthma, allergic rhinitis or atopy.

Tipo de datos

boolean

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

alcohol or drug abuse

Tipo de datos

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.
Descripción

other trial

Tipo de datos

boolean

Medizinische Konzepte
Descripción

Medizinische Konzepte

Alter
Descripción

Age

Tipo de datos

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Descripción

Disease

Tipo de datos

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
COPD
Descripción

COPD

Tipo de datos

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
Descripción

Spirometry

Tipo de datos

string

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

Airway Obstruction

Tipo de datos

string

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

FEV1/VC

Tipo de datos

string

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

ECCS

Tipo de datos

string

Alias
UMLS CUI
C0524592
Pack years (assessment scale)
Descripción

Pack Year

Tipo de datos

string

Alias
UMLS CUI
C1277691
SNOMED CT 2010_0731
315609007
Test
Descripción

Test

Tipo de datos

string

Alias
UMLS CUI
C0392366
SNOMED CT 2010_0731
C47891
Lungenfunktionstest
Descripción

Pulmonary function tests

Tipo de datos

string

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

PEFR

Tipo de datos

string

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

PEFR monitoring using diary

Tipo de datos

string

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

Home Medications

Tipo de datos

string

Alias
UMLS CUI
C0013227
Einverständniserklärung
Descripción

Informed Consent

Tipo de datos

string

Alias
UMLS CUI
C0021430
Subject Participation Status in Clinical Study
Descripción

Study Subject Participation Status

Tipo de datos

string

Alias
UMLS CUI
C2348568
disease risk
Descripción

disorder risk

Tipo de datos

string

Alias
UMLS CUI
C1281905
Herzinfarkt
Descripción

Myocardial Infarction (MI)

Tipo de datos

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
Descripción

Cardiac Arrhythmia

Tipo de datos

string

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

Drug Therapy

Tipo de datos

string

Alias
UMLS CUI
CL428482
Heart failure
Descripción

Heart failure

Tipo de datos

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
Descripción

Oxygen Therapy

Tipo de datos

string

Alias
UMLS CUI
CL426373
Aktive Tuberkulose
Descripción

Active tuberculosis

Tipo de datos

string

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

Cancer

Tipo de datos

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
Descripción

Basal cell carcinoma

Tipo de datos

string

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

Lung

Tipo de datos

string

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

Obstruction

Tipo de datos

string

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

Cystic Fibrosis (CF)

Tipo de datos

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
Descripción

Bronchiectasis

Tipo de datos

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
Descripción

Thoracotomy

Tipo de datos

string

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

Lung excision

Tipo de datos

string

Alias
UMLS CUI
C0396565
SNOMED CT 2010_0731
119746007
Atemweginfektion
Descripción

Respiratory Infections

Tipo de datos

string

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

Screening

Tipo de datos

string

Alias
UMLS CUI
C1409616
Pulmonary rehabilitation programme completed
Descripción

Pulmonary rehabilitation program completed

Tipo de datos

string

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

Anticholinergic allergy

Tipo de datos

string

Alias
UMLS CUI
C0570982
SNOMED CT 2010_0731
294065003
Laktoseintoleranz
Descripción

Lactose Intolerance

Tipo de datos

string

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

Inhalation Drug Administration

Tipo de datos

string

Alias
UMLS CUI
C0001559
SNOMED CT 2010_0731
243132000
Prostatahypertrophie
Descripción

Prostatic Hypertrophy

Tipo de datos

string

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

Bladder obstruction

Tipo de datos

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
Descripción

Anatomical narrow angle glaucoma

Tipo de datos

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
Descripción

Corticosteroids

Tipo de datos

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Prednisolon
Descripción

prednisolone

Tipo de datos

string

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

pregnant

Tipo de datos

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillzeit
Descripción

Lactation

Tipo de datos

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Kontrazeption
Descripción

Contraception

Tipo de datos

string

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

Contraceptives, Oral

Tipo de datos

string

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

Intrauterine Devices

Tipo de datos

string

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

Subdermal implantation of progesterone

Tipo de datos

string

Alias
UMLS CUI
C0864560
Implant, device
Descripción

Implant

Tipo de datos

string

Alias
UMLS CUI
C0021102
SNOMED CT 2010_0731
40388003
subkutan
Descripción

subdermal

Tipo de datos

string

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

Contraceptive diaphragm

Tipo de datos

string

Alias
UMLS CUI
C0042241
SNOMED CT 2010_0731
20359006
Asthma
Descripción

Bronchial Asthma

Tipo de datos

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
Descripción

Allergic rhinitis

Tipo de datos

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
Descripción

Atopy

Tipo de datos

string

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

Alcohol abuse

Tipo de datos

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
Descripción

Drug abuse

Tipo de datos

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
Descripción

Investigational Drug

Tipo de datos

string

Alias
UMLS CUI
C0013230
Screening
Descripción

Screening

Tipo de datos

string

Alias
UMLS CUI
C1409616
patient encounter
Descripción

visit

Tipo de datos

string

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

Randomization

Tipo de datos

string

Alias
UMLS CUI
C0034656

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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