ID

20567

Beschreibung

A Study of Iron Oligosaccharide in CHF Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00537186

Link

https://clinicaltrials.gov/show/NCT00537186

Stichworte

Versionen (1)
  1. 03.03.17 03.03.17 -
Hochgeladen am

3. März 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Heart Failure, Congestive NCT00537186

Englisch

Eligibility Heart Failure, Congestive NCT00537186

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
congestive heart failure
Beschreibung

congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
≥ 18 years of age at screening
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
haemoglobin < 110 g/l (or 6.8 mmol/l)
Beschreibung

hb

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
serum ferritin < 800 µgram/l
Beschreibung

serum ferritin

Datentyp

boolean

Alias
UMLS CUI [1]
C0696113
life expectancy beyond 12 months
Beschreibung

life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
willingness to participate after written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
non iron deficiency anaemia
Beschreibung

non iron deficiency anaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0162316
iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
Beschreibung

Iron Overload | Iron Metabolism Disorders | Hemochromatosis | Hemosiderosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0282193
UMLS CUI [2]
C0012715
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0019114
drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono-or disaccharide complexes)
Beschreibung

drug allergy, Hypersensitivity; Iron-Dextran Complex

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022092
patients with a history of multiple allergies
Beschreibung

history of multiple allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0489531
UMLS CUI [1,2]
C0439064
decompensated liver cirrhosis and hepatitis (alanine aminotransferase > 3 times normal)
Beschreibung

Decompensated cirrhosis | Hepatitis | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0201836
acute or chronic infections
Beschreibung

acute or chronic infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
rheumatoid arthritis with symptoms or signs of active inflammation
Beschreibung

rheumatoid arthritis with symptoms or signs of active inflammation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0333361
pregnancy and nursing
Beschreibung

pregnancy and nursing

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085537
to avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
Beschreibung

Childbearing Potential | Postmenopausal state | Infertility | Female Sterilization | Sexual Abstinence | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0700589
active bleeding
Beschreibung

active bleeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0019080
planned elective surgery during the study where significant blood loss is expected
Beschreibung

elective surgery, significant blood loss

Datentyp

boolean

Alias
UMLS CUI [1]
C0206058
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C0750502
participation in any other clinical trial within 3 months prior to screening
Beschreibung

study subject participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Heart Failure, Congestive NCT00537186

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
age
Item
≥ 18 years of age at screening
boolean
C0001779 (UMLS CUI [1])
hb
Item
haemoglobin < 110 g/l (or 6.8 mmol/l)
boolean
C0518015 (UMLS CUI [1])
serum ferritin
Item
serum ferritin < 800 µgram/l
boolean
C0696113 (UMLS CUI [1])
life expectancy
Item
life expectancy beyond 12 months
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
willingness to participate after written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
non iron deficiency anaemia
Item
non iron deficiency anaemia
boolean
C0002871 (UMLS CUI [1])
C1298908 (UMLS CUI [2,1])
C0162316 (UMLS CUI [2,2])
Iron Overload | Iron Metabolism Disorders | Hemochromatosis | Hemosiderosis
Item
iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
boolean
C0282193 (UMLS CUI [1])
C0012715 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
C0019114 (UMLS CUI [4])
drug allergy, Hypersensitivity; Iron-Dextran Complex
Item
drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono-or disaccharide complexes)
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0022092 (UMLS CUI [2,2])
history of multiple allergies
Item
patients with a history of multiple allergies
boolean
C0489531 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
Decompensated cirrhosis | Hepatitis | Alanine aminotransferase measurement
Item
decompensated liver cirrhosis and hepatitis (alanine aminotransferase > 3 times normal)
boolean
C1619727 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
acute or chronic infections
Item
acute or chronic infections
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
rheumatoid arthritis with symptoms or signs of active inflammation
Item
rheumatoid arthritis with symptoms or signs of active inflammation
boolean
C0003873 (UMLS CUI [1,1])
C0333361 (UMLS CUI [1,2])
pregnancy and nursing
Item
pregnancy and nursing
boolean
C0032961 (UMLS CUI [1])
C0085537 (UMLS CUI [2])
Childbearing Potential | Postmenopausal state | Infertility | Female Sterilization | Sexual Abstinence | Contraceptive methods
Item
to avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
boolean
C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
active bleeding
Item
active bleeding
boolean
C0205177 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
elective surgery, significant blood loss
Item
planned elective surgery during the study where significant blood loss is expected
boolean
C0206058 (UMLS CUI [1])
C3163616 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
study subject participation status
Item
participation in any other clinical trial within 3 months prior to screening
boolean
C2348568 (UMLS CUI [1])
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