ID

39486

Description

Studies Investigating Co-morbidities Aggravating Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01872299

Lien

https://clinicaltrials.gov/show/NCT01872299

Mots-clés

  1. 16/01/2020 16/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Heart Failure NCT01872299

Eligibility Heart Failure NCT01872299

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of heart failure;
Description

Heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C0018801
objective evidence of cardiac dysfunctions as evidenced by at least one of the following:
Description

Cardiac dysfunction

Type de données

boolean

Alias
UMLS CUI [1]
C3277906
left ventricular ejection fraction ≤ 40%;
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
left atrial dimension >4.0 cm (or >2.5 cm/m in height)
Description

Left atrium Dimension | Left atrium Dimension Height

Type de données

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0439534
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C0489786
nt-probnp >400 pg/ml [>47.3 pmol/l] (or bnp >150 pg/ml)
Description

N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement

Type de données

boolean

Alias
UMLS CUI [1]
C3272900
UMLS CUI [2]
C1095989
current treatment with loop diuretics;
Description

Loop Diuretics

Type de données

boolean

Alias
UMLS CUI [1]
C0354100
age >18 years;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
willingness to provide informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
congenital heart disease;
Description

Congenital heart disease

Type de données

boolean

Alias
UMLS CUI [1]
C0152021
any life-threatening disease other than heart failure;
Description

Life threatening illness | Exception Heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
active malignancy of any type, or history of a malignancy within previous 5 years;
Description

Malignant Neoplasm Type Any | History of malignant neoplasm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0455471
previous heart transplantation;
Description

Heart Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0018823
intra-venous therapy for heart failure given within the previous 72 hours;
Description

Intravenous therapy Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0455142
UMLS CUI [1,2]
C0018801
severe neuro-muscular disease;
Description

Neuromuscular Disease Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027868
UMLS CUI [1,2]
C0205082
history of unstable angina, myocardial infarction or stroke within 3 months prior to the study;
Description

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
pregnancy;
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease;
Description

Therapeutic immunosuppression | Steroid therapy Rheumatoid Arthritis | Steroid therapy Obstructive Lung Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0600260
significant renal dysfunction, defined as serum creatinine >250 μmol/l [>2.8 mg/dl];
Description

Renal dysfunction | Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
severe liver disease, defined as any liver function tests >3 times the upper limit of normal;
Description

Liver disease Severe | Increased liver function tests

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0877359
unable to understand and comply with protocol or to give informed consent.
Description

Study Protocol Comprehension Unable | Protocol Compliance Unable | Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582

Similar models

Eligibility Heart Failure NCT01872299

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
clinical diagnosis of heart failure;
boolean
C0018801 (UMLS CUI [1])
Cardiac dysfunction
Item
objective evidence of cardiac dysfunctions as evidenced by at least one of the following:
boolean
C3277906 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction ≤ 40%;
boolean
C0428772 (UMLS CUI [1])
Left atrium Dimension | Left atrium Dimension Height
Item
left atrial dimension >4.0 cm (or >2.5 cm/m in height)
boolean
C0225860 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0225860 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C0489786 (UMLS CUI [2,3])
N-Terminal ProB-type Natriuretic Peptide Measurement | Brain natriuretic peptide measurement
Item
nt-probnp >400 pg/ml [>47.3 pmol/l] (or bnp >150 pg/ml)
boolean
C3272900 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
Loop Diuretics
Item
current treatment with loop diuretics;
boolean
C0354100 (UMLS CUI [1])
Age
Item
age >18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congenital heart disease
Item
congenital heart disease;
boolean
C0152021 (UMLS CUI [1])
Life threatening illness | Exception Heart failure
Item
any life-threatening disease other than heart failure;
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Malignant Neoplasm Type Any | History of malignant neoplasm
Item
active malignancy of any type, or history of a malignancy within previous 5 years;
boolean
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0455471 (UMLS CUI [2])
Heart Transplantation
Item
previous heart transplantation;
boolean
C0018823 (UMLS CUI [1])
Intravenous therapy Heart failure
Item
intra-venous therapy for heart failure given within the previous 72 hours;
boolean
C0455142 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Neuromuscular Disease Severe
Item
severe neuro-muscular disease;
boolean
C0027868 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Angina, Unstable | Myocardial Infarction | Cerebrovascular accident
Item
history of unstable angina, myocardial infarction or stroke within 3 months prior to the study;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Therapeutic immunosuppression | Steroid therapy Rheumatoid Arthritis | Steroid therapy Obstructive Lung Disease
Item
treatment with immunosuppressive therapy, e.g. steroids for rheumatoid arthritis or obstructive lung disease;
boolean
C0021079 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0600260 (UMLS CUI [3,2])
Renal dysfunction | Creatinine measurement, serum
Item
significant renal dysfunction, defined as serum creatinine >250 μmol/l [>2.8 mg/dl];
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver disease Severe | Increased liver function tests
Item
severe liver disease, defined as any liver function tests >3 times the upper limit of normal;
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877359 (UMLS CUI [2])
Study Protocol Comprehension Unable | Protocol Compliance Unable | Informed Consent Unable
Item
unable to understand and comply with protocol or to give informed consent.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial