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Informações:
Falhas:
ID
28194
Descrição
Eligibility form Prüfung der Eignung zur Studienteilnahme NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes
Palavras-chave
Versões (3)
- 09/07/2017 09/07/2017 -
- 28/12/2017 28/12/2017 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
Saarland University
Transferido a
28 de dezembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility HOMe aFers 1 NCT02905539
Eligibility HOMe aFers 1 NCT02905539
- StudyEvent: ODM
Similar models
Eligibility HOMe aFers 1 NCT02905539
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Written informed consent
Item
Written informed consent,
boolean
C0021430 (UMLS CUI [1])
Female
Item
Female,
boolean
C0015780 (UMLS CUI [1])
Gynaecological blood losses
Item
Gynecological blood losses,
boolean
C0018417 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
C3163616 (UMLS CUI [1,2])
Age ≥ 18 years
Item
Age ≥ 18 years,
boolean
C0001779 (UMLS CUI [1])
Iron deficiency anemia
Item
Iron deficiency anemia,
boolean
C0162316 (UMLS CUI [1])
Hemoglobin < 12.0 g/dl
Item
Hemoglobin < 12,0 g/dl,
boolean
C0019046 (UMLS CUI [1])
Serum ferritin and transferrin saturation
Item
Serum-Ferritin 100 ng/ml or Serum-Ferritin 300 ng/ml and Transferrin-saturation 30 %,
boolean
C0696113 (UMLS CUI [1])
C1277709 (UMLS CUI [2])
C1277709 (UMLS CUI [2])
Intolerance to or inefficacy of an oral iron supplement
Item
Intolerance to or inefficacy of an oral iron supplement
boolean
C3537005 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C3537005 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
C1744706 (UMLS CUI [1,2])
C3537005 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
eGFR > 15 mL/min/1.73 m^2
Item
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
boolean
C3811844 (UMLS CUI [1])
Healthy Volunteers
Item
Healthy Volunteers
boolean
C1708335 (UMLS CUI [1])
Hypersensitivity to MonoFer or FERINJECT
Item
Known hypersensitivity to MonoFer or FERINJECT,
boolean
C0020517 (UMLS CUI [1,1])
C2985193 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2984025 (UMLS CUI [2,2])
C2985193 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2984025 (UMLS CUI [2,2])
Severe hypersensitivity to other intravenous iron preparations
Item
Severe, known hypersensitivity to other intravenous iron preparations,
boolean
C0020517 (UMLS CUI [1,1])
C4305398 (UMLS CUI [1,2])
C4305398 (UMLS CUI [1,2])
Plasma phosphate < 2.5 mg/dL
Item
Plasma Phosphate < 2.5 mg/dl at screening,
boolean
C0523826 (UMLS CUI [1])
Haemochromatosis
Item
Hemochromatosis,
boolean
C0018995 (UMLS CUI [1])
Untreated hyperparathyroidism
Item
Untreated hyperparathyroidism,
boolean
C0020502 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,2])
Renal replacement therapy
Item
Renal replacement therapy/kidney transplantation,
boolean
C0206074 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0022671 (UMLS CUI [2])
Active malignant disease
Item
Active malignant disease, disease-free survival for less than 5 years,
boolean
C0205177 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
Intravenous iron administration within the last 30 days
Item
Intravenous iron administration within the last 30 days,
boolean
C4305398 (UMLS CUI [1])
Treatment with erythropoietin or erythropoisis stimulating agents, red blood cell transfusion, radiotherapy, chemotherapy within the last 60 days
Item
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
boolean
C0014822 (UMLS CUI [1])
C1959590 (UMLS CUI [2])
C0086252 (UMLS CUI [3])
C1384668 (UMLS CUI [4])
C3665472 (UMLS CUI [5])
C1959590 (UMLS CUI [2])
C0086252 (UMLS CUI [3])
C1384668 (UMLS CUI [4])
C3665472 (UMLS CUI [5])
Surgery under anesthetic within the last 10 days
Item
Surgery under anesthetic within the last 10 days,
boolean
C0543467 (UMLS CUI [1,1])
C0002932 (UMLS CUI [1,2])
C0002932 (UMLS CUI [1,2])
ASAT or ALAT 1.5-fold increased
Item
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [2])
Acute febrile infections within the last 7 days
Item
Acute febrile infections within the last 7 days,
boolean
C0948233 (UMLS CUI [1])
Chronic inflammatory disease
Item
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
boolean
C3646020 (UMLS CUI [1,1])
C1096024 (UMLS CUI [1,2])
C1096024 (UMLS CUI [1,2])
Self-reported severe asthma or eczema
Item
self-reported severe asthma or eczema,
boolean
C0581126 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
C0013595 (UMLS CUI [2])
Further contraindication (allergies, immunologic or inflammatory diseases)
Item
Presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
boolean
C0522473 (UMLS CUI [1])
C1527304 (UMLS CUI [2])
C0021053 (UMLS CUI [3])
C1290884 (UMLS CUI [4])
C1527304 (UMLS CUI [2])
C0021053 (UMLS CUI [3])
C1290884 (UMLS CUI [4])
Pregnancy
Item
Pregnancy,
boolean
C0032961 (UMLS CUI [1])
Woman of childbearing potential without effective contraception method
Item
Women of childbearing potential without an effective method of contraception,
boolean
C4324275 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0549184 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Lactating women
Item
Lactating women,
boolean
C0006147 (UMLS CUI [1])
Present alcohol or drug dependency
Item
Present alcohol or drug dependency,
boolean
C0038580 (UMLS CUI [1])
History of a psychological illness or seizures
Item
Patients with a history of a psychological illness or seizures,
boolean
C0004936 (UMLS CUI [1])
C0205191 (UMLS CUI [2,1])
C1540600 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,1])
C1540600 (UMLS CUI [2,2])
Non-compliance or other study participation within the last 30 days
Item
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
boolean
C0457432 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C1516648 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,1])
C1516648 (UMLS CUI [2,2])
Eligibility criteria not fulfilled
Item
boolean
C3242266 (UMLS CUI [1])
Eligbility criteria fulfilled
Item
boolean
C1302261 (UMLS CUI [1])
Date
Item
date
C0011008 (UMLS CUI [1])
Investigator name
Item
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
text
C2346576 (UMLS CUI [1])