ID

12428

Description

Low-dose Methotrexate for Reduction GINA 5 Medications in Chronic Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02124226

Link

https://clinicaltrials.gov/show/NCT02124226

Keywords

  1. 11/17/15 11/17/15 -
  2. 11/17/15 11/17/15 - Julian Varghese
Uploaded on

November 17, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Low Dose Methotrexate in Severe Chronic Asthma NCT02124226

Eligibility Low Dose Methotrexate in Severe Chronic Asthma NCT02124226

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a diagnosis of csa taking gina step 5 medications (i.e. regular ocs and/or omalizumab for a minimum of 6 months);
Description

Diagnosis of CSA

Data type

boolean

Alias
UMLS CUI [1]
C0520680
2. failure in weaning patients completely from step 5 medications during run-in;
Description

Failure in weaning

Data type

boolean

Alias
UMLS CUI [1]
C0043084
3. male and female individuals age 18 - 75 years;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. patients must be able to provide consent;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. use of immunomodulatory therapies in the preceding 3 months;
Description

Immunomodulatory therapies

Data type

boolean

Alias
UMLS CUI [1]
C1963758
2. recent or current history of alcoholism;
Description

Recent or current history of alcoholism

Data type

boolean

Alias
UMLS CUI [1]
C0038586
3. high liver enzyme levels (greater than 2.5 times the upper limit of the normal range);
Description

High liver enzyme levels

Data type

boolean

Alias
UMLS CUI [1]
C0235996
4. serum creatinine levels greater than 2.0 mg/dl
Description

Serum creatinine levels

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. acute illness within 15 days of study medication administration;
Description

Acute illness

Data type

boolean

Alias
UMLS CUI [1]
C0743842
6. leucopenia (below 3.0x109/l) and/or thrombocytopenia (below 100x109/l).
Description

Leucopenia and/or thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0040034
7. pregnancy or planning to become pregnant;
Description

Pregnancy or planning to become pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Low Dose Methotrexate in Severe Chronic Asthma NCT02124226

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of CSA
Item
1. patients with a diagnosis of csa taking gina step 5 medications (i.e. regular ocs and/or omalizumab for a minimum of 6 months);
boolean
C0520680 (UMLS CUI [1])
Failure in weaning
Item
2. failure in weaning patients completely from step 5 medications during run-in;
boolean
C0043084 (UMLS CUI [1])
age
Item
3. male and female individuals age 18 - 75 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
4. patients must be able to provide consent;
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunomodulatory therapies
Item
1. use of immunomodulatory therapies in the preceding 3 months;
boolean
C1963758 (UMLS CUI [1])
Recent or current history of alcoholism
Item
2. recent or current history of alcoholism;
boolean
C0038586 (UMLS CUI [1])
High liver enzyme levels
Item
3. high liver enzyme levels (greater than 2.5 times the upper limit of the normal range);
boolean
C0235996 (UMLS CUI [1])
Serum creatinine levels
Item
4. serum creatinine levels greater than 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Acute illness
Item
5. acute illness within 15 days of study medication administration;
boolean
C0743842 (UMLS CUI [1])
Leucopenia and/or thrombocytopenia
Item
6. leucopenia (below 3.0x109/l) and/or thrombocytopenia (below 100x109/l).
boolean
C0023530 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
Pregnancy or planning to become pregnant
Item
7. pregnancy or planning to become pregnant;
boolean
C0032961 (UMLS CUI [1])

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