ID

36450

Description

A Open-label Study of Ultra-High Dose Dexamethasone for Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02402725

Lien

https://clinicaltrials.gov/show/NCT02402725

Mots-clés

Versions (1)
  1. 15/05/2019 15/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

15 mai 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02402725

Anglais

Eligibility Multiple Myeloma NCT02402725

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. relapsed multiple myeloma (mm) with measurable disease parameters according to the international myeloma working group (imwg) criteria for the diagnosis of multiple myeloma
Description

Multiple myeloma recurrent | Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C1513041
2. relapsed is defined as the development of disease progression following the achievement of stable disease (sd), partial response (pr), very good partial response (vgpr), complete response (cr) or stringent complete response (scr) to the most recent anti-myeloma regimen
Description

Disease Progression | Status post Stable Disease | Status post Partial response Therapy Multiple Myeloma | Status post Very Good Partial Response Therapy Multiple Myeloma | Status post Complete response Therapy Multiple Myeloma | Status post Stringent Complete Response Therapy Myeloma

Type de données

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677946
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1521726
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0026764
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C4053871
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0026764
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0677874
UMLS CUI [5,3]
C0087111
UMLS CUI [5,4]
C0026764
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C4050416
UMLS CUI [6,3]
C0087111
UMLS CUI [6,4]
C0026764
3. received ≥ 2 prior regimen for mm
Description

Prior Therapy Quantity Multiple Myeloma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
4. the patient or the patient's legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)
Description

Informed Consent | Informed Consent Patient Representative | Authorization Use of Health information

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0680281
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0850397
5. ≥18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
6. karnofsky performance status score of ≥70
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
7. able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
8. adequate hepatic function, as evidenced by serum bilirubin values <6.0 mg/dl and serum alanine transaminase (alt) and/or aspartate transaminase (ast) values <3 × the upper limit of normal (uln) of the local laboratory reference range. (patients with isolated elevations in alkaline phosphatase [alp] <5 × uln in the presence of bony disease are not excluded from participating in the study)
Description

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase raised Isolated | Bone Disease Present

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C0151849
UMLS CUI [5,2]
C0205409
UMLS CUI [6,1]
C0005940
UMLS CUI [6,2]
C0150312
9. if a female participant is of childbearing potential, she must have a negative pregnancy test (urine or serum) at baseline (cycle 1, day 0). (a female participant is considered to be not of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Bilateral oophorectomy | Menopause Without Menstruation

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3]
C0278321
UMLS CUI [4,1]
C0025320
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C0025344
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. received any of the following therapies: radiotherapy within 2 weeks of cycle 1 day 1; systemic therapy within 3 weeks of cycle 1 day 1
Description

Therapeutic radiology procedure | Systemic therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1515119
2. prior peripheral autologous stem cell transplant within 12 weeks of cycle 1 day 1
Description

Autologous peripheral hematopoietic stem cell transplant

Type de données

boolean

Alias
UMLS CUI [1]
C1142466
3. prior allogeneic stem cell transplant
Description

Allogeneic Stem Cell Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C2242529
4. active systemic infection requiring treatment
Description

Sepsis Treatment required for

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332121
5. active malignancy (the following are allowable: patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/ml; or cervical intraepithelial neoplasia).
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma PSA Level | Exception Cervical Intraepithelial Neoplasia

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1336527
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C4086720
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0206708
6. known or suspected human immunodeficiency virus (hiv) positive or hepatitis b surface antigen-positive status or is known or suspected to have an active hepatitis c infection
Description

HIV Seropositivity | HIV Seropositivity Suspected | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0019196
UMLS CUI [5,1]
C0019196
UMLS CUI [5,2]
C0750491
7. if female, patient is lactating
Description

Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
8. history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with:
Description

Cardiovascular Disease | Nervous system disorder | Endocrine System Diseases | Gastrointestinal Diseases | Respiration Disorders | Inflammatory disorder | Illness Study Subject Participation Status Excluded | Illness Risk Unacceptable | Illness Interferes with Interpretation Research results

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0035204
UMLS CUI [6]
C1290884
UMLS CUI [7,1]
C0221423
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C0332196
UMLS CUI [8,1]
C0221423
UMLS CUI [8,2]
C0035647
UMLS CUI [8,3]
C1883420
UMLS CUI [9,1]
C0221423
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0459471
UMLS CUI [9,4]
C0683954
1. congestive heart failure (new york heart association [nyha] class 3 or 4
Description

Congestive heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
2. unstable angina
Description

Angina, Unstable

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
3. cardiac arrhythmia
Description

Cardiac Arrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0003811
4. recent (within the preceding 6 months) myocardial infarction or stroke
Description

Myocardial Infarction | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
5. hypertension requiring >3 medications for adequate control
Description

Hypertensive disease Requirement Pharmacotherapy | Pharmaceutical Preparations Quantity Control

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0243148
6. chronic obstructive pulmonary disease
Description

Chronic Obstructive Airway Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0024117
9. history of uncontrolled diabetes mellitus (type i or ii) (hemoglobin a1c>8.5)
Description

DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0743113
UMLS CUI [2]
C0743118
UMLS CUI [3]
C0474680
10. any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
Description

Other medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Social Condition Study Subject Participation Status Excluded | Other medical condition Risk Unacceptable | Mental condition Risk Unacceptable | Social Condition Risk Unacceptable | Other medical condition Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Social Condition Interferes with Completion of clinical trial | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | Social Condition Interferes with Interpretation Research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C1883420
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C1883420
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0035647
UMLS CUI [6,3]
C1883420
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2732579
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2732579
UMLS CUI [9,1]
C0037403
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2732579
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0459471
UMLS CUI [10,4]
C0683954
UMLS CUI [11,1]
C3840291
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0037403
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
11. history of adverse reaction to dexamethasone or other corticosteroids.
Description

Adverse reactions Dexamethasone | Adverse reactions Adrenal Cortex Hormones

Type de données

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0011777
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0001617
12. history of allergic reaction attributable to any of the required prophylactic medications (proton pump inhibitor (ppi), fluconazole, trimethoprim-sulfamethoxazole) or reasonable alternative medications
Description

Allergic Reaction Prophylactic drug therapy | Allergic Reaction Proton Pump Inhibitors | Allergic Reaction Fluconazole | Allergic Reaction Trimethoprim-Sulfamethoxazole

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0420172
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0358591
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0016277
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0041044
13. inability to monitor glucose at home with glucometer if glucose is found to be abnormal at any study center visit
Description

Blood Glucose Self-Monitoring Glucometer Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0472226
UMLS CUI [1,3]
C1299582
14. known or suspected al amyloidosis
Description

Amyloidosis | Amyloidosis Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0002726
UMLS CUI [2,1]
C0002726
UMLS CUI [2,2]
C0750491
15. currently receiving an investigational agent for any reason
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Multiple Myeloma NCT02402725

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Multiple myeloma recurrent | Measurable Disease
Item
1. relapsed multiple myeloma (mm) with measurable disease parameters according to the international myeloma working group (imwg) criteria for the diagnosis of multiple myeloma
boolean
C1370446 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Disease Progression | Status post Stable Disease | Status post Partial response Therapy Multiple Myeloma | Status post Very Good Partial Response Therapy Multiple Myeloma | Status post Complete response Therapy Multiple Myeloma | Status post Stringent Complete Response Therapy Myeloma
Item
2. relapsed is defined as the development of disease progression following the achievement of stable disease (sd), partial response (pr), very good partial response (vgpr), complete response (cr) or stringent complete response (scr) to the most recent anti-myeloma regimen
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0677946 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1521726 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0026764 (UMLS CUI [3,4])
C0231290 (UMLS CUI [4,1])
C4053871 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0026764 (UMLS CUI [4,4])
C0231290 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0026764 (UMLS CUI [5,4])
C0231290 (UMLS CUI [6,1])
C4050416 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C0026764 (UMLS CUI [6,4])
Prior Therapy Quantity Multiple Myeloma
Item
3. received ≥ 2 prior regimen for mm
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Informed Consent | Informed Consent Patient Representative | Authorization Use of Health information
Item
4. the patient or the patient's legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0680281 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0850397 (UMLS CUI [3,3])
Age
Item
5. ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
6. karnofsky performance status score of ≥70
boolean
C0206065 (UMLS CUI [1])
Protocol Compliance
Item
7. able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion
boolean
C0525058 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase raised Isolated | Bone Disease Present
Item
8. adequate hepatic function, as evidenced by serum bilirubin values <6.0 mg/dl and serum alanine transaminase (alt) and/or aspartate transaminase (ast) values <3 × the upper limit of normal (uln) of the local laboratory reference range. (patients with isolated elevations in alkaline phosphatase [alp] <5 × uln in the presence of bony disease are not excluded from participating in the study)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0151849 (UMLS CUI [5,1])
C0205409 (UMLS CUI [5,2])
C0005940 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Bilateral oophorectomy | Menopause Without Menstruation
Item
9. if a female participant is of childbearing potential, she must have a negative pregnancy test (urine or serum) at baseline (cycle 1, day 0). (a female participant is considered to be not of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3])
C0025320 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C0025344 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Systemic therapy
Item
1. received any of the following therapies: radiotherapy within 2 weeks of cycle 1 day 1; systemic therapy within 3 weeks of cycle 1 day 1
boolean
C1522449 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
Autologous peripheral hematopoietic stem cell transplant
Item
2. prior peripheral autologous stem cell transplant within 12 weeks of cycle 1 day 1
boolean
C1142466 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
3. prior allogeneic stem cell transplant
boolean
C2242529 (UMLS CUI [1])
Sepsis Treatment required for
Item
4. active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma PSA Level | Exception Cervical Intraepithelial Neoplasia
Item
5. active malignancy (the following are allowable: patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/ml; or cervical intraepithelial neoplasia).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1336527 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C4086720 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0206708 (UMLS CUI [5,2])
HIV Seropositivity | HIV Seropositivity Suspected | Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected
Item
6. known or suspected human immunodeficiency virus (hiv) positive or hepatitis b surface antigen-positive status or is known or suspected to have an active hepatitis c infection
boolean
C0019699 (UMLS CUI [1])
C0019699 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019196 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
Breast Feeding
Item
7. if female, patient is lactating
boolean
C0006147 (UMLS CUI [1])
Cardiovascular Disease | Nervous system disorder | Endocrine System Diseases | Gastrointestinal Diseases | Respiration Disorders | Inflammatory disorder | Illness Study Subject Participation Status Excluded | Illness Risk Unacceptable | Illness Interferes with Interpretation Research results
Item
8. history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with:
boolean
C0007222 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C1290884 (UMLS CUI [6])
C0221423 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C0332196 (UMLS CUI [7,3])
C0221423 (UMLS CUI [8,1])
C0035647 (UMLS CUI [8,2])
C1883420 (UMLS CUI [8,3])
C0221423 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0459471 (UMLS CUI [9,3])
C0683954 (UMLS CUI [9,4])
Congestive heart failure New York Heart Association Classification
Item
1. congestive heart failure (new york heart association [nyha] class 3 or 4
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable
Item
2. unstable angina
boolean
C0002965 (UMLS CUI [1])
Cardiac Arrhythmia
Item
3. cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident
Item
4. recent (within the preceding 6 months) myocardial infarction or stroke
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Hypertensive disease Requirement Pharmacotherapy | Pharmaceutical Preparations Quantity Control
Item
5. hypertension requiring >3 medications for adequate control
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0243148 (UMLS CUI [2,3])
Chronic Obstructive Airway Disease
Item
6. chronic obstructive pulmonary disease
boolean
C0024117 (UMLS CUI [1])
DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement
Item
9. history of uncontrolled diabetes mellitus (type i or ii) (hemoglobin a1c>8.5)
boolean
C0743113 (UMLS CUI [1])
C0743118 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Other medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Social Condition Study Subject Participation Status Excluded | Other medical condition Risk Unacceptable | Mental condition Risk Unacceptable | Social Condition Risk Unacceptable | Other medical condition Interferes with Completion of clinical trial | Mental condition Interferes with Completion of clinical trial | Social Condition Interferes with Completion of clinical trial | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | Social Condition Interferes with Interpretation Research results
Item
10. any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C1883420 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C1883420 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C1883420 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
C0037403 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2732579 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
C3840291 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0037403 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Adverse reactions Dexamethasone | Adverse reactions Adrenal Cortex Hormones
Item
11. history of adverse reaction to dexamethasone or other corticosteroids.
boolean
C0559546 (UMLS CUI [1,1])
C0011777 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Allergic Reaction Prophylactic drug therapy | Allergic Reaction Proton Pump Inhibitors | Allergic Reaction Fluconazole | Allergic Reaction Trimethoprim-Sulfamethoxazole
Item
12. history of allergic reaction attributable to any of the required prophylactic medications (proton pump inhibitor (ppi), fluconazole, trimethoprim-sulfamethoxazole) or reasonable alternative medications
boolean
C1527304 (UMLS CUI [1,1])
C0420172 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0358591 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0016277 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0041044 (UMLS CUI [4,2])
Blood Glucose Self-Monitoring Glucometer Unable
Item
13. inability to monitor glucose at home with glucometer if glucose is found to be abnormal at any study center visit
boolean
C0005803 (UMLS CUI [1,1])
C0472226 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Amyloidosis | Amyloidosis Suspected
Item
14. known or suspected al amyloidosis
boolean
C0002726 (UMLS CUI [1])
C0002726 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Investigational New Drugs
Item
15. currently receiving an investigational agent for any reason
boolean
C0013230 (UMLS CUI [1])
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