ID

31055

Beskrivning

Phase I/II Calcitriol in Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00794547

Länk

https://clinicaltrials.gov/show/NCT00794547

Nyckelord

  1. 2018-07-15 2018-07-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 juli 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Cancer NCT00794547

Eligibility Non Small Cell Lung Cancer NCT00794547

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. proven histological or cytological diagnosis of stage iiib (malignant pleural effusion) iv nsclc.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0080032
2. age more than 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. performance status must be ecog 0-1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. no prior or concurrent malignancy, except non-melanoma skin cancer, or cis of the cervix, unless documented disease-free for more than 2 years.
Beskrivning

Malignant Neoplasms Previous Absent | Cancer Other Absent | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
5. no prior use of chemotherapy for stage iv nsclc; adjuvant therapy is permitted.
Beskrivning

Prior Chemotherapy Absent Non-Small Cell Lung Carcinoma TNM clinical staging | Adjuvant therapy allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0007131
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0683607
6. adequate bone marrow, hepatic, and renal function, as evidenced by the following: wbc 3.0 x 109/l, neutrophils 1.5 x 109 /l; platelet count 100 x 109/l; hgb> 10 g/dl (may be transfused to 10g/dl); total bilirubin within the upper limit of the institutional normal range; (transaminases sgot or sgpt) 1.5 times the upper limit of the institutional normal range. creatinine within the upper limit of the institutional normal range; creatinine clearance >50 ml/min
Beskrivning

Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Possible | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0518015
UMLS CUI [8,1]
C1879316
UMLS CUI [8,2]
C0332149
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0151904
UMLS CUI [11]
C0151905
UMLS CUI [12]
C0201976
UMLS CUI [13]
C0373595
7. patients must have measurable or evaluable disease (not required for the phase i part of the study)
Beskrivning

Measurable Disease | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
8. normal cardiac function with no history of uncontrolled heart disease
Beskrivning

Cardiac function | Heart Disease Uncontrolled Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332197
9. female patients must not be pregnant; they must be post-menopausal or practicing an accepted form of birth control. if pregnancy is a possibility, a pregnancy test will be required prior to initiation of therapy.
Beskrivning

Gender Pregnancy Absent | Postmenopausal state | Gender Contraceptive methods | Pregnancy Possible Pregnancy Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0332149
UMLS CUI [4,3]
C0032976
10. life expectancy of at least 12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
11. patient and investigator signed study-specific consent form, indicating the investigational nature of the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
12. patients must be accessible for treatment and follow-up.
Beskrivning

Patient Available Therapeutic procedure | Patient Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
13. no chemotherapy or radiotherapy within 3 weeks of study entry defined here as day 1 of therapy with calcitriol plus chemotherapy (6 weeks for mitomycin c or a nitrosourea).
Beskrivning

Chemotherapy Absent | Therapeutic radiology procedure Absent | Calcitriol | Mitomycin | Nitrosourea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0006674
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0028210
14. no treatment with investigational drugs within 3 weeks of study entry.
Beskrivning

Investigational New Drugs Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332197
15. no other serious illness or medical condition including unstable cardiac disease requiring treatment, new onset crescendo or rest angina; history of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures; or active infection are permitted. no evidence of grade > 2 peripheral neuropathy. no history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Beskrivning

Illness Serious Absent | Other medical condition Serious Absent | Heart Disease Unstable Treatment required for | New onset Unstable Angina | New onset Angina decubitus | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease | Absence Peripheral Neuropathy CTCAE Grades | Absence Severe allergy Docetaxel | Absence Severe allergy Polysorbate 80 Compound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0332121
UMLS CUI [4,1]
C0746890
UMLS CUI [4,2]
C0002965
UMLS CUI [5,1]
C0746890
UMLS CUI [5,2]
C0152172
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0033975
UMLS CUI [9]
C0497327
UMLS CUI [10]
C0036572
UMLS CUI [11]
C0009450
UMLS CUI [12,1]
C0332197
UMLS CUI [12,2]
C0031117
UMLS CUI [12,3]
C1516728
UMLS CUI [13,1]
C0332197
UMLS CUI [13,2]
C2945656
UMLS CUI [13,3]
C0246415
UMLS CUI [14,1]
C0332197
UMLS CUI [14,2]
C2945656
UMLS CUI [14,3]
C0032601
UMLS CUI [14,4]
C1706082
16. palliative radiation is permitted (as long as marrow exposed not greater than 10%; please see appendix iv for reference) at least 1 week since the last palliative xrt.
Beskrivning

Palliative Radiation Therapy | Bone Marrow Percentage Exposure

Datatyp

boolean

Alias
UMLS CUI [1]
C3898008
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0332157
17. treated brain metastasis allowed with no waiting period following gamma knife and at least 2 weeks after whole brain xrt as long as neurologically stable.
Beskrivning

Metastatic malignant neoplasm to brain Treated | Gamma Knife Radiosurgery | Waiting time Absent | Whole brain radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0086330
UMLS CUI [3,1]
C0814636
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1520143
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known hypersensitivity to vitamin d, docetaxel, cisplatin
Beskrivning

Vitamin D allergy | Hypersensitivity Docetaxel | Cisplatin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571828
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0246415
UMLS CUI [3]
C0570702
2. hypercalcemia (patients with serum albumin corrected calcium* > 10.7 mg/dl)
Beskrivning

Hypercalcemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020437
3. history of renal/bladder stones over the past 10 years
Beskrivning

Kidney Calculi | Urinary Bladder Calculi

Datatyp

boolean

Alias
UMLS CUI [1]
C0022650
UMLS CUI [2]
C0005683
4. history of nephrectomy.
Beskrivning

Nephrectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0027695
5. uncontrolled heart disease, unstable angina, heart failure, current digoxin therapy
Beskrivning

Heart Disease Uncontrolled | Angina, Unstable | Heart failure | Digoxin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0012265
6. thiazide, digoxin or glucocorticoid therapy (except the pre-medication dexamethasone used in the study as prescribed)
Beskrivning

Thiazides | Digoxin | Glucocorticoids | Exception Premedication Dexamethasone

Datatyp

boolean

Alias
UMLS CUI [1]
C0541746
UMLS CUI [2]
C0012265
UMLS CUI [3]
C0017710
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0033045
UMLS CUI [4,3]
C0011777
7. unwillingness to stop calcium supplementation
Beskrivning

Calcium supplement therapy Discontinue Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096745
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
8. concurrent use of phenytoin, barbiturates, rifampin, carbamazepine, phenobarbital or st john's wort.
Beskrivning

Phenytoin | Barbiturates | Rifampin | Carbamazepine | Phenobarbital | ST. JOHN'S WORT EXTRACT

Datatyp

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0004745
UMLS CUI [3]
C0035608
UMLS CUI [4]
C0006949
UMLS CUI [5]
C0031412
UMLS CUI [6]
C0813171
9. treatment with any investigational drug within 3 weeks before day 1 of protocol
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
10. any unresolved toxicity (nci ctcae version 3.0,>2) (please see appendix v for link)
Beskrivning

Toxicity CTCAE Grades | Resolution Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
11. pregnancy/lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. patients with iiib nsclc who are eligible for definitive chemoradiation.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging Eligibility Chemoradiotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1548635
UMLS CUI [1,4]
C0436307
ca corrected = ca (measured) + (0.8 x (4 - albumin))
Beskrivning

Corrected measurement of calcium

Datatyp

boolean

Alias
UMLS CUI [1]
C2732404

Similar models

Eligibility Non Small Cell Lung Cancer NCT00794547

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant
Item
1. proven histological or cytological diagnosis of stage iiib (malignant pleural effusion) iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2])
Age
Item
2. age more than 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. performance status must be ecog 0-1.
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasms Previous Absent | Cancer Other Absent | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
4. no prior or concurrent malignancy, except non-melanoma skin cancer, or cis of the cervix, unless documented disease-free for more than 2 years.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Prior Chemotherapy Absent Non-Small Cell Lung Carcinoma TNM clinical staging | Adjuvant therapy allowed
Item
5. no prior use of chemotherapy for stage iv nsclc; adjuvant therapy is permitted.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0677850 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Possible | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Creatinine measurement, serum | Creatinine clearance measurement
Item
6. adequate bone marrow, hepatic, and renal function, as evidenced by the following: wbc 3.0 x 109/l, neutrophils 1.5 x 109 /l; platelet count 100 x 109/l; hgb> 10 g/dl (may be transfused to 10g/dl); total bilirubin within the upper limit of the institutional normal range; (transaminases sgot or sgpt) 1.5 times the upper limit of the institutional normal range. creatinine within the upper limit of the institutional normal range; creatinine clearance >50 ml/min
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C1879316 (UMLS CUI [8,1])
C0332149 (UMLS CUI [8,2])
C1278039 (UMLS CUI [9])
C0151904 (UMLS CUI [10])
C0151905 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
C0373595 (UMLS CUI [13])
Measurable Disease | Evaluable Disease
Item
7. patients must have measurable or evaluable disease (not required for the phase i part of the study)
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Cardiac function | Heart Disease Uncontrolled Absent
Item
8. normal cardiac function with no history of uncontrolled heart disease
boolean
C0232164 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Gender Pregnancy Absent | Postmenopausal state | Gender Contraceptive methods | Pregnancy Possible Pregnancy Test
Item
9. female patients must not be pregnant; they must be post-menopausal or practicing an accepted form of birth control. if pregnancy is a possibility, a pregnancy test will be required prior to initiation of therapy.
boolean
C0079399 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4,1])
C0332149 (UMLS CUI [4,2])
C0032976 (UMLS CUI [4,3])
Life Expectancy
Item
10. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
11. patient and investigator signed study-specific consent form, indicating the investigational nature of the study
boolean
C0021430 (UMLS CUI [1])
Patient Available Therapeutic procedure | Patient Available Follow-up
Item
12. patients must be accessible for treatment and follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Chemotherapy Absent | Therapeutic radiology procedure Absent | Calcitriol | Mitomycin | Nitrosourea
Item
13. no chemotherapy or radiotherapy within 3 weeks of study entry defined here as day 1 of therapy with calcitriol plus chemotherapy (6 weeks for mitomycin c or a nitrosourea).
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006674 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0028210 (UMLS CUI [5])
Investigational New Drugs Absent
Item
14. no treatment with investigational drugs within 3 weeks of study entry.
boolean
C0013230 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Illness Serious Absent | Other medical condition Serious Absent | Heart Disease Unstable Treatment required for | New onset Unstable Angina | New onset Angina decubitus | Nervous system disorder | Mental disorders | Psychotic Disorders | Dementia | Seizures | Communicable Disease | Absence Peripheral Neuropathy CTCAE Grades | Absence Severe allergy Docetaxel | Absence Severe allergy Polysorbate 80 Compound
Item
15. no other serious illness or medical condition including unstable cardiac disease requiring treatment, new onset crescendo or rest angina; history of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures; or active infection are permitted. no evidence of grade > 2 peripheral neuropathy. no history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])
C0746890 (UMLS CUI [4,1])
C0002965 (UMLS CUI [4,2])
C0746890 (UMLS CUI [5,1])
C0152172 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0033975 (UMLS CUI [8])
C0497327 (UMLS CUI [9])
C0036572 (UMLS CUI [10])
C0009450 (UMLS CUI [11])
C0332197 (UMLS CUI [12,1])
C0031117 (UMLS CUI [12,2])
C1516728 (UMLS CUI [12,3])
C0332197 (UMLS CUI [13,1])
C2945656 (UMLS CUI [13,2])
C0246415 (UMLS CUI [13,3])
C0332197 (UMLS CUI [14,1])
C2945656 (UMLS CUI [14,2])
C0032601 (UMLS CUI [14,3])
C1706082 (UMLS CUI [14,4])
Palliative Radiation Therapy | Bone Marrow Percentage Exposure
Item
16. palliative radiation is permitted (as long as marrow exposed not greater than 10%; please see appendix iv for reference) at least 1 week since the last palliative xrt.
boolean
C3898008 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0332157 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain Treated | Gamma Knife Radiosurgery | Waiting time Absent | Whole brain radiation therapy
Item
17. treated brain metastasis allowed with no waiting period following gamma knife and at least 2 weeks after whole brain xrt as long as neurologically stable.
boolean
C0220650 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0086330 (UMLS CUI [2])
C0814636 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1520143 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Vitamin D allergy | Hypersensitivity Docetaxel | Cisplatin allergy
Item
1. known hypersensitivity to vitamin d, docetaxel, cisplatin
boolean
C0571828 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0570702 (UMLS CUI [3])
Hypercalcemia
Item
2. hypercalcemia (patients with serum albumin corrected calcium* > 10.7 mg/dl)
boolean
C0020437 (UMLS CUI [1])
Kidney Calculi | Urinary Bladder Calculi
Item
3. history of renal/bladder stones over the past 10 years
boolean
C0022650 (UMLS CUI [1])
C0005683 (UMLS CUI [2])
Nephrectomy
Item
4. history of nephrectomy.
boolean
C0027695 (UMLS CUI [1])
Heart Disease Uncontrolled | Angina, Unstable | Heart failure | Digoxin
Item
5. uncontrolled heart disease, unstable angina, heart failure, current digoxin therapy
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0012265 (UMLS CUI [4])
Thiazides | Digoxin | Glucocorticoids | Exception Premedication Dexamethasone
Item
6. thiazide, digoxin or glucocorticoid therapy (except the pre-medication dexamethasone used in the study as prescribed)
boolean
C0541746 (UMLS CUI [1])
C0012265 (UMLS CUI [2])
C0017710 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0033045 (UMLS CUI [4,2])
C0011777 (UMLS CUI [4,3])
Calcium supplement therapy Discontinue Unwilling
Item
7. unwillingness to stop calcium supplementation
boolean
C1096745 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Phenytoin | Barbiturates | Rifampin | Carbamazepine | Phenobarbital | ST. JOHN'S WORT EXTRACT
Item
8. concurrent use of phenytoin, barbiturates, rifampin, carbamazepine, phenobarbital or st john's wort.
boolean
C0031507 (UMLS CUI [1])
C0004745 (UMLS CUI [2])
C0035608 (UMLS CUI [3])
C0006949 (UMLS CUI [4])
C0031412 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
Investigational New Drugs
Item
9. treatment with any investigational drug within 3 weeks before day 1 of protocol
boolean
C0013230 (UMLS CUI [1])
Toxicity CTCAE Grades | Resolution Lacking
Item
10. any unresolved toxicity (nci ctcae version 3.0,>2) (please see appendix v for link)
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
11. pregnancy/lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma TNM clinical staging Eligibility Chemoradiotherapy
Item
12. patients with iiib nsclc who are eligible for definitive chemoradiation.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0436307 (UMLS CUI [1,4])
Corrected measurement of calcium
Item
ca corrected = ca (measured) + (0.8 x (4 - albumin))
boolean
C2732404 (UMLS CUI [1])

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