ID

31055

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00794547

Palavras-chave

Versões (1)
  1. 15/07/2018 15/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00794547

Inglês

Eligibility Non Small Cell Lung Cancer NCT00794547

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

Measurable Disease | Evaluable Disease

Tipo de dados

boolean

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

Cardiac function | Heart Disease Uncontrolled Absent

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Life Expectancy

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

boolean

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

Patient Available Therapeutic procedure | Patient Available Follow-up

Tipo de dados

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).
Descrição

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

Tipo de dados

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.
Descrição

Investigational New Drugs Absent

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

Palliative Radiation Therapy | Bone Marrow Percentage Exposure

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Exclusion Criteria

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

Vitamin D allergy | Hypersensitivity Docetaxel | Cisplatin allergy

Tipo de dados

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)
Descrição

Hypercalcemia

Tipo de dados

boolean

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

Kidney Calculi | Urinary Bladder Calculi

Tipo de dados

boolean

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

Nephrectomy

Tipo de dados

boolean

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

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

Tipo de dados

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)
Descrição

Thiazides | Digoxin | Glucocorticoids | Exception Premedication Dexamethasone

Tipo de dados

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
Descrição

Calcium supplement therapy Discontinue Unwilling

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Investigational New Drugs

Tipo de dados

boolean

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

Toxicity CTCAE Grades | Resolution Lacking

Tipo de dados

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
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Non-Small Cell Lung Carcinoma TNM clinical staging Eligibility Chemoradiotherapy

Tipo de dados

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))
Descrição

Corrected measurement of calcium

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2732404
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00794547

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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