ID

28425

Beschreibung

A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma (CHAMPION 1); ODM derived from: https://clinicaltrials.gov/show/NCT01677858

Link

https://clinicaltrials.gov/show/NCT01677858

Stichworte

Versionen (1)
  1. 12.01.18 12.01.18 - Julian Varghese
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01677858

Englisch

Eligibility Multiple Myeloma NCT01677858

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. multiple myeloma with relapsing or progressive disease at study entry
Beschreibung

progressive multiple myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1335499
1. serum m-protein ≥ 0.5 g/dl, or
Beschreibung

2. measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to enrollment):

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2984963
UMLS CUI [1,2]
C0229671
2. urine m-protein ≥ 200 mg/24 hours, or
Beschreibung

urine monoclonal protein (M-protein)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2984963
UMLS CUI [1,2]
C0042037
3. only in patients who do not meet a or b, then use serum free light chain (sflc) > 100 mg/l (involved light chain) and an abnormal kappa/lambda ratio
Beschreibung

serum free light chain and abnormal kappa/lambda ratio

Datentyp

boolean

Alias
UMLS CUI [1]
C1168398
UMLS CUI [2]
C0021038
3. prior treatment with 1 to 3 prior regimens for multiple myeloma for phase 1 and phase 2 (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
Beschreibung

prior treatment for multiple myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514463
4. age ≥ 18 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy > 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
6. eastern cooperative oncology group (ecog) performance status 0 or 1
Beschreibung

ecog performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. adequate hepatic function within 21 days prior to enrollment, with bilirubin < 1.5 ×
Beschreibung

hepatic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
the upper limit of normal (uln), and aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 3 × uln
Beschreibung

AST | ALT

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
8. left ventricular ejection fraction (lvef ≥ 40%. 2-d transthoracic echocardiogram (echo) is the preferred method of evaluation. multigated acquisition scan (muga) is acceptable if echo is not available
Beschreibung

left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
9. absolute neutrophil count (anc) ≥ 1000/mm3 within 21 days prior to enrollment. screening anc is to be independent of growth factor support for ≥ 1 week
Beschreibung

neutrophile count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
10. hemoglobin ≥ 8.0 g/dl within 21 days prior to enrollment. use of erythropoietic stimulating factors and red blood cell (rbc) transfusions per institutional guidelines is allowed; however, most recent rbc transfusion must have been at least 7 days prior to obtaining screening hemoglobin
Beschreibung

hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
11. platelet count ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. patients must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count
Beschreibung

Platelets

Datentyp

boolean

Alias
UMLS CUI [1]
C0005821
12. calculated or measured creatinine clearance (crcl) of ≥ 30 ml/min within 21 days prior to enrollment. calculation are to be based on standard formula, such as the cockcroft and gault: [(140 - age) x mass (kg) / (72 x creatinine mg/dl)]; multiply result by 0.85 if female
Beschreibung

creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
13. written informed consent in accordance with federal, local, and institutional guidelines
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
14. female patients of childbearing potential (fcbp) must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
Beschreibung

pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
15. male patients must agree to use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with an fcbp
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. multiple myeloma of igm subtype
Beschreibung

igm multiple myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C2347304
2. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Beschreibung

poems syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0085404
3. plasma cell leukemia (> 2.0 × 109/l circulating plasma cells by standard differential)
Beschreibung

plasma cell leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023484
4. waldenström's macroglobulinemia
Beschreibung

Waldenstroem's macroglobulinemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0024419
5. amyloidosis
Beschreibung

amyloidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0002726
6. glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to enrollment
Beschreibung

glucocorticoid therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0744425
7. cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to enrollment
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
8. treatment with bortezomib (velcade®), thalidomide (thalomid®) or lenalidomide (revlimid®) within 21 days prior to enrollment
Beschreibung

bortezomib | thalidomide | lenalidomide treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C0039736
UMLS CUI [3]
C1144149
9. focal radiation therapy within 7 days prior to enrollment. radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to < 30% of the bone marrow)
Beschreibung

focal radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
10. immunotherapy within 21 days prior to enrollment
Beschreibung

immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
11. major surgery within 21 days prior to enrollment
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
12. active congestive heart failure (new york heart association [nyha] classes iii to iv), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. myocardial infarction within 6 months prior to enrollment
Beschreibung

congestive heart failure | myocardial infarct

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
13. acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hbv), or antifungal agents within 14 days prior to enrollment
Beschreibung

systemic antibiotic antiviral antifungal treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2]
C0003308
UMLS CUI [3]
C0003451
14. known human immunodeficiency virus (hiv) seropositivity
Beschreibung

hiv seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
15. known hepatitis b or c virus infection (except for patients with hbv who are receiving and responding to hbv antiviral therapy: these patients are allowed)
Beschreibung

hepatitis virus infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0220847
16. patients with known cirrhosis
Beschreibung

liver cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
17. second malignancy within the past 3 years, except:
Beschreibung

previous malignant disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
adequately treated basal cell or squamous cell skin cancer
Beschreibung

Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0553723
UMLS CUI [2,2]
C1522326
2. carcinoma in situ of the cervix
Beschreibung

cervix carcinoma in situ

Datentyp

boolean

Alias
UMLS CUI [1]
C0851140
3. prostate cancer < gleason score 6 with stable prostate-specific antigen (psa) over 12 months
Beschreibung

prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
4. breast carcinoma in situ with full surgical resection
Beschreibung

breast CIS resected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279563
UMLS CUI [1,2]
C1521996
5. treated medullary or papillary thyroid cancer
Beschreibung

medullary thyroid cancer treated | papillary thyroid cancer treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0238462
UMLS CUI [2,2]
C1522326
18. patients with myelodysplastic syndrome
Beschreibung

myelodysplastic syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C3463824
19. significant neuropathy (grades 3 to 4) within 14 days prior to enrollment
Beschreibung

neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0442874
20. female patients who are pregnant or lactating
Beschreibung

pregnancy | lactation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
21. known history of allergy to captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
Beschreibung

captisol allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C3846158
22. prior carfilzomib treatment
Beschreibung

carfilzomib

Datentyp

boolean

Alias
UMLS CUI [1]
C2001856
23. prior participation in any onyx-sponsored phase 3 trial
Beschreibung

sponsored phase 3 trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
24. patients with contraindication to dexamethasone
Beschreibung

dexamethasone contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C1301624
25. contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
Beschreibung

contraindication or hypersensitivity to used drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0020517
26. ongoing graft-versus-host disease
Beschreibung

graft-versus-host disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
27. patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
Beschreibung

pleural effusions | ascites

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
28. uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Beschreibung

uncontrolled hypertension | uncontrolled diabetes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
29. any other clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT01677858

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
progressive multiple myeloma
Item
1. multiple myeloma with relapsing or progressive disease at study entry
boolean
C0026764 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
serum monoclonal protein (M-protein)
Item
1. serum m-protein ≥ 0.5 g/dl, or
boolean
C2984963 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
urine monoclonal protein (M-protein)
Item
2. urine m-protein ≥ 200 mg/24 hours, or
boolean
C2984963 (UMLS CUI [1,1])
C0042037 (UMLS CUI [1,2])
serum free light chain and abnormal kappa/lambda ratio
Item
3. only in patients who do not meet a or b, then use serum free light chain (sflc) > 100 mg/l (involved light chain) and an abnormal kappa/lambda ratio
boolean
C1168398 (UMLS CUI [1])
C0021038 (UMLS CUI [2])
prior treatment for multiple myeloma
Item
3. prior treatment with 1 to 3 prior regimens for multiple myeloma for phase 1 and phase 2 (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
age
Item
4. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
6. eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
hepatic function
Item
7. adequate hepatic function within 21 days prior to enrollment, with bilirubin < 1.5 ×
boolean
C0232741 (UMLS CUI [1])
AST | ALT
Item
the upper limit of normal (uln), and aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 3 × uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
left ventricular ejection fraction
Item
8. left ventricular ejection fraction (lvef ≥ 40%. 2-d transthoracic echocardiogram (echo) is the preferred method of evaluation. multigated acquisition scan (muga) is acceptable if echo is not available
boolean
C0428772 (UMLS CUI [1])
neutrophile count
Item
9. absolute neutrophil count (anc) ≥ 1000/mm3 within 21 days prior to enrollment. screening anc is to be independent of growth factor support for ≥ 1 week
boolean
C0200633 (UMLS CUI [1])
hemoglobin
Item
10. hemoglobin ≥ 8.0 g/dl within 21 days prior to enrollment. use of erythropoietic stimulating factors and red blood cell (rbc) transfusions per institutional guidelines is allowed; however, most recent rbc transfusion must have been at least 7 days prior to obtaining screening hemoglobin
boolean
C0019046 (UMLS CUI [1])
Platelets
Item
11. platelet count ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to enrollment. patients must not have received platelet transfusions for at least 7 days prior to obtaining the screening platelet count
boolean
C0005821 (UMLS CUI [1])
creatinine clearance
Item
12. calculated or measured creatinine clearance (crcl) of ≥ 30 ml/min within 21 days prior to enrollment. calculation are to be based on standard formula, such as the cockcroft and gault: [(140 - age) x mass (kg) / (72 x creatinine mg/dl)]; multiply result by 0.85 if female
boolean
C0373595 (UMLS CUI [1])
informed consent
Item
13. written informed consent in accordance with federal, local, and institutional guidelines
boolean
C0021430 (UMLS CUI [1])
pregnancy
Item
14. female patients of childbearing potential (fcbp) must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
contraception
Item
15. male patients must agree to use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with an fcbp
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
igm multiple myeloma
Item
1. multiple myeloma of igm subtype
boolean
C2347304 (UMLS CUI [1])
poems syndrome
Item
2. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
boolean
C0085404 (UMLS CUI [1])
plasma cell leukemia
Item
3. plasma cell leukemia (> 2.0 × 109/l circulating plasma cells by standard differential)
boolean
C0023484 (UMLS CUI [1])
Waldenstroem's macroglobulinemia
Item
4. waldenström's macroglobulinemia
boolean
C0024419 (UMLS CUI [1])
amyloidosis
Item
5. amyloidosis
boolean
C0002726 (UMLS CUI [1])
glucocorticoid therapy
Item
6. glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to enrollment
boolean
C0744425 (UMLS CUI [1])
chemotherapy
Item
7. cytotoxic chemotherapy with approved or investigational anticancer therapeutics within 28 days prior to enrollment
boolean
C0392920 (UMLS CUI [1])
bortezomib | thalidomide | lenalidomide treatment
Item
8. treatment with bortezomib (velcade®), thalidomide (thalomid®) or lenalidomide (revlimid®) within 21 days prior to enrollment
boolean
C1176309 (UMLS CUI [1])
C0039736 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
focal radiation therapy
Item
9. focal radiation therapy within 7 days prior to enrollment. radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to enrollment (ie, prior radiation must have been to < 30% of the bone marrow)
boolean
C1522449 (UMLS CUI [1])
immunotherapy
Item
10. immunotherapy within 21 days prior to enrollment
boolean
C0021083 (UMLS CUI [1])
major surgery
Item
11. major surgery within 21 days prior to enrollment
boolean
C0679637 (UMLS CUI [1])
congestive heart failure | myocardial infarct
Item
12. active congestive heart failure (new york heart association [nyha] classes iii to iv), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. myocardial infarction within 6 months prior to enrollment
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
systemic antibiotic antiviral antifungal treatment
Item
13. acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hbv), or antifungal agents within 14 days prior to enrollment
boolean
C0003232 (UMLS CUI [1])
C0003308 (UMLS CUI [2])
C0003451 (UMLS CUI [3])
hiv seropositivity
Item
14. known human immunodeficiency virus (hiv) seropositivity
boolean
C0019699 (UMLS CUI [1])
hepatitis virus infection
Item
15. known hepatitis b or c virus infection (except for patients with hbv who are receiving and responding to hbv antiviral therapy: these patients are allowed)
boolean
C0019163 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
liver cirrhosis
Item
16. patients with known cirrhosis
boolean
C0023890 (UMLS CUI [1])
previous malignant disease
Item
17. second malignancy within the past 3 years, except:
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
adequately treated basal cell or squamous cell skin cancer
boolean
C0007117 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0553723 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
cervix carcinoma in situ
Item
2. carcinoma in situ of the cervix
boolean
C0851140 (UMLS CUI [1])
prostate cancer
Item
3. prostate cancer < gleason score 6 with stable prostate-specific antigen (psa) over 12 months
boolean
C0600139 (UMLS CUI [1])
breast CIS resected
Item
4. breast carcinoma in situ with full surgical resection
boolean
C0279563 (UMLS CUI [1,1])
C1521996 (UMLS CUI [1,2])
medullary thyroid cancer treated | papillary thyroid cancer treated
Item
5. treated medullary or papillary thyroid cancer
boolean
C0238463 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0238462 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
myelodysplastic syndrome
Item
18. patients with myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
neuropathy
Item
19. significant neuropathy (grades 3 to 4) within 14 days prior to enrollment
boolean
C0442874 (UMLS CUI [1])
pregnancy | lactation
Item
20. female patients who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
captisol allergy
Item
21. known history of allergy to captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
boolean
C0013182 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
carfilzomib
Item
22. prior carfilzomib treatment
boolean
C2001856 (UMLS CUI [1])
sponsored phase 3 trial
Item
23. prior participation in any onyx-sponsored phase 3 trial
boolean
C2348568 (UMLS CUI [1])
dexamethasone contraindication
Item
24. patients with contraindication to dexamethasone
boolean
C0011777 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
contraindication or hypersensitivity to used drugs
Item
25. contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
boolean
C1301624 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
graft-versus-host disease
Item
26. ongoing graft-versus-host disease
boolean
C0018133 (UMLS CUI [1])
pleural effusions | ascites
Item
27. patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
uncontrolled hypertension | uncontrolled diabetes
Item
28. uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
boolean
C0011849 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
compliance
Item
29. any other clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
boolean
C1321605 (UMLS CUI [1])
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