Presence of concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia.
Any other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation (for treatment phase)
Has a medical condition that requires immunosuppression
Any other condition that may interfere with compliance of the study protocol
High likelihood of protocol non-compliance (in opinion of investigator)
Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient (see Section 4.4-4.10).
Any serious medical condition that interferes with adherence to study procedures.
Patient must not have a co-morbid condition(s) that, in the opinion of the investigator, prevent safe treatment
Any condition, in the opinion of the investigator, that compromises compliance with study requirements
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
History of any major disease that might interfere with safe protocol participation, as determined by the investigator
Any serious medical condition that interferes with adherence to study procedures.
Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment
Serious cardiopulmonary medical condition
Any other medical or social condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign informed consent
PROCUREMENT EXCLUSION CRITERIA: Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation
Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
Have other concurrent severe and/or uncontrolled medical condition that would, in the site Investigator's judgment contraindicate the patient's participation in the clinical study
Any significant psychiatric disease, medical or other condition, which in the opinion of the principal investigator could prevent adequate informed consent or compromise participation in the clinical trial
Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator’s judgment
Any other pathology or condition which the principal investigator may deem to negatively impact treatment safety
Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition, medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
Patients whose comorbid medical condition, in the investigator’s opinion, would make participation in this trial and adherence to the protocol guidelines difficult should be excluded
Any other medical intervention or condition which could compromise adherence to study requirements or confound the interpretation of study results.
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Patients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trial
Patients with rapidly progressing disease in the opinion of the principal investigator
Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.
The recipient has another medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery in which the opinion of the principal investigator would place the recipient at unacceptable risk
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
Any other condition that in the investigator’s judgement would significantly increase the risks of participation.
Significant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to study drugs and procedures.
Presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.
Any other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial results
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria
Medical history that includes any condition, or requires the use of concomitant medications which, in the investigator's judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes.
Subjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Any other sound medical, psychiatric, and/or social reasons as determined by the investigator
Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
Subjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment
Subjects with medical condition that could adversely impact the study participation or assessments.
Male subjects will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)
Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study
Part of another study that may interfere with our outcome of interest, unstable mental condition
Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
History of severe eczema (as determined by the investigator) requiring medical treatment
Unstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the risk to the patient associated with his or her participation in the study
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
Any other pathology or condition that the principal investigator deems to negatively impact treatment safety
Patients with uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which CB transplantation is proposed), or psychiatric condition that would limit informed consent.
Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
Patients with known diabetes whose glucose control or general health condition may be adversely affected by the use of metformin as per the study protocol as deemed by either the study investigator or endocrinologist are excluded
Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled
Concurrent severe and/or uncontrolled medical condition or psychiatric condition
Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
Presence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of DS-8273A and nivolumab in treated subjects
Has known serious neuropsychiatric condition
Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood [CB] transplantation is proposed), or psychiatric condition that would limit informed consent
Current evidence of any of the following:\r\n* Uncontrolled hypertension \r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated\r\n* Any condition that in the opinion of the investigator, would preclude participation in this study
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or chest-X-ray and according to the investigator’s judgment
Patients with any other severe and/or uncontrolled concurrent disease affecting the cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures/results or compromise compliance with the protocol.
Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator
History of any other significant medical disease such as major gastric or small bowel surgery, recent drainage of significant volumes of ascites or pleural effusion (as per Investigator's judgement) or a psychiatric condition that might impair the subject's well-being or preclude full participation in the trial
Current evidence of any of the following:\r\n* Uncontrolled hypertension\r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)\r\n* Any chronic medical condition requiring a dose of corticosteroid higher than 10 mg prednisone/prednisolone once daily\r\n* Any condition that, in the opinion of the site investigator, would preclude participation in this study\r\n* Moderate or severe hepatic impairment (Child Pugh class B or C)
Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation
Patients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study
Serious medical or psychiatric illness/condition likely in the judgment of the Investigator to interfere with compliance to protocol treatment/research
Active, uncontrolled infection, any other concurrent disease, or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
No active major medical or psychosocial problems that could be complicated by study participation
Life expectancy of ? 2 months. 6. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include: • Unstable cardiovascular conditions at Baseline including but not limited to:
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study results
Other investigational procedures while participating in this study that could affect the primary objective of the study as determined by the principal investigator (PI) are excluded
Major active medical or psychosocial problems that could be exacerbated by the study treatment
The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk
Any other medical condition for which the treating physicians deem might lead to unacceptable toxicity or morbidity for that treatment plan for the patient e.g., allergy to a component of therapy or a medical condition that might be aggravated by the therapy and increases potential risk of toxicity in the opinion of the treating physicians
History of psychiatric disorder or any other condition which may compromise compliance with transplant protocol or expose patient to unnecessary risk as determined by principal investigator or lead associate investigator
Patient does NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Any other pathology or condition where the principle investigator may deem to negatively impact treatment safety
Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or non-AML-associated pulmonary disease requiring >2 liters per minute (LPM) oxygen, or any other condition that puts the subject at an imminent risk of death.
Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
History of severe eczema (as determined by the Investigator) requiring medical treatment
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
In the judgment of the investigator, participation in the protocol offers acceptable risk/benefit ratio when considering current NF2 disease status, medical condition, and the potential benefits of and risks of surgery or irradiation
No active major medical or psychosocial problems that could be complicated by study participation
Infection or any other severe systemic disease or medical or surgical condition deemed significant by the principal investigator
Any co morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
A serious underlying medical condition other than NSCLC such that life expectancy is less than 2 years.
Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject. Additional Exclusion Criteria for Cohort 1:
Any active and persistent dermatological condition
Any condition that prevents compliance with the protocol or adherence to therapy.
Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
Have at least stable disease, as determined by the investigator.
Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition- medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject’s ALL
History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
In the investigator's judgment, any other condition that jeopardizes the patient's participation in the treatment phase
Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
Concurrent medical condition that precludes safe participation in this study
Evidence of any other serious medical condition (such as psychiatric illness, infectious diseases, physical or laboratory findings) that may interfere with the planned treatment, affect compliance or place the patient at high risk from treatment-related complications or potentially interfere with the completion of the treatment as per the protocol
History of and or medical condition (e.g. diverticular disease; aneurysm) that predisposes to risk of major hemorrhage
Any serious medical condition that interferes with adherence to study procedures.
History of intratumoral or peritumoral hemorrhage if deemed significant by the treating investigator; if there are questions, the treating investigator should contact the study overall principal investigator (P.I.), Eudocia Quant Lee, medical doctor (MD), at 617-632-2166 or eqlee@partners.org
Active infection or other medical condition that would make prednisone use contraindicated
Any other therapy or serious medical condition, as specified in the protocol, or abnormality in clinical laboratory tests that, in the investigator's judgement, precludes the participant's safe participation in and completion of the study
Any concurrent or past medical condition that, in the opinion of the Investigator, would exclude the subject from participation or any psychosocial conditions that would hinder study compliance or follow-up, at the discretion of the Investigator
No new or worsened existing acute medical condition that would require a dose hold or delay
Any other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial results
Uncontrolled psychiatric condition
Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy
Patients may be excluded at the discretion of the PI/LAI if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk
Patients may be excluded at the discretion of the principal investigator (PI) or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk
Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study
Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.
Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
No coexisting medical problems of sufficient severity to limit compliance with the study
Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient’s ability to participate in the trial
Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol
Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the protocol principal investigator, excess risk associated with study participation or study agent administration
Have evidence of any other serious systemic disease, including active bacterial or fungal infection, or any medical condition that, in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)
Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator or the sponsor's medical monitor.
Any new condition or worsening of existing condition that could make the patient unsuitable for participation, or interfere with the patient participating in and/or completing the study
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)
Presence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of panobinostat and ipilimumab in treated subjects
Requires myelofibrosis therapy, in the opinion of the investigator
Subject is diagnosed with a known medical condition associated with a hypercoagulable state.
Any other medical condition that in the opinion of the investigator may interfere with a subject participation in, or compliance with, the study
Physical abnormality or medical condition that limits swallowing multiple pills, or has a history of non-adherence to oral therapies.
No coexisting medical problems of sufficient severity to limit compliance with the study
Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (eg, chronic pancreatitis, etc.).
Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
Patient has any severe psychiatric disease that would interfere with participation in the trial as determined by the study investigator
Any other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial results
Any medical condition that precludes the surgery necessary to administer DNX-2401 into the tumor using the cannula
Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator’s judgment, would interfere with participation in the trial
Any medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on study treatment
Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
High likelihood or protocol non-compliance (in opinion of investigator)
Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
Any clinically significant medical or psychiatric condition that would interfere with protocol treatment
Any clinically significant medical or psychiatric condition that would interfere with protocol treatment
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
the patient is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT
Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.
Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion
General medical condition: fit for the proposed surgery and/or radiation treatment as determined by the treating investigator
Any medical condition which would, in the investigator's opinion, compromise the patient's ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the study
No other serious medical condition that would interfere with follow-up
Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation; (excluding primary disease for which cord blood [CB] transplantation is proposed), or psychiatric condition that would limit informed consent
Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.
Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
DONOR: The presence of any medical condition that the investigator deems incompatible with participation in the trial
Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.
Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
Any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.
Significant, concurrent, uncontrolled medical condition which, in the opinion of the investigator, may interfere with patient participation in the study.
Uncontrolled diabetes or other medical condition that may interfere with assessment of toxicity.
Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Any other medical condition that, in the opinion of the principal investigator (PI), may interfere with a subject's participation in or compliance with the study
Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
Key Inclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to screening,\n             determined to be consistent with LRTI by the local radiologist, relative to the most\n             recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be\n             obtained for screening.\n\n          -  Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and\n             lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous\n             sputum) respiratory tract as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture).\n             All samples must have been collected ? 6 days prior to Day 1, or as determined at\n             screening as per protocol.\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and investigator or his/her designee.\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Key Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n          -  Use of a moderate or strong cytochrome P450 enzyme inducer including but not limited\n             to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan,\n             etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of study\n             drug\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical conditions:\n\n          -  Requiring invasive mechanical ventilation at the time of randomization\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus),\n             from the lower respiratory tract sample as determined by local testing\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for individuals without an NG tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspartate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigator\n\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Documented to be RSV-positive as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)\n             using an upper respiratory tract sample collected ? 6 days prior to Day 1\n\n          -  New onset of at least 1 of the following respiratory symptoms for ? 7 days prior to\n             Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of\n             these chronic (associated with a previously existing diagnosis, eg, chronic\n             rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ? 7 days\n             prior to Day 1\n\n          -  No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the\n             most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is\n             not available or was not obtained during standard care < 48 hours prior to screening,\n             a chest X-ray must be obtained for screening\n\n          -  O2 saturation ? 92% on room air\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and the investigator or his/her designee\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical condition at screening:\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus)\n             within 7 days prior to the screening visit, as determined by local testing (additional\n             testing is not required)\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for participants without an nasogastric tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspertate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigator
A medical condition that precludes adequate study treatment or increases patient risk
Requires myelofibrosis therapy, in the opinion of the investigator
Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including but not limited to uncontrolled infection, heart failure, pulmonary hypertension, etc.
Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia
Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
Patients with uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which CB transplantation is proposed), or psychiatric condition that would limit informed consent
Concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
Ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the Investigator's medical opinion, should exclude participation in the study
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's NHL
Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
Patients with a co-morbid condition(s) that, in the opinion of the investigator, prevents safe surgery/biopsy procedure
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
DONOR: The presence of any medical condition that the Investigator deems incompatible with participation in the trial
Have a history of thrombocytopenia with complications including hemorrhage or bleeding >= grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator
Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
Active infection or antibiotics within one-week prior to study, including unexplained fever; any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trial
Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.
Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol compliance
Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure
Inclusion Criteria:\n\n        18 years;\n\n          -  Clinical confirmation of adrenocortical carcinoma that is locally advanced or\n             metastatic and not amendable to surgical resection;\n\n          -  Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based\n             chemotherapy regimen;\n\n          -  Able to understand and comply with the protocol requirements;\n\n          -  Willing and able to provide informed consent.\n\n        Exclusion Criteria:\n\n          -  Mitotane level > 5\n\n          -  Use of contraindicated concomitant medications\n\n          -  Unstable medical condition that, in the judgment of the investigator, could interfere\n             with study procedures or data interpretation.
The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
Subjects may not have an underlying medical condition that in the opinion of the investigator could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of dasatinib and ipilimumab in treated subjects
Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study Cancer-Specific Exclusion Criteria
Donor must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.
Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator or co-investigators, could prevent adequate informed consent or compromise participation in the clinical trial
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
Patients who are severely underweight in the opinion of the investigator
Presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes
PATIENTS: Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
Have a history of thrombocytopenia with complications including hemorrhage or bleeding of ?Grade 2 per NCI CTCAE v4.03 that required medical intervention or have any hemolytic condition or coagulation disorder that would make participation unsafe in the opinion of the investigator.
Concurrent ocular or intraocular condition that requires medical or surgical intervention to prevent or treat vision loss
Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
Has been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigator
In the opinion of the principal investigator (PI) or an associate investigator (AI), the subject has significant cognitive or emotional difficulties that would prevent them from being able to understand and/or participate fully in the intervention or the measures
Subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial; there are no therapy restrictions or restrictions regarding the use of other investigational agents
Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay
Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)
Either the child or the parent has a mental health or medical condition that, in the opinion of investigators or the treating oncologist, would make it difficult to participate in the study
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
History of a chronic medical condition that has the potential to significantly impact upper extremity function (e.g. stroke, Parkinson’s disease, multiple sclerosis)
Medical, psychiatric condition which in the investigators opinion will affect the successful completion of study
Known previous or concomitant serious illness (other than advanced cancer with metastatic bone disease) or medical condition, such as, HIV, significant gastrointestinal disease, or cardiovascular event that in the opinion of the investigator may worsen and/or interfere with participation in the study
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the participants safe participation in and completion of the study
Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.
Caregivers: Absence of a serious medical condition likely to influence cortisol assessment in their hair
Participants who, in the judgment the study principal investigator (PI), have severe or unstable mental illness which could interfere with participation in the trial
Subjects with current alcohol use, illicit drug use, or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule
Any mental or physical condition, in the opinion of the principal investigator (PI) or PI designee, which could interfere with the ability of the subject to understand or adhere to the requirements of the study
Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
Acute or chronic medical disorder that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study
Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria
A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)
Patients must have no significant medical or psychiatric condition that would preclude study completion; tests and exams for this determination should be completed within 28 days prior to registration
Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject’s successful completion of this study
Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
Significant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician (or licensed medical professional designated to consult in his absence) or principal investigator (PI)
Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including follow-up), or would interfere with the evaluation of the trial endpoints
Uncontrolled concurrent medical condition likely to limit compliance with the study interventions
Any other medical condition(s) that, in the judgment of the Site Investigator, might interfere with the study or require treatment that might interfere with the study
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principle investigator (PI)
Subjects with any other condition that would contraindicate participation, as determined by the Investigator.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil the inclusion criteria related to organ system function.
Medical comorbidities that in the opinion of the investigator limits the patient’s ability to complete this study
Subject has significant uncontrolled medical condition within 6 months prior to enrollment, as determined by the investigator.
Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change
Individuals suffering from any unstable medical condition precluding the use of NRT (identified using the Medical History Questionnaire given at baseline)
Have any condition that in the opinion of the investigator would confound the efficacy, safety and tolerability assessments, such as oral thrush.
Positive history of a medical condition that precludes use of the nicotine patch
Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)
Any medical condition judged by the investigator to constitute a risk to safe participation
Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)
A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures
Subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies
Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary\r\ndisease
Any condition, medical or psychosocial, that in the opinion of the principal investigator would hinder compliance
Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
History of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)
Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
HEALTHY VOLUNTEER: Any other condition precluding subject participation as per investigator judgment
Any condition which, in the opinion of the investigator, might interfere with study objective
DONOR: Any condition which, in the opinion of the investigator, might interfere with study objective
Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Unstable medical condition, such as ischemic heart disease, or any other disease or medical condition that may place the patient at added risk during the study, as assessed by the Principal Investigator. A patient with a seizure disorder, focal or generalized, not adequately controlled by anti-convulsant therapy, and /or patient who have experienced an event of focal or generalized seizure within 7 days prior to screening will be considered neurologically unstable.
Medical condition uncontrolled by treatment making completion of study unlikely
Patients will be referred by the Urology or Medical Oncology Departments for participation in the study
Medical condition uncontrolled by treatment making completion of study unlikely
Any other condition which in the opinion of the investigator would interfere with successful completion of this clinical trial.
Any other local condition including bacterial superinfection which in the opinion of the investigator would interfere with the efficacy evaluation.
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures
Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
BIODISTRIBUTION COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
DYNAMIC COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
No unstable and significant medical conditions as determined by medical history (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)
No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications, to be determined by medical history and Prime- doctor of medicine (MD) (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)
Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator’s judgment, would interfere with participation in the trial
Concurrent disease or condition that interferes with participation or safety
Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation
Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the principal investigator or by the attending palliative care physician
Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.