--- a +++ b/clusters/3009knumclusters/clust_290.txt @@ -0,0 +1,438 @@ +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who are able to comply with the protocol follow-up schedule +Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements +Inability to comply with visit schedule or other protocol requirements. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements. +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Ability and willingness to comply with the requirements of the study protocol +Able to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator are unable to comply with the safety monitoring requirements of the study +Patient must have the ability to comply with all study requirements +Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Must be able to adhere to the study visit schedule and other protocol requirements. +Patients willing to comply with study requirements +Must be able to comply with the study and follow-up requirements +Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +If premenopausal, patient must be willing to comply with pregnancy requirements +ADJUVANT COHORT: If premenopausal, patient must be willing to comply with pregnancy requirements +Subjects must agree to adhere to all study requirements, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring +Patients unwilling to or unable to comply with the protocol or who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Be able to comply with the requirements of the entire study. +Subject is willing and able to adhere to the study visit schedule and other protocol requirements. +Be willing to comply with clinical trial instructions and requirements. +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Agree to adhere to all study protocol requirements. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to comply with the study visit schedule and other protocol requirements. +Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. +Patient willing to conform to the study requirements +Willing and able to participate in the trial and comply with all trial requirements. +Subject is able to understand and willing to comply with protocol requirements and instructions +Willing and able to adhere to the prohibitions and restrictions specified in this protocol +Patients must be able to comply with all protocol requirements +Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and/or requirements. +The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment. +Must be able to adhere to the study visit schedule and other protocol requirements. +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Willing and able to comply with study requirements for follow-up +Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration. +Able to adhere to study schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator may be unable to comply with the safety monitoring requirements of the study +Are willing and able to comply with the protocol requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Subject is able to understand and comply with protocol requirements and instructions +Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule and other protocol requirements in the opinion of the investigator. +Willingness and capability to comply with the requirements of the study. +Ability and willingness to comply with the requirements of the study protocol +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Able to comply with the study protocol, in the investigator’s judgment +Able to adhere to the study visit schedule and other protocol requirements. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. +Able to adhere to the study visit schedule and other protocol requirements +STUDY ENTRY: Ability and willingness to comply with the requirements of the study protocol. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to swallow the study drug and comply with study requirements +Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Understand and voluntarily sign informed consent prior to any study-related assessments or procedures are conducted and are able adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol. +Ability to adhere to the protocol requirements and study visit schedule. +Subject (and when applicable, with parental/legal representative) is willing and able to adhere to the study visit schedule and other protocol requirements. +Patient must be willing to give written informed consent and must be able to adhere to dosing and visit schedules, and meet all study requirements. +Able to comply with study protocol, in the investigator’s judgment +Ability and willingness to comply with the requirements of the study protocol +Ability and willingness to comply with the requirements of the study protocol +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Ability to adhere to the study visit schedule and other protocol requirements +Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements. +Subject is able to understand and willing to comply with protocol requirements and instructions +Ability to comply with protocol requirements. +Patient, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Ability and willingness to comply with the requirements of the study protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Able to swallow sunitinib and comply with study requirements +Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule +Willingness and ability of subject to comply to study requirements +Patients who cannot comply with the study requirements +Ability and willingness to comply with the requirements of the study protocol +Ability and willingness to comply with the requirements of the study protocol +Patients unwilling to or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Ability to provide informed written consent and be able to adhere to the study visit schedule and other protocol requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator may not be able to comply with IL-2 or ECP treatment requirements or the safety monitoring requirements of the study, will be excluded from participation +Ability to adhere to the study visit schedule and other protocol requirements +Any reason, at the investigator’s discretion, that the participation of the patient in this protocol would not be in patient’s best interest, or where the patient would be unable to adhere to the study requirements +Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements +Be willing to participate in the study and comply with all study requirements +Able to swallow study drug and comply with study requirements +Able to swallow study drug and comply with study requirements +Able to comply with the treatment schedule +Non-compliance; defined as any subject, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule and other protocol requirements +Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient is able to comply with the necessary visits and assessments as part of the rollover study +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patient that is not able to understand or to comply with the study instructions and requirements, or has a history of non-compliance to the medical regimen +Patient must be able to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are NOT eligible for either Stratum +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements +Able to adhere to the study visit schedule and other protocol requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Ability to provide informed written consent and be able to adhere to the study visit schedule and other protocol requirements +Participants must be able to understand and willing to comply with protocol requirements as assessed by the investigator. +Able to understand and comply with protocol requirements for the entire length of the study +Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. +Subject is, in the investigator’s opinion, willing and able to comply with the protocol requirements +Willing to comply with proposed visit and treatment schedule +DONOR: Able and willing to comply with the requirements of the protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to swallow study drug and comply with study requirements +Inability to comply with the safety monitoring requirements of the study, as judged by the investigator +Subject is able and willing to comply with the requirements of the protocol. +Unstable psychiatric disorder that would render the patient unable to comply with study requirements. +Unable to comply with study requirements in the opinion of the Investigator. +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Willing and able to comply with all study requirements, including treatment, and attending required assessments +Negative serum or urine pregnancy tests during screening and then within 3 days prior to Day 1. 12. Sexually active men - effective contraceptive methods in subject and partner from the time of informed consent and until ? 4 weeks after discontinuing study drugs. 13. Able to adhere to the study visit schedule and other protocol requirements. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to swallow the study drug and comply with study requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +The subject is able to understand and comply with protocol requirements, timetables, instructions and protocol-stated restrictions +Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol +Research participants will be excluded, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Participant must be willing and comply with the requirements of the protocol +Patients, who in the opinion of the investigator and another independent party, may not be able to adhere to the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to comply with the treatment schedule +Able to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator may not be able to comply with all the study requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule and other protocol requirements +Willing/able to adhere to the prohibitions and restrictions specified in this protocol +Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements +Ability to swallow study drugs and to comply with study requirements throughout the study +Be able to comply with the requirements of the entire study. +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements. +Patient is unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator that the patient is not suitable for participation in the study. +Participant must be able to adhere to study visit/procedure schedule and protocol requirements +Participant unwilling to adhere to study visit/procedure schedule and protocol requirements +Can understand and voluntarily sign an informed consent form prior to any study-related assessments or procedures, and are able to adhere to the study visit schedule and other protocol requirements +Ability to adhere with the study visit schedule and other protocol procedures +Must be able and willing to adhere to protocol requirements, visits and vaccination timeline +Ability to voluntarily sign consent for and adhere to the entire study visit schedule and all protocol requirements +Be willing and able to comply with the protocol-required visit schedule and visit requirements and provide written informed consent +Able to adhere to study visit schedule and other protocol requirements. +Able to adhere to study visit schedule and other protocol requirements +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Ability and willingness to comply with the requirements of the study protocol. +Patients must agree/be able to comply with all protocol specific requirements +Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements +Able to comply with the study protocol, in the investigator’s judgment +Ability to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Ability and willingness to comply with the requirements of the study protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Patients should be able to swallow enzalutamide and comply with study requirements +Non-compliance: subjects who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study will be considered non-compliant +Ability and willingness to comply with the requirements of the study protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Non-compliance: if it is the opinion of the investigator that a subject may be unable to comply with the safety monitoring requirements of the study, they will be excluded +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Be able and willing to adhere to the study visit schedule and other protocol requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Medically and psychologically able to comply with all study requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Medically and psychologically able to comply with all study requirements +Willing to adhere to the study visit schedule and prohibitions and restrictions specified in this study protocol +Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Ability and willingness to comply with all study requirements +Subject is willing and able to adhere to the study visit schedule and other protocol requirements. +Vasectomy or surgical castration ? 6 months prior to Screening. 13. Subjects able to swallow study medication 14. Subjects able to comply with study requirements +Able to adhere to the study visit schedule and other protocol requirements Disease Specific 4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry. +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Subject is able to adhere to the study visit schedule and other protocol requirements. +The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment. Inclusion Criteria: +The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment. +Subject is willing and able to adhere to the study visit schedule and other protocol requirements +Willing and able to adhere to the study visit schedule and other protocol requirements. MDS Cohort: +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Willing and able to give written informed consent and comply with study visit schedule +Subjects who in the opinion of the Investigator will be unlikely to fully comply with protocol requirements. +Able to adhere to the study visit schedule and other protocol requirements. +Willing and able to adhere to the study visit schedule and other protocol requirements. +Able to adhere to the study visit schedule and other protocol requirements. +Ability to adhere to the study visit schedule and all protocol requirements; +Able to adhere to the study visit schedule and other protocol requirements +Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol +Willing and able to give written informed consent and comply with study visit schedule. +Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol +Understand and voluntarily sign an informed consent prior to any study-related assessments or procedures are conducted and are able adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements. +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements and/or follow-up studies of this trial +The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment. +Patients who in the opinion of the investigator may be unable to comply with the safety monitoring requirements of the study +Patient is able and willing to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Patient must be willing to give written informed consent and must be able to adhere to dosing and visit schedules, and meet all study requirements. +Patient must be able to adhere to the study visit schedule and other protocol requirements +Participant is willing to adhere to the study visit schedule and other protocol requirements. +Must be able to adhere to the study visit schedule and other protocol requirements +Ability and willingness to comply with the requirements of the study protocol +Subject must be able to swallow study drug and comply with study requirements. +Ability and willingness to comply with the requirements of the study protocol +Willing and able to comply with all study requirements, including treatment and required assessments +Subject must be able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements +Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator’s opinion, willing and able to comply with the protocol requirements +Patient is willing and able to participate in the study and comply with all study requirements. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements +Is willing and able to adhere to the study visit schedule and other protocol requirements. +Ability to provide informed written consent and be able to adhere to the study visit schedule and other protocol requirements +Subjects unwilling to or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Research participants will be excluded, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule and other protocol requirements +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Individuals not willing to comply with the procedural requirements of this protocol +Able to adhere to the study visit schedule and other protocol requirements +Ability to voluntarily sign consent for and adhere to the entire study visit schedule and all protocol requirements +Subject is able to swallow the study drug and comply with study requirements. +The patient or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator. +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Ability and willingness to comply with the requirements of the study protocol +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Individuals not willing to comply with the procedural requirements of this protocol +Willing/able to adhere to the prohibitions and restrictions specified in this protocol +Able to swallow the study drug and comply with study requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule (ie, clinic visits at the study sites are mandatory, unless noted otherwise for particular study visits) and other protocol requirements. +Patient is willing and able to adhere to the study visit schedule and other protocol requirements +Ability to adhere to the study visit schedule and other protocol requirements +Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Patients who, in the opinion of the investigator, are unable to comply with the requirements of the study protocol are not eligible +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Must be able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to swallow the study drug and comply with study requirements +Able to adhere to study schedule and other protocol requirements +Willing and able to adhere to the protocol requirements, including but not limited to study drug dosing, study drug visits, medication and treatment restrictions, and laboratory tests +Was willing and able to adhere to the study visit schedule and other protocol requirements. +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements. +Must be able to comply with study and follow up requirements +Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol +Able to adhere to the study visit schedule and other protocol requirements +Subjects must be willing to adhere to the study visit schedule and other protocol requirements +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible +Patient must be able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Ability and willingness to comply with the requirements of the study protocol +Patient must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. +Able to adhere to the study visit schedule and other protocol requirements +Must be able to adhere to the study visit schedule and other protocol requirements. +Must be able to adhere to the study visit schedule and other protocol requirements. +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Subject is able to adhere to the study visit schedule and other protocol requirements +Sufficient mental capacity to comply with the protocol requirements, +Willing and able to participate in the trial and comply with all trial requirements. +Participant is willing and able to comply with the requirements of the protocol +Ability and willingness to comply with the requirements of the study protocol +Able to swallow the study drug as prescribed and comply with study requirements +Willing and able to participate in the trial and comply with all trial requirements +Participant is willing and able to comply with the requirements of the protocol +Subject is willing and able to comply with the requirements of the protocol. +Ability to swallow study drugs and to comply with study requirements throughout the study. +Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions +Able to adhere to the study visit schedule and other protocol requirements. +Able to comply with the treatment schedule +Subject is able to understand and comply with protocol requirements and instructions +Ability to adhere to the study visit schedule and other protocol requirements +Willing and able to participate in the trial and comply with all trial requirements. +As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements +Inability to co-operate with the study visit schedule and other requirements of the protocol +Ability and willingness to comply with the requirements of the study protocol +Able to adhere to the study visit schedule and other protocol requirements. +Able to adhere to the study visit schedule and other protocol requirements +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +The patient must be willing and able to comply with study requirements, remain at the clinic, and be willing and able to return to the clinic for the follow-up evaluation as specified in this protocol during the study period. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Able to adhere to the study visit schedule and other protocol requirements +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Willing and able to comply with post-operative treatment protocol and follow-up visit schedule. +Able to adhere to the study visit schedule and other protocol requirements. Disease Specific +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Able to adhere to the study visit schedule and other protocol requirements +Able to comply with study visit schedule and assessments. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Able and willing to comply with protocol requirements, in the opinion of the investigator. +Must be able and willing to comply with the study visit schedule and study procedures. +Must be able to understand and comply with protocol requirements and instructions +Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol +Subject is able and willing to comply with the requirements of the protocol. +Unable to comply with study requirements in the opinion of the Investigator. +Participant is willing and able to comply with the requirements of the protocol +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment. +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to study visit schedule and other protocol requirements +In the view of the investigator, the patient can and will comply with the requirements of the protocol. +Able to adhere to the study visit schedule and requirements of the protocol +Able to understand and comply with the requirements of the protocol +Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study +In the view of the investigator, the patient can and will comply with the requirements of the protocol. +Able to adhere to the study visit schedule and other protocol requirements +Able to adhere to the study visit schedule and other protocol requirements +Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Willing and able to meet all study requirements +Subjects must be willing to adhere to the study visit schedule and other protocol requirements +Able to swallow enzalutamide and comply with study requirements +Able to adhere to study schedule and other protocol requirements +Subjects who in the opinion of the Investigator will be unlikely to fully comply with protocol requirements. +Be willing/able to adhere to the prohibitions and restrictions specified in this protocol +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Willing and able to do all study requirements +Willing and able to meet all study requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Are willing and able to complete study requirements +Willing and able to meet all study requirements +Able and willing to give informed assent and comply with study requirements +Willing and able to meet all study requirements +Willing and able to comply with the requirements of the protocol +Ability to understand and comply with the requirements of this study +Able to adhere to the study visit schedule and other protocol requirements +Willingness to adhere to the study visit schedule and prohibitions as specified in this protocol +Patient that is not able to understand or to comply with the study instructions and requirements or has a history of non-compliance to the medical regimen +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Patient is able to understand and comply with protocol requirements and instructions +Any patient, in the opinion of the investigator, who is unable or unlikely to comply fully with the study requirements or procedures for any reason +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Unwillingness to comply with the requirements of the protocol +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Non-compliance defined as any subject, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Willing to follow protocol requirements +Willingness to sign informed consent and comply with all protocol requirements +Able to co-operate with the investigator and to comply with the requirements of the entire study. +Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Be able to adhere to the study visit schedule and other protocol requirements. +Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. +Ability to comprehend and comply with the requirements of the Study +Subject is willing and able to adhere to the study visit schedule and other protocol requirements. +Subjects who the investigator believes can and will comply with the requirements of the protocol. +Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study. +Subjects who the investigator believes can and will comply with the requirements of the protocol +Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. Cohort A Only: +Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol +Able to understand study requirements +Willing to comply with protocol requirements +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Patient is willing to comply with protocol requirements +Willing and able to follow the protocol requirements. +Not willing to comply with the procedural requirements of this protocol +Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study +Women willing to comply with protocol requirements +Patients willing to comply with protocol requirements +Able to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment +Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements +Patients must be able to comply with the safety monitoring of the study in the opinion of the investigator +As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements +Willingness to comply with the requirements of the study +As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements +Required observations: Subjects who in opinion of investigator may not be able to comply with required safety and monitoring requirements are not eligible +Patients who are able to comply with the protocol. +Willing and able to adhere to the study visit schedule and other protocol requirements +Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study