[c09aa8]: / clusters / 9knumclustersv2 / clust_2054.txt

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Willing to return to enrolling medical site for all study assessments
Subject has voluntarily agreed to abide by all protocol required procedures including study related assessments, and management by the treating institution for the duration of the study and long-term follow-up.
Able to undergo all screening assessments outlined in the protocol.
Lack of availability for follow up assessments
Able to understand and willing to complete symptom assessments using a patient reported outcomes instrument
Lack of availability for follow up assessments
Lack of availability of study subject for immunological and clinical follow up assessments
Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment and would interfere with follow-up assessments through year
Any of the following ECG findings or assessments including: Baseline QTcF interval >= milliseconds; Clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Patients (female or male) must provide informed written consent and must complete all screening assessments as outlined in the protocol
Subjects with medical condition that could adversely impact the study participation or assessments.
Inability to complete neurocognitive assessments per investigator discretion
Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator
Current or recurrent disease that could affect the action or disposition of IT-, or clinical or laboratory assessments.
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
Total bilirubin =< . x ULN, within days of study registration (within days for pulmonary and cardiac assessments)
Patients must complete all screening assessments as outlined in the protocol
Inability to undergo contrast radiological assessments
Patients must complete all screening assessments
Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments
Willingness to return to the enrolling medical site for all study assessments
Any conditions that would preclude a patient from completing all study assessments
Other active malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
Willing to return for all required study assessments
Screening laboratory assessments:
Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival.
Be willing to complete Quality of Life assessments during the study
Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
Notes: subjects may not have had a transfusion within days of screening assessments; concomitant elevation of bilirubin and AST/ALT above the IULN is not allowed
Patients must have at least one metastatic lesion that can be followed on baseline imaging obtained no more than days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with mTc labelled diphosphonates
Lack of availability for immunological and clinical follow-up assessments.
Satisfactory completion of dosing & efficacy assessments in ISIS -CS
Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival
Unable to comply with lab appointments schedule and PRO assessments
Completion of screening and baseline assessments
Acceptable laboratory assessments obtained within days prior to Randomization
Lack of availability for immunological and clinical follow-up assessments.
All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments; however mild to moderate deficits in these functions due to tumor are allowed
Patients must complete all screening assessments as outlined in the protocol
Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessments
Subject is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
Grade or eye disorder at study entry, unless stable and longstanding (> months) and unlikely to interfere with protocol-required ophthalmology assessments.
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Lack of availability for immunological and clinical follow-up assessments.
Completion of screening assessments (Refer to protocol for further details)
Cancer patients greater than years of age who have completed all assessments required to meet the primary objectives of a parental phase , or clinical study of iniparib as monotherapy or in a combination regimen.
Willingness to participate in Patient-Reported Outcomes assessments
Has completed study K--WW, including weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments
Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
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.
Subject has agreed to abide by all protocol required procedures including study related assessments, and management by the treating institution for the duration of the study and long term follow-up.
Willingness and ability to participate in study assessments and the eight-week intervention
Unable to complete the baseline assessment questionnaires or functional assessments
Able to complete study assessments, including keeping a daily diary
In the judgment of investigators/consenting professionals, able to comprehend English to complete study assessments
Able to complete study assessments
Able to complete study assessments
Cognitively able to complete assessments as judged by the study team
Patients who are able to complete the assessments
Unable to complete the baseline assessment questionnaires or functional assessments
Other injury or condition that prevents ambulation or completion of study assessments
Able to complete study assessments
Able to complete study assessments
Unable to comply with protocol and/or not available for follow-up assessments
English insufficient to complete baseline patient-reported outcomes (PRO) assessments
Patients must complete all pre-entry assessments
PHASE II: Able to complete all study assessments and procedures in English
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
FOLLOW-UP ASSESSMENTS:
FOLLOW-UP ASSESSMENTS: Agree to providing consent for release/review of their medical record
With evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
Lack of availability for follow-up assessments
Any condition conflict based on the investigations clinical judgment that would prevent the patient from completion all trial assessments and visits
Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
Subjects must complete all baseline screening assessments
Active other malignancy requiring treatment that would interfere with the assessments of this study
Willingness to provide multiple contacts (i.e., phone numbers, addresses of close others) if not reached for follow-up assessments
Be willing and capable of completing the assessments and adhering to protocol requirements.