Patients must be deemed able to comply with the treatment plan and follow-up schedule
Patients who are able to comply with the protocol follow-up schedule
Patients must be deemed able to comply with the treatment plan and follow-up schedule
Must be able to comply with the treatment plan and follow-up schedule
Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
Ability to comply with the treatment schedule
Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Ability and willingness to obtain all required scans per study schedule
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
Able to comply with the treatment schedule
Willing to comply with proposed visit and treatment schedule
Ability to comply with the treatment schedule
Able to comply with the treatment schedule
Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
Willingness to follow the requirements of the intravenous ascorbic acid program schedule
Inability to give consent or adhere to follow-up schedule
Willing and able to comply with follow-up schedule
Clinical history, current alcohol (ethanol), or illicit drug use which, in the judgment of the investigator, will interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Willing and able to give written informed consent and comply with study visit schedule
Patients must comply with the treatment plan and follow-up schedule.
Willing and able to give written informed consent and comply with study visit schedule.
Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.
Unable to comply with lab appointments schedule and PRO assessments
Willing to schedule definitive resection of DCIS 2-5 weeks after study enrollment
Inability to provide informed consent or to comply with the schedule of office and treatment visits
Able to comply with the treatment schedule
Unable to comply with the study follow-up schedule
Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
Willing to give consent and comply with study-related evaluation and treatment schedule; and
Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
Able to comply with study visit schedule and assessments.
Patient is unwilling or unable to comply with the follow-up schedule
Must be able and willing to comply with the study visit schedule and study procedures.
Unable to commit to intervention schedule (6 weekly group meetings)
Chemotherapy treatment schedule < 12 weeks
Able to commit to a long term follow-up schedule
Patients must be deemed able to comply with the treatment plan and follow-up schedule
Unwilling or unable to comply with the follow-up schedule
Cannot commit to the intervention schedule
Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study agent
Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
Inability to commit to the intervention schedule
Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol
Patient is not likely to comply with the follow-up evaluation schedule
Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol
Patient is not likely to comply with the follow-up evaluation schedule
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Participant is willing to comply with the protocol for the duration of the study, and undergo treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Ability to understand and the willingness to sign a written informed consent document. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, including follow-up
Ability to understand and the willingness to sign a written informed consent document; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Ability to understand and the willingness to sign a written informed consent document; patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Willing and able to comply with the protocol, including follow-up visits and examinations
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations with follow up.
Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
Willing and able to comply with the protocol, including follow-up visits and examinations
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
PHASE I: Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Willing and able to comply with the protocol, including follow-up visits and examinations
Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Ability to understand and the willingness to sign a written informed consent document; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and exams including follow up
Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Willing and able to comply with the protocol, including follow-up visits and examinations.
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Patient must be willing and able to comply with the protocol for the duration of the study, including attending scheduled visits, examinations, the biopsy procedure, and having their tumor and blood molecularly characterized
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
Participant is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Able to undergo all screening assessments outlined in the protocol.
Any uncontrollable intercurrent illness, infection, or other conditions that could limit study compliance or interfere with assessments.
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 5
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
Inability to complete neurocognitive assessments per investigator discretion
Current or recurrent disease that could affect the action or disposition of IT-141, or clinical or laboratory assessments.
Patients must complete all screening assessments as outlined in the protocol
Patients must complete all screening assessments
Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments
Any conditions that would preclude a patient from completing all study assessments
Willing to return for all required study assessments
Screening laboratory assessments:
Adequate baseline laboratory assessments
Adequate baseline 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
Notes: subjects may not have had a transfusion within 7 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 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with 99mTc labelled diphosphonates
Lack of availability for immunological and clinical follow-up assessments.
Satisfactory completion of dosing & efficacy assessments in ISIS 420915-CS2
Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival
Completion of screening and baseline assessments
Acceptable laboratory assessments obtained within 14 days prior to Randomization
Adequate baseline laboratory assessments, including
Lack of availability for immunological and clinical follow-up assessments.
Patients must complete all screening assessments as outlined in the protocol
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
Adequate baseline laboratory assessments
Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 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)
Adequate baseline laboratory assessments, including:
Adequate baseline laboratory assessments
Willingness to participate in Patient-Reported Outcomes assessments
Has completed study 3200K1-4000-WW, including 2 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
Willingness and ability to participate in study assessments and the eight-week intervention
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
Other injury or condition that prevents ambulation or completion of study assessments
Able to complete study assessments
Able to complete study assessments
Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments
English insufficient to complete baseline patient-reported outcomes (PRO) assessments
Willingness to comply with all study interventions of acupuncture and follow-up 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: Must be non-adherent for CRC screening at the time of the educational program
FOLLOW-UP ASSESSMENTS: Self-identify as African American
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 investigation’s 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
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.
Patients with inability to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
Able to return for treatment and follow-up on the specified days
Patients with inability to return for follow-up visits to assess toxicity to therapy
Patients with known inability to return for follow-up visits or obtain follow-up studies required to assess for toxicity to therapy will be excluded
Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
Ability to attend required study visits and return for adequate follow up, as required by this protocol
Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy; telemedicine visits are acceptable
Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol
Inability or unwillingness to return for all the required follow-up visits
Inability or unwillingness to return for all the required follow-up visits
Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to device usage plan, other study procedures, and study restrictions
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Patients must be willing to return to the clinic for follow-up visits
Inability or unwillingness to return to required visits and follow-up exams
Inability to Participate Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
Ability to attend required study visits and return for adequate follow up, as required by this protocol
Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Subjects with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol
Inability to return for follow-up visits or obtain follow-up studies required to assess toxicity and response to therapy
Patients who are unable to return for follow-up visits as required by this study
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
NON-PROGRESSED DIPG (STRATUM 2): Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
Agreement to return for the trial required follow-up visits
Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Unable to return for follow-up visits and tests
Subjects, who, in the opinion of the clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-up visits
Return for follow-up visits
Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
In the investigator’s judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
Ability to attend all scheduled study visits
Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.
In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
Willing to travel to the NIH for follow-up visits
Inability to attend scheduled clinic visits
Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
In the investigators judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation
Willing to travel to the National Institutes of Health (NIH) for follow-up visits
Resident in the area and willing to attend up to 7 clinic visits for a 36-month period at the Virology Research Clinic (VRC)
Unavailable for follow-up visits after treatment
Patients must be willing to travel to the study site for follow-up visits
Subject is willing and able to comply with all protocol required visits and assessments.
Willing to travel to the National Institutes of Health (NIH) for follow-up visits
Ability to understand and willingness for follow-up visits.
Agree to attend study visits outside of standard of care visits, if needed
The subject is willing and able to comply with the protocol, and agrees to return to the hospital for follow?up visits and examination
Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up
Able to attend all study visits (i.e., life expectancy of at least 3 months).
Subject is willing and able to comply with all protocol required visits and assessments, including biopsy if assigned.
Patients who are able and willing to give consent and able to attend all study visits
Able to attend all study visits (i.e. life expectancy of at least 3 months).
Must be able and willing to adhere to protocol requirements, visits and vaccination timeline
Willing to travel to the National Institutes of Health (NIH) for follow-up visits
The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site.
Subject is willing and able to comply with all protocol required visits and assessments, including biopsy if assigned to the MTD expansion cohort;
Patient is willing and able to give consent and attend all study visits as defined in the protocol
Ability and agreement to attend protocol-specified visits at the study site
Willing to travel to the NIH, MSKCC, DFCI, BIDMC for follow-up visits
Patients must be willing to travel to the study site for follow-up visits
Willing and able to participate in clinic visits and study interactions at specified intervals and to maintain contact with the investigators for at least three months
Ability and willingness to follow the guidelines of the clinical protocol including visits to National Institute of Child Health and Human Development (NICHD) and NCI, Bethesda, Maryland for treatment and follow up visits
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.
Willing to travel to the NIH for follow-up visits
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
Subject agrees to comply with follow up visits
signed informed consent for the HIFU treatment study through the 12 month follow-up visit (7 visits) and then through the extended follow-up period of 5 years (4 additional visits);
No social support or inability to attend study-related visits
Patients (or guardians/parents) who are able and willing to give consent (and assent where applicable) and able to attend all study visits
Anticipated non-availability for study visits/procedures
Anticipated non-availability for study visits/procedures.
Ability and willingness to follow the guidelines of the clinical protocol including visits to NCI, Bethesda, Maryland for treatment and follow up visits
Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits.
Willing and able to comply with the protocol, including follow-up visits, examinations as well as having the ability to self-report pain and fatigue using a Patient-Reported Outcome (PRO) instrument
Patients who are able and willing to give consent and able to attend all study visits
Being able and willing to attend study appointments
Transportation issues interfering with return study visits
Must be able to comply with follow up visits
Willing and able to attend study visits at the University of Wisconsin (UW) – Madison
SUBJECT: History of medical non-compliance or difficulty completing previous required study tasks or visits that suggest the participants would not follow through with the home study procedures.
Subject is willing and able to meet study requirements, including follow up visits
Participate in the specified study visits and laboratory testing including three (20 mL) blood draws and three 24 hour urine collections
Are willing and able to attend 3 study visits at the University of Wisconsin (UW)
Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits
Have visits planned with the oncology physician for at least 3 months and be willing to come in for study visits
Any participant who cannot be present for the related study visits and/or complete the post-test assessment
Unavailable for follow-up visits
Willing to travel to MD Anderson’s main campus for 2 visits (baseline and 6 months post-baseline)
The subject is able to complete the study and comply with study instructions, including attending all study visits
Inability to complete all study-related visits
Is willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
Willing to attend monthly clinic visits at University of California, San Francisco (UCSF)
Planned relocation which would make follow-up visits impossible during the course of the study
Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.
Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
Subject is willing and able to comply with all protocol required visits and assessments;
Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).
Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits
Willingness to comply with study procedures:\r\n* Willing to have a blood draw for serum to archive bioavailable estradiol, sex hormone-binding globulin (SHBG), FSH, and bazedoxifene levels as well as a chemistry profile to ensure reasonable normal organ function at baseline and 6 month visits (approximately four tubes of blood collected)\r\n* Willing to have a DEXA scan for body composition and waist measurement at baseline and 6-8 months\r\n* Willing to have a repeat mammogram and RPFNA at 6-8 months following initiation of study drug\r\n* Willing to undergo a history, physical, vitals and breast exam at baseline and 6 month visits\r\n* Willing to be contacted by the trial coordinator at months 1 and 3 during the 6 month study period\r\n* Willing to complete a 29 item validated menopause quality of life intervention questionnaire and hot flash assessment at baseline and 6 month visits\r\n* Willing to sign and able to understand separate consents for the RPFNAs and for study participation
Willing to complete all study visits
Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
Are geographically able to have study visits at UCLA’s Warren Hall or the Clinical Translational Research Center
Patient is willing and able to give consent attend all study visits and complete all questionnaires as defined in the protocol
Ability to attend clinic visits
Willing to complete all study visits
Must be willing to attend all scheduled study visits, complete all study questionnaires, and allow biological specimen collection including a bronchoscopy within 3-4 months after enrollment into the study
Willingness to travel to National Institutes of Health (NIH) for follow-up visits
Patients must be willing and able to be compliant with all procedures and visits required for this protocol (pre-treatment, during treatment, and optionally throughout follow-up period)
Able to understand, follow written instruction and willing to participate in all visits without rescheduled more than one or missed a visit without cancellation or rescheduling (no show)
Willingness to travel to National Institutes of Health (NIH) for follow-up visits
Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
Willingness to travel to National Institutes of Health (NIH) for follow-up visits
Available for all study visits and able to comply with all study requirements.