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.