[c09aa8]: / clusters / 9knumclustersv2 / clust_2201.txt

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Patients and physicians must be willing to comply with treatment assignment:
Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if necessary
Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
Subject is able to understand and willing to sign the ICF, according to institutional standards, prior to the initiation of any study related procedures;
Willing to consent to tumor biopsies during the study
Willing to agree to periodic contact with a member of the study team during the period that the cancer has not recurred and/or has not become platinum resistant
Is willing to undergo tumor genotyping for TP mutation, insertion, or deletion at screening. Confirmation of TP nonmutant status is encouraged, but not required prior to DS-b dosing.
Patients >= years must be willing to comply with the mandatory biopsies.
Able and willing to undergo the required bone marrow biopsies; correlative studies are strongly encouraged
Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number -
Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number -
Willing to travel to a radioimmunotherapy site for Zevalin, if necessary
Willing and able to give blood sample
Willing and able to fill out a pill diary to ensure compliance
Must be willing and able to undergo three research PET scans
Willing to be smoke-free for days
Subjects must be willing to undergo a cystoscopy.
Willing to discontinue or not initiate the use of prophylactic hemin throughout the study.
Patients must receive insurance approval for or be willing to pay for commercial gefitinib
Subjects must be willing to adhere to the dietary modification outlined in the protocol.
Subjects must be willing to have prostate biopsies nine months after enrollment into the protocol.
Willing to undergo the intra-tumoral (IT) injection of the poly-ICLC into the prostatic tumor as per the protocol
Must be willing and able to undergo three research PET scans
Must be willing and capable of understanding and cooperating with the requirements of the study.
Subjects able to complete the study duration.
Willing to consent and accept randomization
Willing to use Fitbit band to monitor physical activities
Willing to provide an email address to register their Amazon Echo speaker at their home
Willing to undergo craniotomy and resection of their glioblastoma at Mayo Clinic
Willing to receive an mpMRI
Patients must be willing to undergo endotracheal intubation, mechanical ventilation, dialysis, cardiopulmonary resuscitation (CPR), and electrical defibrillation; patients must be willing to receive vasopressor drugs and all other standard intensive care unit interventions; any living will must be amended to allow these interventions or the patient will not eligible
DONOR: Able and willing to undergo apheresis
Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than hours.
IMMUNE RECONSTITUTION STUDY ONLY: Be willing and able to provide written consent/assent for the immune reconstitution portion of the trial only
Available haploidentical donor willing and eligible to undergo a peripheral blood collection
Patients must be able to provide blood and marrow samples and to undergo the procedures required for this protocol
Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
Willing to reside < kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion
Patient must be willing to consent to MSKCC protocol - (Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy)
Patients must be willing to consent for protocol #- for IMPACT testing
Must be willing to be treated with SBRT only at Johns Hopkins Hospital
Willing to travel to a Legacy Health/Oregon Health & Science University (OHSU) facility if necessary
Subjects must be willing to undergo malignancy genotyping for tumor protein (TP) mutation, insertion, or deletion at screening
Patient and partner are willing to use condoms for months after receiving Toca or until there is no evidence of the virus in his/her blood, whichever is longer.
Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
Willing to have tumor biopsies collected in cPoP
Must be willing and able to undergo two research MRI scans, one before study treatment begins and another shortly after SBRT
Willing to set a quit date within weeks
Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the Investigator. Cohort B (Combination Expansion): Osteosarcoma subjects who progressed in Cohorts or B and opt to receive combination therapy.
Not willing to stay at the study site for hours after each PRTX- infusion
COHORT II: Patients must be willing to undergo breast cancer surgery minimally , maximally weeks post APBI
Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, , and months post end of radiation therapy)
Patients must be willing to provide biological samples as required by the study
Willing to withdraw from selective serotonin reuptake inhibitors and tricyclic antidepressants prior to treatment initiation
Must be willing and able to accept at least two tumor biopsies
Able and willing to give informed consent, and to undergo staging including PET scanning
Patients willing and able to complete the questionnaires
Patient must be willing to return to the treating physicians office for outpatient follow-up once outpatient treatment is completed
Patients and donors must be able to sign consent forms; partially mismatched (at least haploidentical) first degree relative should be willing to donate
Must be willing to provide blood samples prior to the start of treatment on this study for exploratory tumor molecular profiling analyses.
Providers and patients must be willing to defer new systemic or cutaneous topical treatment of aGvHD for at least hours after administration of Neihulizumab.
Females - not pregnant and willing to follow contraceptive guidance
Males - Willing to follow contraceptive guidance
Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires.
Willing to undergo blood transfusions as deemed clinically necessary.
Willing to undergo multiple cystoscopies during the study for TAR- removal and post-insertion examination.
Deemed eligible for and willing to undergo RC by the attending urologist.
Patients must be willing to undergo additional radiologic imaging while on study
Dose level ( mg) and higher: willing to provide baseline and on treatment tumor biopsies ( weeks after RXDX- treatment initiation), provided the procedure is clinically feasible and not deemed unsafe by the investigator.
Willing to undergo routine surveillance with breast ultrasound and/or mammography
Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
Subject must be willing to undergo protocol directed biopsies and blood draw for immune profiling
Subjects must be able and willing to undergo serial biopsies of injected lesion(s) and, when applicable and clinically feasible, non-injected lesions
Subjects must be willing to undergo myeloma genotyping for TP mutation, insertion, or deletion at screening
Willing to avoid household contacts =< months old or household contact with known immunodeficiency week after treatment
Patients must be willing and able to check and record daily blood pressure readings if receiving cediranib
Participants must be able and willing to follow protocol instructions and schedules
Willing not to smoke
Willing to complete a pill diary each day
Be willing to undergo a second core or excisional biopsy of a bone metastasis on therapy (approximately after weeks of study therapy or after doses of radium- if delays have occurred)
DONOR: Able and willing to have up to separate mobilized apheresis collections performed or if unable to undergo apheresis agrees to a bone marrow harvest (requires additional consent)
DONOR: Able and willing to undergo apheresis
Willing to undergo testing for gBRCA.
Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
Must be willing and able to accept at least two tumor biopsies
Be willing to comply with effective antiretroviral therapy (ARV)
Patients will have at least one melanoma deposit that can undergo serial biopsy (at least time points) during the neoadjuvant phase of the protocol; patients must be willing to provide tumor samples at the time points specified in the Study Procedure Tables
Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study and collect involved blood specimen prior to the start of radiation therapy, IRB number -.
History of >= grade allergic reaction to mFOLFOX (patients successfully desensitized to oxaliplatin are eligible or those willing to undergo desensitization during the first two cycles of mFOLFOX per institutional guidelines)
Willing to allow blood collections; and capable of performing a simple test for assessing cardiopulmonary fitness
Patients must have an intraperitoneal (IP) port in place; if a patient does not have an IP port, she must be willing to undergo surgical placement of one
Willing to take AA on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose AA is taken
Willing and capable of undergoing apheresis for collection of mononuclear cells
Patients must have been surgically or medically castrated; if the patient is being treated with medical castration, he must be willing to continue this treatment for the duration of the study; ADT should not be initiated, terminated, or dose-adjusted during the study
Willing to abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study
DONOR: Able and willing to undergo an apheresis procedure (unmobilized) for iTreg production and have up to separate mobilized apheresis collections performed for PBSC transplant
Willing to follow pregnancy precautions
DONOR: Able and willing to undergo apheresis
Willing and able to complete neurocognitive examination without assistance from family and companions; Note: because neurocognitive testing is one of the primary goals of this study, patients must be able to utilize English language booklets (and/or French booklets if enrolled in Canada)
Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance
DONOR: Able and willing to have up to separate apheresis collections
MATCHED RELATED DONOR: Donors must be physically able to and willing to tolerate marrow harvest collection preferably, or in the absence of this option, able and willing to donate via peripheral blood pheresis
Subject must be willing to fast for approximately hours predose and hours postdose on day of each period in the pharmacokinetic phase.
Willing to receive their standard multimodality therapy at Mayo Clinic, Rochester
Patient must be willing to undergo surgery at MUSC within - weeks of completing chemoradiation
Willing to remain on-site for approximately hours after administration of AVB- or, if required, stay overnight after the surgical procedure
Male patients not willing to use a condom
Inclusion Criteria:\n\n years;\n\n - Clinical confirmation of adrenocortical carcinoma that is locally advanced or\n metastatic and not amendable to surgical resection;\n\n - Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based\n chemotherapy regimen;\n\n - Able to understand and comply with the protocol requirements;\n\n - Willing and able to provide informed consent.\n\n Exclusion Criteria:\n\n - Mitotane level > \n\n - Use of contraindicated concomitant medications\n\n - Unstable medical condition that, in the judgment of the investigator, could interfere\n with study procedures or data interpretation.
Mentally, physically, and geographically able to undergo treatment and follow up
For certain subjects, willing and able to provide pre- and post-treatment fresh tumor biopsies
Patients must be willing to comply with the photosensitivity guidelines for a minimum of six weeks to be in the PDT treatment group (Group )
Patients that are not willing to adhere to the photosensitivity guidelines will not be eligible
Able and willing to use the MEMS TrackCap (e.g., not using a pillbox or prescribed liquid MP)
Willing/able to attend brief introductory session and use assigned device for the assigned period of time ( minutes once or twice per day), at least days per week for weeks
Have their own e-mail address, or be willing to sign up for a new one
Able/willing to have an online interaction with a Reimagine Pillar Guide
Being able and willing to attend study appointments
Patient is willing and able to consent and travel to the class location for weekly -hour sessions
FCG is willing and able to consent and travel to the class location for weekly -hour sessions
PHASE & : Own and use a smartphone or be willing to use a smartphone
Patients must be willing to spend time for the study.
PATIENTS: Willing to be seen at least monthly.
Able and willing to attend in-person PCO workshop at a location convenient to them
Participants must be willing and able to receive email newsletters via computer or smartphone for months AND/OR willing and able to receive texts via cellphone for months\r\n* Participants must have a personal email address to receive newsletters\r\n** If a participant does not have an email address but has access to a smartphone or a computer, at the baseline data collection visit Columbia University Medical Center (CUMC) study staff will create a free personal Google Gmail email account.
Participants must be willing and able to attend four -hour in-person sessions
Participants must be willing and able to travel to CUMC for data collection and optional blood draws at two baseline visits, -month and -month visit; if needed and depending on staff availability, optional blood draws can be completed at a participants home by a certified phlebotomist from our research team
The subject is willing to consent to randomization of lavage vs. standard lavage
The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard
Willing to undergo phlebotomy
Be able to complete a steep ramp test
Patients willing and able to complete the EPIC questionnaire in its entirety
Able/willing to have an online interaction with a PillarsLife group weekly for nine weeks
Willing and able to undergo study assessment
Patients will have to present on one of the three days per week that geriatric assessments are available, and be willing to be seen for geriatric co-management on one of the two geriatrician clinic days
Must be willing to come to MD Anderson Main Campus (Texas Medical Center) for intervention
Able and willing to follow prescribed diet intervention
Willing to come to MD Anderson for the intake and follow up data acquisition and to receive their equipment.
Willing to allow research staff to come to their homes or to return the equipment to MD Anderson (MDA) in the case of equipment malfunction.
Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment
Patients must be willing to adhere to the PNP intervention and the entire -month study
Are willing to attempt reduction of sitting time
Willing to complete the UNC GA
Willing to undergo a form of cancer therapy and subsequent follow-up care
Willing to wear the FitBit throughout the study period
Subjects have to be willing to attend weekly voice therapy sessions
Be willing and able to travel to UCSF for pre- and post-study blood collection
ONCOLOGY NURSE: Be willing to attend the -session MODEL Care intervention for providers at the specified location, date, and time
PATIENT: Be willing and able to travel to the class location for weekly -hour sessions
Not willing or able to follow procedures specified by the study and/or instructions of the researcher; prior to randomization, participants must provide a signed authorization and medical clearance from their personal physician or our nurse practitioner
Patient unable or not willing to perform all study related biopsies and blood draws for exploratory endpoints will not be enrolled on study as all study related procedures are mandatory
Eligible for and willing to undergo RC per the attending urologist.
Willing to return mail-in questionnaires during the observation phase of the study
Willing and able to use a computer to complete study questionnaires
Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza
Be able and willing to wear an Actiwatch for the entire hours of each day they are scheduled to wear it
Willing to provide locator information for follow-up contact
Willing to use and return the technology provided by the study
The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group
The subject is willing to comply with -day follow-up in the office and answer quality-of-life questionnaires per protocol
The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group
The subject is not willing to comply with -day follow-up in the office and answer quality-of-life questionnaires per protocol
Willing to have about mL of blood (approximately tablespoons) drawn
Have access to a healthcare provider and be willing to share genetic results with that provider
Must be willing to have about cc of blood (approximately tablespoons) drawn at each aspiration visit
Must be willing to keep the clinic informed of their breast health status for years when requested
Must be willing to have height and weight recorded at each aspiration visit
If applicable, must be willing to collect a stool specimen and bring to the clinic; special collection kits will be provided
Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC
Women must be willing to take supplemental omega- fatty acids provided by the study
Willing to set a quit date in the next days
Willing to undergo study measurements
Willing to engage in a -day quit attempt as part of study procedures
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 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 - months\r\n* Willing to have a repeat mammogram and RPFNA at - months following initiation of study drug\r\n* Willing to undergo a history, physical, vitals and breast exam at baseline and month visits\r\n* Willing to be contacted by the trial coordinator at months and during the month study period\r\n* Willing to complete a item validated menopause quality of life intervention questionnaire and hot flash assessment at baseline and month visits\r\n* Willing to sign and able to understand separate consents for the RPFNAs and for study participation
PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
Subjects must be willing and able to come to the University of Pittsburghs Smoking Research Group lab for visits over a - week period, as well as a ninth and final visit months after their quit date, and to monitor behavior via an electronic diary for weeks.
Willing to be followed-up for months
Willing to undergo study measurements
Subjects must have an Internet connection and be able and willing to use an applicable device\r\n* If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study)
Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing
Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
Willing to undergo a history and physical at baseline and months and be contacted periodically by the trial coordinator during the month study period
Willing to repeat RPFNA at months following initiation of study agent
Willing to have blood drawn at baseline and months; if non-menstruating, an additional draw will be performed at approximately months so as to predict when to perform the RPFNA
Women who are willing to have a Mirena IUD inserted at least days prior to risk-reducing surgery or who already have the Mirena in place
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena IUD
Willing and able to provide stool and blood samples at baseline (week ), week , and week
Willing and able to attend a gym - days a week for weeks between week and week
Willing and able to maintain current dietary behaviors for the duration of the study
Are willing to receive and respond to text messages from the study teams, throughout the duration of the study
Subjects must be willing to restrict food intake to a hour period every day ( am to pm) and wear a smartwatch on their dominant hand
Male or female subjects ? years-of-age with the demonstrated ability to swallow capsules whole and who are willing to provide access to previously obtained biopsy results
If undergoing adjuvant therapy (e.g. tamoxifen or aromatase inhibitors) willing and able to remain on current regimen for entire -month study period
Participants must be able and willing to undergo a bronchoscopy before and after treatment for months
Willing to take Progesterone
Willing to set a quit date within weeks of enrollment date
Patients who are willing and capable to follow the instructions required to complete the study
Willing to make a quit attempt within week of enrollment
The patient must be willing to provide blood, urine, stool and saliva samples as required by the study
Willing to come to MSK main campus for baseline and follow-up MP-MRIs
Be willing to allow for investigators to collect archival tumor tissues from surgical procedures that may have been performed before or after enrollment into this trial for research purposes (in-house cases and/or outside cases). These samples will be obtained by study staff as long as subject continues on follow-up. Blocks of tissue will be requested, and if blocks are not able to be obtained, micron slides (-) will be sufficient
Be willing to be injected with C-methyl-L-tryptophan (C-AMT)
Able and willing to undergo anal cytology, anal molecular testing, and high resolution anoscopy with targeted anal biopsies
Willing to provide existing relapse-confirmatory DLBCL tumor sample
Patients must be willing and able to adhere to a special low-carb diet - hours prior to and fast - hours prior to every F-FDG PET scan
Willing to sign release of information for any radiation and/or follow-up records
Patients must be willing to undergo serial imaging procedures
Willing and able to undergo colposcopy and biopsy and endocervical curettage within weeks after study Visit .
Willing to use electronic (e)-cigarettes
Willing to abstain from cruciferous vegetable consumption other than the study vegetables during the study period
Willing to avoid cruciferous vegetable intake during the study period ( weeks)
Willing to maintain contact with the investigators for months
Willing to allow blood collections
Patients must be willing to be audio recorded during the sessions
Participants not willing to complete interviews or survey instruments (usability test and RCT)
TIPs INCLUSION: Willing and able to attend in person TIPs training sessions
Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
Able and willing to complete the entire study
Should be willing to submit local HSV- serostatus within days prior to enrollment.
Able and willing to complete the entire study