Has inadequate venous access and/or contraindications to leukapheresis
Subject is fit for leukapheresis and has adequate venous access for the cell collection.
Patients must not be on therapeutic anti-coagulation; prophylactic anti-coagulation (i.e., intraluminal heparin) of venous or arterial access devices is allowed
Patients who have undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to study enrollment
Major surgery within 3 weeks of starting study treatment; there is no minimum time requirement for minor procedures such as biopsy or vascular access placement
Patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia but excluding a procedure for insertion of central venous access)
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than that required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first dose of study drug
Major surgery within 28 days of day 1 (does not include central venous access or shunts)
Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
Participants must be >= 2 weeks since any major surgery (excluding vascular access placement, mediastinoscopy, or biopsies performed by an interventional service)
Poor peripheral venous access
EXPANDED ACCESS COHORT: Participants must be experiencing clinical benefit from the 13-506 study drug combination as judged by the treating investigator
EXPANDED ACCESS COHORT: ECOG performance status =< 2
EXPANDED ACCESS COHORT: Platelets >= 50,000/mcL
EXPANDED ACCESS COHORT: Serum creatinine =< 1.5 x institutional ULN OR
Recurrent glioma where injection in either arm A or B of the biologic agent would require access and/or considerable spillage into the ventricular system
Minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy
Participants must be >= 4 weeks since any major surgery (excluding vascular access placement, mediastinoscopy, or biopsies performed by an interventional service)
Patients who have had minor surgical procedures (with the exception of the placement of porta cath or other central venous access) within 7 days prior to registration
Inability to undergo venipuncture and/or tolerate venous access
Adequate central venous access potential
Central venous access, such as a Portacath or Hickman Line
DONOR: Inability to achieve adequate venous access
Major surgery within 28 days prior to the start of BGB324 - excluding skin biopsies and procedures for insertion of central venous access devices
Major surgery, excluding skin biopsies and procedures for insertion of central venous access devices, within 28 days prior to the start of COTI-2.
Adequate venous access (for leukapheresis and blood draws)
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Major surgery within 4 weeks prior to initiating treatment, excluding the placement of vascular access
DONOR: must have adequate peripheral venous access for leukapheresis or must agree to placement of a temporary central venous catheter
Patients with inadequate bilateral peripheral venous or central venous catheter access for the required apheresis to allow generation of the autologous AdHER2 DC vaccine product
At least 7 days after minor surgery (such as central venous access) or biopsy and recovery to =< grade 1 treatment-related toxicity
Regular access to a computer with internet service
Research participant must have appropriate venous access
Poor venous access for study drug administration
Adequate venous access for apheresis as assessed by apheresis team; NOTE: If a central venous catheter is required for apheresis, the patient is not eligible
Suitable venous access for the study-required blood sampling.
Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
Must have internet access at their home via Wi-Fi and carry any kind of smart phone
Requires vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. Factor Xa antagonists are permitted.
Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
Adequate vascular access for leukapheresis procedure (either peripheral line or surgically placed line)
Major surgery (excluding skin biopsies and procedures for insertion of central venous access devices) within 2 weeks of first dose of study drug
Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.
Adequate vascular access for leukapheresis procedure
Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.
Must have adequate venous access for apheresis; (pheresis catheter placement for cell collection is allowed)
Inability to be venipunctured and/or tolerate venous access
Major surgery within 28 days prior to the start of BGB324, excluding skin biopsies and procedures for insertion of central venous access devices
Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment
Have inadequate venous access for or contraindications to leukapheresis
Reliable telephone access so as to be able to receive calls from an interactive voice response (IVR) system (only applicable to patients participating in the optional symptom burden assessment portion)
The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
Must have adequate venous access for apheresis
Subjects must not have inadequate venous access for or contraindications to leukapheresis
The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1
Access to a telephone
Suitable venous access for the study-required blood sampling, including pharmacokinteic (PK) and pharmacodynamic (PD) sampling and blood transfusion support.
Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access
Research participant must have appropriate venous access
Research participant must have appropriate venous access
If research participant is undergoing leukapheresis he/she must have appropriate venous access
Central vascular access device(s) (e.g. infusaport, tunneled central veinous catheter [CVC] &/or peripherally inserted central catheter [PICC] line) providing a combined 3 access ports is advised for all patients
Have had major surgery within 21 days of starting therapy. Placement of a venous access device within 21 days of starting therapy is allowed.
Have access via central line (e.g., portacath)
RECIPIENT: Adequate central venous access potential
MATCHED RELATED DONOR: Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Access to bathing facilities (Cohort 2)
COHORT 3: ATOPIC DERMATITIS PATIENTS: Access to bathing facilities
Patients on therapeutic anticoagulation; Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Adequate central venous access potential
MATCHED RELATED DONOR: Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis, if applicable
HAPLOIDENTICAL RELATED DONOR: Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis (if applicable)
DONOR: Adequate venous access for peripheral leukapheresis, or consent to use a temporary central venous catheter for leukapheresis
Venous access: a double lumen central vascular access device or its equivalent and an additional peripherally inserted central catheter (PICC) line will be required for all patients entered on protocol
Three lumens of central vascular access will be required for all patients entered on protocol due to the need for a dedicated line for continuous infusion cyclosporine
Adequate intravenous (IV) access
Poor or unsuitable venous access
Major surgery (excluding placement of vascular access) ?21 days from beginning of the study drug or minor surgical procedures ?7 days. No waiting is required following implantable port and catheter placement.
Patients who are currently taking Coumadin or Coumadin derivatives other than to maintain patency of venous access lines.
Poor venous access for study drug administration unless patient can use silicone based catheters
Patients without access to the duodenum or ampulla are not candidates for ERCP and stenting
Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
Part 1: have telephone access so they can be contacted by the research nurse
Adequate vein access: consider peripherally inserted central catheter (PICC) or other central line
Poor peripheral venous access
Patients on therapeutic anticoagulation Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Inability to tolerate venous access
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Inclusion of ECP in the treatment of any patient is contraindicated with any of the following:\r\n* Unstable hemodynamics requiring vasopressors or other support measures not amenable to or medically appropriate for continuation during the procedure\r\n* Uncontrolled infection\r\n* Inability to maintain acceptable venous access\r\n* Uncontrolled or uncorrectable coagulopathy
Reliable venous access suitable for weekly study drug infusions
Adequate central venous access potential
Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
No major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Subject with a BMI ?50, which may interfere with access to the surgical site and increase overall operative risk.
Subject is fit for leukapheresis and has adequate venous access for the cell collection.
Patients who have had major surgery within 4 weeks of initiation of study medication, excluding the placement of vascular access
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube) within 28 days of C1D1
Minor surgical procedure(s) within 7 days of enrollment or randomization, or not yet recovered from prior surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ? 1 day before enrollment or randomization is acceptable)
Suitable venous access for the study-required blood sampling.
Suitable venous access for the study required blood sampling (that is, including pharmacokinetic (PK) and biomarker sampling).
Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding.
At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule; minor: central venous access catheter placement).
Undergone major surgery within 28 days prior to first dose of study drug or have subcutaneous venous access device placement within 7 days prior to first dose. Additional Exclusion Criteria For Part D
Inability to be venipunctured and/or tolerate venous access
Major surgery within 14 days before enrollment\r\n* Does not include placement of venous access device, bone marrow biopsy, GVHD diagnostic biopsy, or other routine procedures in chronic GVHD or post-transplantation care
Surgery within 21 days prior to enrollment\r\n* Does not include placement of venous access device, bone marrow biopsy, GVHD diagnostic biopsy, or other routine procedures in chronic GVHD or post-transplantation care
The participant underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization.
Have insufficient peripheral venous access to permit completion of the study dosing and compliance with study phlebotomy regimen
Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.
Suitable venous access for the study-required blood sampling.
Adequate venous access - consider peripherally inserted central catheter (PICC) or central line
Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements
Adequate IV access
Suitable venous access
Suitable venous access for the study-required blood sampling
Inability to obtain venous access in the antecubital region to administer PHO or sedation for endoscopy procedures
Participants who will have a central access catheter or a peripheral intravascular central catheter (PICC) should schedule this procedure at least 10 days prior to the start date of study drug
Incomplete recovery from any prior surgical procedures or had surgery =< 4 weeks prior to registration, excluding the placement of vascular access
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Recent major surgery within the prior 4 weeks; (mediastinoscopy or placement of a central venous access will be allowed as long as placement was more than 7 days prior to receiving study drug)
Minor surgical procedures except placement of tunneled central venous access device within 3 days prior to enrollment
Less than 7 days have passed from core biopsies or other minor surgical procedures excluding placement of a vascular access device
Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
Must have adequate venous access for apheresis.
Adequate IV access
All prospective participants must have an Ommaya reservoir (or equivalent ventricular access device) inserted as part of their standard clinical care prior to initiation of study treatment
Local access to commercially available GSK2110183.
A vascular access device (port) or other central venous access for administration of chemotherapy is recommended
Central venous access, such as a Portacath or Hickman Line
Absence of central venous access for administration of the study drug
DONOR: Donor must consent to placement of a central venous catheter in the event that peripheral venous access is limited
The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization
Local access to commercially available GSK2118436
No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
Major surgery within 28 days of starting study treatment; there is no minimum time requirement for minor procedures such as biopsy or vascular access placement
At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)
Patients must have adequate access for leukapheresis procedure as assessed by staff from the Memorial Sloan-Kettering Cancer Center (MSKCC) Donor Room
Reliable telephone access to receive calls from an interactive voice response system (IVR) (only applicable to patients who will participate in optional symptom burden assessment)
DONOR: Inability to achieve adequate venous access
DONOR: Inability to achieve adequate venous access
Adequate central or peripheral vascular access for leukapheresis procedure
Adequate venous access
Adequate venous access
Has suitable venous access for the study-required blood sampling.
Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ? 1 day before enrollment is acceptable)
Must have a pre-existing central venous access such as a port, Hickmann catheter or a peripherally inserted central catheter (PICC line) or be willing and able to have one inserted.
Caregiver: Must demonstrate basic computer literacy skills, defined as at least one-hour per week spent using a computer, and have access to an internet terminal (required for the use of oNCF testing)
Central venous access
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug
Subjects with sufficient vascular access to accommodate the RBCx procedure as determined by the medical staff responsible for obtaining intravenous access.
Suitable venous access for the study-required blood sampling, including pharmacokinetics.
Adequate venous access for repeated blood sampling according to study schedule;
Suitable venous access for the study-required blood sampling for MLN4924 pharmacokinetic (PK) and pharmacodynamic assessments.
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Does the subject have adequate venous access?
Central venous access
Adequate venous access
Suitable venous access for the study-required blood sampling
Suitable venous access
Suitable venous access for the study-required blood sampling
Adequate venous access
Minor surgical procedures, placement of tunneled central venous access device within 3 days prior to randomization/enrollment
Use of venous access devices made of materials other than silicone for the infusion of ganetespib; patients with these devices are eligible as long as the device is not used for the infusion
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization
DONOR: Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis
Must have access to a telephone; if a patient does not have access to a phone or has difficulty paying for minutes for a mobile phone, the research team should contact the Wake Forest investigators or site coordinators to arrange for assistance
The patient must have access to a telephone and phone number where they can be reached
Regular access to a smart phone, tablet or computer
Have reliable internet access
People without internet access
Consistent daily access to a smartphone
No access to a smart phone or text messaging plan less than 150 messages per month
Daily access to a telephone
Have access to the internet during the 4-hour online course and at least once per month to participate in post-training virtual meetings, discussion board postings, email, and periodic audio chat conferences
Have access to a computer, tablet, or smartphone (iPhone or Android) with built-in camera and microphone
Internet access through computer, laptop, tablet, or other mobile device
Have regular access (e.g. home or work) to high speed/satellite broadband Internet on desk/laptop or wireless iPad, Android or iPhone throughout the 3 months of the study\r\n* Several iPads with wireless plan will be available to women who are eligible, but do not have computer access
Wireless internet connection or a home computer that is connected to the internet
Patients who do not have home access to the internet
Have access to a telephone
Ability to access the internet and watch videos online
Subject is fit for apheresis and has adequate venous access for the cell collection.
Lack of suitable venous access for the study-required blood sampling for TAK-659.
Do not have access to at least one intervention format
Has internet access at home
PATIENT & PARTNER: Have access to internet connectivity
Have access to a phone for contact with health coach
Usability Testing and the randomized control trial (RCT): have access to a computer, a smartphone or an i-Pad/tablet equivalent with internet access
Telephone or email access and agreement to engage with the research personnel via phone or email
Access to either wireless internet (WiFi) or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team)
History of difficult intravenous access
Lack of internet and email access
The participant has access to the internet
The participant has access to short message service (SMS) text messaging or email
Patient must have telephone access to be contacted by the research staff
Phase I: Access to the internet
Phase II: Access to the internet
Eligible patients must have access to a mobile phone with internet and text messaging capabilities
Eligible patients must be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
Patients with no regular access to the internet or a mobile phone and those who are unable to fill out forms on the web or navigate websites
Access to refrigerator or freezer
Patient must have access to the internet through computers or mobile devices (smart phones and tablets)
Have access to mobile hot spot, wireless internet, and/or cellular service
Patient must have home internet or smartphone access
Have high-speed access to the internet at home or work; this could be broadband, digital subscriber line (DSL), and/or access on a smartphone or tablet via a wireless provider
YBCS: Access to an internet connection
HCP: Access to an Internet connection
DCG: Will be able to access internet (phone, computer, etc.)
Patients must have the ability to access the internet at least once per week, and this can occur in the patient’s home, relatives’ homes, work setting, or Dana-Farber (in addition to coffee shops, libraries, etc. if applicable); having a computer is not required; an iPad will be provided to any patient who needs one for the duration of the study
Has internet access
Surgery that would not allow access to at least one P6 site
Patients must have regular access to a computer or tablet with internet access
TECHNOLOGY REQUIREMENT: Patients willing to provide their own internet access for this study; this will include either a data plan or wireless-fidelity (Wi-Fi) access on the patient’s smart phone for use of the Jawbone App; they will also need internet access (through their smart phone or home computer) for setting up a Self-Generated Health Information Exchange (SGHIx) account; patients are welcome to use the free guest Wi-Fi access within the Duke outpatient clinic area for the purpose of this study
SUBJECT: Have regular access to a computer (either personal computer [PC] or Mac with a built-in Universal Serial Bus [USB] port).
Inability to access a computer with internet or inability to use a computer with internet provided by the study as indicated by self-report
SUPPORT PROVIDER: Inability to access a computer with internet or inability to use a computer with internet provided by the study as indicated by self-report
Unreliable phone access
Participants are also required to have access to internet; either through their cell phone, home, or secondary location
Have access to the internet and an active email account
Have access to a computer with an internet connection at home
Have access to and are able to use the internet at a minimum of once per week
PHASE I AIM 1: Internet access at home
PHASE I AIM 3.1: Internet access at home
PHASE I AIM 3.2: Internet access at home
PHASE II AIM 2: Internet access at home
Research participants who have no computer and internet access and/or do not use a computer even if one is present in the household
Has access to a personal computer with internet access
PHASE II: Has home internet access
Telephone access
Have access to the internet and a computer, tablet, or smart phone, and
Participant must have access to a working telephone and be willing and available to participate by this modality as needed
Verification of a functioning email address and access to electronic device(s) capable of charging and syncing the FitBit
Patients must have working email address and internet access
Access to email and a computer with internet
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Must have access to either wireless Internet and a phone capable of receiving text messages
Patient must have telephone access to be contacted by the research nurse
Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices
Access to smartphone device compatible to sync with PAM device
Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
No regular access to the internet and not able to fill out forms on the web, communicate by email and navigate websites
Patients have internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the Cancer Center
Access and ability to use a computer for completion of online measures
Wi-Fi internet access at home (estimated at > 75% of the SJLIFE cohort)
Participant must have telephone access and agree to engage with telephone access with the research personnel
CANCER PATIENT GROUP: Has access to a smartphone or computer with internet capabilities
NON-CANCER PATIENT GROUP: Has access to a smartphone or computer with internet capabilities
Have access to an International Business Machines (IBM)-compatible or Macintosh personal computer with Internet access (either in home or at a community center)
Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
Patients: Telephone access
Stage II only: have access to the Internet or a smart phone
Access to a telephone, computer (e.g. desktop, laptop, smartphone, tablet), and internet
Have telephone access to be contacted by the research nurse/coordinator
Patients who have home access to a computer, or compact disc audio player
No access to a computer, or compact disc audio player
No access to the internet in a private location
Access to a computer at home or public location
Have access to a telephone
Have a computer, laptop, smartphone, or tablet with internet access
Have access to a mobile phone
Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
Patients with no regular access to the internet or a mobile phone or who are unable to fill out forms on the web or navigate websites
Have reliable internet and daily access to computer with audio/speakers
Reliable internet access
Has access to and is able to operate a computer with internet access
Have access to a mobile phone
Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
CAREGIVER: Have access to a mobile phone
CAREGIVER: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
If participants are unable to access a computer they will be excluded
Limited or no access to a touch tone phone
Have access to high speed internet
Have access to a healthcare provider and be willing to share genetic results with that provider
Unable to access the internet
Have access to a DVD player or computer that can play DVDs
Adults with access to the Internet or ability to travel to Washington University to participate in person; despite a recruitment focus in St. Louis, residency is not required for participation
Patient must have access to a smart phone with Android 4.3 or later or iOS 7.1 or later or computer (laptop/desktop) with a connection to the internet to create an account and be able to sync the Sqord device (accelerometer)
Functioning Central Venous Access Device
Patients who only have a totally implanted port as their central venous access will not be eligible for this study
Internet access (daily).
Regular access to an internet-enabled device that can be synched with the Fitbit wristband
Women will be excluded if they are established colposcopy clinic patients, have a known diagnosis of cancer; are pregnant, incarcerated, or unable to consent; or do not have access to a working contact phone number
No daily internet access
Access to devices that play DVDs
Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel
Has access to a computer or mobile device with wireless internet
Have access to a cell phone with unlimited texting ability and have knowledge of text messaging
Lack telephone access
Regular access to computer with a reliable internet connection
Access to phone
PILOTS I, II AND III: Have access to internet
Healthy post-pubescent teens with access to a telephone
Have access to a telephone or mobile phone
Access to smart phone or computer with internet access.
Any patient who does not have Internet access
Internet access and a compatible device\r\n* If patients do not own a compatible device the study team may loan a device to be returned at the end of the study
Lack access to a telephone
Participants who report not having access to an internet-connected computer with a modem through home, work, or their community (public library, community center, neighbor’s house, etc.)
Have access to a telephone
No access to a telephone
PHASE II: Must indicate telephone and internet access
Access to either a smart phone or computer on a daily basis to sync Fitbit data to the data repository
Participants must have access to a telephone
Has email address and internet access to complete online surveys
Participant must have adequate venous or central access for irinotecan administration
Major surgery within 28 days of starting study treatment; there is no minimum time requirement for minor procedures such as biopsy or vascular access placement
Individuals that do not have access to a working telephone
Patients who are unable to have placement of intravenous line access
Inadequate venous access per assessment of treating health care provider
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [carbon C 13 (1-13 C)] pyruvate injection)
No known problems with peripheral IV or central line access
Inadequate venous access (a single antecubital or equivalent venous access sites are required for study drug injection)
Patients must be able to lie flat to obtain the functional scans or have blood access for blood samples
Agrees to allow access to clinical records regarding response to treatment and long term follow up
Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [ 18 F] 4-L-Fluoroglutamine (2S,4R) injection and blood draws)
Patients must agree to allow access to clinical records regarding response to treatment and long term follow up
Subjects who have vascular access ports or other implanted devices rated as anything other than “safe” or “conditional 6”
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of 18F SKI-249380 injection and blood draws)
Presence of any indwelling line or drain. Note: Dedicated central venous access catheters such as a Port-a-Cath are permitted.
Subjects with a central venous line
Subjects who have vascular access ports or other implanted devices rated as anything other than “Safe” or “Conditional 6”
Inadequate venous access
Inadequate venous access per assessment of treating health care provider
Inadequate venous access (two antecubital or equivalent venous access sites)
Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
Internet access\r\n* If patients do not own a compatible device the study team will loan a device to be returned at the end of the study
Patient has esophageal narrowing limiting access to the intended sites of ablation
Access to a telephone
Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
Must have internet access and a valid email address
Patients must have access to a computer or smartphone and internet connection at home on which they would be willing to do a telehealth study
No access to a computer, smartphone or internet
Has access to telephone
Must have telephone access and agree to engage with research personnel using telephone (PCS study)
No home access to internet (PCS study)
Mothers must have ready and consistent access to a telephone to participate in the trial's assessments
Own a cell phone, are able to send and receive text message and access the internet, and
Suitable venous access for the study-required blood sampling (including pharmacokinetic [PK] sampling).
Able to access a computer, tablet or smartphone at home or public location
Access to a device capable of receiving plain text messages
Suitable venous access for the study-required blood sampling that is, including PK and pharmacodynamic sampling.
Suitable venous access for the study-required blood sampling (including PK sampling).
Suitable venous access for the study-required blood sampling (that is, PK).
Suitable venous access for the study-required blood sampling, including PK and pharmacodynamic (PD) sampling.