SUB-PROTOCOL AIM A: Platelet count >= 100,000/mm^3
SUB-PROTOCOL AIM A: Hemoglobin >= 9.0 g/dL
SUB-PROTOCOL AIM A: Serum cholesterol =< 350 mg/dL
SUB-PROTOCOL AIM A: Serum triglyceride =< 300 mg/dL
SUB-PROTOCOL AIM A: Serum creatinine =< 1.5 x ULN
SUB-PROTOCOL AIM A: Previously treated patients who have failed, unable to tolerate, or refused other available active therapies
SUB-PROTOCOL AIM A: Patients with a history of interstitial lung disease and/or pneumonia
SUB-PROTOCOL AIM A: Patients with a history of alcoholism, drug addiction or psychotic disorders
SUB-PROTOCOL AIM A: Patients who required therapeutic doses of anticoagulants
AIM 2: Have an actual or potential diagnosis of thoracic cancer
Due to receive at least 6 weeks (for aim 1 and 2) or 12 weeks (for aim 3) of CTX at enrollment
PHASE I AIM 1 (STAKEHOLDER INPUT)
PHASE I AIM 1: Malignant diagnosis in any cancer type at any stage
PHASE I AIM 1: Receiving any type of cancer treatment
PHASE I AIM 1: Life expectancy of at least six months
PHASE I AIM 1: Current outpatient status
PHASE I AIM 1 (STAKEHOLDER INPUT) EXCLUSION
PHASE I AIM 1: Prisoners
PHASE I AIM 1: Pregnant women
PHASE I AIM 3.1 (EVALUATION STUDY)
PHASE I AIM 3.1: Malignant diagnosis in any cancer type at any stage
PHASE I AIM 3.1: Receiving any type of cancer treatment
PHASE I AIM 3.1: Life expectancy of at least six months
PHASE I AIM 3.1: Current outpatient status
PHASE I AIM 3.1 (EVALUATION STUDY) EXCLUSION
PHASE I AIM 3.1: Prisoners
PHASE I AIM 3.1: Pregnant women
PHASE I AIM 3.2 (PILOT STUDY)
PHASE I AIM 3.2: Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU) cancer at any stage
PHASE I AIM 3.2: Receiving surgery and/or chemotherapy treatment
PHASE I AIM 3.2: Life expectancy of at least six months
PHASE I AIM 3.2: Current outpatient status (participation will be suspended during hospitalization)
PHASE I AIM 3.2 (PILOT STUDY) EXCLUSION
PHASE I AIM 3.2: Prisoners
PHASE I AIM 3.2: Pregnant women
PHASE I AIM 3.2: Currently participating in other psychosocial studies
PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL)
PHASE II AIM 2: Malignant diagnosis of breast, lung, or colorectal cancer at any stage
PHASE II AIM 2: Receiving any type of cancer treatment
PHASE II AIM 2: Life expectancy of at least six months
PHASE II AIM 2: Current medical oncology outpatient status (participation will be suspended during hospitalization)
PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL) EXCLUSION
PHASE II AIM 2: Prisoners
PHASE II AIM 2: Pregnant women
PHASE II AIM 2: Currently participating in other psychosocial studies
For Aim 2, all patients must meet the following criteria:
For Aim 2 only: individuals who took part in the focus group
AIM 1 (SURVEY)
AIM 2 (VACCINE EVALUATION)
Meets all inclusion criteria outlined in Aim 1
AIM 2 (VACCINE EVALUATION)
Aim 5: Organization was contacted to participate in Aim 3
Inclusion criteria for Aim 1:
Inclusion criteria for Aim 2:
AIM 2: Having a short message service (SMS) capable mobile phone that is not shared with anyone else
AIM 2: Text messaging more than once a month
AIM 2: Will consider participants from phase 1 of this study ineligible for this phase of the study
AIM 2: Will not re-screen participants who were considered ineligible for phase 1 of this study, as determined from study records
AIM 1-3
AIM 3 ONLY
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Males and females aged 18-50 years
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Subjects must participate fully and be willing to comply with the procedures of the protocol
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Subjects must be co-enrolled in National Institutes of Health (NIH) protocol 08-HG-0059
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Ability of subject to understand and provide written informed consent
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Access to bathing facilities (Cohort 2)
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Ability to swallow capsules or tablets
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Does not meet inclusion criteria
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Any female with symptoms and/or serum hormone levels consistent with perimenopause
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of systemic antibiotics in 12 months preceding baseline sampling
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Family history of toxic epidermal necrolysis
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Known allergy or sensitivity to sodium hypochlorite (NaOCl)
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: History of AD and asthma
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Inability to comply with the requirements of the protocol
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Pregnant or lactating
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Any chronic past or present medical illness, including chronic skin diseases like psoriasis
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Subjects receiving or planning to receive an investigational new drug (IND) agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants
LGBT SUB-STUDY: Participants are healthy volunteers currently living in San Diego Portland, or Albuquerque who attend bars or nightclubs in the LGBT random sample; both current (past 30 day) smokers and nonsmokers will be included in the focus groups and surveys
Normal volunteers, either male or female
Healthy volunteers and normal patients not undergoing endoscopy
EXCLUSION - HEALTHY VOLUNTEERS: Prior or current malignancy
EXCLUSION - HEALTHY VOLUNTEERS: Known kidney disease
For healthy volunteers only: Must have no known medical problems that would make undergoing the scan hazardous to the health of the patient or interfere with the results. In particular subjects should not have any cardiac or immunological disorders as these would likely affect the scan results. Subjects should have had a full physical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
CRITERIA FOR HEALTHY VOLUNTEERS: Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease
Healthy volunteers for the Dosimetry Studies Arm must not\r\n* Have a history of cardiopulmonary conditions requiring any treatment or medical intervention\r\n* Be a current smoker
Participants/volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for “all participants” described above
Healthy volunteers
NORMAL ADULT VOLUNTEERS
PATIENT VOLUNTEERS
PATIENT VOLUNTEERS/CONTRAST ENHANCEMENT SUB-GROUP
Patient Volunteers/Contrast Enhancement Sub-group: Not pregnant or breast-feeding
Patient Volunteers/Contrast Enhancement Sub-group: Ability to lie motionless for up to 5 minutes
NORMAL ADULT VOLUNTEERS:
PATIENT VOLUNTEERS:
Patient Volunteers: Inability to understand the risks and benefits of the study
PATIENT VOLUNTEERS/CONTRAST ENHANCEMENT SUB-GROUP:
Patient Volunteers/Contrast Enhancement Sub-group: Positive urine pregnancy test or currently breast-feeding
Patient Volunteers/Contrast Enhancement Sub-group: Inability to understand the risks and benefits of the study
HEALTHY VOLUNTEERS: Patient is willing to provide informed consent
HEALTHY VOLUNTEERS: Must have no known medical problems and have had a full medical exam within 6 months of the study; if healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures
Normal volunteers
HEALTHY VOLUNTEERS: Age greater than or equal to 18
HEALTHY VOLUNTEERS: Able to tolerate supine position
Healthy volunteers
PART A: Healthy volunteers enrolled from within the Department of Radiology at University of California San Francisco (UCSF)
NORMAL VOLUNTEERS: Be >= 18 years of age
NORMAL VOLUNTEERS: Have a ECOG performance status of 0-2
NORMAL VOLUNTEERS: Be informed of the investigational nature of this study
NORMAL VOLUNTEERS: Have a known allergy to iodinated contrast agent
NORMAL VOLUNTEERS: Have electrically, magnetically, or mechanically activated implants that would preclude MRI
NORMAL VOLUNTEERS: Be using more than one antihypertensive drug
NORMAL VOLUNTEERS: If female, pregnant or breastfeeding at time of consent
NORMAL VOLUNTEERS: Have history of paraproteinemias or multiple myeloma
NORMAL VOLUNTEERS: Have collagen vascular disease
NORMAL VOLUNTEERS: Currently treated for hyperthyroidism
NORMAL VOLUNTEERS: Be receiving any active pharmaceutical treatments for cancer
Healthy volunteers
Severe psychiatric disorders that may interfere with study procedures (though volunteers will not be otherwise screened for psychopathology or drug use, which are prevalent among smokers)