• Age ≥ 18 years.
• Cytologically or histologically confirmed colorectal cancer.
• Undergoing biopsy or surgical procedures as part of routine clinical care.

• Individuals < 18 years.
• Vulnerable patients.
• Unable to provide informed consent.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Pre-Registration:

• Age ≥ 18 years and ≤ 45 years of age.
• Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy.
• Had a live birth ≤ 5 years prior to pre-registration.
• Pre-menopausal.
• Provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Willingness to provide mandatory blood and urine specimens for correlative research.
• Willingness to provide mandatory tissue specimens for correlative research.

Inclusion Criteria
•Registration:

• Age ≥ 18 years and ≤ 45 years of age.
• Histological confirmation of benign breast disease (i.e., no evidence of DCIS or invasive cancer).
• Registration must be completed ≤ 30 days after pre-registration biopsy performed for this study.
• Hemoglobin ≥ 9.0 g/dL (obtained ≤ 30 days prior to registration).
• Platelet count ≥ 100,000/mm^3 (obtained ≤ 30 days prior to registration.
• Serum creatinine ≤ 2.0 mg/dl (obtained ≤ days prior to registration).
• Negative pregnancy test done ≤ 7 days prior to registration.
• Willing to use contraception while on treatment.
• Provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Willingness to provide mandatory blood and urine specimens for correlative research.
• Willingness to provide mandatory tissue specimens for correlative research.
• Willing to return to enrolling institution for follow-up.

Exclusion Criteria
•Pre-Registration:

• History of breast cancer including ductal breast carcinoma in situ (DCIS).
• Received systemic treatment for any other cancer at any time.
• Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within ≤ 5 days prior to pre-registration and no more than four doses within ≤ 30 days prior to pre-registration).
• Currently taking other agents for the prevention of breast cancer.
• Currently taking anticoagulants.
• Contraindication for aspirin use.

Exclusion Criteria
•Registration:

• No research tissue collected during pre-registration biopsy performed for this study.
• Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • NOTE: no doses within ≤ 5 days prior to registration and no more than four doses within ≤ 30 days prior to registration.
• Co-morbid illnesses/conditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Any contraindication to aspirin use including but not limited to:
  • Bleeding disorders (e.g., hemophilia);
  • Stomach or intestinal bleeding ≤ 6 months prior to registration;
  • Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs).
• Currently taking anticoagulants.
• Any malignancy requiring systemic therapy.
• Currently pregnant or planning to become pregnant in the next 90 days.
• Post-menopausal:
  • Prior bilateral surgical oophorectomy; or
  • No menses for > 1 year with estradiol levels within postmenopausal range, according to institutional standard.

Eligibility last updated 1/3/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Patient:

• Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
  • Patients with new diagnosis ≥ 60 years of age;
  • An antecedent hematologic disorder;
  • Therapy related-disease;
  • Relapsed or primary refractory AML.
• Receiving treatment with either:
  • intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or
  • hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.

Inclusion Criteria
•Caregiver:

• Adult (≥ 18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.

Exclusion Criteria
•Patient:

• Patients with a diagnosis of acute promyelocytic leukemia (APML).
• Patients with AML receiving supportive care alone.
• Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures.

Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.

Case

Eligibility last updated 9/26/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Obese Subjects with Type 2 Diabetes:

• Age ≥ 25 or ≤ 65 years.
• HbA1c ≤ 8.5% (type 2 diabetic subjects).
• HbA1c ≤ 6.5% (obese and lean subjects).
• BMI ≥ 28 Kg/M^2 (Obese subjects with and without type 2 diabetes).
• BMI ≤ 25 Kg/M^2 (Lean subjects without type 2 diabetes).
• Use of sulfonylureas or metformin only (type 2 diabetec subjects).
• For female subjects: negative pregnancy test at the time of enrollment or study.
• No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• No active systemic illness or malignancy.
• No symptomatic macrovascular or microvascular disease.
• No contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit > 35%.
• TSH > 0.4 or < 5.5.
• Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.

Exclusion Criteria
•Obese Subjects with Type 2 Diabetes:

• Age ≤ 25 or ≥ 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
• HbA1c ≥ 8.5%.
• BMI ≤ 28 Kg/M^2.
• Use of insulin or agents other than sulfonylureas or metformin.
• For female subjects: positive pregnancy test at the time of enrollment or study.
• History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• Active systemic illness or malignancy.
• Symptomatic macrovascular or microvascular disease.
• Contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit < 35%.
• TSH < 0.4 or > 5.5.
• Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.

Inclusion Criteria
•Obese Subjects without Type 2 Diabetes:

• BMI ≥ 28 Kg/M^2.
• > 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique.

Exclusion Criteria
•Obese Subjects without Type 2 Diabetes:

• Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
• HbA1c ≥ 6.5%.
• BMI ≤ 28 Kg/M^2.
• Use of any glucose-lowering agents including metformin or sulfonylureas.
• For female subjects: positive pregnancy test at the time of enrollment or study.
• History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• Active systemic illness or malignancy.
• Symptomatic macrovascular or microvascular disease.
• Contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit < 35%.
• TSH < 0.4 or > 5.5.
• Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.

Inclusion Criteria - Lean Subjects without Diabetes:

• Age ≥ 25 or ≤ 65 years (match subjects with T2DM).
• BMI ≤ 25 Kg/M^2). 

Exclusion Criteria
•Lean Subjects without Diabetes:

• Age ≤ 25 or ≥ 65 years (match subjects with T2DM).
• HbA1c ≥ 6.5%.
• BMI ≥ 25 Kg/M^2.
• Use of any glucose-lowering agents including metformin or sulfonylureas.
• For female subjects: positive pregnancy test at the time of enrollment or study.
• History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• Active systemic illness or malignancy.
• Symptomatic macrovascular or microvascular disease.
• Contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit < 35%.
• TSH < 0.4 or > 5.5.
• Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
• Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

• Patients with a diagnosis of soft tissue sarcoma.

• Unable or unwilling to provide informed consent

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

• The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable.
• The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
• In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.

• None.

Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.

• Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).  
• Age ≥ 18 years.
• On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
• NYHA class II-III symptoms.
• able to complete a six-minute walk test.

• Patients experiencing syncope or exertional syncope.
• Patients not experiencing exertional dyspnea.
• Inability to walk.
• Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).

Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.

- History of myelodysplastic syndrome (MDS) or AML

- History of another cancer within 3 years before Day 1 of study treatment, with the
exception of basal or squamous cell carcinoma of the skin that has been definitively
treated. A history of other malignancies with a low risk of recurrence, including
appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate
cancer with a Gleason score less than or equal to 6, are also not excluded

- If female, is pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.

• Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
• Adults ≥ 18 years old.
• Ability to receive and respond to electronic text messages.

• Unable or unwilling to provide informed consent.
• Patients who require Intensive Care Unit admission after surgery.
• Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

• Male or female adults (≥ 18 years old).
• Frequent premature ventricular complexes or documented episode(s) of sustained VT, or evidence of appropriate ICD therapy in patients already implanted with ICDs.
• Structural heart disease, defined as impairment of left ventricular ejection fraction on echocardiography or MRI and/or presence of structural abnormality on imaging (myocardial late gadolinium enhancement on MRI, myocardial wall thinning, hypodensity or calcification on MDCT), and/or borderline, possible or definite diagnosis of arrhythmogenic right ventricular cardiomyopathy according to modified Task Force criteria.

• Contraindications to VT/PVC catheter ablation:
  • Current intra-cardiac thrombus;
  • Unstable angina and other acute or reversible cause;
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic.
• Unwillingness to undergo CT and/or MRI imaging.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Patients:

• Adults ≥ 18 years
• Appointment to discuss osteoporosis management

Exclusion Criteria
•Patients:

• Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment)

Inclusion Criteria
•Clinicians:

• Clinicians who meet with patients to discuss osteoporosis management.

Exclusion Critieria
•Clinicians:

• None

Inclusion Critieria
•PAG Members:

• Adults ≥ 18 years
• Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

Subjects are eligible to be randomized in the study only if all of the following inclusion criteria and none of the exclusion criteria apply. To mirror the STEP-HFpEF trials CAMEO-SEMA will utilize essentially the same entry criteria, except for an EF cutoff. CAMEO-SEMA will use an EF value of ≥ 50% (rather than ≥ 45%) to define HFpEF, to harmonize with the recently published universal definition of HFpEF.59.

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Age ≥ 18 years at the time of signing informed consent.
• BMI ≥ 30.0 kg/m^2.
• NYHA Class II-IV.
• LVEF ≥ 50 % within the preceding year.
• No hospitalizations due to heart failure in the preceding 30 days.
• At least one of the following:
  • Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise;
  • If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):
    • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
    • PA systolic pressure > 35 mmHg;
    • Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
    • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.
  • Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):
    • Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15;
    • PA systolic pressure > 35 mmHg;
    •  
    • LA enlargement (LA width ≥ 3.8 cm or LA length ≥  5.0 cm or LA area ≥ 20.0 cm^2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m^2);
    • LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm;
    • Ongoing use of diuretic therapy for at least 30 days prior to screening.

Cardiovascular-related:

• Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
• Systolic blood pressure > 160 mmHg at screening.
• Planned coronary, carotid or peripheral artery revascularization.
• Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
  • Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.
• Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome,  lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice.  This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive.  Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.

Obesity-related:

• Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
• A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

Glycemia-related:

• HbA1c ≥ 6.5% based on latest available value from medical records, no older than 3 months or if unavailable at local measurement at screening.
• History of type 1 or type 2 diabetes (history of gestational diabetes is allowed).
• Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.

General health and safety:

• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Presence of acute pancreatitis within the last 180 days prior to screening.
• History or presence of chronic pancreatitis.
• End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
• Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
• Known or suspected hypersensitivity to trial product(s) or related products.
• Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.
• Receipt of any investigational medicinal product within 30 days before screening.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
• Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
• Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
• The criteria will be assessed at the investigator’s discretion unless otherwise stated.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/11/23. Questions regarding updates should be directed to the study team contact.

• 18 years or older.
• Diagnosis of Myhre Syndrome.

• Individuals < 18 years of age.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•RISK Primary

• New onset refractory status epilepticus with or without fever.
• Failure to respond to 2 or more first-line anti-seizure drugs.
• Age 0 to 18 years.
• Etiology for status epilepticus unknown:
  • No history of pre-existing epilepsy;
  • No pre-existing major developmental impairment;
  • No evidence of prodromal dyskinesia, hallucinations, or psychiatric symptoms;
  • No evidence of structural, cerebrovascular, neoplastic, metabolic, traumatic, or toxic etiology.

Inclusion Criteria
•RISK Primary

• Epileptiform abnormality on EEG.
• Seizure frequency at least weekly.
• Failure to respond to 2 or more first-line anti-seizure drugs.
• Age 0 to 18 years.
• Clinical and electrophysiological profile not consistent with:
  • self-limited focal epilepsy syndrome;
  • unifocal epilepsy.
• Normal 3T epilepsy protocol MRI (if available).
• Normal epilepsy panel or no evidence of known epilepsy mutations by whole exome sequencing (if available).
• No evidence of autoimmune, cerebrovascular, neoplastic, metabolic, traumatic, or toxic etiology.

Inclusion Criteria
•RISK Retrospective Recruitment Inclusion Criteria (~100 patients):

• Prior diagnosis consistent with NORSE or DRE.
• No evidence of autoimmune, infectious, structural, cerebrovascular, neoplastic, metabolic, or toxic etiology.
• Negative genetic epilepsy panel.
  • Note: No exclusions based on disease-modifying therapies, including immunomodulatory or immunosuppressive treatments (e.g., IV corticosteroids, plasma exchange, intravenous immunoglobulin, and anti-cytokine drugs such as anakinra or tocilizumab).

• Validated autoimmune disorder.
• Smoker.
• Pregnant.
• Weight < 9 kg.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

• Adult patients age ≥ 18.
• Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

• Individuals < 18 years of age.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Age ≥ 18 years.
• Ability to read and write in English.
• Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
• Treatment plan includes chemotherapy.
• Able to provide written voluntary consent before performance of any study related procedure.
• Aim 1 only: after completion of initial chemotherapy.
• Aim 2 only: prior to starting chemotherapy.

• Inability to provide informed consent.
• Exposure to chemotherapy prior to ovarian cancer diagnosis.
• Life expectancy < 3 months or in hospice care or nursing home.

Inclusion Criteria:

• Age ≥ 18 years.
• Ability to read and write in English.
• Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
• Treatment plan includes chemotherapy.
• Able to provide written voluntary consent before performance of any study related procedure.
• Aim 1 only: after completion of initial chemotherapy.
• Aim 2 only: prior to starting chemotherapy.

• Inability to provide informed consent.
• Exposure to chemotherapy prior to ovarian cancer diagnosis.
• Life expectancy < 3 months or in hospice care or nursing home.

• Age ≥ 18 years.
• Primary total knee arthroplasty.
• Patients staying at least one night in the hospital after surgery.

• Individuals < 18 years.
• Same day discharge.
• Revision or partial total knee arthroplasty.
• Corticosteroid use within 3 months prior to surgery.
• Inflammatory arthritis
• Current systemic fungal infection.
• Renal or liver failure.
• Prior adverse reaction to corticosteroid.
• Primary TKA requiring hardware removal.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

• Patients with TOF or TOF-related variants.
• Age ≥ 18 years.
• Planned transcatheter valve placement in native RVOT.

• Individuals < 18 years.
• Non-TOF related variants (i.e., pulmonary stenosis, PA-IVS, etc.).
• Prior catheter or surgical ablation of ventricular tachycardia (VT).

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

• Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
• Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
•  Admission to the system within one year of injury.
• Discharge from the System Rehab as:
  • Having completed inpatient acute rehabilitation;
  • Deceased.
• Signed informed consent and HIPAA authorization forms.
• Reside in the geographic catchment area of the system at the time of the injury.  Patients may be injured outside of the catchment area.
• A US citizen or non-US citizen who is expected to stay in the catchment area.

• Must not have previously been treated at another model system for the injury.
  • Ensures that patients are enrolled into the database by only one model system.
• Must not have completed an organized rehabilitation program prior to the admission to the system.

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

• Is 18 years old or older.
• Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
• Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.

• Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

Patient

• Adults ≥ 18 years with biopsy proven resected NSCLC.
• Appointment to discuss adjuvant treatment of resected NSCLC.

Patient

• Major barriers to providing informed consent (i.e. dementia, severe hearing or visual impairment).

Clinician

• Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC.

Clinician

• None.

PAG Member

• Adults ≥ 18 years.
• Member of the KER Unit PAG.

PAG Member

• None.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years old.
• Presence of fatigue and post exertional malaise.
• Presence of headache
• Clinical diagnosis of post COVID syndrome.
• They have consented to participate in the study
• They have the ability to participate in all aspects of the study.

• Age < 18 years old.
• Pregnant.
• Prior adverse reaction to 14FDG.
• Active implantable medical device e.g. pacemaker, hearing aid implant
• Metallic device e.g. stent, orthopedic hardware in neck
• Using another electronic device at the same time e.g. TENS, mobile phone. 
• Any other condition deemed exclusionary by the study principal investigator

Eligibility last updated 1/26/22. Questions regarding updates should be directed to the study team contact.

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

• Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.

• Patients undergoing surgery with an expected blood loss of less than 135cc.
• Provisions for inclusion of minorities: 
  • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.