• Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
• Males or females ≥ 18 years of age.
• Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤ 4 days (96 hours) before randomization defined as:
  • ≥ 1 blood culture positive for yeast or Candida; OR
  • Positive test for Candida from a Sponsor-approved rapid IVD; OR
  • Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
• Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤ 12 hours prior to the qualifying positive culture through time of randomization.
• Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
• Female subjects of childbearing potential (all female subjects between 18 years < 2 years post-menopausal unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
• For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.

• Any of the following forms of invasive candidiasis at baseline:
  • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed;
  • Osteomyelitis;
  • Endocarditis or myocarditis;
  • Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection;
  • Chronic disseminated candidiasis;
  • Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract. 
• Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for > 48 hours (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent) ≤ 4 days (96 hours) before randomization.
  • Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible.
• Alanine aminotransferase or aspartate aminotransferase levels > 10-fold the upper limit of norma.
• Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score > 9).
• Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis.
• Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients.
• Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher.
• History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease).
• Planned or ongoing therapy at Screening with a known neurotoxic medication.
• Previous participation in this or any previous rezafungin study.
• Current participation in another interventional treatment trial with an investigational agent.
• Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening.
• Pregnant or lactating females.
• The Principal Investigator (PI) is of the opinion the subject should not participate in the study

• Must be ≥ 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing ≥ 30 kilogram (kg) at time of randomization.
• Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA) matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder.
• For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
• Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG) (antithymocyte globulin-Fresenius [ATG-F] or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded.
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 2 for participants aged ≥ 18 years at randomization or ≥ 60 percent (%) using the Karnofsky performance status for adolescent subjects aged ≥ 16 years at randomization or the Lansky performance status for adolescent participants aged 12 to ≤ 16 years at randomization.

• Had prior allo- HSCT.
• Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in-vivo or ex-vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin).
• Planned allo-HSCT for nonmalignant hematological disorders (example; aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).

• Patients must have histologically or cytologically confirmed papillary thyroid cancer (PTC), follicular thyroid cancer (FTC), or Hurthle cell thyroid cancer (HTC). Follicular variant of PTC or any of the above mixed histology will be allowed, as well as tall cell, insular, or poorly-differentiated thyroid cancers. Patients with anaplastic thyroid cancers (ATC) or medullary thyroid cancers (MTC) are not eligible.
• Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Patients must have radioactive iodine (RAI)-refractory/resistant disease as defined by one or more of the following criteria: 
  • One or more measurable lesions that do not demonstrate RAI uptake;
  • Progressive disease (PD) (new lesion or progression of previously known lesions), as defined by RECIST v1.1, within 12 months of prior RAI therapy;
  • One or more measurable lesion present after cumulative RAI dose of > 600 mCi; or 
  • Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan-positive disease (SUV ≥ 5 in tumor lesion).
• The patient's disease must have progressed on one line of VEGFR-targeted therapy (including, but not limited to, sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib, etc.) as defined by PD per RECIST v1.1 while receiving VEGFR-targeted therapy. Patients who have received more than one line of prior VEGFR-targeted therapy will not be eligible.
• Prior external beam radiation to extra-osseous disease, systemic cytotoxic chemotherapy or BRAF- or non-VEGFR-targeted therapies will be allowed, provided that > 4 weeks has elapsed since receiving prior treatment. Radiation to bone metastases is allowed up to 2 weeks prior to initiation of study treatment.
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status  ≤ 2 (Karnofsky ≥ 60%).
• Patients must have recovered to baseline or ≤ Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy .
• Absolute neutrophils ≥ 1,500/mcL.
• Platelets ≥ 100,000/mcL.
• Hemoglobin ≥ 9 g/dL.
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ≤ 3.0 x ULN for patients with Gilbert's syndrome.
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 x institutional ULN .
• Alkaline phosphatase ≤ 3.0 x institutional ULN; ≤ 5.0 x ULN with documented bone metastases.
• Creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 50 mL/min (if using the Cockcroft-Gault formula).
• Serum albumin ≥ 2.8 g/dL.
• Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis.
• Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg.
• Serum phosphorus, calcium, magnesium, and potassium within institutional normal limits.
• Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test < 1.3 x ULN.
• Patients with a history of human immunodeficiency virus (HIV) infection must be on an effective anti-retroviral regimen utilizing agents that do not strongly induce or inhibit cytochrome P450 (CYP) 3A4, and must have an undetectable viral load measured within 6 months prior to study registration.
• Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
• The effects of XL184 (cabozantinib), nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use an adequate method to avoid pregnancy for 5 months after the last dose of study therapy. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity: 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study therapy. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of < 1% per year. Men who receive study therapy and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of study therapy. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
• WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level < 40 mIU/mL.
• WOCBP and men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 5 and 7 months, respectively, after the last dose of study therapy. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days.
• Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) must inform the treating physician immediately.
• Patients must be able to swallow tablets.
• Patients must be able to understand be willing to sign a written informed consent document.
• Patients with impaired decision-making capacity (IDMC) will be eligible if they have a legally authorized representative (LAR) or caregiver available to assist them.

• Patients must not have had prior treatment with XL184 (cabozantinib), any MET-targeting tyrosine kinase inhibitor (TKI), or any MET-targeting monoclonal antibody (MetMAb), such as onartuzumab.
• Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
• Patients must not have a tumor invading or encasing any major blood vessels, and must not have evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum, or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of XL184 (cabozantinib).
• Patients must not have a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Adjuvant hormonal therapy for history of prostate or breast cancer is allowed.
• Patients must not have received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks, or nitrosoureas/ mitomycin C within 6 weeks, before the first dose of study treatment. Patients may continue on bone-modifying agents (denosumab or bisphosphonates) with caution.
• Patients must not have received radiation therapy:
  • o the thoracic cavity, abdomen, or pelvis within 4 weeks before the first dose of study treatment; 
  • To bone metastases within 14 days before the first dose of study treatment;
  • To any other sites within 4 weeks before the first dose of study treatment.
• Patients must not have clinically relevant, ongoing complications from prior radiation therapy. Palliative (limited-field) radiation therapy is permitted as long as the patient does not have disease progression according to RECIST v 1.1.
• Patients must not have received any type of small molecule kinase inhibitor (including investigational kinase inhibitors) within 4 weeks before the first dose of study treatment.
• Patients must not have received any other type of investigational agent within 4 weeks before the first dose of study treatment.
• Patients must not have a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 msec by electrocardiogram (EKG) within 28 days before the first dose of study treatment.
  • Note: if a single EKG shows a QTcF with an absolute value > 500 msec, two additional EKGs at intervals of approximately 3 min must be performed within 30 min after the initial EKG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
• Patients should not have known, untreated brain metastases or leptomeningeal metastases because of poor prognosis and concerns that progressive neurologic dysfunction could confound the evaluation of neurologic and other adverse events. However, patients will be eligible if metastases have been treated, and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment for metastases is complete and within 28 days prior to the first dose of study treatment.
• Patients must not require concomitant treatment with oral anticoagulants (e.g., warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). The following anticoagulants are allowed: 
  • Low-dose aspirin for cardioprotection (per local applicable guidelines);
  • Low-dose low molecular weight heparins (LMWH);
  • Therapeutic doses of LMWH are allowed in patients without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Patients must not require systemic corticosteroids treatment (≥ 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if ≥ 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy.
• Patients must not have a history of severe hypersensitivity reactions to any monoclonal antibodies.
• Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
• Patients must not require concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, or St. John's wort). Because lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list. Medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, patients will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
• Patients must not have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders: 
    • Congestive heart failure New York Heart Association (NYHA) class 3 or 4;
    • Unstable angina pectoris;
    • Serious cardiac arrhythmias;
    • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment within seven days prior to the first dose of study treatment;
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis [DVT], pulmonary embolism [PE]) within 6 months before first dose.
  • GI disorders including those associated with a high risk of perforation or fistula formation: 
    • The patient has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction;
    • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Complete healing of an intra-abdominal abscess must be confirmed before first dose.
  • Clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose.
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
  • Lesions invading or encasing any major blood vessels.
  • Other clinically significant disorders that would preclude safe study participation:
    • Serious non-healing wound/ulcer/bone fracture;
    • Uncompensated/symptomatic hypothyroidism;
    • Moderate-to-severe hepatic impairment (Child-Pugh B or C).
• Patients must not have had major surgery (e.g., GI surgery or removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment and from minor surgery (e.g., simple excision or tooth extraction) at least 10 days before the first dose. Patients with clinically relevant ongoing complications from prior surgery are not eligible.
• Pregnant women are excluded from this study because XL184 (cabozantinib) has the potential for teratogenic or abortifacient effects, and the effects of nivolumab and ipilimumab on the developing fetus are not well known. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued if the mother is treated with XL184 (cabozantinib), nivolumab, or ipilimumab.
• Patients with ac

• Provision of signed and dated informed consent form.
• Stated availability and willingness to comply with all study procedures until referred to a clinical trial.
• Age 50-85 (inclusive).
• Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia.
• Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function.
• In good general health as evidenced by medical history.
• Adequate visual and auditory acuity to allow neuropsychological testing.
• Fluent in English or Spanish.
• For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan.
• Completed six grades of education or has a good work history.
• Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center.

• Treatment with another anti-amyloid investigational drug or other intervention within 12 months.
• Enrolled in another interventional clinical trial within the last 12 weeks.
• Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
• Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
• History of schizophrenia (DSM V criteria).
• History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria).
• Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
• History within the last 3 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
• Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
• Clinically significant abnormalities in screening laboratories or ECG.
• For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin).
• Participants whom the Site PI deems to be otherwise ineligible.
  • Site PIs should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC would be appropriate.

Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director and Coordinating Center.

• Subjects who have received at least one dose of GSK3377794 in the interventional study.
• Subjects who have either completed the interventional study or have withdrawn from it.
• Male or female subjects.
• Capable of giving signed informed consent prior to the study participation.

• None.

Inclusion Criteria
•Aim 1:

• Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
• Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
• Able to read and understand English.
• Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
• Stroke diagnosis with stroke event occurring within 36 months.

Inclusion Criteria
•Aim 2: 

• Clinical diagnostic testing via laboratory or home-based sleep study indicates diagnosis of obstructive sleep apnea.
• Currently use an appropriate Apple (iOS9 or higher) or Android (4.2 or higher) smartphone device.
• Able to read and understand English.
• Prescribed continuous or auto-titrated PAP treatment for obstructive sleep apnea.
• Stroke diagnosis with stroke event occurring no more than 10 years prior to referral to Center for Sleep Medicine.
• Functional and cognitive  ability to manage smartphone application and PAP device with minimal to no assistance.
• Agree to using a smartphone application and wearable wrist sensor.

Inclusion Criteria
•Aim 3:

• Health care provider (MD, APRN, PA, RN) providing care to patients with OSA and history of stroke.
• Sleep Medicine.
• Primary Care.

• Communication or cognitive impairments that limit ability to read and/or follow directions.
• Currently participating in other lifestyle programs (e.g., active, formal weight loss program or research study; smoking cessation program, etc.).
• Has lost 10lb or 4.5kg or more over the past 4 weeks.
• Other acute or severe health, cognitive, or psychological conditions that prevent participation.
• Self-report of pregnant, lactating, or trying to become pregnant.
• Decide to use different PAP device than ResMED Airsense 10.
• Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night).
• Daily opioid medication use at night.
• Unwilling to discontinue use of any current wearable sensor for the duration of the trial.
• Previous documented history of treatment/referral for claustrophobia.
• Previous PAP use.
• Other conditions determined by a sleep medicine team member that may interfere with full participation in the trial.
• Planning to travel for more than seven consecutive nights during the trial.
• Currently engaging in shiftwork defined as night shift or rotating day and night shifts.
• Unwilling to have an in-person follow-up appointment at the Center for Sleep Medicine in Rochester.

• Age 18+ Years Old.
• Diagnosis of Chronic Lymphocytic Leukemia (B-CLL).

• Pregnant.

• Individuals with spinal cord injury who have received an epidural spinal stimulation implant for return of functional return.
• Individuals who have received an epidural spinal stimulation implant but have since had it removed.
• English speaking individuals.

• Individuals with spinal cord injury who have received an epidural spinal stimulation implant for pain.
• Non-English speaking individuals.

Inclusion Criteria (Prostate Cancer Patients):

• ≥ 18 years of age.
• Able to give informed consent.
• Patients with prostate cancer.
• Patients treated with primary prostatectomy.

Inclusion Criteria (Female Control Patients)

• ≥ 18 years of age. 
• Able to give informed consent.                                                        

Exclusion Criteria (Prostate Cancer Patients): 

• Unable or unwilling to provide informed consent.
• Metastatic prostate cancer – defined radiographic evidence of metastatic disease on pre-procedural testing.

Exclusion Criteria (Female Control Patients)

• Unable or unwilling to provide informed consent.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

• Men and women age 65 years or older.
• Current PD diagnosis with symptoms severity at Hoehn & Yahr (H&Y) stage 1-4 based on an expert assessment (movement disorders neurologist report or telemedicine evaluation).
• Willing and able to continue in follow-up for at least 2 years.
• Willing and able to provide informed consent.

• History of hip fracture.
• Any use of a bisphosphonate drug within the last 12 months.
• Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last 6 months.
• Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months.
• Non-ambulatory; i.e., unable to walk without assistance of another person.
• Undergoing kidney dialysis.
• A diagnosis of multiple myeloma or Paget's disease.
• Unable to speak or read English sufficiently to complete informed consent.
• Any other criteria, which would make the patient unsuitable to participate in this study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol addiction).

• Provide written informed consent.
• Male or female aged ≥ 18 and < 80 years at the time of signing the informed consent for entry.
• Baseline endoscopic biopsy with ≥ 30 eosinophils/hpf in 5 hpf in the stomach and/or ≥ 30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD, without any significant cause for the eosinophilia.
• Prior EGD may be used for eligibility as long as the EGD occurred within 30 days of the first screening visit for the AK002-016 study and was performed and centrally assessed as for the AK002-016 study.
• Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
• A weekly average score of abdominal pain, nausea, and/or diarrhea ≥ 3 on the PRO questionnaire (score from 0–10) and a weekly average TSS of ≥ 10 for at least 2 weeks of screening.
• Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
• If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
• Willing and able to comply with all study procedures and visit schedule including follow-up visits.
• Female patients must be either post-menopausal for at least 1 year with FSH level > 30 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.

Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.

• Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.
• Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to screening.
• Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
• Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
• Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and histology per repeat EGD and symptoms still qualify for enrollment after treatment.
• Confirmed history of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
• History of bleeding disorders and/or esophageal varices considered to be clinically significant by the Investigator.
• Other significant causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).
• Confirmed diagnosis of Hypereosinophilic Syndrome (HES).
• Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
• Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
• Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
• History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled.
• Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
• Positive helminthic infection on Ova and Parasite (O&P) test.
• Seropositive for Strongyloides stercoralis at screening, except for patients with past but resolved disease.
• Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved disease.
• Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
• Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration or 90 days or 5 half-lives, whichever is longer, for biologic products.
• Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant.
• Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.

Surgery Cohort

• Maternal age ≥ 18 years old.
• Pregnant with a congenital anomaly diagnosis.
• Undergoing endoscopic in utero fetal intervention.
• Singleton pregnancy
• Delivery planned at Mayo Clinic.

Control Cohort

• Maternal age ≥ 18 years old.
• Pregnant with normal ultrasound findings.
• Singleton pregnancy
• Delivery planned at Mayo Clinic.

• Delivery planned elsewhere.
• Abnormal fetal karyotype.
• Multiples (i.e. twins/triplets, etc)
• Undergoing open in utero fetal intervention

• Patients with diagnosis of mitral annular calcification (MAC) (case group) and patients coming to the Valve Clinic without MAC diagnosis (control group).
• Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC (case group) or without diagnosis of MAC (control group).

• Subjects unwilling to participate or to provide consent.

• Male and female patients aged 18 years or more.
• Patients with IBD, Celiac disease, and a history of receiving a liver transplant, or potential conditions or on drugs that may predispose them to osteoporosis.
• Ability to undergo a research DEXA scan on Gonda 2.
• Patients able and willing to sign informed consent.

• Patients not meeting inclusion criteria will be excluded.
• Patients unable or unwilling to provide informed consent.
• Patients with metal artifacts affecting the regions of interest.
• Pregnancy.
• Body mass index of more than 30.

Inclusion Criteria
•Patients:

• Age  ≥ 18 years old.
• English fluency.
• No diagnosed severe cognitive impairment.
• Diagnosis of advanced, incurable solid tumor cancer.
• Expected prognosis > 6 months.
• Provide informed consent (written or electronic).
• Ability to complete questionnaire(s) by themselves or with assistance.
• Patient baseline distress score ≥ 4/10 OR identified as having distress that would benefit from program by care team or provider.
• Ability to do first Resilient Living session in person.

Inclusion Criteria - Caregivers:

• Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study.
• Provide informed consent (written or electronic).
• Ability to complete questionnaire(s) by themselves or with assistance.
• Age ≥ 18 years old.
• English fluency.
• No diagnosed severe cognitive impairment.
• Ability to do first Resilient Living session in person.

• As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
• Other psychological co-morbidities such as untreated schizophrenia, bipolar disease.
• Participated in the Mayo Clinic study entitled “Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals with Advanced Cancer Undergoing Outpatient Chemotherapy."

• Male and female subjects between 18 and 64 years of age, inclusive.
• Body mass index (BMI) between 18 and 40 kg/m^2, inclusive.
• Subjects with a diagnosis and history of photoparoxysmal response on EEG.
• Subjects must be stable for 1 month prior to screening. Stable is defined as having no change in concomitant therapy and no worsening in the opinion of the investigator.
• Subjects may be treatment-naïve to AEDs or currently treated with up to 3 AEDs.
• Subjects must have a reproducible standardized photosensitivity range on EEG of at least 3 points in at least 1 eye condition.
• Subjects who agree to remain abstinent, or practice double-barrier forms of birth control, from trial to screening through 90 days after the last dose of IMP, OR males and females of non-childbearing potential who are documented as sterile (i.e., male subjects who have undergone bilateral orchidectomy and female subjects who have undergone bilateral oophorectomy, bilateral salpingectomy, or hysterectomy, or who have been postmenopausal for at least 12 months.

• History of non-epileptic seizures.
• History of status epilepticus in the past 5 years.
• An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results.
• Positive urine drug screen for substance of abuse or upon check in to the trial site. Benzodiazepines are excluded as a drug of abuse, but are allowed as rescue medication or when part of subject's stable concomitant medication at enrollment.
• History of drug and/or alcohol abuse within 24 months prior to screening.
• Consumption of grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 7 days prior to dosing.
• Consumption of more than 1 alcoholic drink within 24 hours prior to dosing. Food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate) must remain stable throughout the trial.
• Extreme physical activity within 24 hours before screening and visit.
• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
• Subject having taken an investigational drug within 30 days preceding screening.
• Use of over-the-counter drugs, herbal medicines, or vitamin supplements within 14 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics within 30 days prior to dosing.
• Subjects who had neurosurgery in last 6 months. -Subjects on a ketogenic diet.
• History of significant sleep disorders, or any disorder or activity that causes sleep deprivation.
• Subjects who work "night shifts."
• Subjects with uncontrolled sleep disorders; subjects should be on a stable dose of sleep medications.
• History of, or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV), and/or HIV antibodies.

• Individuals 25 years of age or over.
• Individuals with a regular schedule of at least 5 working days a week that are not shift work.
• Ability to relocate to the Well Living Lab for four weeks (25 nights).
• Willing to remain in the lab after waking up until all specimens and measures are completed.
• Ability to fulfill scripted tasks, including cooking and cleaning.
• Ability to have blood drawn and urine samples collected one time prior to move-in and two times per week for a four-week period.
• Ability to provide informed consent.

• Individuals with abnormal blood tests of lipids or biomarkers of liver and kidney dysfunction.
• Individuals who are smokers or having quit smoking <1 year prior.
• Individuals who have a respiratory infection.
• Individuals who have signs and symptoms of obstructive pulmonary disease, asthma, heart failure or cardiac arrhythmia.
• Individuals who use corticosteroids, anti-arrhythmic medication, beta-blockers, anti-inflammatory drugs or aspirin.
• Individuals who have occupations with increased air pollution exposure.
• Women who are pregnant or intend to become pregnant during the duration of the study.
• Women who are experiencing menopausal transition.
• Individuals with a history of mood or psychiatric disorders.

Individuals who perform shift work.

• Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
• Age: 18-75 years old.
• Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
• Women of childbearing potential must agree to use a method of effective contraception during study participation.
• Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
• Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.

• History of Abdominal bariatric surgery.
• Weight is greater than 450 lbs. (204 kg).
• Recent use (within the last three months) of any antiobesity medication.
• Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
• Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
• Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
• Hypersensitivity or contraindication to the study medication.
• Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
• Principal Investigator discretion.

• Male or female aged 18 years and older.
• Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle.  Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
• Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer.  Monitoring will include perinatal and neonatal outcome.  Any SAEs associated with pregnancy will be recorded. 
• AIS grade A or B of SCI at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional improvement
• SCI must be traumatic, blunt/non-penetrating in nature and not degenerative.
• Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments.
• Full understanding of the requirements of home exercise program prescribed by physical and occupational therapists.
• Once the nature of the study is fully explained and prior to any study-related procedure is initiated the subject is willing to provide written, informed consent and complete HIPAA documentation.

• Pregnant or nursing, or planning on becoming pregnant during the study period.
• AIS grade of SCI other than A or B at the time of injury.
• Non-traumatic SCI.
• History of receiving mesenchymal stem cell, gene or exosome therapy for any indications.
• History of intra-spinal infection
• History of superficial infection in the index spinal level within 6 months of study.
• Evidence of current superficial infection affecting the index spinal level at the time of enrollment.
• On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
• Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
• Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
• Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline.
• Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater.
• Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes, osteoporosis).
• History of malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
• History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
• Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
• Known allergy to local anesthetics of other components of the study drug.
• Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
• History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry.
• Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment.

• Able to give a written Informed Consent Form.
• Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting).
• Female patients aged ≥ 21 and < 50 years.
• Patient who meets either A or B or both in the following criteria:
  • Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation;
  • Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
• Patient who meets either A or B in the following criteria:
  • Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have reqular menses (i.e., 21-38 days) within 38 days prior to the study participation;
  • Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period 6. Patient has a moderate to severe endometriosis associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation.

• Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
• Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
• Patient has more than five surgical histories in pelvic area.
• Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
• Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
• Patient has a planned surgery during the study.
• Patient had a surgery within 4 weeks prior to the study participation.
• Patient has a planned trip overseas during the study participation.
• Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.

• Patients who are > 18 years of age.
• Patients who are either known to be HIV seropositive or have a positive syphilis serology or who require HIV or syphilis serologic testing as part of their routine care.

• Unable due to cognitive or physical limitations to understand dried blood spot collection instructions or to safely perform finger-stick for DBS self-collection.
• Patients who are unable to give informed consent.

• Males and females, age ≥ 18 years.
• Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either:
  • Deemed a candidate for complete macroscopic resection of the primary sarcoma; OR
  • Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy.
• No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
• Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3.
• Life expectancy greater than 6 months.
• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Ability to provide written informed consent.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

• Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma.  In other words, treatment on this trial would require re-irradiation of tissues.
• Patients with nodal or distant metastases.
• Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
• Any of the following:
• • •  
  • Pregnant women;
  • Nursing women;
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.

• Healthy participants above the age 18 years old.
• Participants capable of performing submaximal exercise.

• Participants less than the age of 18 years and older than 65.
• Participants with compromised cardiovascular or pulmonary function.
• Unable to pedal an exercise ergometer.

• Severe Pneumonia defined as hospitalization for acute (< 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L), OR known current immunosuppression preventing inflammatory response.
• Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.

• A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments).
• Contraindication or known allergy to inhaled corticosteroids or beta-agonists.
• Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation).
• Intubation (or impending intubation) prior to enrollment.
• This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment.
• Do Not Intubate order but does not include a "Do Not Resuscitate" order.
• Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome.
• Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization.
• Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours, or K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved.
• Younger than 18 years of age.
• Pregnancy.

• Age ≥ 18 years.
• Able to provide written consent.
• Patient has given permission to give tumor/blood sample for research testing.
• Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
• Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV.
• Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits.
• Consent to allow blood specimens to be shared with potential external collaborators.
• Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC):
  • FIGO 2019 Stage IB2-IIIC or not a surgical candidate;
  • Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy.

• Other active malignancy ≤ 2 years prior to registration. 
  • EXCEPTIONS:  Non-melanotic skin cancer.
  • NOTE:  If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer.
• Pregnancy or lactation.
• Inability on the part of the patient to understand the informed consent to be compliant with the protocol.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

• Consented adult (18+) male and female subjects who are admitted to the Mayo Clinic Hospital (Saint Marys Campus) Inpatient Epilepsy Monitoring Unit.
• Have a confirmed diagnosis of epilepsy (by a Mayo Clinic Neurologist).

• Subjects who are pregnant or may be pregnant.
• Pediatric patients (< 18 years of age).
• Subjects who are unable to provide consent.
• Those admitted primarily for classification of indeterminate (possibly non-seizure) events.
• Subjects who plan to have more than one additional person in the room with them during nocturnal hours (10 pm – 6 am) (excluding clinical providers).
• Subjects who have an implanted vagal nerve stimulator or other neurostimulation device.
• Patients with implantable drug delivery systems or implanted cardiac devices (including pacemakers and defibrillators).

• Women 18 years of age or older.
• Patients who receive neuraxial anesthesia for elective cesarean delivery.
• Singleton or multiple gestations.

• Age < 18 years old.
• Gestational age < 32 weeks.
• Women whose infants have died or are in the neonatal intensive care unit after delivery.
• Inability to read or understand written English.
• Failed neuraxial anesthesia requiring general anesthesia.

• Men and women.
• Ages ≥ 18 to ≤ 65 years old.
• Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
• Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).

• No contraindication to MRI.
• No implanted devices within the body (shunts, clips, plates, etc.).
• No dental braces or retainer wires.

• Children 0-18-years-old.
• Children who undergo flexible bronchoscopy with BAL as above part of their clinical management.

• Exclusion criteria for the control and PBB groups included the presence of hereditary.
• Respiratory diseases (such as cystic fibrosis), clinical history of primary aspiration, neuromuscular problems.
• Primary or secondary immune deficiencies, invasive infections such as Mycobacterium tuberculosis.

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

Eligibility last updated10/11/22. Questions regarding updates should be directed to the study team contact.