• Female participants must have histologically or cytologically confirmed invasive breast cancer
• Presence or suspicion of recurrent or metastatic breast cancer is required, and only those for whom a biopsy is clinically recommended will be included (biopsy cannot be for research purposes only)
• Male participants must have biopsy proven breast cancer
• All participants must be able to understand and willing to sign an informed consent document.

• Dementia 
• Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent 
• History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
• Any other condition, which in the opinion of the patient’s treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.

• Women and men aged 18 – 100 years
• Repeat fractures
• Presence of normal or near normal bone mineral density measured by DXA (spine and hip BMD Z-scores (for patients under 50) or T-scores (for patients over 50) above -2.0.

• Adults lacking ability to give informed consent
• Women who know they are pregnant.      

• Children aged 0-17 years falling into one of the 10 major diagnostic categories.
• At least one parent accompanying.
• Children aged 5-17 years, and accompanying parent, must be able to speak English or Spanish.

• Children aged 5-17 years who are unable to verbally communicate.
• Cognitive impairment / developmental delay precluding ability to answer questions.

• Individuals identified radiographically or pathologically with an intracranial or intraspinal cavernous malformation will be included in this study
• Electronic medical record states they were told of the finding of a cavernous malformation

• Patients ≥ 18 year
• Polycystic liver, defined by > 20 liver cysts on imaging

• Patients unable to speak or read the English properly
• History of kidney or liver transplantation
• Dialysis
• Current use of experimental drugs (e.g. lanreotide, octreotide)
• Recent liver resection or major surgery
• Other comorbidities that can affect the outcome of the questionnaire, as deemed by the investigators

• Patients must be 18 years of age or older. 
• Patients must have signed an informed consent form

• Patients who are currently scheduled for a clinical MRI scan for inner symptoms (hearing loss, tinnitus, etc.) who do not meet clinical criteria for Meniere’s disease.

• Prior ear surgeries

• Children who are undergoing a sleep study (polysomnography) for clinical purposes

• Refusal to participate

• Olmsted County residents ages 30+ are eligible to participate.

• Non-Olmsted County residents are not eligible.

• Patients that have a pacemaker 
• >18 years of age

• Patients that do not have a pacemaker 
• <18 years of age
• Patients with other metal or devices that cannot be removed from their body will also be excluded.

• Adult patients ≥18 years old with bicuspid aortic valve diagnosed by echocardiogram.
• Adult patients ≥18 years old without bicuspid aortic valve.
• Able to provide fully informed consent.
• For retrospective analysis/repository:
  • Patients who indicated Yes to MN Research Authorization.

• For retrospective analysis/repository:
  • Patients who indicated No to MN Research Authorization.

Inclusion Criteria

• Male, 45 years of age or older.
• Diagnosis of prostate adenocarcinoma.
• Clinical stage T1c or T2a.
• Gleason score of 7 (3+4 or 4+3) or less.
• Three or fewer biopsy cores with prostate cancer.
• No single biopsy core with greater than 50% of tumor involvement.
• One, two, or three tumor suspicious regions identified on multiparametric MRI
• Negative radiographic indication of extra-capsular extent.
• A documented Karnofsky performance status of at least 70.
• Estimated survival of 5 years or greater, as determined by treating physician.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent.
• MR-guided biopsy confirmation of one or more radiographically visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.

Exclusion Criteria

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• History of other primary non-skin malignancy within previous three years.

Inclusion Criteria

• Study Participant
  • 18 years of age or older
  • Has cancer or an autoimmune disease
• Healthy Control
  • Does not have any autoimmune disease
  • No history of cancer
  • Non-smoker

Exlcusion Criteria

• None

• Individuals age 0-100 yrs. with DPD deficiency and symptoms of ID
• Unaffected adult biological parents and/or siblings

• Subjects with allergy to subcutaneous lidocaine, bupivacaine, or epinephrine.

• No abdominal surgery (except appendectomy and cholecystectomy)
• Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter

• History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.
• History of gastroenteritis in six months prior to Campylobacter enteritis
• Pregnancy

• Patients greater than 18 years of age

• Patients who cannot be placed in the supine position and hold their breath for 20 seconds or less
• Patients who are claustrophobic
• Patients with more than minimal pleural effusions
• Patients who are pregnant

Inclusion Criteria

• Has a diagnosis of Pancreatic cancer, with at least 1 site accessible for biopsy
• Willing to undergo research biopsy for creation of xenograft
• Ability to provide written consent
• Genetic variant on screening test that affects DNA repair, or a personal/family history of cancer strongly suggestive of such a variant

Exclusion Criteria

• Must have no contraindications to biopsy (e.g. bleeding disorders, or a need for anticoagulation that cannot be safely held or bridged)

Inclusion criteria:

1. All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
2. Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.

Exclusion criteria:

1. Age less than 18 years (Exparel has not been tested in a pediatric population)
2. Pregnant or nursing (Exparel has not been tested in this patient population)

• Subjects with DM1 which is genetically proven or clinically diagnosedFamily members of subjects with DM1 who are affected or unaffected by the disease
• Ability to understand and willingness to sign the informed consent documents
• Age ≥18 yrs

• Unable or unwilling to sign or understand the informed consent documents
• Unwilling to participate in the research
• Unwilling to allow genetic testing
• Unwilling to allow samples to be sent to other institutions for testing
• Not meeting the inclusion criteria

 Inclusion Criteria

• Either gender
• Caucasian ethnoracial category
• ≥ 18 years of age
• Has open angles
• Ability to cooperate for visual testing
• Nonprescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study
• Able to participate on site over the multi-visit study period

Exclusion Criteria

• Has narrow angles with complete or partial closure
• Chronic or recurrent inflammatory eye disease
• Ocular trauma within the past 6 months
• Ocular infection or ocular inflammation in the past 3 months
• Clinically significant retinal disease
• Corneal abnormalities interfering with Goldmann tonometry
• Previous intraocular surgery, except uncomplicated cataract extraction
• Recent changes to systemic medications
  • Must be on a stable regimen for at least 30 days prior to visit 1 regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.)

• Patients admitted to the hospital for initiation of dofetilide or sotalol on the basis of routine electrophysiologic care
• All patients admitted to the hospital for dofetilide initiation will be eligible. 

Inclusion Criteria

• Age 18 or below
• Ability to obtain MRI without sedation
  • This in practice comes down to age > 5-6
• Evaluation at Mayo Clinic by pediatric neurologist for groups 1-3
• Group 1
  • Pediatric onset Multiple Sclerosis
  • Clinically isolated syndrome (single demyelinating event with abnormal MRI of the brain)
• Group 2
  • Non-specific T2 signal change on MRI
  • Clinical history not consistent with MS
  • Acquired or inherited WM disease, e.g. low grade neoplasm, leukodystrophy
• Group 3
  • Patients with epilepsy
• Group 4
  • Healthy controls
  • No neurological disease

Exclusion Criteria 

• Claustrophobia or sedation required to obtain MRI
• Standard exclusion criteria for MRI, e.g.
  • Pacemaker
  • Implanted device
  • Etc

• Children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. Material from adults may be collected as a control group.

• Surgeries where spinal tissues are not being removed.

1. Patients must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:

   1. Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge
   2. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities
   3. Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts
   4. Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole)
   5. Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3, measured by enzyme-linked immunoassay

2. Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease:

   1. No disease manifestations that would be scored as a major element in the BVAS/WG
   2. Absence of any disease feature that poses an immediate threat to either a critical individual organ or the patient's life
3. Age 15 and older
4. Willing and able to comply with treatment and follow-up procedures
5. Both women and men must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, oral contraceptives (birth control pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical sterilization.
6. Willing and able to provide written informed consent with the written assent of those < 18 years of age

1. Presence of involvement that does not meet the criteria for non-severe disease
2. Treatment with CYC within 3 months prior to screening
3. Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment
4. Treatment with prednisone > 30 mg/day for > 28 days immediately prior to study entry
5. Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening
6. Evidence of active infection (includes chronic infection)
7. Patients who are pregnant or who are nursing
8. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen
9. Inability to comply with study guidelines
10. Cytopenia: platelet count < 100,000/mm3, white blood cell count (WBC) < 3,000/mm3 (3 x 109/L), absolute neutrophil count < 1500/mm3, hemoglobin (Hgb) < 8.5 g/dL
11. Chronic renal insufficiency defined by a creatinine clearance of < or = to 20 ml/min
12. Known current use of illegal drugs
13. Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures
14. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
15. Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer)
16. A live vaccination fewer than 3 months before enrollment
17. Current clinical, radiographic, or laboratory evidence of active tuberculosis
18. A history of active tuberculosis within the past 3 years even if treated
19. A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
20. Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
21. Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control (CDC)) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest xray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., CDC) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines.
22. History of herpes zoster that resolved less than 2 months prior to enrollment
23. Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months or past treatment with rituximab or any other biologic B cell depleting agent where the B lymphocyte count remains < 60 cells/uL
24. Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months
25. Treatment with intravenous immunoglobulin or plasma exchange within the past 3 months
26. Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any other biologic agent within the past 3 months or 5 half lives of the agent (whichever is longer)

• Trauma patients who arrive to Mayo Clinic Hospital
  •Saint Marys Emergency Deparment and are classified as Level Red and Yellow activations.
• Male and female patients 18 years of age or older (no upper age limit).
• Blunt and/or penetrating traumatic injuries.

• Are on therapeutic anticoagulation, to include Coumadin/Pradaxa or antiplatelet agents (excluding Plavix, aspirin or ibuprofen).
• Have preexisting coagulopathy (cirrhosis and inherited clotting disorders including Hemophilia A & B, Factor IX, Factor XI deficiencies).
• Patients greater than 12 hours from time of injury.
• Have history of known malignancy (no clinical evidence within 3 months).
• Active diagnosis of sepsis at the time of injury.
• Renal failure on dialysis.
• Patients with thermal injuries ( not including “road rashes”).
• Patients on high dose steroids or autoimmune medications.
• Patients who have experienced traumatic injuries within the past 1 year.
• Known pPregnancy.
• Prisoners.
• Have a preexisting medical condition that, in the judgment of the investigator, would preclude participation in this study.

Inclusion Criteria

• Subject provides informed consent
• Subject is >18 years of age
• Subject is deemed competent for making medical decisions
• Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
• A negative pregnancy test is required in women of child-bearing potential, as standard of care.
• Subject is mentally capable of understanding study procedures.

Exclusion Criteria

Study subject has any disease or condition that interferes with safe completion of the study including:

• Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5
• Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
• Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
• Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements.
• Concurrent participation in another study involving investigational drugs or investigational medical devices
• Absence of or limited access to the pleural space during medical pleuroscopy.
• Inability to read and understand the necessary study documents.

Inclusion Criteria

• Any woman undergoing evaluation for maternal-fetal surgery for myelomeningocele will be included for screening
• If eligible and has the surgery after 12/15/2010, information from surgery will be collected 
• Informed consent to collect this information will be done at their surgical evaluation visit
• If not able to be consented at this visit, they will be called and consented verbally

General Exclusion Criteria

• Intolerance or allergic reaction to a study medication without a suitable management alternative. 
• GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy. 
• Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes. 
• Severe dementia. 
• History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
• Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol. 
• Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke. 
• Patient objects to future blood transfusions. 
• Platelet count <100,000/ml or history of heparin-induced thrombocytopenia. 
• Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. 
• Chronic atrial fibrillation. 
• Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation. 
• Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism. 
• Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization). 
• Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months. 
• Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value. 
• Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment. 
• Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month.  
• Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min. 
• Major (non-carotid) surgery/procedures planned within 3 months after enrollment. 
• Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney). 
• Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2. 
• Inability to understand and cooperate with study procedures or provide informed consent. 
• Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy). 
• Previous ipsilateral CEA or CAS. 
• Ipsilateral internal or common carotid artery occlusion. 
• Intra-carotid floating thrombus. 
• Ipsilateral intracranial aneurysm > 5 mm. 
• Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period.
• Coronary artery disease with two or more proximal or major diseased coronary arteries with ≥ 70% stenosis that have not, or cannot, be revascularized. 

Specific Carotid Endarterectomy Exclusion Criteria 

Patients who are being considered for revascularization by CEA must not have any of the following criteria: 

• Serious adverse reaction to anesthesia not able to be overcome by pre-medication. 
• Distal/intracranial stenosis greater than index lesion.
• Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility – inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel. 

Specific Carotid Artery Stenting Exclusion Criteria 

Patients who are being considered for revascularization by CAS must not have any of the following criteria: 

• Allergy to intravascular contrast dye not amenable to pre-medication. 
• Type III, aortic arch anatomy. 
• Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. 
• Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis. 
• Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion. Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).) 
• Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. 
• Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD). 
• Non-contiguous lesions and long lesions (>3 cm). 
• Qualitative characteristics of stenosis and stenosis-length of the caroitd bifurcation (common carotid) and/or ipsilteral external carotid artery, that preclude safe sheath placement.
• Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. “String sign” of the ipsilateral common or internal carotid artery.
• Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.

Inclusion Criteria:

• Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy.
• Willing and able to consent to research protocol.
• Fasting as required per routine instruction for upper endoscopy.
• Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on.
• Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy.

Exclusion Criteria:

• Non-fasting per protocol, or known to have had food or drink outside of routine protocol.
• Non-English speaking.
• < 18 years of age.
• Unable or unwilling to consent to research protocol.
• Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.).
• Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed).
• Any prior chemotherapy for esophageal cancer
• History of squamous cell carcinoma.
• History of gastric or esophageal surgery.
• Per PI discretion, any current medical problem that could alter intended study data collection.

Eligibility last updated 3/25/22. Questions regarding updates should be directed to the study team contact.

• Adult (18 and older).
• Diagnosed with acoustic neuroma tumors.

• Patients under the age of 18 will be excluded.