• Will utilize the Mayo Clinic Biobank to identify randomly- selected individuals encompassing the age span of 25-65 years old.
• No history of diabetes.
• Reside within a 100 mile radius of Mayo Clinic, Rochester, MN.
• Individuals who have expressed interest in participating in research will then be contacted and invited to participate in the study.

• Age < 25 or > 65 years old (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 ≥ 6.5%.
• Use of glucose-lowering agents.
• 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.
• Hormone therapy >0.625 mg premarin daily.

• Up to 60 weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester will be recruited.
• Potentially eligible subjects who express a desire to be contacted by the research team will be invited to meet with the PI and / or another member of the study team.
• Interested subjects will come to the Clinical Research Trials Unit for a screening visit.

• Age < 25 or > 65 years old (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 ≥ 6.5%.
• Use of glucose-lowering agents.
• 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.
• Hormone therapy >0.625 mg premarin daily.

• Female patients age 18 years and greater.
• Willing and able to give informed consent.
• Mastectomy with immediate reconstruction using tissue expander or direct to implant.

• Antibiotic use within 14 days of operation.
• Prior history of breast implant placement.
• Male patients.
• Vulnerable subjects (prisoners, institutionalized individuals).
• Non-English speaking patients without adequate interpreter assistance.

• Male and female volunteers aged 18-80 years old.
• Persistent upper gastrointestinal symptoms (nausea, vomting, bloating, post prandial fullness or post prandial pain) for > 6 months.
• Having capacity to provide written informed consent before participating in the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
• Undergoing a clinically indicated a gastric emptying study or having completed a gastric emptying study.

• Severe nausea or vomiting, which may preclude study assessments.
• Use of medications that, in the opinion of the investigator have the potential, to alter GI motility (e.g., narcotics, medications with significant anticholinergic effects, prokinetic agents) and which cannot be discontinued for 4 half-lives prior to the imaging studies.
• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  A history of inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis).  However, participants with microscopic or collagenous colitis will be eligible to participate.
• Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy).  Appendectomy, cholecystectomy, tubal ligation,  hysterectomy, herniorrhaphy, and limited colonic resection are permissible.
• Participants who are allergic to eggs or decline to consume milk.
• History of radiation therapy to the abdomen.
• Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire 11.
• Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*
• Pregnant women, breast-feeding women, prisoners and institutionalized individuals.*
• Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain.
• Positive tissue transglutaminase antibodies (TTG).
• Poor peripheral venous access, if central venous access is not available.
• Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.

• Smokers of Hookah (shisha tobacco).
• 18 years of age or older.
• Able to participate fully in all aspects of the study.
• Understand and verbally consent to participate in the study.
• Has the ability to have 25 cc of blood drawn over the course of 2 hours through a catheter.

• Study subjects not meeting the Inclusion Criteria above.

• Subjects 18 years and older.
• 80 healthy individuals employed at Mayo Clinic, Rochester MN. 

• Subjects under the age of 18.
• Pregnant women.
• Subjects with a history of liver or kidney disease, acute illness, taking medications (such as glucocorticoids).
• Subjects who have conditions (such as chronic inflammatory muscular diseases or Cushing’s syndrome) that affect muscle mass.
• Individuals with pacemakers and implantable cardiac defibrillators.
• Individuals who conduct any other type of resistance training (> 45 minutes/week).
• Individuals who have regular “high” alcohol consumption (> 80g/day on 5 days a week).
• Subjects unable to consent to or participate in the 16-week EMS intervention or be available for follow up.

• Ages 9+ years old.
• Scheduled for surgical intervention (e.g., joint preservation surgery).

• Unable to consent due to mental faculty.
• Pregnant women.
• Non-English speaking patients.
• Prisoners or other vulnerable populations.

• Up to 40 weight-stable, non-diabetic subjects will be recruited from Biobank participants at Mayo Clinic, Rochester.
• Potentially eligible subjects who express a desire to be contacted by the research team will be invited to meet with the PI and / or another member of the study team.
• Interested subjects will come to the Clinical Research Unit for a screening visit.

• Age < 25 or > 65 years old (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 ≥ 6.5%.
• Use of glucose-lowering agents.
• 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.
• Hormone replacement therapy > 0.625 mg premarin daily.

• Histologically confirmed primary or recurrent invasive breast cancer with plans for adjuvant radiation therapy at the Mayo Clinic.
• Oligometastatic breast cancer (≤ 3 sites of metastases) is permitted provided that the disease is managed with curative intent.
• Patients treated with lumpectomy or mastectomy.
• Patients must have indication for regional nodal irradiation.
• Age 18 or older.
• Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts.
• Patients must have completed their final breast surgery including re-excision of margins for invasive cancer and DCIS or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
• Bilateral breast cancer is permitted.
• Positive or close margins is allowed.

• Other active malignancy ≤ 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix).
• Pregnancy or lactation.
• Inability on the part of the patient to understand the informed consent to be compliant with the protocol.

• Newly diagnosed GVHD that meets criteria for Minnesota standard risk.
• Ann Arbor 1 GVHD by biomarkers.
• GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed).
• Any donor type, HLA-match, conditioning regimen is acceptable.
• Age 12 years and up (children < 18 years must also weigh 50 kg or more).
• Patients must be engrafted post-transplant (ANC > 500/μL and platelet count > 20,000). Use of growth factor supplementation to maintain neutrophil count is allowed. 
• Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment. 
• ALT/SGPT and AST/SGOT must be < 5 x the upper limit of the normal range within 3 days prior to enrollment. 
• Signed and dated written informed consent obtained from patient or legal representative.

• Patients currently being treated with any JAK inhibitor including ruxolitinib. 
• Relapsed, progressing, or persistent malignancy requiring withdrawal of systemic immune suppression.
• Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis).
• Severe organ dysfunction including requirement for dialysis, mechanical ventilation or oxygen supplementation exceeding 40% FiO2 within 7 days of enrollment. 
• Creatinine clearance or estimated glomerular filtration rate < 30 ml/min as calculated by institutional practice (e.g., Cockcroft-Gault equation, CKD-EPI equation, etc.).
• A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment .
• Patients receiving corticosteroids >10 mg/day prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds.
• Patients who are pregnant. 
• Patients receiving investigational agents within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of itacitinib.
• History of allergic reaction to itacitinib or any JAK inhibitor.

Arm 1:

• Treatment with oral and/or intravenous FQ antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, delafloxacin) that has been initiated upon, or within 24 hours of, admission to the HIM service or at time of initial Infectious Diseases consultation and lasting > 48 hours.

Arm 2:

• Previously received FQ antibiotics in the past and symptomatic.

Arm 1
•any of the following:

• FQ antibiotic treatment that has been initiated > 24 hours prior to admission that has not yet been completed (e.g., patient is admitted or transferred to HIM or had ID consult when they are already on day 3 of a 7-day course of treatment);
• Active cancer;
• Chemotherapy or radiation therapy within the past 6 months;
• Physical and/or cognitive impairment to the extent that patient cannot be fully assessed for or asked about symptoms of adverse reactions associated with fluoroquinolones;
• Currently pregnant;
• Blood transfusion within the past 4 months;
• Previous bone marrow or organ transplant;
• currently on nucleoside reverse transcriptase inhibitors;
• Pre-existing mitochondrial disease;
• < 18 years of age; 
• Prior treatment with FQs within 1 week of admission;
• Active history of routine alcohol use.

Arm 2:

• Previously received FQ antibiotics in the past and not symptomatic.

PLEASE NOTE:   At this time, only Arm 2 is open to enrollment at Mayo Clinic.

Eligibility last updated 6/2/23. Questions regarding updates should be directed to the study team contact.

• Patients admitted with encephalopathy concerning for non-convulsive seizures or NCSE who can also undergo conventional multi-lead EEG monitoring.
• ≥ 18 years of age.

• Patients who have dermatologic contraindication to the adhesive by which the portable EEG device is attached.
• < 18 years of age.

• Male or female patients with presenting symptoms suggestive of Adolescent Autonomic Dysfunction.
• Able to provide Informed Consent (or parental ability to provide informed consent if under age 18).
• Has a Mayo Clinic Number.

• Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent, non-English speaking) or whose parents are unable to provide informed consent if under age 18.

• Adult male and non-pregnant women 18 years old or older.
• Subject is able to understand the study procedure and provide informed consent.

• Subject is pregnant or breast feeding.
• Patient pregnancy status will be obtained through standard of care at Mayo Clinic per Pre-Procedure Pregnancy Reasonably Excluded Guide (PREG) protocol: http://mayoweb.mayo.edu/sp-forms/mc2700-mc2799/mc2722-13.pdf.
• Subject is unable to provide informed consent.
• Subject has a pre-existing respiratory condition.

• Meets centers’ normal candidacy requirements for cochlear implantation or has already received their cochlear implant.
• Must be able to provide consent to participate.

• For participants that have not yet received their cochlear implant.
• A cochlear abnormality that might prevent insertion of the electrode array.
• Additional handicap that would limit the patient from being able to follow study instructions.

Inclusion Criteria - Part A and B:

• Weakness attributable to ALS and documented SOD1 mutation at Screening Visit 2. 
• A forced vital capacity (FVC) ≥50% of predicted value as adjusted for sex, age, and height (from the sitting position). Participants with stable FVC <50% but ≥45%, whose FVC has not declined by more than 5% in the last 6 months may be considered for inclusion, at the discretion of the Investigator. 
• If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit.
• Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.

Exclusion Criteria - Part A and B:

• History of or positive test result for human immunodeficiency virus. 
• History of, or positive test result at Screening, for hepatitis C virus antibody.
• Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) or vaccination (defined as positive anti-HBs) are eligible to participate in the study. 
• Treatment with another investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering ribonucleic acid, stem cell therapy, or gene therapy is allowed. 
• Current enrollment in any other interventional study.
• Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis (N4-methylthiosemicarbazone)) or pyrimethamine.
• Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.

Inclusion Criteria
•Part C:

• Weakness attributable to ALS and confirmed SOD1 mutation at Screening Visit.
• If taking riluzole, participant must be on a stable dose for ≥ 30 days prior to Day 1 and expected to remain at that dose until the final study visit. 
• If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study. 
• Medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.

Exclusion Criteria - Part C:

• History of or positive test result for human immunodeficiency virus. 
• History of, or positive test result at Screening, for hepatitis C virus antibody.
• Current hepatitis B infection (defined as positive for HBsAg and/or anti-HBc). participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive IgM anti-HBc, and positive anti-HBc) or vaccination (defined as positive anti-HBs) are eligible to participate in the study. 
• Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs), biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering RNA, stem cell therapy, or gene therapy is allowed. 
• Current enrollment in any other interventional study. 
• Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis(N4-methylthiosemicarbazone)) or pyrimethamine. 
• Current or anticipated need, in the opinion of the Investigator, of a DPS during the study period.
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

• Infants born at or after 37 weeks gestational age at Methodist hospital in the level 1 nursery, who currently live in Olmsted County, and will receive primary care within Employee Community Health (ECH).
• Infants born to mothers age 18 or older.
• For multi-gestation births, only the first born child is eligible.
• A score of > 3 on the Infant Unhealthy Growth Factor assessment.
• Families who require interpreter services are eligible for the study as OCPHS Family Home Visiting utilizes interpreters and there are interpreters available in the nursery.

• Those not meeting the inclusion criteria.
• Families with grandparent(s) as primary caregivers or if infant has been determined in nursery to be going to foster care or CPS.
• Families who have previously qualified for and participated in on-going home visits over a period of months to years or who have recently accepted OCPH home visits to be scheduled in the near future and anticipated to span over months to years.

• ≥ 18 years of age.
• Histologic documentation of stage I-IV diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), as defined by the 2016 WHO classification. This would include all entities within this category including germinal center B-cell and non-germinal center B-cell subtypes and those with a double expressor phenotype. Also eligible are stage I-IV high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma, NOS.
• Completion of at least 3 cycles of a rituximab-containing, anthracycline-based combination chemotherapy regimen (R-CHOP preferred but not mandated).
• Negative post-chemotherapy PET-CT scan or negative interim PET-CT scan performed within 2 weeks of the final cycle of chemoimmunotherapy. This is defined as a score of 1-3 on the PET Five Point (Deauville) Scale using the Modified Lugano Response Criteria for Non-Hodgkin’s Lymphoma.
• ANC ≥ 1000 and platelet count ≥ 40,000.
• Negative serum pregnancy test in women of child-bearing potential within 24 hours of initiating RT.
• Signed study-specific informed consent.

• Primary central nervous system lymphoma, primary cutaneous DLBCL, leg type, T-cell/histiocyterich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, or other distinct non-Hodgkin lymphomas arising from large B-cells included in the WHO classification.
• Any absolute contraindications to irradiation.

• Male or female subjects.
• 2 to < 17 years of age.
• Having confirmed or possible CIDP.

• Absence of CIDP symptoms.
• History or family history of inherited neuropathy.
• Diagnosed developmental delay or regression.
• History of thrombotic episode.
• Known or suspected hypersensitivity to Privigen.
• Known allergic or other severe reactions to blood products.
• Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study.
• Pregnant or breastfeeding mother.

• Subjects must be adults with age ≥ 18 years at the time of study entry.
• Subjects with any cancer diagnosis may be included.
• Subjects must be identified as new patients to hematology oncology at Mayo Clinic Florida, Arizona, Rochester, and Mayo Clinic Cancer Center at St. Vincent’s.
• Subjects must be willing to provide informed consent for the study.

• Patients reported to have an estimated life-expectancy of  < 6 months, as assessed by their clinician.
• Patients not willing to complete the Clinical Trials Study survey.

• Subjects 60 years of age or older.
• Able to speak and read English, Spanish or Mandarin.
• Eligible for first allogeneic transplantation based on institutional standards.
• Subjects must have a planned allogeneic transplantation for a hematologic malignancy.
• Any allogeneic graft source or donor type will be permitted. Subjects must provide informed consent.

• Patients meeting the following criteria will be considered eligible for this study:
  • Patient and/or legally authorized; representative must be willing and able to give informed consent/assent for participation in the study;
  • Patient and their caregiver must be willing and able (in the Investigator’s opinion) to comply with all study requirements;
  • Patient must be between 2 and 18 years of age (inclusive) at Screening.
  • Patient must have a diagnosis of DS as defined by:
    • Onset prior to 12 months of age with recurrent focal motor or hemiconvulsive or generalized tonic-clonic seizures, which are often prolonged and triggered by hyperthermia;
    • No history of causal magnetic resonance imaging (MRI) lesion (MRI not required to confirm absence of lesion);
    • No other known etiology;
    • Normal development at seizure onset;
    • Patient must have a documented pathogenic or likely pathogenic genetic mutation in the SCN1A gene associated with DS. Patients with SCN1a testing results only of Variant(s) of Uncertain Significance identified or Negative (no variants of clinical significance identified) cannot be enrolled;
    • Patient has had in the past at least two treatments for epilepsy that either had lack of adequate seizure control (requiring an additional AED) or had to be discontinued due to an adverse event(s);
    • Patient must have experienced 4 or more convulsive seizures (all countable atonic, tonic, clonic, and tonic-clonic seizures) in the past 4 weeks prior to Screening;
    • Patient must currently be taking at least one AED at a dose which has been stable for at least 4 weeks prior to Screening;
    • All medications or interventions for epilepsy (including ketogenic diet) must have been stable for 4 weeks prior to Screening;
    • Patient and/or family (or caretaker) must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.

The patient may not enter the study if ANY of the following apply:

• Patient has one of the following mutations in the SCN1A gene:
  • Thr226Met, Val422Leu, Q1489K, L1624P, L1649Q, or L1670W.
• Patient is currently being treated with a sodium channel blocker including:
  • phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), lamotrigine (Lamictal), or lacosamide (Vimpat).

• Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.

• Patients without BE or EAC or that are not planned for ESD treatment.

• Men and women, aged 18-55 years old.

• Patients with safety contraindications to MRI scanning at 3T. 
• Patients unable to adequately perform the fMRI task due to physical, neurological, or cognitive disability. 
• Patients that demonstrate 3 mm or greater translational head motion during scanning of the fMRI rhyming task data sets. 
• Pregnant women.
• Patients that have implanted medical devices or other safety contraindications for a 7T or 3T MRI exam.

• Patients 18 years or older.
• Patients who have cardiac implantable electronic devices (CIED), whether conditional or unconditional, regardless of the type of device; e.g., ICD, pacemakers, leadless pacemakers, who undergo magnetic resonance imaging (MRI) for any reason.

• Patients under age 18.
• Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks.
• Pregnant patients.
• Patients who cannot provide informed consent because of cognitive dysfunction.

• Patients who are undergoing elective direct current cardioversion, either externally or via the patient’s internal cardioverter-defibrillator.

• Patients under age 18.

• Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks.

• Pregnant patients.

• Patients who cannot provide informed consent because of cognitive dysfunction.

• Premenopausal women (18-50 years old).
• Subjects with endometriosis.

• Postmenopausal women.
• AP diameter when lying supine greater than 32 cm 
• Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
• Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)
• Pregnant 

• Only participants who completed the parent PVDOMICS study will be approached for the L-PVDOMICS Study.  This includes all participants:
  • PH, comparators and controls with a minimum 6 months post-enrollment in PVDOMICS. 
• See the parent PVDOMICS protocol for full details of inclusion/exclusion criteria.
• Any PH, comparators or control participant previously enrolled in the parent PVDOMICS protocol with a minimum of six months post-enrollment.
• Dialysis dependent renal function since the parent study acceptable.

Participant Level 1

• Previously received a heart and/or lung transplant
• In the clinician’s opinion, too ill to perform L-PVDOMICS testing even if limited testing.
• Participants who withdrew from the parent PVDOMICS study.
• Pregnant or nursing.
• Concurrent participation in any pulmonary hypertensioninvestigational drug study or other blinded placebo-controlled drug clinical trial.

Participant Level 2:  

• Transplant other than heart or lung.
• Participants who withdrew from the parent PVDOMICS study.

Participant Level 3:  

• Participants who withdrew from the parent PVDOMICS study.

• Patients aged 0-100 years with clinically diagnosed spinal muscular atrophy (SMA).
• Subjects aged > 18 years who are biologically related to an individual clinically diagnosed with SMA.

• Subjects who are not clinically diagnosed with SMA and are not biologically related to an individual diagnosed with SMA.
• Unaffected children < 18 years of age are ineligible for this study.
• Patients with an allergy to subcutaneous lidocaine or bupivacaine (if undergoing a dermal punch biopsy).
• Subjects unable to consent to the study (or have both parents/guardian/witness sign on their behalf).

• Patients with pouch-related disorders will be recruited from participating sites at the time of clinic visits.
• At the time of enrollment, patients will be classified as having one of four inflammatory pouch conditions (acute pouchitis, CADP, CARP, or CD of the pouch).
• All visits will be standard of care visits, where patients are identified as potential candidates for enrollment based on presentation with a pouch-related diagnosis.
• Following the initial recruitment and data collection, patients will complete online questionnaires at 3, 6, and 12 months following enrollment in the prospective pouch registry.