• Patient is currently enrolled in the DelIVery for PAH Study (G100017).
• The physician and patient determine that continued use of the PIVoT system is medically advisable.
• Patient is willing to sign and date the Patient Informed Consent Form.

• < 18 years of age. 

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

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.

• Scheduled to undergo tympanostomy tube insertion in the clinic. 
• Children 2 to 21 years old.
• Signed parental consent, and child assent documents as applicable.
• Parent is fluent in English.

• Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
• Anatomy precludes sufficient visualization and access to the tympanic membrane.

• Patients ≥ 18 years of age.
• Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria. 
• Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis. Patients must have a minimum of 2 therapeutic paracenteses in the 30 Days prior to enrollment.
• Not a candidate for (e.g., refused, contraindicated) Transjugular intrahepatic portosystemic shunt (TIPS) or previously implanted TIPS is permanently obstructed or non-functioning.
• Screened for esophageal varices and on optimal management. Absence of contraindications to prophylactic antibiotic use from time of pump implant.
• Life expectancy of at least 6 months following pump implant (approximately 10 months from enrollment).
• Capable of giving written informed consent, willing to comply with study procedures including the 3-month pre-implant observation period and ability to operate and charge the device. 
• Women of childbearing age should use adequate contraceptives. Reassessed at time of implant procedure (Pivotal Cohort Only): 
• Has required a minimum of 5 therapeutic paracenteses in the 3-month observation period prior to pump implant.

• Renal failure defined as serum creatinine higher than or equal to 1.5 mg/dL.
• More than one episode of spontaneous bacterial peritonitis over the previous 6 months.
• Recurrent urinary infections as per standard criteria, defined as 2 or more episodes over the last 6 months.
• Evidence of loculated ascites, as per imaging.
• Hepatocellular carcinoma, exceeding Milan criteria or for which RF ablation is anticipated.
• Pregnant females or females anticipating pregnancy during study period.
• Patients currently enrolled in another interventional clinical study that has not reached the primary endpoint assessment point, or (for pivotal cohort) patients who have previously had an alfapump implanted.
• Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months (corticosteroids at stable dose over the last 4 months but < 15 mg/day, or in tapering doses are allowed).
• Known or suspected hepatic or extra hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for ≥ 3 years.
• History of bladder cancer.
• BM I > 40 presenting a risk for technical difficulties for surgery or catheter implantation.
• Contraindications to general anesthesia.
• Comorbid condition or other reason (example hypertension) that may preclude stopping diuretics after enrollment.
• MELD-Na Score > 18.
• Budd Chiari syndrome (Pivotal cohort only).
• Clostridium difficile infection within the past year.  Assessed or re-assessed at time of pump implant: 
• Acute gastrointestinal hemorrhage requiring transfusions over the previous 42 days.
• Condition that prevents continued cessation of diuretic use.
• Patient condition does not allow the implant procedure to be performed within the limits of acceptable risk (e.g., cardiovascular comorbidities).
• Hepatocellular carcinoma exceeding Milan criteria or for which RF ablation is anticipated.
• ICU admission since enrollment.
• INR ≥ 2.0.
• Platelet count of < 50,000 /μL at the time of implantation, unless the platelet count is ≥ 30,000 / μL and bleeding risk can be satisfactorily addressed with means such as platelet infusion during the implant procedure and/or thrombopoietin receptor agonists.
• Bacterial peritonitis within 4 weeks of implant procedure (this includes peritonitis diagnosed at the time of intervention).
  • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of SBP within four weeks of the implant procedure date.
• Bacterascites within 4 weeks of implant procedure (this includes bacterascites diagnosed at the time of intervention).
  • Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode of bacterascites within four weeks of the implant procedure date.
• Serum sodium < 125 mmol/L.
• Urinary infection within the last 2 weeks.
• Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
• Evidence of renal failure, defined as serum creatinine higher than or equal to 1.5 mg/dL, in the preceding 30 days.
• Evidence of loculated ascites, as per imaging.
• Pregnant females or females anticipating pregnancy during study period.

Eligibility last updated 11/10/21.  Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years
• Willing to provide samples at baseline.
• Cirrhosis
  •where Cirrhosis is defined as:
  • At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis; OR
• If no liver biopsy, the following imaging + laboratory criteria define cirrhosis for the purposes of this protocol:
  • Evidence on imaging, of stiffness, or of varices according to the MOP, AND;
  • Either: FIB-4 > 2.67 OR platelets < 150 (within 180 days prior to consent or during Screening).

• Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
• Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
• Known prior solid organ transplant or bone marrow transplant.
• Current participation in active medication treatment trials at the time of consent for LCN POST.
• Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits.
• Bariatric surgery in the last 180 days prior to consent.
• Known history of fontan procedure-associated liver disease (FALD).
• Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with or prevent follow-up per protocol.
• Current liver-unrelated end-stage organ failures (Dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen, current known active malignancy besides non-melanomatous skin cancer or carcinoma in situ).
• Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent.
• Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis).
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent.
• Documented cardiac cirrhosis.
• Known recent (within the last 365 days) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding.
• Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples).
• Current model for end-stage liver disease (MELD) cut off ≥ 15*.
• Current Child-Turcotte-Pugh (CTP) B or C*.
• Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR).
• Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy*.
• In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) > 2X upper limit of normal (ULN) within 60 days prior to consent or during Screening*.
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent or during Screening*.

*Indicates an exclusion criterion that may depend on laboratory results and other clinical assessments to be ordered during Screening after confirming the participant is otherwise eligible. If the test was performed as standard-of-care in the 60 days prior to consent, it does not need to be re-done for eligibility.  

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

1. The diagnosis of AH will be established on published criteria this is based on:
   1. Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator
   2. Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required.
   3. Subjects with HBV, HCV and/or HIV will be eligible for enrollment 

Exclusion criteria

1. Evidence of other liver diseases such as autoimmune or drug-induced
2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
3. Abstinence of alcohol use > 6 weeks immediately preceding enrollment
4. Hemochromatosis
5. Wilson Disease
6. Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

1. Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator
2. AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits

Exclusion criteria

1. Evidence of liver disease
2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
3. Abstinence of alcohol use > 2 weeks immediately preceding enrollment
4. Hemochromatosis
5. Wilson Disease
6. Active intravenous drug use
7. Prior history of known alcoholic liver disease
8. Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease

CASES: Heavy drinkers with alcoholic hepatitis

Inclusion criteria

1. The diagnosis of AH will be established on published criteria this is based on:
   1. Average daily ethanol consumption of > 40 grams/day for women and > 60 grams/day for men for a minimum of 6 months and within the 6 weeks prior to study enrolment. Judgment regarding daily and yearly alcohol use will be made by the site investigator
   2. Clinical evaluation and appropriate laboratory testing as defined by total bilirubin > 2 mg/dL and AST > 50 U/L. When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required.
   3. Subjects with HBV, HCV and/or HIV will be eligible for enrollment 

Exclusion criteria

1. Evidence of other liver diseases such as autoimmune or drug-induced
2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
3. Abstinence of alcohol use > 6 weeks immediately preceding enrollment
4. Hemochromatosis
5. Wilson Disease
6. Active intravenous drug use

CONTROLS: Heavy drinkers without alcoholic hepatitis

Inclusion criteria

1. Average daily ethanol consumption of > 40 grams /day for women and > 60 grams/day for males for a minimum of 6 months and within the 6 weeks prior to study enrollment. In addition, heavy drinkers who have just become abstinent within prior 2 weeks are eligible to be enrolled. Judgment regarding daily and yearly alcohol use will be made by the site investigator
2. AST and ALT ≤ 50 and total bilirubin levels within normal range. If bilirubin is increased due to a suspected Gilbert's Syndrome, patient may be enrolled if the direct bilirubin is within normal limits

Exclusion criteria

1. Evidence of liver disease
2. Significant concomitant medical illnesses such as uncontrolled congestive heart failure or COPD, or multiorgan failure
3. Abstinence of alcohol use > 2 weeks immediately preceding enrollment
4. Hemochromatosis
5. Wilson Disease
6. Active intravenous drug use
7. Prior history of known alcoholic liver disease
8. Presence of hepatosplenomegaly from the physical examination/radiographic imaging or stigmata of liver disease

• Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30
• Has a global Clinical Dementia Rating (CDR) scale score at screening of 0
• Has a Logical Memory II score at screening of 6 to 18
• Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening
• 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)

• Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline
• Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
• Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
• Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness
• Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment
• Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
• Is clinically judged by the investigator to be at serious risk for suicide
• Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)
• Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM

• Age 18+.
• Diagnosis of reactive lymphoid hyperplasia with or without IgG4+ plasma cells.
• Diagnoses will include but not limited to orbital pseudolymphoma, IgG4-RD, pseudolymphoma NOS, autoimmune pancreatitis, retroperitoneal fibrosis, reactive lymphoid hyperplasia NOS.

• Ages 1-17.
• Malignant lymphoma.

• Volunteers:
  • The volunteer population will be comprised of non-pregnant adults having age at least 18 years.
• Patients:
  • The patient population will be comprised of individuals who present with a cancer diagnosis requiring radiotherapy in the chest or abdominal region
  • Patients must be at least 7 years of age.
  • For each case, the non-FDA approved sequence(s) will only be prescribed if there is evidence that this new MRI technology may add value to the current standard of care (namely, evaluation of breathing motion for radiation planning using 4D-CT alone.) .
  • Only those patients having received 4D-CT as part of routine treatment planning will be considered for this pilot study

• Volunteers:
  • Pregnancy
  • All exclusions associated with routine MRI safety screening apply.
  • We will discourage persons who have previously experienced claustrophobia during MRI scans from enrolling.
• Patients:
  • Pregnancy
  • All exclusions associated with routine MRI safety screening apply.

1. NMOSD/AQP4-IgG positive at time of enrollment, or historically positive sample tested on a reliable assay [ex. cell based assay (CBA), or fluorescence-activated cell sorting (FACS)].
2. Diagnosis of NMOSD
3. Male and female children
4. Age between 2-17 years at time of enrollment
5. Ability to give consent/assent (by patient or caregiver) as appropriate per IRB guidelines
6. Ability and willingness to complete the study

1. Inability to provide informed consent
2. Inability to complete required forms via phone, mail or email.

• Patients with a diagnosis of cervical esophageal diverticulum, with Zenker's as most common, or CP bar (with diagnosis of early Zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments.
• Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

• Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.

Inclusion Criteria:

1. Adults >18years of age
2. Attending Mayo Clinic
3. At least 1 prior documented episode of CDI
4. Presenting with diarrhea with at least 3 bowel movements/24 hours of Bristol type 6-7, no alternative diagnosis
5. Not started on antimicrobial treatment
6. Written informed consent

1. Prior diagnosis of Irritable Bowel Syndrome
2. Fulminant CDI (hypotension or shock, ileus, or megacolon)
3. Severe CDI (WBC >15,000/ul , or creatinine >1.5 mg/dL)
4. Diagnosed Inflammatory Bowel Disease
5. Concomitant laxative intake

1. Healthy donor, or a donor with a specified disease condition
2. Age ≥18 years
3. Full understanding of the requirements of the study and willingness to comply
4. Females of childbearing potential must have a negative pregnancy test prior to the adipose tissue collection
5. Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure

1. Active infection
2. Any evidence or expectation of abnormal wound healing
3. Taking anticoagulant medications (significant amounts)
4. Any illness or condition which in the judgement of the investigator, or the donor’s physician, will compromise patient safety
5. Pregnant or nursing females

• Any patient with optic neuritis or suspected to have an autoantibody mediated optic neuropathy or autoimmune disease.

• None

• Unique adult patients discharging from an inpatient general medicine team (Mayo Clinic Rochester Med 1-14) to home.
• Taking one or more chronic (anticipated to be taken ≥1 year) standing (e.g. not PRN) tablet-or-capsule-delivered medication(s) at time of discharge.
• Paying full-cash price out-of-pocket for outpatient medications (e.g., uninsured or Medicare A/B without Part D coverage).

• Those not meeting the Inclusion Criteria.
• Receiving no e-prescription(s).
• Not signing the research consent.
• Residing as inmates in the Federal Medical Center, Rochester.
• And/or enrolled in an alternate patient medication cost adjustment study.

1. Patients between the ages of 1 day and 100 years of age.

1. Individuals unable to provide consent or assent.
2. Pregnancy women and prisoners will not be asked to participate.
3. Patient considered unsuitable for enrollment in the opinion of the PI.

• Age 18-55 years old.
• BMI 21.0 – 32.0 kg/m^2.

• BMI > 32.0 kg/m^2.
• For the 20 participants who are involved in training - participation in structured exercise (>2 times per week for 30 minutes or longer).
• For the 10 participants in the aerobic arm
  •do not participate in structured exercise > 5 times per week.
• For all participants
  •cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease, orthopedic problems that would keep them from being able to perform leg extensions; medications that are known to have an impact on mitochondrial function: 
  • Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist), smoking, pregnancy. 
  •  

• 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).

• Age 18 or older.
• Able to read, understand, and give written informed consent.
• Receiving or have received care at the Mayo Clinic Rheumatology outpatient clinic in Rochester.
• Patients meeting the 2006 Sydney Classification Criteria for Definite APS.
• Patients who have not had clinical events that fulfill the Sydney criteria, but have a positive antiphospholipid antibody laboratory test.

• Patients not meeting the case definitions listed above will be ineligible.

• Patients 18 years old or older.
• Patients with one or more acute traumatic rib fractures.

• Individuals under 18 years of age.
• Inability to position appropriately.
• Unconscious or heavily sedated.
• Patients who are critically ill such that care should not be delayed for regional anesthesia.
• Vulnerable populations including prison inmates and pregnant patients.
• Overlying skin infection, wound, or dressing/equipment (i.e., chest tube).
• Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
• Known or documented allergy to ropivacaine or other amide local anesthetic.

• 18 years of age or older.
• Patients undergoing bowel resection by any standard surgical approach.

• Female who is pregnant.
• Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.
• Currently receiving or have received chemotherapy in the past 2 weeks.

•  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.

• Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

Eligibility last updated 3/8/23 to match clinicaltrials.gov. Questions regarding updates should be directed to the study team contact.

• Children diagnosed with autism spectrum disorder (ASD).
• Between 2 years, 0 months to 4 years, 11 months of age.
• With less than phrased speech.
• Child must have at least one caregiver willing to participate in the study.

• Children and parents if they do not meet the above inclusion criteria.

   

• Parents or guardians of children who were between 4 and 10 years old at the time of PICU admission at Mayo Rochester in 2022 and discharged home afterwards.

• Parents or guardians who do not speak English. This is recognized as a limitation and the need to study non-English-speaking population in the future.

Eligibility last updated 10/24/22. Questions regarding updates should be directed to the study team contact.

• Patients received platelet-rich plasma (PRP) for knee osteoarthritis (OA) vs patients who received standard care including total knee replacement that are found in Mayo-Epic database.

• < 18 years of age. 

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.