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

Eligibility last updated 12/28/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

• Age 18 or older, or, if under 18 years of age, have a parent/guardian over the age of 18 who is able and willing to sign the HIPAA authorization form;
• Have a spinal cord injury;
• Are interested in participating in research at Mayo Clinic;
• Live within the United States

Exclusion Criteria

• Are unwilling or unable to sign the HIPAA authorization form;
• Do not live in the United States

Eligibility Criteria:

• Patients treated with radiation therapy at one of the participating centers.
• Age < 21 years old at time of treatment start.
• Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
• Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
• Patients may be enrolled on the PPCR concurrently with another study or clinical trial.

Exclusion Criteria

• Patients 22 years and older at the time of treatment start.

Patients must meet the following inclusion criteria to participate in this registry.

1. Patient is between the ages of 12 and 65 years old at the time of surgery
2. Has at least one cartilage defect present in the knee joint
3. Has a defect as determined by a medical professional
4. Is a candidate for the surgical use of fresh osteochondral allografts for a primary or revision procedure
5. Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol

Patients must not meet any of the following criteria to be considered for this clinical trial.

1. None

• Patients must be considered suitable candidates for a penile prostheses as dictated by the surgeon.
• All stages of PP surgery will be included: primary implants, revision, salvage, infected.
• Patients with prior histories of penile prostheses will have data obtained about their prior devices where available. This information will include the number of devices, penile prostheses-related surgeries, and complications relating to these procedures.
• Each time a new device or new component is placed (revision, salvage) will result in a new data entry point.

• Patients with pouch-related conditions.
• Chronic antibiotic refractory pouchitis (CARP).
• Crohn’s disease (CD) of the pouch.

• None.

• ≥  18 years of age.  
• Capacity to consent.
• BMI ≤ 30.
• Systolic BP ≤ 140mmHg.
• Diastolic BP ≤ 90.
• eGFR > 30 (within prior 3 months).
• Able to undergo an MRI.

• History of Cardiovascular disease that may affect the results of the testing performed.
•  Any Current orthopedic limitations.
• Currently taking any cardiac medication.
• Pregnancy.

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

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

• At least 18 years of age
• Able to provide informed consent
• Has diagnosed or suspected blood disorders associated with immune cytopenia (primary or secondary) including, though not restricted, to the following better-defined diseases
  • Immune hemolytic anemia
    • Cold-agglutinin disease
    • Evans syndrome
    • Paroxysmal cold hemoglobinuria
    • Warm autoimmune hemolytic anemia
  •  Immune neutropenia
  •  Immune thrombocytopenia
  •  Pure red cell aplasia
  •  Thrombotic thrombocytopenic purpura (acquired)
• Hemoglobin levels greater than 8

• This study will include both a prospective component looking forward, and a retrospective component looking backward.
• Participants in the established clinical HABIT program will be invited to participate in this study, including patients diagnosed with Mild Cognitive Impairment and a partner. The partners are often spouses, but could be adult children, other family members, or friends.
• In addition, this study includes a retrospective arm, using information already collected under related IRB-approved studies.

• Any inclusion criteria that cannot be met.

• Patients diagnosed with or suspected to have a mitochondrial disorder
• Adult carriers of known mitochondrial DNA mutations
• Patients with laboratory analysis indicative of a mitochondrial disorder.
• Medical information and tissue samples are also accepted from deceased individuals who fulfill the above criteria.

• Patients not suspected of having a mitochondrial disorder
• Patients not suspected of carrying a mitochondrial DNA or nuclear DNA mutation that affects mitochondrial function.

• Patient age is 18 years and older.
• Patient is willing and capable of providing written informed consent.
• Patients scheduled for a procedure who have clinical indication for ICE and in compliance with IFU.

• Patients in whom placement of an ICE catheter in the cardiac space or the vessel is contraindicated or technically not feasible.
• If femoral venous access is planned for ICE and IVC filter/IVC stent/iliac or femoral vein stent are present, an alternate access point should be used.

• Age ≥ 18 years.
• BMI ≤ 30.
• No current cardiac medications.
• Systolic BP ≤ 140 mmHg.
• Diastolic BP ≤ 90 mmHg.
• Capacity to consent.

• Age < 18 years.
• To be assessed via EMR screening.
• Patient confirmation during screening visit.
• Screening tests as applicable.
• History of cardiovascular disease.
• eGFR < 30.
• Current orthopedic limitations.

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

Inclusion Criteria

• Has Syringomyelia and Chiari 1 Malformation

Exclusion Criteria 

• Chooses not to participate in the study

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

• Inflammatory bowel disease
• Screening colonoscopy
• Barrett's esophagus
• Colon polyps
• Celiac disease

• Platelet count <50,000
• Unwilling to provide informed consent

HF Inclusion Criteria (HeartShare Registry):

• Age ≥ 30 years.
• Prior diagnosis of HF in the EHR (any left ventricular ejection fraction).

Non-HF Group Inclusion Criteria (HeartShare Registry):

• Age ≥ 30 years.
• No known prior diagnosis of HF or use of loop diuretics.
• No known prior history of BNP >100 pg/ml or NTproBNP > 300 pg/ml, if prior laboratory tests are available in the EHR.

Exclusion Criteria (HeartShare Registry):

• For non-HF group: any prior known left ventricular ejection fraction <50%.
• Prior history of solid organ transplantation.
• Prior history of mechanical circulatory support.
• Prior history of non-cardiac cirrhosis.
• Inability to provide written consent to the study.

HFpEF Inclusion for the HeartShare Deep Phenotyping Cohort:

• Age ≥ 30 years.
• Left ventricular ejection fraction ≥ 50% measured by echocardiography.
• Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following:
  • Elevated BNP (> 100 pg/ml in sinus rhythm or > 300 pg/ml in atrial fibrillation/flutter) or NTproBNP (> 300 pg/ml in sinus rhythm or > 900 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center;
  • Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels [using the thresholds listed above], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography);
  • Elevated pulmonary capillary wedge pressure (PCWP) at rest (≥ 15 mmHg) or during exercise (≥ 25 mmHg for supine exercise or PCWP/cardiac output ratio ≥ 2 mmHg/L/min for upright exercise);
  • Elevated H2FPEF score26 (≥ 5) or HFA-PEFF27 score (≥ 5).

Non-HFpEF Group Inclusion Criteria (HeartShare Deep Phenotyping Cohort):

• Age ≥ 30 years.
• Left ventricular ejection fraction ≥ 50% measured by echocardiography.
• No known prior diagnosis of HF or use of diuretics for fluid management.
• No known prior history of BNP > 100 pg/ml or NTproBNP > 300 pg/ml, if prior laboratory tests are available in the EHR.
• BNP < 100 pg/ml or NTproBNP < 300 pg/ml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center.

Exclusion Criteria (HeartShare Deep Phenotyping Cohort):

• Life expectancy estimated to be < 1 year.
• Primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension).
• Any prior known left ventricular ejection fraction <40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation).
• Clinically significant valvular heart disease defined as:
  • Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis;
  • Any mitral stenosis;
  • Moderate or greater aortic regurgitation;
  • Greater than moderate mitral regurgitation.
• Any planned cardiac surgery or cardiac intervention in the next 3 months.
• Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator.
• Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment.
• Known symptomatic epicardial coronary artery disease that is not revascularized.
• Any non-elective hospitalization in the preceding 2 weeks.
• Prior history of solid organ transplantation.
• Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.
• Prior history of mechanical circulatory support.
• Prior history of non-cardiac cirrhosis.
• Estimated GFR < 20 ml/min/1.73m^2 or currently on dialysis.
• Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.
• Inability to provide written consent to the study.
• Current acute decompensated heart failure.
• Currently pregnant.
• Uncontrolled heart rate (> 110 bpm) at time of screening.

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.

• Subject must be ≥ 18 years and ≤ 75 years of age.
• Body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF)/assent form.
  • Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to 17 years inclusive) will only enroll subjects who are 18 years of age or older. Enrollment of adolescent subjects will begin only after the applicable regulatory requirements for enrolling subjects in that age group have been satisfied and the necessary health authority approvals have been granted. Where national or regional guidelines for the definition of adolescence differ from the definition stated above, the national or regional guidelines may be used to determine eligibility.
• Subject has histologic evidence of EoE, defined as a peak count of ≥ 15 eosinophils per high-power field (hpf) at any 2 levels of the esophagus (proximal, mid, and/or distal) when off anti-inflammatory therapy (eg, corticosteroids, see Exclusion Criterion 7) for EoE. The histologic criterion for diagnosis of EoE must be confirmed by a centrally read histological assessment of an EGD specimen during the Screening Period prior to randomization.
• Subject has symptoms of dysphagia of at least 4 DD, as assessed with the mDSD instrument, over the last 2 consecutive weeks (14 days) prior to Day 1 when off anti- inflammatory therapy (eg, corticosteroids, see Exclusion Criterion 7) for EoE. Subjects are required to have at least 11 days of diary data out of the final 14-day period of screening mDSD collection in order to be enrolled in the study. During these 11 days, responses to questions 2 through 5 of the mDSD instrument must be complete.
• Subject must have previously received an adequate trial of proton-pump inhibitor (PPI) medication (8 weeks per guidance, Dellon, 2013) that did not provide complete response to EoE, or the subject remains symptomatic with continued use (Dellon, 2018b; Lucendo, 2017). Prospective subjects who discontinued use of a PPI must not have received a PPI for at least 4 weeks before their first Screening Visit and must agree not to restart a PPI during the study.  If a prospective subject is receiving a PPI medication at screening, he or she must have been receiving a stable dose for at least 4 weeks prior to the first Screening Visit and agree to continue the same dose throughout the study.
• Subject must either:
  • be naïve or have had an adequate response to corticosteroid therapy (i.e., classified as Steroid Responders/Naïve); or
  • have had an inadequate response to corticosteroid therapy and is not considered to be a candidate for continued corticosteroid therapy, or is intolerant to corticosteroid therapy. For subjects who have previously received systemic or swallowed topical corticosteroids for EoE, designation of the status of Steroid Inadequate Responders/Intolerant will include either of the following definitions. Note that if any of the below criteria are met, a subject will be deemed Steroid Inadequate Responders/Intolerant (approximately 70% of the study population) and cannot be classified as Steroid Responders/Naïve (approximately 30% of the study population).
    • Inadequate response to corticosteroid therapy (failed to respond or lost response) and not considered a candidate for continued corticosteroid therapy: subjects who have had a trial of at least 6 weeks of swallowed topical corticosteroid treatment; or
    • 4 weeks of systemic corticosteroids at doses in accordance to published guidelines for the management of EoE (Lucendo, 2017), or a trial for the treatment duration specified in the prescribing information for approved products and judged by the treating physician as not achieving clinical improvement or having clinical improvement initially but lost response while on therapy;
• • Intolerant to corticosteroid therapy: subjects who initiated systemic or swallowed topical corticosteroid treatment but were unable to achieve treatment durations or dose levels due to intolerance because of side effects, including intolerance from use of corticosteroids for conditions other than EoE, or subjects with underlying conditions in which corticosteroid use is not recommended or contraindicated.
• Documentation of type of therapy, treatment duration, and outcome details will be collected when possible.
• Subjects must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or EoE) from the first Screening Visit and throughout the duration of the study, and subjects must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit. Subjects must agree not to introduce any changes in their diet while participating in the study.
• Subjects currently receiving inhaled corticosteroids, leukotriene receptor antagonists (e.g., montelukast), or mast cell stabilizers (e.g., cromolyn sodium) for indications other than EoE, or medium potency topical corticosteroids (eg, mometasone furoate cream or lotion) for dermatologic conditions, must maintain stable doses/regimens for at least 4 weeks prior to the first Screening Visit and regimens must remain stable throughout the duration of the study. If recently discontinued, the medication must have been discontinued at least 4 weeks prior to the first Screening Visit.
• Female subjects of childbearing potential must agree to practice a highly effective method of contraception. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
• A female of childbearing potential (FCBP) is a female who:
  • has achieved menarche at some point;
  •  has not undergone a hysterectomy or bilateral oophorectomy; or
  •  has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:
• • Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study and through the Final 16-week Safety Follow-up Visit. This applies even if the subject practices true abstinence* from heterosexual contact;
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, highly effective contraception without interruption throughout the study and for 5 months after the last dose of IP. Acceptable methods of birth control in this study are the following (birth control must be effective by the time the FCBP subject is randomized into the study [e.g., hormonal contraception should be initiated at least 28 days before randomization]):
    • combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal;
    • progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable placement of an intrauterine device (IUD);
    • placement of an intrauterine hormone-releasing system (IUS);
    • bilateral tubal ligation; or bilateral tubal occlusion (if an implantable device was recently placed, the subject must use an additional effective method of birth control until full occlusion has been confirmed and documented);
    • vasectomized partner (vasectomized partner is a highly effective birth control method provided that the partner is the sole sexual partner of the FCBP and has received medical assessment of the surgical success);
    • sexual abstinence.
• Subject is willing to receive weekly SC injections throughout the study.
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• True abstinence is acceptable when this is the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhea method are not acceptable methods of contraception.

• Subject has clinical or endoscopic evidence of the presence of any other disease that may interfere with or affect the histologic, endoscopic, and clinical symptom endpoints for this study (eg, erosive esophagitis Los Angeles [LA] classification Grade B or above, Barrett's esophagus, esophageal lichen planus, upper gastrointestinal bleed, achalasia, inflammatory bowel disease, diagnosed eosinophilic gastroenteritis [clinical symptoms and/or EGD findings and confirmatory eosinophilia in gastric and/or duodenal mucosa], or significant hiatal hernia [> 3 cm], etc.).
• Subject demonstrates presence of esophageal varices.
• Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition.
• Subject has evidence of a severe endoscopic structural abnormality in the esophagus (e.g., high-grade stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of the screening EGD).
• Subject had esophageal dilation for symptom relief during the Screening Period or within 8 weeks prior to the first Screening Visit, or esophageal dilation is anticipated to be performed within 48 weeks of dosing during the study.
• Subject demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs (e.g., anti-IL-13 antibodies [except IP in this study], IL-4 receptor alpha antagonist antibodies [eg, dupilumab], anti-IL-5 antibodies, anti-IL-17 antibodies, anti-immunoglobulin E [IgE] antibodies, α4β7 integrin inhibitor antibodies, or any other monoclonal antibody, methotrexate, cyclosporine, azathioprine, mercaptopurine, interferon alpha [IFNα], tumor necrosis factor alpha [TNFα] inhibitors, etc.) within 5 drug half-lives prior to the first Screening Visit. Any use of these medications will be prohibited during the study.
• Subject is currently receiving systemic or swallowed topical corticosteroid medication. Prospective subjects with EoE previously treated with a corticosteroid must not have received a systemic corticosteroid within 8 weeks or swallowed topical corticosteroid within 4 weeks of the first Screening Visit.
• Subject is currently receiving a high potency topical corticosteroid (e.g., augmented betamethasone dipropionate, clobetasol propionate, etc.) for dermatologic use. Prospective subjects must not have received a high potency topical corticosteroid for dermatologic use within 8 weeks of the first Screening Visit. Any use will be prohibited during the study.
• Subject is currently receiving a leukotriene receptor antagonist (e.g., montelukast) or mast cell stabilizer (e.g., cromolyn sodium) for the indication of EoE. Subjects must not have received a leukotriene receptor antagonist or mast cell stabilizer for EoE within 4 weeks of the first Screening Visit. Any use for the treatment of EoE during the study will be prohibited.
• Subject is currently successfully treated for EoE with dietary modifications (e.g., food elimination diet) and is able to fully adhere to the diet resulting in a complete response to EoE (i.e., the subject does not meet the symptoms of dysphagia requirement of at least 4 DD and histologic criterion for diagnosis of EoE per Section 4.2, Inclusion Criteria 2 and 3).
• Subject has received oral or sublingual immunotherapy within 6 months of the first Screening Visit; any use will be prohibited during the study. Subjects receiving SC immunotherapy may participate but must be on stable doses for at least 3 months prior to the first Screening Visit and during the study.
• Subject is receiving concurrent treatment with another IP, including through participation in an interventional trial for COVID-19. Prospective subjects may not participate in a concurrent IP study or have received an IP within 5 drug half-lives prior to signing the ICF/assent for this study. Further, for subjects who received an investigational COVID-19 vaccine as part of a clinical trial prior to the first Screening Visit, enrollment must be delayed until the biologic impact of the vaccine is stabilized, as determined by discussion between the Investigator and the Clinical Trial Physician.
• Subject has received a live attenuated vaccine within one month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the course of the study. Administration of any live attenuated vaccine will be prohibited during the study through the Final 16-week Safety Follow-up Visit.
• Subject has previously received CC-93538 treatment (formerly known as RPC4046 and ABT-308) through participation in the Phase 2 Study, RPC02-201, or any Phase 1 clinical study.
• Subject has any other disease that would make conduct of the protocol or interpretation of the study results difficult or that would put the prospective subject at risk by participating in the study (eg, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, gastritis, colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE).
• Subject has liver function impairment or persisting elevations of aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) that are 2 times the upper limit of normal (ULN), or total bilirubin 1.5 times the ULN. Subjects with elevations that are not clinically significant in total bilirubin associated with Gilbert’s syndrome may participate.
• Subject has an active parasitic/helminthic infection or a suspected parasitic/helminthic infection. Subjects with suspected infections may participate if clinical and laboratory assessments, if needed, rule out active infection prior to randomization.
• Subject has an ongoing infection (e.g., hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines).
• Subject had a previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening. Symptoms must have completely resolved and based on Investigator assessment in consultation with the Clinical Trial Physician, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
• Subject has known hereditary fructose intolerance (HFI).
• Subject is pregnant or lactating.
• Subject has a history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent.
• Subject has a history of cancer or lymphoproliferative disease, other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or adequately treated cervical carcinoma in situ, within 5 years of screening.
• Subject has a history of alcohol or drug abuse within 5 years prior to initiation of screening.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.

Inclusion criteria:

• Pathological diagnosis CNS inflammatory demyelinating disease (IIDD) consistent with MS, confirmed by a pathologist
• FFPE tissue with sufficient area for pathological analyses

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

• Must be a legal adult, ≥ 22 years old.
• Capable of giving informed consent, as required per institution.
• Willing to return for routine clinic visits as required for Inspire therapy management.

Any patient who meets any of the following criteria will not be eligible to participate in the registry:

• Has a life expectancy of less than 1 year.
• Any reason the clinician deems patient is unfit for participation in the study.

1. Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc.).

1. Age < 18 years old.

2. Pregnancy.

3. Hepatocellular carcinoma outside Milan criteria (i.e., a single lesion < 5 cm or multiple lesions [maximum of three], the largest of which measures ≤ 3 cm).

4. Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years.

5. Previously known severe extrahepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe congestive heart disease [NYHA class ≥ 3]; severe chronic obstructive pulmonary disease [GOLD class ≥ 3], psychiatric disorders).

6. Previous solid organ transplantation.

7. HIV infection with CD4 ≤ 250/µL.

8. Patients who cannot provide prior informed consent and no legal surrogate decision maker.

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

Subjects who meet ALL of the following criteria may be included in the study.

1. Subjects that are candidates for primary arthroplasty, and will be surgically treated using TKA or UKA prosthesis systems with Vitamin E polyethylene manufactured by Arthrex.
2. The subject voluntarily consents to participate in the study and signed the IRB approved informed consent form prior to enrollment
3. The subject is eighteen (18) years of age or older
4. The subject can comply with all post-operative evaluations, visits, and completion of subjective questionnaires.
5. Non inflammatory osteoarthritis

Subjects will be excluded from the study if they present with ANY of the following:

1. Workman’s compensation cases
2. Previous distal femoral or proximal tibial osteotomy including tibial tubercle osteotomy procedure
3. Pre-existing hardware that requires removal except cruciate ligament hardware
4. BMI > 40
5. Varus/Valgus deformity > 15 degrees from mechanical axis
6. Blood supply limitations and previous knee infections, which may retard healing
7. Foreign body sensitivity
8. Conditions that tend to limit the subject's ability or willingness to restrict activities or follow directions during the healing period
9. Concomitant procedure with UKA

• An informed consent or waiver
• Patient has experienced an acute ischemic stroke
• Treatment within 8 hours of stroke onset

• Concurrent participation in a randomized study

Inclusion Criteria

• Male or female.
• 18 years or older.
• Will undergo breast or breast cancer related surgery at Mayo Clinic for either a benign or malignant condition.

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

• Individual with deleterious (pathogenic) or likely deleterious (likely pathogenic) mutation in a cancer susceptibility gene OR
• Individual with a variant of uncertain significance (VUS) in a cancer susceptibility gene                                              OR
• Family members, either tested or not tested, who are part of a family known to be transmitting a deleterious or likely deleterious mutation or a variant of uncertain significance in a cancer predisposition gene.

• Inability or refusal to participate in consent discussion.
• Is less than 18 years old.

• Females
• Age 18 years or older
• Diagnosed with primary or recurrent EMPD of vulva and/or perianal region of the body
• Willing and able to provide signed informed consent

• Males
• Diagnosis of Paget's Disease in body areas other than vulvar or perianal region

Inclusion Criteria

• Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
• First diagnostic kidney biopsy within 5 years of study enrollment.
• Access to first kidney biopsy report and/or slides.
• All ages.
• Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
• Informed consent and, where age appropriate, informed assent.

 Exclusion Criteria

• ESKD, defined as chronic dialysis or kidney transplant.
• Institutionalized.
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
  • Diabetes mellitus;
  • Histopathologic findings of diabetic glomerulosclerosis;
  • Systemic lupus erythematosus;
  • HIV infection;
  • Active malignancy, except for non-melanoma skin cancer;
  • Active Hepatitis B or C infection, defined as positive viral load.

• Age ≥ 18 years.
• Cirrhosis or chronic liver disease (defined as FIB-4 > 1.45 or other non-invasive markers that show > F3 fibrosis on outpatient values).
• Admitted for non-elective reasons.
• Able to consent or have a legal representative who can consent.

• Individuals < 18 years of age.
• Acute liver failure.
• Unable to consent.
• Admitted electively.
• Life expectancy < 48 hours.
• Prisoners.
• HCC without loco-regional control for > 6 months or patients on systemic therapy for Hepatocellular Carcinoma (HCC) currently.
• COVID-19 diagnosis confirmed during the current admission.
• Post-TIPS if TIPS is > 6 months prior.
• Known recent MI (< 6 months) or stroke with residual defects.