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

Eligibility last updated 11/4/22. Questions regarding updates should be directed to the study team contact.

• Different conditions based on the top 20 diseases as determined by patients seeking stem cells (Smith et al., 2020 Regen Med) (ResearchMatch permits the selection of participants based on specific conditions).
• Equal numbers of women and men (ResearchMatch provides sex at birth).
• Different states and rural/urban populations (ResearchMatch provides state information).
• Diverse racial/ethnic backgrounds including minorities (ResearchMatch permits the selection of participants based on race and ethnicity).
• Moderate and high SCI seekers (by administering a short email survey of 8 questions determining SCI seeking intent.
• Participation will be determined based on desire for information about SCIs, race/ethnicity, geographic location, condition, and gender (equal numbers of women and men).

• < 18 years of age.

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

Eligibility last updated 11/4/22. Questions regarding updates should be directed to the study team contact.

• Patients with a histologic diagnosis of:
  • Newly diagnosed;
  • Progressive;
  • Relapsed lymphoma (any NHL HL, or CLL histology) who are initiating or changing therapy (chemotherapy, radiotherapy, or clinical trial/ investigational agent), or who have measurable disease and are being expectantly monitored. Patients whose lymphoma is in remission and who are being monitored expectantly are eligible as a separate cohort.
• Age > 18 years.
• May be s/p autologous or allogeneic bone marrow transplant.
• Ability to understand and willing to sign a written informed consent document.
• Patients with a histologic diagnosis of relapsed lymphoma or multiple myeloma who are scheduled to undergo CAR T cell therapy (up to 25 patients).
• Newly diagnosed, untreated DLBCL patients confirmed by pathologic review. 

​​

• Patients already receiving any investigational agents or chemotherapy at time of baseline sample collection.
• Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.                               
• Patients with CNS disease or lymphoma related to prior chemotherapy (new DLBCL cohort only).
• Patients with hemoglobin level of 8 or below.

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

Eligibility last updated 3/17/23. Questions regarding updates should be directed to the study team contact.

• ≥ 18 and ≤ 59 years of age.
• BMI ≥ 18.5.
• Indoor office workers employed full-time at the Mayo Clinic or another business within and around Rochester, MN.
• Report working a desk-based job, such as clerical and administrative staff.
• Fully vaccinated and boosted against COVID-19.
• Be willing to not wear a mask while in the office module.
• Allowed to work from home for at least a whole week (5 consecutive workdays in Background Work-from-Home Condition).
• Able to relocate to the WLL office during the workday, complete work in an open office space, be present for 80% of the total study for four consecutive work weeks, and be able to complete at least 80% daily tasks.
• Each workday, short personal meetings/calls and lunch break outside the office is allowed, but the participants should spend no less than 6 hours per day in the office.
• Be able to provide informed consent.

• Individuals who are lactating, pregnant, or intend to become pregnant during the study.
• Shift-workers.
• Individuals who are taking medications (either prescribed or over-the-counter) which may affect mental status.
• Drug (illegal or prescription narcotic), nicotine, or alcohol dependency.
• Asthma or allergies to any airborne pollutants, such as pollen and dust.
• Individuals diagnosed with pre-existing respiratory, neurological, or severe sleep disorders given their potential impact on study outcomes;.
• Individuals who have medical conditions associated with higher risk for severe COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html).

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

Eligibility last updated 11/8/22. Questions regarding updates should be directed to the study team contact.

• Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
• Eligible patients will have at least one caregiver who is also willing to participate in the study.
• Eligible patients must receive primary care through one of 3 MCHS sites connected to the study: Onalaska/La Crosse, Redwing, and Faribault.

• Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
• Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
• Patients will be excluded if their enrolled caregiver has active substance  dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.

Eligibility last updated 11/10/22. Questions regarding updates should be directed to the study team contact.

- No available autologous iPSC-CL as defined by the manufacturer's release criteria.
(This applies to Part II of the study and applies to the treatment arm only).

- History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation
or escalation of medications.

- Heart failure with preserved ejection fraction.

- Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease,
refractory anemia).

- QTc greater than 500 ms.

- Stage III or higher chronic kidney disease.

- History of liver cirrhosis.

- History of coronary artery disease.

- Uncontrolled diabetes mellitus.

- Any history of cancer.

- Contraindication for use of amiodarone for up to 3 months (treatment arm only).

- Contraindication for insertion of Insertable Cardiac Monitor.

- Contraindication for placement of LifeVest cardioverter defibrillator.

- Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.

- Obesity with BMI greater than 30.

- Current alcohol or drug abuse precluding heart transplantation.

- Active infection requiring ongoing treatment.

- Contraindication to anesthesia.

- Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality of the data
obtained from the study.

- Inability or unwillingness of a participant to give written informed consent or comply
with study protocol.

- History of non-compliance.

- Inability to be accompanied around the clock for any part of the first 3 weeks post
product administration.

- Uncontrolled depression.

- Denied heart transplant due to social determinants.

- Current participation in another cardiac interventional clinical trial that could
confound the results of this study.

- Previous heart transplant.

Eligibility last updated 1/30/23. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 11/21/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 and ≤ 80 years of age.
• Diagnosis of CLL will be required to participate in Aim 2 of this study.

• Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular, musculoskeletal, or pulmonary disease.

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

Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years or age.
• Undergoing open cubital tunnel release at the level of their elbow will be selected to collect muscle biopsies of their biceps muscle.

• Previous history of peripheral nerve injury involving the musculocutaneous nerve.
• Previous history of surgery at the level of the arm (fractures around the shoulder or elbow).
• Medical history of neurological diseases.

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

Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

• Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.
• Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic.
• Heart Team determines patient is a recommended candidate for the VDyne System.
• Age 18 years or older.
• Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for
• treatment with the VDyne System.

• Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs.
• Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed.
• Hypersensitivity to nickel or titanium.

Clinical Exclusion Criteria (assessed by pre-procedural imaging):

• Left Ventricular Ejection Fraction (LVEF) < 30%.
• Severe RV dysfunction.
• Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
• Sepsis including active infective endocarditis (IE) (within last 6 months).
• Right ventricular or atrial thrombus or vegetation.
• Severe tricuspid annular or leaflets calcification.
• Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg.

CONCOMITANT PROCEDURES

• Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
• Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
• Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
• Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
• Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
• Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
• Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g., valve replacement, edge to edge repair).
• Severe valvular heart disease requiring intervention other than the tricuspid valve.
• Known significant intracardiac shunt (e.g., septal defect) (PFO's without significant shunts are allowed).

COMORBIDITIES

• Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
• Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
• Acute myocardial infarction (AMI) within 30 days.
• Significant renal dysfunction (eGFR<30 ml/min/1.73m^2) or on dialysis.
• End-stage liver disease (MELD > 11 / CHILD class C).
• Bleeding requiring transfusion within 30 days.
• Coagulopathy or other clotting disorder that cannot be medically managed.
• Chronic immunosuppression or other condition that could impair healing response.
• Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy
• Unwilling to receive blood products.

General

• Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.
• Life expectancy less than 12 months due to non-cardiac comorbidities.
• Treatment is not expected to provide benefit (futile).
• Current IV Drug user (must be free drug abuse for > 1 year).
• Pregnant, lactating or planning pregnancy within next 12 months. (female of child-bearing potential use two reliable contraceptive methods during the study -hormonal methods such as pill and condom).
• Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).
• Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.
• Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted.
• Patient unable or unwilling to comply with study required testing and follow-up visits.

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

• Assenting adolescents (13-17 years).
• Consenting adolescents (18-21 years).
• Parent / legal guardian of assenting or  consenting adolescent.
• Ability to participate in remote study visits, if applicable.

• Individuals who do not meet inclusion criteria.
• Those who do not communicate in English.
• Individuals with developmental disabilities that interfere with their ability to make independent decisions.
• Participants whose permanent address is more than 100 miles from Cincinnati Children's Hospital Medical Center.

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

Eligibility last updated 5/11/23. Questions regarding updates should be directed to the study team contact.

• Able to read English fluently.
• Can consent for themselves.
• Age 18 years or older.
• Diagnosis of vestibular schwannoma (also called acoustic neuroma).
• Prior enrollment in IRB protocol 21-003059.

• Lack of capacity to consent since enrollment in IRB protocol 21-003059.
• Unable to participate in an interview by Zoom.

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

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

• Healthy male and female volunteers ≥ 18 years of age.
• Patients diagnosed with irritable bowel syndrome (IBS) ≥ 18 years of age.
• Patients with risk of developing POI or with clinical diagnosis ≥ 18 years of age.
• Patients with evidence of partial bowel obstruction ≥ 18 years of age.

• Inability or unwillingness to participate in study.
• Age ≤ 17 years old.

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

Eligibility last updated 12/19/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Patients:

• Adults ≥ 18 years.
• Have an appointment scheduled in primary care.

Inclusion Criteria
•Clinicians:

• Clinicians who meet with patients in primary care.

• Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment).

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

Eligibility last updated 1/23/23. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age.
• No additional confounding cardiorespiratory, metabolic, or musculoskeletal conditions.   
• All inclusion criteria will be at the discretion of the principal investigator.

• < 18 years of age.

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

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Patients age ≥ 18 years.
• Patients who previously underwent a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester [VAKM(M3] between January 1st, 1950 – present.
• Patients who plan to undergo a total laryngectomy or tracheostomy by an Otorhinolaryngology-Head and Neck Surgery department provider at Mayo Clinic Rochester.
• Patients with capacity to consent to the study.

Exclusion criteria:

• Patients who declined Minnesota research authorization for the retrospective patient identification.

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

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.

• Patients presenting to the catheterization laboratory to undergo non-emergent cardiac catheterization procedures including coronary angiography, percutaneous coronary intervention, right heart cath, ablation, myocardial biopsy.
• Adult patients (18 years old or older).
• Patient willing and able to give informed consent.

• Emergent procedure.
• ST elevation > 1 mm on any two contiguous ECG leads.
• Hemodynamic instability (SBP > 220 or < 80, HR > 160).
• Patients < 18 years old (children).
• Patients known or suspected to be pregnant.
• Incarcerated patients (FMC patients).
• Patients with a pacemaker or defibrillator.
• Metal implants in the body (that are not MRI safe).
• Patients that are unable to lie down in the MCG machine or stay still.
• Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
• Patients without the capacity to provide written informed consent.

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

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

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

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

• Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation.
• Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
  • had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis; or
  • had a serum or plasma estradiol and/or follicle stimulating hormone (FSH) concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis.
• Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole; within 14 days prior to randomization or be planning to start initial treatment with standard of care oral ET within 14 days after randomization.
• Participants who currently have ovarian function (estradiol above the postmenopausal range) must be planning to undergo ovarian suppression or ablation concomitantly with oral ET medication, starting before or at the same time as oral ET initiation.
• Participants with chemotherapy-induced amenorrhea or ovarian failure at time of registration must be planning to start ovarian suppression or ablation if they have recurrence of ovarian function during study participation (circulating estradiol concentration in the premenopausal range or recurrence of menses).
• Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization NOTE: Concomitant radiotherapy at the time of randomization and/or during study participation is allowed.
• Participants who received chemotherapy must have finished it at least 14 days prior to randomization.
  • NOTE: Concomitant maintenance targeted or biologic therapy (e.g., human epidermal growth factor receptor 2 [anti-HER2] therapy, poly-ADP ribose polymerase [PARP] inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy) at the time of randomization and/or during study participation is allowed.
• Participants must be ≥ 18 years of age.
• Participants must have a complete medical history within 60 days prior to randomization.
• Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish.
• Participants must:
  • agree to complete PROs at all scheduled assessments; and
  • complete the pre-registration (baseline) PRO forms within 14 days prior to randomization.
• Participants must be able to complete symptom questions on a web browser (on a smartphone, tablet, or computer) or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments.
  • NOTE: Participants who do not have access to the internet and who cannot receive telephone calls for interactive voice response system (IVRS) assessments are not eligible.
• Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG). specimen tracking system.
• Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

• Participants must not have distant metastatic breast cancer.
• Participants who have started or plan to start treatment with tamoxifen during study participation must not have received prior tamoxifen for treatment or prevention of breast cancer.
• Participants who have started or plan to start treatment with an aromatase inhibitor during study participation must not have received prior aromatase inhibitor therapy for treatment or prevention of breast cancer.
• Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation.

NOTES: 

• Participants who start or plan to start treatment with an aromatase inhibitor may have previously received tamoxifen for prevention of breast cancer or treatment of a prior cancer.
• Participants may have received prior treatment with an aromatase inhibitor for infertility treatment.
• Participants must not be planning to become pregnant during the 80 weeks of study participation.
• Participants must not receive additional anti-cancer treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial.
• Participants must not have a non-breast malignancy for which they are currently receiving treatment.

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

Eligibility last updated 3/16/23. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma.
• Planned subtotal resection due to tumor location, size, or other clinical indication deemed appropriate by the surgeon.
• Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of ceerebal spinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis.
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
• Platelet ≥ 100 x 10^9/L, without transfusion within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration)
• Hemoglobin ≥ 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained ≤ 14 days prior to registration).
• Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (obtained ≤ 14 days prior to registration)
• Total serum bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration).
• The patient is clinically euthyroid.
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≤ 60 mL/min/1.73 m^2 for patients with serum creatinine levels above 1.5 x ULN (obtained ≤ 14 days prior to registration).
• Negative serum or urine pregnancy test is required for female subjects of childbearing age.

• Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
• Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
• Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication.
  • NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
• Patients with known hypersensitivity or allergy to DFMO or AMXT 1501.
• Contraindication to MRI or administration of gadolinium.

Eligibility last updated 3/21/23. Questions regarding updates should be directed to the study team contact.