• All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
• If patients declined MN research authorization, they may be contacted for consent for approval.

• Patients that did not undergo cochlear implantation at the Mayo Clinic.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

• Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
• Adults ≥ 18 years old.
• Ability to receive and respond to electronic text messages.

• Unable or unwilling to provide informed consent.
• Patients who require Intensive Care Unit admission after surgery.
• Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

1. Provide written informed consent for the trial.

2. Adults 18 years or older on the day of signing informed consent.

3. Histologically or cytologically confirmed CRC that is metastatic.

4. Primary and/or metastatic tumor(s) that is known to be MSS as determined locally

5. Must have had 2-3 prior lines of therapy for CRC in the advanced or metastatic setting, including all of the following in the absence of contraindications: a) fluoropyrimidine, b) oxaliplatin, c) irinotecan, d) one or more biologics depending on the clinical scenario. Prior regorafenib and/or TAS-102 are allowed but not required. Note: a line of therapy is generally considered >2 weeks of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g. 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.

6. Willingness to undergo biopsy prior to study therapy and after approximately 6 weeks of study therapy. If biopsy on study is not feasible, then archival tissue must be available from within 90 days of signing consent.

7. Willingness to undergo buccal swab prior to study therapy for the determination of HLA profile.

8. Documented radiographic progression after the last regimen prior to entry on this study.

9. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation.

10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

11. Adequate organ functions as defined by the following laboratory parameters at baseline (laboratory parameters outside of these ranges that are deemed clinically insignificant should be discussed with the medical monitor):

      1. Absolute neutrophil count ≥1.5 x 109/L;

      2. Hemoglobin ≥9 g/dL: transfusion to achieve this cutoff is not allowed within 14 days of first dose of study therapy;

      3. Platelet count ≥100,000/mm3;

      4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN)
•ASL and/or ALT may be ≤5 x ULN in the setting of liver metastases;

      5. Total bilirubin ≤ 1.5 x institutional ULN;

      6. Serum creatinine within normal limits or calculated creatinine clearance >60 mL/min/1.73 m2 using the Cockroft-Gault method (Appendix 2) for participants with serum creatinine levels above or below the institutional normal range;

      7. Albumin ≥3.0 g/dL;

      8. Acceptable coagulation parameters including international normalized ratio (INR) <1.5 and partial thromboplastin time (PTT) ≤ institutional ULN in the absence of anticoagulation (participant on anticoagulants must be discussed with the medical monitor).

12. Has no major existing comorbidities or medical conditions that will preclude therapy in the view of the investigator.

13. Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v 5.0) of all clinically significant toxic effects of prior therapies (with exception of peripheral neuropathy).

14. Female participants are eligible to participate if at the time of screening are not pregnant, not breastfeeding, and at least one of the following conditions applies:

      (a) Not a woman of childbearing potential (WOCBP); or (b) WOCBP who (i) agrees to use highly effective contraception starting with the screening visit through 90 days after the last dose of study treatment; and (ii) must have a negative urine or serum       

      pregnancy test within 72 hours prior to receiving any dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. -Childbearing potential is defined by at least one of the following: (a) ≥50

     years of age and has not had menses for greater than 1 year; (b) amenorrheic for ≥2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation; (c)

      has had hysterectomy, bilateral oophorectomy or tubal ligation. -Highly effective contraception is defined in Appendix 3 or per national or local guidelines. -Abstinence is acceptable if this is the established and preferred method of contraception/lifestyle of the

      participant.

15. Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraception throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received by the male participant.

      Male participants with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. -Abstinence is acceptable if this is the established and preferred method of contraception of the participant.

1. Prior treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other checkpoint inhibitors.

2. Has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 28 days of the first dose of study therapy or 5 half-lives (whichever is shorter) if at least 10 days have elapsed between the last dose of such agents and the first dose of study therapy. NOTE: Patients who have been given palliative radiotherapy to peripheral sites (e.g., bone metastases) may enroll before 28 days have elapsed if they have recovered from any acute toxicities.

3. Has received a live vaccine within 28 days of the first dose of study therapy.

4. Has had major surgical procedure, open biopsy or significant traumatic injury within 28 days of the first dose of study therapy.

5. Participating in another research study involving receipt of an investigational product 21 days prior to study therapy.

6. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are also eligible for this study.

7. Receiving systemic corticosteroids within one week prior to the first dose of study therapy. Exceptions: corticosteroid use as a premedication for intravenous (IV) contrast, intermittent corticosteroid use (e.g., daily prednisone at doses of ≤10 mg or equivalent), bronchodilators, inhaled steroids, or local steroid injections (except at the proposed injection site of PolyPEPI1018) are acceptable.

8. History of anaphylaxis in relation to vaccination or the administration of a protein product.

9. Has known allergy to any component of the study treatment formulation(s).

10. Has symptomatic interstitial lung disease (ILD) or ILD which may interfere with detection and management of new immune-related pulmonary toxicity.

11. Prior allogeneic bone marrow transplantation or solid organ transplant.

12. Has known, active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with previously treated, stable CNS metastases may participate if (a) there is no evidence of progression by imaging [magnetic resonance imaging (MRI) or computed tomography (CT) as used during the prior imaging] at least 28 days prior to the first dose of study therapy; (b) resolution or return to baseline of neurologic symptoms; and (c) no requirement for steroids to manage symptoms of brain metastases for at least 28 days prior to first dose of study therapy.

13. Active infection requiring systemic therapy.

14. Significant liver cirrhosis defined as Child-Pugh Class B or C (Appendix 4).

15. Active infection with human immunodeficiency virus (HIV) except participants who are currently stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART during study therapy, have HIV viral load of <400 copies per milliliter (/mL) at screening (or undetectable per local criteria), and have CD4 T cell counts ≥200/microliter.

16. Active hepatitis B (HBV) or C (HCV) infection. For participants with evidence of HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. For participants with HCV, infection must have been treated and cured or participants are currently on treatment and have an undetectable HCV viral load.

17. History or evidence of cardiovascular disease, chronic respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder or any other medical or psychiatric condition that in the opinion of the investigator will significantly increase the safety risk for the subject or confound the interpretation of the study data.

18. Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of study treatment.

19. History of another active malignancy that has required therapy within 2 years prior to first dose of study therapy, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, prostate cancer or in situ cervical cancer that has undergone potentially curative therapy or is felt by the investigator to be at low risk for recurrence is allowed.

20. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.

21. In the opinion of the investigator, participant has rapidly progressing disease, OR has life expectancy <3 months, OR would be unable to receive at least one study treatment.

Inclusion Criteria
•Patients:

• Adults ≥ 18 years
• Appointment to discuss osteoporosis management

Exclusion Criteria
•Patients:

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

Inclusion Criteria
•Clinicians:

• Clinicians who meet with patients to discuss osteoporosis management.

Exclusion Critieria
•Clinicians:

• None

Inclusion Critieria
•PAG Members:

• Adults ≥ 18 years
• Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

• 18 years or older.
• Diagnosis of Myhre Syndrome.

• Individuals < 18 years of age.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

• Adult subject 18 years or older.
• Scapula and proximal humerus must have reached skeletal maturity.
• Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy.
• Willing and able to comply with the protocol.
• Willing and able to sign the informed consent form.
• Patients with an adjusted Constant Score ≤ 65.

• Active local or systemic infection, sepsis, or osteomyelitis.
• In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
• In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
• In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
• In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
• Metabolism disorder that could compromise bone formation, or Osteomalacia.
• Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
• Known allergy or suspected allergy to the materials.
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Medical condition(s) or balance impairments that could lead to falls (e.g., epilepsy not well-controlled with medication, Multiple Sclerosis, etc).
• Previous failed arthroplasty.
• Nonfunctional deltoid muscle.
• Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
• Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
• Currently, or within the last six months, or planning to be on chemotherapy or radiation.
• Recent or ongoing alcohol or drug abuse as determined by the investigator.
• Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
• Currently enrolled in any clinical research study that might interfere with the current study.
• Known history of severe depression.
• Primary insurance is Workers’ Compensation.
• The study has completed 109 implant attempts for the randomized treatment arm.
• Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
• Chronic shoulder dislocation with or without fracture, > 6 weeks.
• Parkinson’s disease.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

• Adult patients age ≥ 18.
• Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

• Individuals < 18 years of age.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Age ≥ 18 years.
• Ability to read and write in English.
• Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
• Treatment plan includes chemotherapy.
• Able to provide written voluntary consent before performance of any study related procedure.
• Aim 1 only: after completion of initial chemotherapy.
• Aim 2 only: prior to starting chemotherapy.

• Inability to provide informed consent.
• Exposure to chemotherapy prior to ovarian cancer diagnosis.
• Life expectancy < 3 months or in hospice care or nursing home.

Inclusion Criteria:

• Age ≥ 18 years.
• Ability to read and write in English.
• Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
• Treatment plan includes chemotherapy.
• Able to provide written voluntary consent before performance of any study related procedure.
• Aim 1 only: after completion of initial chemotherapy.
• Aim 2 only: prior to starting chemotherapy.

• Inability to provide informed consent.
• Exposure to chemotherapy prior to ovarian cancer diagnosis.
• Life expectancy < 3 months or in hospice care or nursing home.

• Patients with TOF or TOF-related variants.
• Age ≥ 18 years.
• Planned transcatheter valve placement in native RVOT.

• Individuals < 18 years.
• Non-TOF related variants (i.e., pulmonary stenosis, PA-IVS, etc.).
• Prior catheter or surgical ablation of ventricular tachycardia (VT).

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

• Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
• Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
•  Admission to the system within one year of injury.
• Discharge from the System Rehab as:
  • Having completed inpatient acute rehabilitation;
  • Deceased.
• Signed informed consent and HIPAA authorization forms.
• Reside in the geographic catchment area of the system at the time of the injury.  Patients may be injured outside of the catchment area.
• A US citizen or non-US citizen who is expected to stay in the catchment area.

• Must not have previously been treated at another model system for the injury.
  • Ensures that patients are enrolled into the database by only one model system.
• Must not have completed an organized rehabilitation program prior to the admission to the system.

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

• Patients subject to a laparoscopic hysterectomy procedure necessitating uterine manipulator use,
• Age 18-65.

• Patient known to have a vesicovaginal or rectovaginal fistula.
• Patients who have a documented tape allergy.
• Patients know to have an active pelvic infection.
• Patient diagnosed or known to have fecal incontinence.
• Patients diagnosed or known to have severe external hemorrhoids.
• Patients with a very short perineal body with < 2cm.
• Patients who were found to have a disruption in the occlusive dressing seal at the end of the case (blood soilage).
• Patients necessitating a rectal exam or manipulation as part of the procedure.
• Patient with visible skin irritation or inflammation around the anal orifice.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

• Is 18 years old or older.
• Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
• Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.

• Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

Patient

• Adults ≥ 18 years with biopsy proven resected NSCLC.
• Appointment to discuss adjuvant treatment of resected NSCLC.

Patient

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

Clinician

• Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC.

Clinician

• None.

PAG Member

• Adults ≥ 18 years.
• Member of the KER Unit PAG.

PAG Member

• None.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

• Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater than six months after stopping chemotherapy.
• Average pain intensity ≥ 5 on 11-point numeric rating scale (NRS) in the lower extremities at enrollment.
• Failed conventional medication management with at least two neuropathic pain medications.
• Have electrophysiological evidence of length-dependent peripheral neuropathy.
• Underwent a 10-kHz spinal cord stimulator implant for a primary indication of CIPN.
• Have stable neurological status.
• Be on a stable analgesic regimen.
• Be an appropriate candidate for surgical procedures required in this study.
• Be able to read and understand English-written questionnaires and sign an informed consent form in English.
• Be willing and capable of giving informed consent.
• Be willing and able to complete study-related requirements, procedures, and visits.

• Patient refusal to be included in study.
• Presence of lower limb mononeuropathy.
• History of lower limb amputation or ulceration.
• Presence of another painful condition that is unrelated to CIPN and that is not intended to be treated in this study.
• BMI ≥ 40.
• OME > 120 mg.
• Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis).
• Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease.
• Obtaining another interventional procedure unrelated to SCS to treat limb pain.
• Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist.
• Have a life expectancy of less than one year.
• Have untreated addiction or dependency to medications, alcohol, or illicit drugs.
• Have active, disruptive, and/or unstable psychological or psychiatric disorder.

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

• 18-60 years of age at time of enrollment.

• Failure to give consent or follow simple commands.
• History of balance concerns reported by participant.
• History of chronic pain syndrome of the spine and/or the shoulder reported by participant.
• Insufficient active range of motion of bilateral shoulders resulting in inability to perform forward or lateral reaching tasks.
• Any illness or condition which, based on the research team’s assessment, will compromise the patient’s ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Eligibility last updated 1/27/22. Questions regarding updates should be directed to the study team contact.

• Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.

• Patients undergoing surgery with an expected blood loss of less than 135cc.
• Provisions for inclusion of minorities: 
  • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

• Patients referred to the Mayo Clinic HF Clinic with a diagnosis of heart failure who have a clinical blood draw scheduled.
• Adults ≥ 18 years old.

• Individuals < 18 years old.
• Any history of Hemoglobin less than 9 mg/dL during the past 3 months.
• Active cancer.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

• Male patients.
• Age 45-80 years, with > 10 years life expectancy.
• Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
• Stage ≤ T2c, N0, M0.
• ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
• PSA ≤ 20 ng/mL reported within 3 months of baseline.
• Treatment naïve.
• Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.  

• Inability to undergo MRI or general anaesthesia.
• Suspected tumour > 30 mm from the prostatic urethra.
• Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:                
  • Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
• Unresolved urinary tract infection or prostatitis.
• History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
• Artificial urinary sphincter, penile implant or intraprostatic implant.
• Less than 10 years life expectancy.
• Patients who are otherwise not deemed candidates for RP.
• Inability or unwillingness to provide informed consent.
• History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

• Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.

• Multiple pregnancy.
• Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
• Intrauterine growth retardation or fetal macrosomia.
• Maternal age under 18 or over 50.
• Maternal body mass index (BMI) of less than 18 and more than 40.
• Pregnancy less than 37 weeks of completed gestation.

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

• Diagnosis of seropositive rheumatoid arthritis (either Rheumatoid factor or anti-CCP positive).
• Age-matched Healthy Controls.

• Chronic active viral infection.
• History of chemo/radiotherapy.
• History of cancer.
• Other autoimmune disease.
• Pregnancy.

Eligibility last updated 3/23/22. Questions regarding updates should be directed to the study team contact.

• Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
• According to the Investigator's opinion, will benefit from continuing treatment with relacorilant.

• Premature discontinuation from a relacorilant parent study.
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
• Has poorly controlled hypertension.
• Has Stage ≥ 4 renal failure.

Eligibility last updated 2/8/22. Questions regarding updates should be directed to the study team contact.

• Adults over the age of 18 and who are willing and able to give informed consent.
• Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
• Volunteers of any race, any gender.
• Range of physiques.

• Injury or skin disturbance in the area of the test device.
• Pregnant.
• Currently smokes cigarettes.
• Has known respiratory conditions such as:
  • Flu;
  • Pneumonia/bronchitis;
  • Shortness of breath/respiratory distress;
  • Respiratory or lung surgery;
  • Emphysema, COPD, lung disease.
• Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function.
• Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask).

• Patients ≥ 18 years old
• Patients undergoing POEM for:
  • Achalasia (types I, II, and III);
  • Non-achalasia esophageal motility disorders (e.g., diffuse esophageal spasm).
• POEM performed at Mayo Clinic by providers in the Division of Gastroenterology or the Division of Thoracic Surgery.

• Patients < 18 years old.
• Patients with prior POEM performed outside of Mayo Clinic.
• Prior upper gastrointestinal surgery.
• No authorization for research participation at Mayo Clinic.
• Inability to communicate/provide history of symptoms.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

• Men and women ≥ 50 years of age.
• The patient has met eligibility criteria and is planned to undergo LAAO with the WATCHMAN FLX device as part of clinical care.
• The patient is able and willing to undergo non-invasive cognitive testing using the Viewmind headset by a trained personal.
• The patient is able to give informed consent for the procedure.

• The patient unwilling or unable to complete cognitive testing using the specialized virtual reality googles.
• Primary language is not English.

Eligibility last updated 3/11/22. Questions regarding updates should be directed to the study team contact.

• Subjects 50-75 years old
• Able to provide a signed informed consent.
• Willing and able to comply with the specified study requirements and can be contacted by telephone.
• Scheduled for colonoscopy procedure no later than 60 days after C-Scan ingestion
• Maximal abdominal circumference < 125 cm.

• Subject who is not a suitable candidate for a colonoscopy.
• Known history of dysphagia or other swallowing disorders.
• History of the following:
  • Colorectal polyps;
  • A personal history of CRC;
  • A family history of CRC or adenomatous polyps diagnosed in a relative before 60 years of age;
  • A history of inflammatory bowel disease of significant duration;
  • One of two (2) hereditary syndromes.
• Known motility disorders:
  • Chronic Constipation: less than three (3) bowel movements/week, without the use of laxatives within the last 3 months;
  • Ongoing diarrhea defined as passage of loose or watery stools at least three times within 24-hour;
  • Delayed gastric emptying;
  • Known IBD (Crohn's, Ulcerative Colitis).
• Prior history of gastrointestinal tract surgery.
• Prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by a physician.
• Any condition believed to have an increased risk for capsule retention, known strictures, known bowel adhesion or 'obstacles' to free passage of the capsule (such as diverticulosis, intestinal tumors, radiation enteritis) or incomplete colonoscopies as determined by a physician.
• Significant change in diameter and frequency of stool within the last 3 months.
• GI bleeding within the last 3 months; i.e., rectal outlet bleeding, hematochezia or melena.
• Implanted cardiac device or any other implanted active device.
• Known sensitivity to iodine.
• Acute kidney failure.
• Known condition which precludes compliance or is contraindicated with study and/or device instructions.
• Any procedure requiring contrast agent, or which may introduce electronic interference (such as magnetic resonance imaging, DEXA scan) or an imaging procedure pre-scheduled within 14 days of C-Scan ingestion.
• Nuclear imaging procedure within the four (4) weeks preceding the C-Scan procedure.
• Known condition of opioid use disorder and/or alcoholism.
• Women who are either pregnant or nursing at the time of screening (to be verified by urine or serum pregnancy test for woman of child- bearing potential who are not post-menopausal or undergone surgical sterilization).
• Concurrent participation in another clinical trail using any investigational drug or device.

Eligibility last updated 3/31/22. Questions regarding updates should be directed to the study team contact.

• Practicing physicians, nurses and allied health staff that participate in surgery process.   

• Physicians, Nurses and allied health staff that do not have time to participate in the study.

Eligibility last updated 3/8/22. Questions regarding updates should be directed to the study team contact.

• Adult male and female, age from 18 years old.
• Having signs and symptoms of HFpEF.
• With 1, 2, 3 grades or indeterminate degree of DD (ACC/AHA stages C and D HF).

• Reduced Ejection Fraction (EF ≤ 50%), mitral valve prosthesis, mitral stenosis.

Eligibility last updated 6/20/22. Questions regarding updates should be directed to the study team contact.

• An adult male patient who:
  • Is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a Nuclear Medicine Physician or Radiologist in the Nuclear Medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB).
  • Is acceptable to be potentially eligible for therapy but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future.
  • Is acceptable to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer.
  • Is eligible to be documented in the medical record by the clinical practice.
  • Has not received a 68Ga-PSMA-11 PET/CT or PET/MR, or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility.
  • Does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan.
  • An adult above the age of 18.

• A patient who is:
  • Under the age of 18.
  • Unable to consent per Mayo guidelines.
  • Unable to lay still, or otherwise successfully complete the imaging exam.

Eligibility last updated 4/15/22. Questions regarding updates should be directed to the study team contact.

Premenopausal group

• Age 40-48 at the time of original study recruitment.
• Regular menstrual periods for at least 1 year on no hormonal contraception at the time of their participation in the original study.

Postmenopausal group

• Age 52-60 at the time of original study recruitment.
• Confirmed menopausal status at the time of their participation in the original study: no menstrual periods for at least 1 year (but no more than 2 years).

• History of hysterectomy.
• History of surgical, chemical, or radiation-induced menopause (i.e., oophorectomy, aromatase inhibitors, chemotherapy for cancer treatment, or radiation therapy).
• Use of any drug that can affect estrogen production or signaling (e.g., GnRH agonists and antagonists, estrogen receptor modulators, etc.).
• Use of systemic estrogen and/or progesterone (oral contraceptives, contraceptive implants, hormone replacement therapy).
• Use of non-hormonal contraceptive methods that can affect the regularity of menstrual cycles (e.g., intrauterine devices).
• History of hypothalamic or pituitary disease (e.g., pituitary adenomas, empty sella, pituitary surgery, hypothalamic masses).
• Patients who denied future use of biological samples or further contact from the previous listed IRBs.

Eligibility last updated 4/18/22. Questions regarding updates should be directed to the study team contact.