• Patients between the ages of 18 and 80 years old.
• Patients with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors.
• Patients previously diagnosed with Eosinophilic Esophagitis and are now in histologic remission due to treatment and have <15 eos hpf.
• Controls
  •Patients without EoE or GERD having an Upper Endoscopy.

• Acute allergy to wheat or soy.
• Currently taking steroids.
• Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy.

• Patients with known or suspected genetic disorders.
• Patients with disorders where the genetic basis is not known.
• Control subjects.

• Patients with no known genetic disorders.

Eligibility last updated 10/20/22 Questions regarding updates should be directed to the study team contact.

• Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines. 
• Patient is at least 18 years of age and meets age requirements per local law. 
• Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.

• Patient is unwilling or unable to personally provide Informed Consent. 
• Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication). 
• Patient with an existing pacemaker, ICD, or CRT device implant or leads. 
• Patients with these medical interventions are excluded from participation in the study: 
  • Prior sternotomy;
  • Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis);
  • Prior abdominal surgery in the epigastric region;
  • Planned sternotomy;
  • Prior chest radiotherapy Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
• Patient has previous pericarditis that:
  • Was chronic and recurrent; or
  • Resulted in pericardial effusion; or
  • Resulted in pericardial thickening or calcification. 
• Patients with these medical conditions or anatomies are excluded from participation in the study: 
  • Hiatal hernia that distorts mediastinal anatomy;
  • Marked sternal abnormality (e.g., pectus excavatum);
  • Decompensated heart failure;
  • COPD with oxygen dependence;
  • Gross hepatosplenomegaly.
• Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
• Patients with a medical condition that precludes them from undergoing defibrillation testing: 
  • Severe aortic stenosis;
  • Intracardiac LA or LV thrombus;
  • Severe proximal three-vessel or left main coronary artery disease without revascularization;
  • Hemodynamic instability;
  • Unstable angina;
  • Recent stroke or transient ischemic attack (within the last 6 months);
  • Known inadequate external defibrillation; 
  • LVEF < 20%;
  • LVEDD > 70 mm.
• Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator. 
• Patient with any evidence of active infection or undergoing treatment for an infection. 
• Patient is contraindicated from temporary suspension of oral/systemic anticoagulation.
• Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body. 
• Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 months). 
• Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. 
• Patient with any exclusion criteria as required by local law (e.g., age or other).
• Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.

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

Eligibility last updated 4/21/23. Questions regarding updates should be directed to the study team contact.

• Parent or LAR has signed information consent.
• Subject weighs between 2.5-10 kg (or 5.5-22 lbs).
• Subject is receiving medical care in an intensive care unit.
• Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
• Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT.

• Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator.
• Subject has irreversible brain damage, in the opinion of the investigator.
• Subject is intolerant to anticoagulation, as documented in the medical record.
• Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days.
• Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) < 30 ml/min/1.73m^2.
• Subject has received at least 12 hours of CRRT with another machine (not including ECMO) during the current hospitalization.
• Subject is currently or has chronically been treated with a circulatory support device (i.e., left ventricular assist device (LVAD)) other than ECMO.
• Subject has had prior CRRT treatments using the Carpediem™ system.
• Subject is enrolled in clinical trials or being treated with other investigational therapeutic devices or products for acute kidney injury or fluid overload.
• Subject has any other medical condition that may confound the study objectives, in the opinion of the investigator.

Eligibility last updated 12/9/21. Questions regarding updates should be directed to the study team contact.

• Primary hyperoxaluria: Patients diagnosed with type I PH by genetic testing and part of the Rare Kidney Stone Consortium (RKSC) Primary hyperoxaluria registry
• Enteric hyperoxaluria: Patients with Roux-en-Y-gastric-bypass
• Idiopathic CaOx stone : History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment
• Healthy participants with no history of kidney or bowel disease

• History of kidney or liver transplant
• History of antibiotics use within 6 months of recruitment

• Patients that have a pacemaker 
• >18 years of age

• Patients that do not have a pacemaker 
• <18 years of age
• Patients with other metal or devices that cannot be removed from their body will also be excluded.

• Male and female patients age 6 to 99 years of age
• Patients referred for CT imaging of the head, torso, or extremities within the Department of Radiology; and/or MRI of the abdomen
• Patients who are able and willing to sign the informed consent will be enrolled
• For abdomen or pelvis CT scans, negative pregnancy test if subject is of child bearing age

• Children younger than 6 years of age
• Patients unable to provide written informed consent
• Pregnancy

Inclusion Criteria - Prospective Arm:

• Mothers and fathers, 18-45 years of age.
• Pregnant women with a previously identified mutation in a known LQTS gene or pregnant women whose partner (and the father of the baby) has a previously identified mutation in a known LQTS gene will be invited to participate. If the pregnant partner of a man with a LQTS gene is enrolled, then the man/father of child will be enrolled as well.
• Women at 7-30 weeks of gestation.
• Mothers with a previously identified mutation in a known LQTS gene or whose partner (father of the baby) has a previously identified mutation in a known LQTS gene that have had a child that was born after April 1, 2016.
• Newborns for ECG data collection post-delivery.

Exclusion Criteria - Prospective Arm:

1. Phenotype positive but genotype negative pregnant woman or father of the fetus.
2. Fetuses with congenital or chromosomal anomaly identified before or after birth.
3. Pregnant women who present beyond 30 weeks of pregnancy.

Inclusion Criteria
•Retrospective Arm:

• Mothers and fathers, 18-45 years of age.
• Children conceived between January 1, 2013 and April 1, 2016.
• Women with a previous pregnancy and a known LQTS gene or where the father of the baby had a known LQTS gene.
• Women with a mutation in a known LQTS gene.
• Women whose partner/father of the baby has a mutation in a known LQTS gene (the father of the child will be enrolled if mother of child is enrolled).
• Newborns for ECG data collection post-delivery

Exclusion Criteria
•Retrospective Arm:

• Phenotype positive but genotype negative pregnant woman or father of the fetus.
• Fetuses with congenital or chromosomal anomaly identified before or after birth.
• Fetal heart rate data unavailable prior to 30 weeks of pregnancy.

Inclusion criteria:

• Men and women.
• Ages 18-65.
• Able to tolerate lying motionless, flat on their back in an MRI scanner for no more than 90 minutes.

Exclusion criteria:

• No contraindication to MRI.
• No implanted devices within the head (shunts, clips, plates, etc.).
• No known brain pathology of any kind (e.g., tumors, strokes, prior surgery, etc.).
• No dental braces or retainer wires.
• Pregnancy.

• Patients with IBD, seen in the pediatric gastroenterology clinic, 10-18 years of age.

• Inability to understand and read English at a grade 5-12 year level, as commensurate to their chronological age
• Research denial by patient or guardian.

• Participants must be classified with a diagnosis of chronic low back pain.
• Participants must be able to speak, listen, read, and understand sentences written in English.

• Participants will be excluded who:
  • display more than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease;
  • have a history of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke);
  • take medications that cause dizziness or slow movement;
  • smoke; or
  • have a body mass-to-height squared ratio greater than 30kg/m^2 or less than 18.4kg/m^2, blood pressure greater than 140/90 mmHg, or a history of heart conditions.
• Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions will also be excluded.

• Patients within the Mayo Clinic Study of Aging 
• Patients 21-50 years old, 51-70 years old, and 71 and older   
• Patients with dementia from the Mayo Clinic ADRC

• Patients with glaucoma or other optic neuropathies will be excluded

• Male and female patients, ≥ 18 years of age
• Cirrhosis of liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
• Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis.
• Not a candidate for (refused, contraindicated) TIPS or previously implanted TIPS is permanently obstructed or non-functioning.
• Life expectancy of at least 6 months.
• Capable of giving written informed consent and able to understand and complete the survey in English.

• Patients that have lost the ability to understand the meaning or importance of something and the ability to talk or write, resulting in the inability to live independently.

Therapeutic Paracentesis is defined as removal of at least 1.5L of ascitic fluid by means of percutaneous drainage with therapeutic intent in patients with symptoms related to fluid accumulation or clear evidence of ascites accumulation (weight gain, abdominal circumference), excluding patients receiving a puncture for diagnostic purpose only.

• Group 1:
  • Age 18-80 years;
  • BMI ≥ 35 kg/m^2;
  • Eligible for bariatric surgery;
  • Ability to provide consent.
• Group 2:
  • Age 18-80 years;
  • BMI ≤ 30 kg/m^2;
  • Undergoing live donor nephrectomy;
  • Ability to provide consent.

• Pregnancy.
• Chronic Inflammatory Disease (e.g., rheumatoid arthritis).
• Active malignancy.
• Recent stroke or myocardial infarction.
• Solid organ transplant recipients.
• Therapeutic doses of immunosuppressive drugs (including calcineurin inhibitors and prednisone (> 10 mg/day).
• Senolytic supplements.
• Subjects on therapeutic doses of anticoagulants [including Warfarin (Coumadin), Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa)].
• Subjects deemed ineligible to comply with study protocol.

• The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
• The patient must be ≥ 18 years old.
• The patient must have an ECOG performance status of 0 or 1.
• Patients must have histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria.
  • NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
• No radiographic evidence of overt metastatic disease within 28 days prior to study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).
• The distal extent of the tumor must be ≥ 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).
• The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.
• The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera.
  • NOTE: Patients with stage IIIA or IIIB colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study, are allowed to be enrolled, and will be retested and placed in either Cohort A or Cohort B depending on the central ctDNA testing result.
  • NOTE: Patients with stage II or IIIC colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study AND have a ctDNA+ve result, are allowed to be enrolled. Patients will have central ctDNA testing, confirmed to be ctDNA+ve, and placed in Cohort B.
• Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.
• The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).
• The interval between surgery (post-operative Day 7) and study entry must be no more than 60 days.
• Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
• Adequate hematologic function within 28 days before study entry defined as follows:
  • Absolute neutrophil count (ANC) must be ≥ 1500/mm^3;
  • Platelet count must be ≥ 100,000/mm^3; and
  • Hemoglobin must be ≥ 9 g/dL;
• Adequate hepatic function within 28 days before study entry defined as follows:
  • Total bilirubin must be ≤ ULN (upper limit of normal) for the lab; and
  • Alkaline phosphatase must be < 2.5 x ULN for the lab; and
  • AST and ALT must be < 2.5 x ULN for the lab.
• Adequate renal function within 28 days before study entry defined as serum creatinine ≤ 1.5 x ULN for the lab or measured or calculated creatinine clearance ≥ 50 mL/min using the CockroftGault formula for patients with creatinine levels > 1.5 x ULN for the lab.
• For Women Creatinine Clearance (mL/min) = (140 – age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL).
• For Men Creatinine Clearance (mL/min) = (140 – age) x weight (kg) 72 x serum creatinine (mg/dL).
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Pregnancy test (urine or serum according to institutional standard) done within 14 days before study entry must be negative (for women of childbearing potential only).
• Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.

• Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
• Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
• Tumor-related bowel perforation.
• History of prior invasive colon malignancy, regardless of disease-free interval.
• History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.
• Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted).
• Other invasive malignancy within 5 years before study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.
• Synchronous primary rectal and/ or colon cancers.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
• Sensory or motor neuropathy ≥ grade 2, according to CTCAE v5.0.
• Blood transfusion within two weeks before collection of blood for central ctDNA testing.
• Active seizure disorder uncontrolled by medication.
• Active or chronic infection requiring systemic therapy.
• Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
• Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism.
• Pregnancy or lactation at the time of study entry.
• Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).

Inclusion Criteria for Cohort A
•Arm 2 Patients on Second Randomization:

• Patient must have developed a ctDNA +ve assay during serial monitoring.
• Patient's willingness to be re-randomized affirmed.
• The patient must continue to have an ECOG performance status of 0 or 1.
• No radiographic evidence of overt metastatic disease.
• Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).
• Adequate hematologic function within 28 days before second randomization defined as follows:
  • Absolute neutrophil count (ANC) must be ≥ 1500/mm^3;
  • Platelet count must be ≥ 100,000/mm^3; and
  • Hemoglobin must be ≥ 9 g/dL.
• Adequate hepatic function within 28 days before second randomization defined as follows:
  • Total bilirubin must be ≤ ULN (upper limit of normal) for the lab; and
  • Alkaline phosphatase must be < 2.5 x ULN for the lab; and
  • AST and ALT must be < 2.5 x ULN for the lab.
• Adequate renal function within 28 days before second randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or measured or calculated creatinine clearance ≥ 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 – age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 – age) x weight (kg) 72 x serum creatinine (mg/dL).

Exclusion Criteria for Cohort A
•Arm 2 patients on Second Randomization:

• Pregnancy or lactation at the time of second randomization.
• No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.

Eligibility last updated 5/26/22. Questions regarding updates should be directed to the study team contact.

• Wrestlers on roster from Rochester Community and Technical College.
• ≥ 18 years of age. 

• Any athlete with a known cardiac condition will be excluded.

Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.

• Subjects with chronic kidney disease (estimated glomerular filtration rate < 60).
• Recruitment will primarily focus on patients with end stage renal disease who are being considered for renal transplantation or initiation of hemodialysis.
• Minorities will be included.

• Individuals < 18 years of age.
• Subjects not diagnosed with chronic kidney disease.

Eligibility last updated 8/18/21. Questions regarding updates should be directed to the study team contact.

• Medical students and interns of the department of general surgery with experience of having placed <5 central venous catheters.

• Participants who do not consent to participate in the study.

• Clinically-indicated, dual-source, dual-energy CT for the purpose of renal stone material differentiation
• Positive for the presence of stone.
• Ability to provide written, informed consent

• Pregnancy

• Patients with documented LEMS (based on clinical, serologic, and electrodiagnostic criteria) will be asked to participate if they fail to respond to standard therapy with cholinesterase inhibitors. 

• Age ≥ 18 years
• Patients with SDH, in whom the decision has been made to evacuate the hematoma surgically.

• Age < 18 years
• Known pregnancy
• Prisoner

Part 1

• Children (<18 years of age)

Part 2

• Age <18 years old
• Allergic disorders: asthma, eczema, allergic rhinitis, IgE-mediated food allergies, eosinophilic esophagitis, chronic urticaria
• Mast cell disorders: Urticaria pigmentosa, mastocytoma, mast cell activation disorders
• Autonomic dysfunction/POTS

Part 1

• Age > 18 years old
• Allergic disorder: asthma, eczema, allergic rhinitis, IgE-mediated food allergies, eosinophilic esophagitis, chronic urticaria
• Mast cell disorders: Urticaria pigmentosa, mastocytoma, mast cell activation disorders
• On medications such as antihistamines, montelukast, NSAIDs

Part 2

• None

• 18 years of age or older.
• Biologically Female.
• Non-Hispanic Black.
• Diagnosis of Breast and/or Ovarian Cancer.
• Family History of Breast and Ovarian Cancer.

• Under age of 18 years.
• Not biologically female.
• ethnicity other than Non-Hispanic Black.
• Has not been diagnosis with breast and/or ovarian cancer.
• Does not have a family history of breast and ovarian cancer.

• Age: 18 and over.
• 30 days after a clinical or laboratory diagnosis of COVID-19.
• Willingness and ability to provide written informed consent.
• Generally healthy, as determined by study investigators, and not meeting any of the exclusion criteria listed below.

• Individuals under 18 years of age.
• Currently pregnant.
• Immunocompromising medical conditions (diabetes mellitus, autoimmune diseases, chronic kidney disease, liver disease, HIV infection, malignancy, or other conditions deemed by the study investigators to be immunocompromising).
• Subject has current anticoagulant therapy or history of bleeding diathesis.
• Weighs ≤ 110 lbs.
• Receipt of oral prednisone or other immunosuppressive medications within 30 days prior to the study blood draw (inhaled, intranasal, or intra-articular corticosteroids are permitted).
• Transgender women/men will be excluded due to the potential impact of this status on immune response.
• Recipient of any blood/blood product transfusion within the last 30 days.

• Adult and pediatric patients.
• Undergoing surgical resection of their brain AVM.
• Have not undergone previous stereotactic radiosurgery or endovascular embolization.  

• Have undergone previous stereotactic radiosurgery or endovascular embolization.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Overactive Bladder:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent.
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation.
• For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion).
• For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria
•Non-Obstructive Urinary Retention:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent..
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation.
• Have a diagnosis of non-obstructive urinary retention as demonstrated by a urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-day period; and chronic non-obstructive urinary. retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria - Fecal Incontinence:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent.
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation.
• Have a diagnosis of fecal incontinence as demonstrated by a bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate, or severe soiling) per week.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria
•Overactive Bladder:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• History of diabetes unless the diabetes is well‐controlled through diet and/or medications.
• Have symptomatic urinary tract infection (UTI).
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component.
• Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study.
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
• Women who are pregnant or planning to become pregnant.
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria - Non-Obstructive Urinary Retention:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• History of diabetes unless the diabetes is well‐controlled through diet and/or medications
• Have symptomatic urinary tract infection (UTI)
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
• Women who are pregnant or planning to become pregnant
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria
•Fecal Incontinence:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• Have uncorrected high grade internal rectal prolapse.
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
• Women who are pregnant or planning to become pregnant.
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years old; AND
• Were treated with curative intent; AND
• Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site; AND
• Provided written informed consent to participate in the study; AND
• Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent; AND
• Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent; AND
• Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer.
• Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts:

• Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III).
• Cohort 2: Non-small cell lung cancer (stage II-III).
• Cohort 3: Invasive breast carcinoma with all of the following:
  • Clinical stage T1-4/N0-3/M0 at presentation; AND
  • Completed preoperative systemic chemotherapy-containing regimen; AND
  • Underwent definitive surgical resection of the primary tumor; AND
  • Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes; AND
  • Hormone receptor and HER2 status are known.

Exploratory Cohorts:

• Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent.
• Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III).
• Cohort 6: Gastric adenocarcinoma (stage II-III).
• Cohort 7: Surgically resected pancreatic adenocarcinoma.
• Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers).
• Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology).
• Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)).
• Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent).
• For the purposes of this study, participants receiving extended (> 6 months planned duration) non-chemotherapy systemic treatment will be considered in their end of primary treatment phase after the initial planned surgery, chemotherapy and/or radiation.
• Determination of stage for eligibility assessment and enrollment should be based on pathologic stage unless the participant received pre-surgical/neoadjuvant therapy, in which case standard pre-treatment clinical staging will be used to determine eligibility.

• History of allogeneic organ or tissue transplant.
• Index cancer has neuroendocrine histology.
• History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
• Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC).
• Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.