• Previously received a positive result from either the antibodies to infliximab (INXAB) OR antibodies to adalimumab (ADLAB) test

• Does not meet inclusion criteria, does not provide consent to participate.

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

Eligibility last updated 9/13/22. Questions regarding updates should be directed to the study team contact.

• Patients ≥ 18 years of age.
• Diagnosis of thyroid eye disease; undergoing balanced decompression surgery at Mayo Clinic Rochester. 

• Pediatric patients; i.e., those < than age 18.
• Pregnant women, and those with thyroid eye disease + optic neuropathy.
• Patients unable to understand the study consent form.
• Patients who do not plan on following up in the ENT department at Mayo Clinic for their TED.

Eligibility last updated 9/14/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

• Age 18 years and older (no upper age limit defined).
• History of chronic migraine as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
• Receiving onabotulinum toxin A injections following a PREEMPT protocol for treatment of chronic migraine for ≥ 1 year.
• Response to therapy with onabotulinum toxin A injections of ≥ 50% improvement in the frequency of headache days when compared to baseline.
• 4 to 14 average number of total headaches days per month during peak efficacy of onabotulinum toxin A injections.
• Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
• Patient agrees to maintain a daily electronic headache diary.
• Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. Subjects owns an iPhone 6s or later with iOS 15 or later operating system installed on iPhone. Apple watch with watch OS6 will be provided by the study.
• Women of childbearing potential shall either be surgically sterile or must agree not to become pregnant for the duration of the study. Subjects of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study.
• If female, the subject may not be pregnant or breastfeeding. As per routine clinical care, patients who become pregnant while receiving onabotulinum toxin A injections will stop receiving the injections and detection of pregnancy will be guided by routine clinical practice.

• Chronic daily headache with no periods of headache freedom.
• ≥ 15 average number of headaches days per month during peak efficacy of onabotulinum toxin A injections.
• Medication overuse headache as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
• Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

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

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.

• All adult patients ≥ 18 years of age.
• Undergoing spinal fusion surgery in which the facet articular cartilage or disc and endplate cartilage is removed and discarded to allow for spinal fusion. Cervical, thoracic, and lumbar.

• < 18 years of age. 

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

• Cardiologists at Mayo Clinic Rochester in Interventional Cardiology, Heart Rhythm Services, Radiology, and Radiation Safety. 

• < 18 years of age. 

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

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

• Voluntarily provide informed consent prior to initiation of study specific activities.
• ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
• Patients must have a confirmed diagnosis of RRMM (as per IMWG):
  • Patients must have received at least 3 prior lines of therapy as defined by IMWG, including a PI, an IMiD, and an anti-CD38 antibody;
  • Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy;
  • For expansion cohorts in Part B only: Have t(4;14) confirmed by standard of care FISH testing or GOF mutation in MMSET confirmed by local sequencing test.
• Measurable disease, including at least 1 of the following criteria:
  • Serum M protein (detected by serum protein electrophoresis [SPEP]) ≥ 0.50 g/dL;
    • For patients with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA ≥ 0.50 g/dL (IgA will similarly be used for response).
  • Urine M protein (detected by urine protein electrophoresis [UPEP]) ≥ 200 mg/24 h;
  • Serum free light chain (sFLC) involved light chain ≥ 10 mg/dL (100 mg/L) provided sFLC ratio is abnormal;
  • ≥ 1 extramedullary lesion on imaging, including ≥ 1 lesion that is ≥ 1 cm in size and able to be followed by imaging assessments (Dose Escalation Only);
  • Bone marrow plasma cells ≥ 10% (Dose Escalation Only).
• Recovery to Grade ≤ 1 for any nonhematologic toxicities due to prior therapy, excluding alopecia or Grade 2 neuropathy.
• Ability and willingness to adhere to study visit schedule and protocol requirements.

• Treatment with the following therapies in the specified time period:
  • Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks prior to C1D1;
  • Cellular therapies (eg, chimeric antigen receptor T-cell) ≤ 8 weeks prior to C1D1;
  • < 100 days post autologous transplant (prior to first dose);
  • ≤ 6 months post allogenic transplant prior to C1D1 or if > than 6 months from allogenic transplant, no active graft-versus-host disease requiring treatment;
  • Major surgery ≤ 4 weeks from C1D1.
• History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis.
• Active central nervous system (CNS) disease: patients with previously treated stable CNS disease are eligible.
• Inadequate bone marrow function defined by:
  • ANC < 1000 cells/mm^3;
  • Platelets (PLT) < 75,000 cells/mm^3;
  • Hemoglobin < 8 g/dL (may be transfused provided no evidence of active bleeding).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN).
• Direct bilirubin > 1.5 × ULN, > 2 × ULN for patients with documented Gilbert’s syndrome.
• Prothrombin time (PT) or partial thromboplastin time (PTT) international normalized ratio (INR) > 1.5 × ULN, OR INR > 1.5 × ULN or within target range if on prophylactic anticoagulation.
• Creatinine clearance < 50 mL/min by Cockcroft-Gault formula.
• Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Prophylactic medications, antimicrobials or antiretroviral therapies are permitted provided the agents are not prohibited per Section 6.4.6 and Appendix 1:
  • HIV-positive patients with CD4+ T-cell counts < 350 cells/μL or not on a stable antiretroviral regimen for > 4 weeks with a viral load > 400 copies/mL prior to enrollment may not be enrolled;
  • Hepatitis C virus (HCV)-positive patients who have not completed curative antiviral treatment and have a quantifiable viral load may not be enrolled;
  • Hepatitis B surface antigen (HBs-AG)-positive and hepatitis B core antigen (anti-HBc)-positive patients may be enrolled following a discussion with the Medical Monitor to discuss anti-hepatitis B virus (HBV) prophylaxis. Patients with chronic HBV infection should complete an anti-HBV therapy regimen with follow-up assessment for response and tolerability prior to initiating study medication.
• Use of prohibited medications, including acid reducing agents and strong inhibitors or inducers of CYP3A4 (Appendix 1), within 14 days or 5 half-lives prior to starting KTX-1001.
• Uncontrolled thromboembolic events or recent severe hemorrhage that, in the opinion of the Investigator or Medical Monitor would pose a risk to patient safety or interfere with the study evaluation, procedures or completion.
• Any history of pulmonary embolism or deep vein thrombosis (DVT) within 1 month of enrollment. Therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT if > 3 months from time of enrollment.
• Active, unstable cardiovascular function; presence of any of the following:
  • Symptomatic ischemia;
  • Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on antiarrhythmics are excluded; patients with first degree atrioventricular or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded);
  • Congestive heart failure or New York Heart Association Class ≥ 3;
  • Myocardial infarction within 3 months prior to C1D1;
  • Uncontrolled hypertension f. QTc > 470 ms.
• Active malignancy not related to myeloma that has required therapy in the last 3 years prior to enrollment or is not in complete remission. Exceptions to these criteria include successfully treated nonmetastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the Medical Monitor.
• Malabsorption syndrome or other condition affecting oral absorption.
• Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 6 months (women) or 3 months (men) after receiving the last dose of study drug. Acceptable methods of effective birth control include sexual abstinence (refraining from heterosexual intercourse; men, women); vasectomy; tubal ligation; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or intrauterine device (women):
  • Pregnancy, or females planning on becoming pregnant while on study or through 6 months after last study drug administration; or females who are lactating/breast feeding or who plan to breastfeed while on study through 6 months after last study drug administration;
  • Male patients must refrain from sperm donation, or attempt to conceive from study drug administration until 3 months after last dose of study drug.
• History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator or Medical Monitor would pose a risk to patient safety or interfere with the study evaluation, procedures or completion, including inability to find alternative concomitant medications that may be potential risk for drug-drug interaction (DDI).

• Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.

• Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment.
• Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
• Patients will be excluded if they speak a language not supported by the Sound Success platform.

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

Eligibility last updated 9/30/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age.
• Status post unilateral uncomplicated pars plana vitrectomy for epiretinal membrane or internal limiting membrane peel (i.e. for epiretinal membrane, vitreomacular traction, lamellar or macular hole).
• The same phakic status in the fellow eye.

• Prior diagnosis of glaucoma, glaucoma suspect, or ocular hypertension.
• Difference in lens status between the two eyes (phakic, pseudophakic, or aphakic).
• Preoperative anisometropia greater than 2.5 diopters.
• Current use of topical, oral, inhaled, injected, or other corticosteroids.
• Abnormalities of the iridocorneal angle, including neovascular glaucoma, ICE syndrome, peripheral anterior synechiae, and plateau iris, among others.
• Monocular status (fellow eye with visual acuity less than 20/100, or phthisical or enucleated/eviscerated fellow eye).
• History of prior vitreoretinal surgery in either eye.
• Pregnancy.
• Inability to remain supine for the duration of testing.

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

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.

• Patients ≥ 18 years of age with Hepatocellular Carcinoma (HCC) and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
• Diagnosis of HCC.

• < 18 years of age. 

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

Eligibility last updated 9/23/22. Questions regarding updates should be directed to the study team contact.

• Healthy, parous, adult volunteers.
• Self-reported urinary incontinence during running with history of at least one prior delivery after 32 weeks gestation. 
• Must regularly run at least 10 minutes per week and be pain-free on the day of data collection.

• Unwillingness to complete all components of the study.
• Urge only urinary incontinence.
• < 3 months postpartum or current pregnancy.
• History of prolapse repair.
• Incontinence surgery.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

- Karnofsky performance status ≥ 60% (Eastern Cooperative Oncology Group [ECOG] ≤ 2).

- Absolute neutrophil count ≥ 1,500/mcL.

- Platelets ≥ 100,000/mcL.

- Hemoglobin ≥ 10 g/dL.

- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN).

- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x
institutional ULN.

- Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m^2.

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retro-viral therapy with undetectable viral load within 6 months are eligible for this trial.

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial.

- 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.

- The effects of selinexor (KPT-330) and temozolomide on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as
deoxyribonucleic acid (DNA) alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 180 days after the last dose of temozolomide. Should a
woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of study treatment administration.

- Ability to understand and the willingness to sign a written informed consent document.  Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible.

Inclusion Criteria
•Case Tissue:

• Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.
• Age ≥ 18 years.

Exclusion Criteria
•Case Tissue:

• Patient has a recurrence of bladder cancer.
• Patient has undergone any prior radiation therapy (including brachytherapy therapy) to target lesion prior to surgery.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.

Inclusion Criteria - Control Tissue:

• Patient is undergoing prostatectomy.  
• Age ≥ 18 years.

Exclusion Criteria
•Control Tissue:

• Patient has undergone any prior radiation therapy (including brachytherapy therapy) to the bladder prior to surgery.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to surgery.
• Patient has had bladder, urothelial or kidney cancer

Inclusion Criteria
•Control Buffy:

• Age ≥ 18 years.

Exclusion Criteria
•Control Buffy:

• Patient has known primary cancer within the last 5 years prior blood collection (not including basal cell or squamous cell skin cancers).
• Patient has undergone prior radiation therapy in the 5 years prior to blood collection.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to blood collection.

Inclusion Criteria
•Case Urine:

Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).

• Patient has a histological diagnosis of muscle invasive urothelial cell carcinoma of bladder.
• Age ≥ 18 years

Exclusion Criteria
•Case Urine:

• Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
• Patient has recurrent bladder cancer.
• Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
• Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
• Patient has had any prior radiation therapy to the target lesion prior to current collection.
• Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
• Patient has undergone cystectomy.
• Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
• Patient a has chronic indwelling urinary catheter.
• Patient has had a urinary tract infection within the 14 days prior to sample collection.

Inclusion Criteria
•Disease Control Urine:

• Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
• Age ≥ 18 years.                                                 

Exclusion Criteria
•Disease Control Urine:

• Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
• Patient has recurrent bladder cancer.
• Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
• Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
• Patient has had any prior radiation therapy to the target lesion prior to current collection.
• Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
• Patient has undergone cystectomy.
• Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection.
• Patient a has chronic indwelling urinary catheter.
• Patient has had a urinary tract infection within the 14 days prior to sample collection.

Inclusion Criteria
•Healthy Control Urine:

• Age ≥ 18 years.                                                  

Exclusion Criteria
•Healthy Control Urine:

• Patient has had a past or current diagnosis of invasive cancer  (this does not include basal or squamous skin cancers).
• Patient has had a solid organ transplant.
• Patient has chronic indwelling urinary catheter.
• Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to sample collection.
• Patient has had a urinary tract infection within 14 days prior to urine collection.

Inclusion Criteria - Case Blood:

Cases will be enrolled from a cohort of patients undergoing diagnostic evaluation and treatment for bladder cancer collected under IRB 21-009854 (PI: Kisiel).

• Patient has a histological diagnosis of invasive urothelial cell carcinoma of bladder..
• Age ≥ 18 years.

Exclusion Criteria
•Case Blood:

• Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
• Patient has recurrent bladder cancer.
• Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
• Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
• Patient has had any prior radiation therapy to the target lesion prior to current collection.
• Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
• Patient has undergone cystectomy.

Inclusion Criteria
•Disease Control Blood (Case patients with non-muscle invasive bladder cancer):

• Patient has history of non-muscle invasive bladder cancer and negative surveillance cystoscopy.
• Age ≥ 18 years.                                     

Exclusion Criteria - Disease Control Blood (Case patients with non-muscle invasive bladder cancer):

• Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
• Patient has recurrent bladder cancer.
• Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
• Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
• Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
• Patient has had any prior radiation therapy to the target lesion prior to current collection.
• Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
• Patient has undergone cystectomy.

Inclusion Criteria
•Healthy Control Blood:

• Age ≥ 18 years.                                            

Exclusion Criteria
•Healthy Control Blood:

• Patient has had a past or current diagnosis of  invasive cancer  (this does not include basal or squamous skin cancers).
• Patient has had a solid organ transplant.

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

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.

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

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

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

• Patients will be recruited from the random sample of cardiologists  with the goal of oversampling racial minorities and other underserved populations.
• Cardiologists from the Mayo Clinic Department of Cardiovascular Medicine will be randomly selected to participate in the proposed study.
• Patients of participating cardiologists will be recruited to form patient-clinician dyads.

• < 18 years of age. 

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

Eligibility last updated 10/4/22. Questions regarding updates should be directed to the study team contact.

Subjects with known or suspected Barrett’s Esophagus (BE) (cases):

• Patient between the ages of 18 – 90.
• Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
• Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
• Undergoing clinically indicated endoscopy.

Subjects without known history of BE (controls):

• Undergoing clinically indicated diagnostic endoscopy.
• Subjects with GERD and one or more additional risk factors for BE including:[IPGM1] 
  • Male sex;
  • age ≥ 50 years;
  • Caucasian race;
  • Presence of central obesity (BMI ≥ 30);
  • Current or past history of smoking.

For subjects with known BE

• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
• Patients with history of surgical resection for esophageal carcinoma. 

For subjects with or without known evidence of BE (on history or review of medical records):

• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia.
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin.
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.
• Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.
• Patients with history of known esophageal or gastric varices or cirrhosis.
• Patients with history of surgical esophageal resection for esophageal carcinoma. 
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.
• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Eligibility last updated 10/5/22. Questions regarding updates should be directed to the study team contact.

• Women age 18-44 years of age.
• Undergoing autologous IVF planning for monitoring at Mayo Clinic Rochester with an antagonist or long luteal protocol, planned fresh embryo transfer, conventional or ICSI insemination with ejaculate sperm.

• Women undergoing donor oocyte, donor embryo cycles, oocyte cryopreservation cycles, planned freeze all, TESE or micro TESE sperm.
•  Patients undergoing cycles for fertility preservation, minimal stimulation in 
  vitro fertilization, or with planned cleavage stage embryo transfer

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

• A Family Medicine Resident at the Mayo Clinic Health System of Eau Claire and Mayo Clinic Family Medicine Residency of Rochester in either the PGY-1 Year, PGY-2 Year, or PGY-2 Year

• Participant is not able to wear the devices for the assigned timeframe. Any condition the investigator considers will prevent compliance with study instructions.

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

• Mayo Clinic patients scheduled for or being seen in the Healthy Longevity Clinic in the Division of General Internal Medicine.
• 18 years of age or older at time of consent
• Have the ability to provide informed consent
• Have the ability to complete all aspects of this trial.

• < 18 years of age. 

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

Eligibility last updated 4/6/23. Questions regarding updates should be directed to the study team contact.

Select

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

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

- Women who are pregnant or breastfeeding. Pregnant women are excluded from this study
because lisinopril is an ACE Inhibitor with the potential for teratogenic or abortifacient effects.
Because there is an unknown but potential risk for adverse events (AEs) in nursing infants
econdary to treatment of the mother with lisinopril. Breastfeeding should be discontinued if
he mother is treated with lisinopril.

- Systolic blood pressure ≥ 161 mm/Hg. Diastolic blood pressure ≥ 111 mm/Hg.

- Participants taking lithium.

• ≥ 18 years of age.
• Previously underwent parotidectomy at Mayo Clinic Rochester for benign and malignant tumors.

• Participants not residing in the United States (to avoid potential EU GDPR compliance issues).

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

Eligibility last updated 11/14/22. Questions regarding updates should be directed to the study team contact.

• Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
• Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
• Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
• Subject completed Week 48 of the Maintenance Phase; OR
• Subject must have participated in Study CC-93538-DDI-001 and completed assessments
• through the end of treatment visit.

- Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.

- Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the
Investigator.

- Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of
contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.

Eligibility last updated 3/13/23. Questions regarding updates should be directed to the study team contact.

• Woman, as defined by sex at birth.
• Age 22 years or older at the time of eligibility screening.
• Premenopausal.
• BMI < 40 kg/m^2.
• Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report.
• English-speaking and able to follow verbal instructions of the remote ultrasound. technologist as determined by the ability to complete the consent process unassisted.
• Ability to manipulate a 1 lb. weight by hand.
• Residence in state where a PI holds a valid license to practice medicine.
• Ability to receive signature delivery of the investigational ultrasound device.
• Ability to return the investigational ultrasound device by specified instructions.

• Pregnant or may be pregnant.
• Has recently given birth, and has had fewer than 3 postpartum menstrual cycles.
• Has recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles.
• Has changed birth control within the current menstrual cycle (one 'washout' cycle is required).
• Turtle Health employees.
• Has known cancer of a pelvic organ, not currently in remission.
• Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made.
• Previous hysterectomy or oophorectomy.
• Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus.
• Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial).

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

Eligibility last updated 10/14/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 10/19/22. Questions regarding updates should be directed to the study team contact.

• 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.

• Patients ≥ 18 years of age being tested for COVID 19 or Influenza.

• Patients < 18 years of age.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

Key