• The participant must have a family member that has been diagnosed with one of the following forms of dementia:
  • Parkinson’s/Lewy body dementia;
  • Any frontotemporal lobar degeneration dementia; or
  • Alzheimer’s dementia.
• The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
• The participant must have been caring for their loved one with dementia for at least 3 months. 
• All participants must have access to a computer and be able to use the internet.
• All participants must be English speaking.
• All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief “virtual” interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
• All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.

• Care Partner’s loved one does not have a confirmed diagnosis of dementia.
• Care Partner is unable to provide consent.
• Care Partner was or has been in that role for less than 3 months.

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

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age. 
• Patients with known genetic predisposition to pheochromocytomas and paragangliomas (PPGL) development.
• Patients with history of (PPGL).

• < 18 years of age. 

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

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Is a male or female, 18 to 65 years of age, inclusive, at Screening.
• Has been diagnosed with PMM2-CDG with genetic test confirmation.
• Has ATIII levels below 80%.
• If the participant is a female of childbearing potential, she must not be pregnant (confirmed by a negative serum pregnancy test), is using a medically accepted method of contraception (abstinence, a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use of an intrauterine device), and must agree to continue using this method for 30 days after the last infusion of GLM101.
• If the participant is a female of non-childbearing potential, she must be pre-pubertal, surgically sterile, or must have an ovarian dysfunction confirmed by a follicle stimulating hormone (FSH) > 40 IU/L.
• If the participant is a sexually active male with female partners, the sexually mature, nonsterile male participant agrees to use a medically acceptable method of contraception (abstinence, the partner taking a hormonal contraceptive in conjunction with a barrier method, double-barrier method, or use by the partner of an intrauterine device) and agrees to continue using this method for 30 days after the last infusion of GLM101. Males are considered surgically sterile if they have undergone bilateral orchiectomy or vasectomy at least 3 months prior to Screening.
• If the participant is male, he must agree to refrain from donating sperm during the study and 30 days after the last infusion of GLM101.
• Is willing and able to provide informed consent/assent, directly or through his/her legally authorized representative.

• Diagnosis of congenital disorder of glycosylation (CDG) other than PMM2.
• Has an active infection requiring parenteral antibiotics, antivirals, or antifungals or treatment with systemic steroids within 7 days prior to Screening.
• Has confirmed active COVID-19 infection or tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or check in to clinical site.
• Has a history of a severe allergic reaction to any drug or excipients of GLM101 (as listed in the GLM101 IB).
• Has a known history of poor venous access.
• Has a history of liver transplant.
• Has a history of drug or alcohol use disorder within the 12 months from Screening.
• Has had a major surgical procedure within 30 days prior to Screening.
• Has Screening or eligibility confirmation laboratory value(s) outside the laboratory reference range considered clinically significant and not related to PMM2-CDG.
• If female, has a positive serum pregnancy test during Screening.
• Has serology positive for hepatitis B surface antigen or hepatitis C antibody during Screening.
• Has history or presence, upon clinical evaluation, of any illness that might impact the safety of GLM101 infusion or evaluability of drug effect based on the Principal Investigator’s and Medical Monitor’s discretion.
• Is currently participating in another interventional clinical study or has completed another clinical study with an investigational drug or device within 30 days or 5 half-lives before GLM101 infusion, except for acetazolamide. Participants may be enrolled and continue treatment with acetazolamide only if they are on a stable dose for at least 30 days prior to dosing with GLM101, and the dose remains unchanged for the duration of the study.

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

Inclusion Criteria

- Clinical diagnosis of focal epilepsy.

- Estimated to have at least 2 countable seizures per month.

- Has not had control with at least 2 anti-seizure medicines.

- Able to maintain a constant medication for duration of the study (rescue meds
allowed).

- Subject or legally authorized representative is able to understand consent and keep a
seizure diary in English.

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

Eligibility last updated 3/15/23. Questions regarding updates should be directed to the study team contact.

• Patients aged 18 years or older
• 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 nonfunctioning.
• Life expectancy of at least 6 months.
• Capable of giving written informed consent and able to understand and complete the survey in English In addition, the clinics were asked to recruit a small number of patients who had received an implanted pump and would have satisfied the eligibility criteria above before receiving the implanted pump. The inclusion criteria for the online survey will be exactly as indicated for the pretest interviews, with the additions described as follows:  Received paracentesis more than 1 time in the last 30 days, confirmed by physician and patient report.
• Stage 0 hepatic encephalopathy, confirmed by physician report.
• Ascites symptoms Stage 1, 2, or 3, confirmed by physician report.
• Has a life expectancy of at least 6 months, confirmed by physician report 6 Therapeutic paracentesis is defined as removal of at least 1.5 L 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. Patient Preference for an Implantable Device to Treat Liver Ascites: Final Protocol 35.
• At least half the sample will include patients who are not candidates for (refused, contraindicated) TIPS or in whom a previously implanted TIPS is permanently obstructed or nonfunctioning.

• Patients who have been enrolled to participate in the clinical trial for the alfapump, including people who have been enrolled but have not been implanted with an alfapump or are no longer implanted.

Eligibility last updated 8/29/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

• Patients who are or will be included in POWER registry.
• Patients aged 6 to 26 years at time of recruitment for the current study.
• Patients who satisfy the criteria for early-onset obesity:
  • Criteria to identify early-onset obesity among patients aged 6 to 26 years will be consistent with the criteria used for the Uncovering Rare Obesity® Program, as follows:
    • For patients aged 6 to 18 years at study recruitment::
    • The patient’s body mass index (BMI) is ≥ 97th percentile at recruitment based on the Centers for Disease Control (CDC) charts, and;
    • The patient has early-onset obesity.
    • Early-onset obesity will be determined based on historical records of weight, height, age, and gender in the electronic medical record or patient chart using the following definitions:
    • Historical measurements from age < 2 years: sex-specific weight for recumbent length is ≥ 97.7th percentile on the World Health Organization (WHO) charts.
    • Historical measurements from age 2-5 years: BMI ≥97th percentile based on the CDC charts.
    • Only patients with verified weight and height information before the age of 6 years and who meet the criteria of early-onset obesity will be included in the study. For new patients without available measurements to confirm early-onset obesity (electronic medical record, patient chart and/or POWER data), at least 1 weight and height measurement prior to the age of 6 years will be obtained by the study investigator at each participating site (either from the electronic medical record or from the patient’s primary care provider).
    • For patients aged ≥ 18 years at study recruitment:
    • The patient’s BMI is ≥ 40 kg/m^2 at recruitment AND
    • The patient has early-onset obesity (as defined above), as documented in the electronic medical record or patient chart.

• Patients with prior testing for variants in the 36 genes of interest.
• Patients who have any of the following potential causes of secondary obesity:
  • Endocrine diagnoses (e.g., hypothyroidism, Cushing syndrome, growth hormone [GH] deficiency);
  • Neurologic diagnoses.;
  • Intracranial injury (including, but not limited to: tumor, trauma, surgery, pituitary resection, irradiation);
  • Hypothalamic obesity;
  • Medication-induced weight gain, as determined by the Investigator.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

• Have a diagnosis of metastatic non small cell lung cancer.
• Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy.
• Subjects will be limited to older than 18 years old at the time of diagnosis.

• Have advanced terminal cancer, severe depression, or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing).
• Regular use of psychotropic medication other than hypnotics (e.g., antidepressants) per chart review.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Patients with a diagnosis of cancer including solid tumor and hematologic malignancy at Mayo Clinic, Rochester.
• To ensure sampling patients likely to have experienced declines in fatigue, all patients will have had at least two in-person encounters for radiation or chemotherapy treatment within the 3 months prior to recruitment. The sampling methodology developed for the CAHPS Cancer Care survey[9] will be modified and used to identify eligible patients from Mayo Clinic’s electronic health record.
• As interviews will be conducted either in person or by video conference (Zoom, Teams, or similar), access to internet is required for those unable or unwilling to travel to the clinic for an in-person interview.
• Answered “Yes” to screening question: “In the past 3 months, have you experienced changes in your level of fatigue?” Yes/No.

Exclusion Criteria: 

• Unwilling to be audio recorded during the interviews.
• Answered “No” for the screening question.

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

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

• ≥ 18 years of age.
• Radiographic findings consistent with a lesion with high pre-procedure probability of malignancy as determined by the investigator to be NSCLC 8th Ed. stage IIB- IIIA cancer or biopsy-confirmed NSCLC 8th Ed. stage IIB-IIIA and lesion size ≤ 5 cm in greatest dimension.
• Lesion is targetable for biopsy and PEF delivery per investigator opinion.
• Patient deemed able to complete neoadjuvant therapy according to their EGFR/ALK mutation status and specific histology (if clinically appropriate) and per the manufacturer’s systemic therapy labeling.
• Patient has been deemed a potential candidate for definitive lung tissue resection by a qualified study investigator.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Patient is able to adhere to protocol requirements 8. Patient is able to tolerate general anesthesia.
• Patient is cleared to undergo paralytic anesthesia.
• Patient has provided informed consent.

• Presence of advanced, inoperable, or metastatic disease.
• Radiographically suspicious findings for stage IIIA patients indicating a single mediastinal lymph node > 3 cm or multiple mediastinal lymph nodes and, therefore, potentially inoperable.
• Patient has recurrent NSCLC or has previously been treated for NSCLC.
• Patient has received chemotherapy or any other cancer therapy in 2 years prior to PEF ablation.
• Prior treatment with any drug that targets T cell co-regulatory pathways (such as checkpoint inhibitors) in 2 years prior to PEF ablation.
• Patient has implanted lung devices or electronic devices.
• Patient has a serious medical condition that, in the investigator’s opinion, could compromise patient safety or confound the interpretation of the patient’s response.
• Patient requires or is likely to require a pneumonectomy.
• Patient with active, known, or suspected autoimmune disease
  • Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immune-modifying or immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
• Patient has any history of primary immunodeficiency including known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
• Patient has any history of organ transplant that requires use of immunosuppressives.
• Patient has clinical signs or symptoms of active tuberculosis infection.
• Patient has history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease.
• Patient with ≥ Grade 2 peripheral neuropathy.
• Patient has received any vaccine against infectious diseases (e.g., influenza, COVID-19, varicella, etc.) within 30 days of PEF procedure.
• Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
• Patient has undergone major surgery within 30 days prior to study enrollment or has planned for other major surgery to be performed while enrolled in the clinical trial.
• Patient is unable or unwilling to complete all required screening and/or follow-up assessments.
• Patient is currently enrolled in another interventional clinical trial or is receiving treatment with an investigational medication or medical device that conflicts with the study protocol.
• Patient is pregnant or nursing.
• Patient for whom the investigator considers that the PEF ablation is not in the patient’s best interest.
• Patient has active alcohol or drug addiction or any other condition that, in the investigator’s opinion, would interfere with their ability to comply with the study requirements or jeopardize the safety of the patient or compliance with the protocol.
• Patient is involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Eligibility last updated 9/6/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.

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

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

• Treated with CARPEDIEM as part of standard of care at a participating institution.
• Within the United States.

• Parents/legally authorized representative unable or unwilling to provide consent.

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

Eligibility last updated 9/12/22. Questions regarding updates should be directed to the study team contact.

• 18 years or older.
• Generally healthy adult (At the discretion of the PI).
• Visitor accompanying a current mayo clinic patient to an appointment.

• Patient and the patient’s visitor cannot be being seen in the dermatology department.
• Known diagnosis of Hidradenitis Suppurativa.

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

• 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 9/16/22. 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.

• 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).

• ≥ 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.

• 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.

• 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.