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

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

• Patients who have received care for hepatobiliary cancer at Mayo Clinic in the past 5 years.
• Caregiver of above patient.
• Clinician providing care for hepatobiliary cancer patients at Mayo Clinic.
• Member of SPORE Patient Advocacy Board.

• Inability to complete an English language electronic survey for any reason. Non-English speaking patients will be offered translation services when available.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

• Adults age 18 years and older.
• Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician.
• IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy.
• Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures .

• Study materials not available in the subject’s preferred language.
• Patients undergoing treatment for active concomitant ventricular arrhythmias.
• Standard exclusions for elective sotalol use (at the time of initiation):
  • Heart rate < 40 bpm or 2nd/3rd degree AV block without pacemaker;
  • QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block);
  • Severe left ventricular hypertrophy (thickness > 1.5 cm).
• Patients who were previously intolerant to antiarrhythmic class III therapy.
• Patients missing key data elements in their electronic health record (for retrospective subjects only).

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

• Adults ≥ age of 18 years.
• Must have a left ventricular assist device (LVAD).
• Must be able to consent.

• No LVAD.
• Unable to consent.
• Under the age of 18 years.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

• Healthy, full-term women (18-35 years old) who underwent elective cesarean section.
• Free of Human Immunodeficiency Virus (HIV) types 1 & 2, Hepatitis A, B, and C, Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhea, and HTLV 1 & 2.
• Able to give written informed consent prior to collection of the cord.

• On chronic, immunosuppressive transplant therapy or having a chronic, immuno-suppressive state, including use of systemic steroids/corticosteroids.
• Takin anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
• Ongoing infectious disease, including but not limited to tuberculosis, HIV, Hepatitis, and syphilis.
• History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.

Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/8/23. Questions regarding updates should be directed to the study team contact.

Key

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

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

• Adults 18 years of age and older.
• Healthy subjects without known cardiovascular disease and thyroid disease.
• Subjects who are on no medications (except oral contraceptive pill).
• Nonsmokers.
• No prior history of caffeine sensitivity or allergy.

• Subjects with known cardiovascular or thyroid disease.
• Subjects currently taking medications other than oral contraceptive pill.
• Smokers.
• Prior history of caffeine sensitivity or allergy.
• Pregnancy.
• • •  
• Subjects who regularly consume energy drinks.
• Subjects who typically go to sleep after midnight.
• Subjects who traveled across 2 time zones in the last 7 days.
• Shift workers.
• Subjects who have or are suspected to have sleep apnea.
• Subjects who have a body mass index > 35kg/m^2.

Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.

• Individuals 18+ years of age.
• Capable of consent.
• Diagnosis of a Congenital Heart Disease.

• Individuals < 18 years of age.
• Unable to consent.
• Unable to undergo a cardiac MRI.

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

• Males and females.
• Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPIbM or VWF:Ag ≤ 30% of pooled normal control plasma on more than one occasion.
• Participants with clinically severe VWD as defined by VWF:RCo or VWF:Ag ≤ 40% of normal with severe bleeding phenotype defined as requiring use of recurrent factor concentrates.
• Co-enrollment in the ATHN dataset.

Exclusion Criteria

• Diagnosis of platelet-type VWD;
• Diagnosis of acquired VWD (clinical diagnosis made by the hemophilia health care provider, typically based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.

• Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam.
• Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report.
• Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be ≥ 3% and ≤ 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria.
• Participants with localized resected pNETS must have a Zaidi score of ≥ 3 derived by the following factors and points:
  • 1 point; symptomatic tumor defined as one of the following:
    • Gastrointestinal bleed;
    • Jaundice;
    • Gastrointestinal obstruction;
    • Pain from primary tumor prior to surgical resection;
    • Pancreatitis.
  • 2 points; primary pancreas tumor size > 2 cm.
  • 1 point; Ki-67 3% to 20% -1 point; lymph node positivity = 1.
  • 6 points; Ki-67 21% to 55%.
• Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection.
• Participants must not have unresected or unablated metastatic disease.
• Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
• Participants must have recovered from effects of surgery as determined by the treating investigator.
• Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
• Participants must not have received somatostatin analogs after surgery.
• Participants must be ≥ 18 years old
• Participants must have Zubrod performance status of 0-2
• Participants must have a complete medical history and physical exam within 28 days prior to registration.
• Patients must have adequate organ and marrow function as defined below within 28 days prior to registration:
  • Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration);
  • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration);
  • Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration);
  • Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration);
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration);
  • Serum creatinine ≤ 1.5 x institutional ULN (within 28 days prior to registration);
  • Calculated creatinine clearance ≥ 50 ml/min (within 28 days prior to registration).
  • Calculated Creatinine Clearance = (140
    •age) X (weight in kg) † 72 x serum creatinine:
  • * Multiply this number by 0.85 if the participant is female.
  • † The kilogram weight is the participant weight with an upper limit of 140% of the IBW.
  • * Actual lab serum creatinine value with a minimum of 0.8 mg/dL.
• Participants must be able to swallow pills.
• Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol.
• Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
• Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
• Participants must not have known absorption issues that would limit the ability to absorb study agents.
• Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
• Participants must not have active or uncontrolled infection.
• Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
• Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential."In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
• No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years.
• Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

• Participants must not have unresected or unablated metastatic disease.
• Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
• Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
• Participants must not have received somatostatin analogs after surgery.
• Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
• Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
• Participants must not have known absorption issues that would limit the ability to absorb study agents.
• Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
• Participants must not have active or uncontrolled infection.
• Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
• Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Eligibility last updated 12/27/21. Questions regarding updates should be directed to the study team contact.

• Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems
• Ability to provide informed written consent
• Known paternity for pregnancy
• Singleton pregnancies

• Mothers < 18 years of age
• Multiple fetuses

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age.
• Able to provide informed consent.
• Individual must have a future treatment plan to receive or has historically received phage therapy.

• Individuals , 18 years of age.
• Unwilling/unable to provide informed consent.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

• Male or female age ≥ 18 years.
• Is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
• Have a ≥ 6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
• Have high-resolution computed tomography (HRCT) and PET scan consistent with active pulmonary sarcoidosis of the lung parenchyma confirmed by central read.
• Have FVCp ≥ 50% to ≤ 90% and DLCO ≥ 50%.
• If receiving prednisone (or equivalent), dose must have been ≤25 mg, and dose must have been stable for at least 4 weeks prior to randomization.
• Symptomatic as indicated by mMRC Dyspnea scale >1 (i.e., Grade 2 or more) in the prior year.
• If receiving methotrexate and/or other immunosuppressive therapy (IST) dose must have been stable for ≥ 3 months prior to randomization.
• Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) throughout the study, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:
  • Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization;
  • Postmenopausal defined as 12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age > 40 years) a documented serum FSH level must be ≥ 30 mIU/mL;
  • Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to the start of dosing, throughout the study, and for 4 months following the last dose of study drug.
• Males who are sexually active must agree to use one of the allowed BC methods. Male subjects must also agree to sufficiently minimize the risk of pregnancy throughout study participation (and for 4 months following the last dose of study drug).
• Body Mass Index (BMI) 18 to 40 kg/m^2 at screening.
• Subjects must agree to steroid taper, and cessation of their IST therapy at randomization.
• Completion of vaccination for COVID-19 at least 2 weeks prior to randomization.

Exlusion Criteria:

• Hospitalized for any respiratory illness ≤ 30 days prior to screening.
• Prednisone dose > 25 mg/day at any time in the previous 4 weeks.
• ≥ 20% fibrosis as indicated on CT-scan that has been confirmed by central read prior to randomization.
• eGFR ≤30 mL/min/1.73 m^2 (MDRD equation) or requiring hemofiltration or dialysis.
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3 × upper limit of normal range (ULN).
• Platelet count <100,000 per mm^3.
• Hemoglobin ≤ 9.5 g/dL.
• Absolute neutrophil count < 1,000 per mm^3.
• History of known anti-GM-CSF autoAb or tests positive at screening, or history of pulmonary alveolar proteinosis (PAP).
• Use of biologic — approved or investigational agents (e.g., anti-TNFα, anti-IL-1, anti-IL-6, anti-IL-17, anti-IL-12/23 or specific anti-IL-23 inhibitors, anti CD20, anti-IL-18) within the 6 months prior to screening.
• Prior use of immunoglobulin within 6 months prior to screening.
• Prior use of any investigational immunomodulator (e.g., NRP2 modulator) within 6 months of screening.
• Prior use of any JAK inhibitor within 3 months of screening.
• Participation in another interventional clinical trial within 6 months prior to screening.
• Known left ventricular ejection fraction (LVEF) ≤30% or NYHA class III or IV heart failure.
• ECG abnormalities that warrant further investigation, in the opinion of the Investigator.
• Pulmonary hypertension requiring therapy.
• Systolic blood pressure (SBP)  < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg.
• Known COVID-19 infection within 3 months prior to screening.
• Have received any live virus or bacterial vaccinations < 3 months of screening. Age-appropriate non-live vaccinations may be administered during screening so long as the last vaccine dose is administered at least 2 weeks prior to planned randomization.
• Any infection requiring antibiotics or pulse of OCS where completion of treatment has been < 30 days prior to screening.
• History of 3 or more lower respiratory tract infections requiring anti-microbial therapy in the past year.
• Any history of mycetoma or fungal respiratory infection.
• Requirement for supplemental oxygen at rest.
• Prior history of, or likely to have any organ transplantation during study including OLE.
• History of smoking (or vaping) in the prior year or current use. Occasional use (defined as less frequently than once per month) is allowable, though subjects should be counseled to remain abstinent during the study including OLE.
• Other significant pulmonary disease likely to interfere with the primary endpoint, in the opinion of the Investigator.
• Other autoimmune disease likely to require therapy during the study.
• Symptoms and features of extra-PS that may warrant treatment in addition to that required for lung involvement.
• Significant ischemic heart disease (i.e., myocardial infarction within 6 months, unstable angina or PCTA/stent within 1 month or planned intervention during study).
• Known or suspected active and untreated/inadequately treated tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may be enrolled if anti-TB therapy is commenced prior to randomization.
• For women: pregnant or planning to become pregnant during the study or currently breastfeeding.
• Prior history of any malignancy or lymphoproliferative disorder (not including fully resected basal cell carcinoma of the skin, fully resected intra-epithelial neoplasia or carcinoma in situ) within the past 5 years.

Eligibility last updated 12/23/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
• The ability to read and respond to questions in English or Spanish.
• Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
• Life expectancy at least 6 months.

• Individuals < 18 years.
• Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

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

•  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.

• Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

• Diagnosis of CVID according to the international consensus document (ICON):
  • Age 4 years or above;
  • Serum IgG at least 2 standard deviations below the age adjusted normal;
  • Decreased serum IgA and/or serum IgM;
  • Abnormal specific antibody response to immunization;
  • Exclusion of secondary immunodeficiency.
• On replacement immunoglobulin for at least 6 months and willing to maintain throughout study.
• Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
• Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 2 months of study entry.
• Signed written informed consent.
• Willing to allow storage of biological specimens for future use in medical research.
• Females of childbearing potential must use a highly effective form of birth control such as hormone-based contraceptive, intrauterine device, or double barrier method.

• History of hypersensitivity to abatacept or any of its components.
• Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months.
• Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as >15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months.
• History of HIV infection (positive PCR).
• Chronic untreated hepatitis B or C (positive PCR).
• Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
• Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart.
• Other uncontrolled infections.
• Live vaccine given within 6 weeks of the start of the trial.
• Malignancy or treated for malignancy within the past year.
• Currently pregnant or breast feeding.
• Life expectancy less than 1 month.
• Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home.
• Other conditions that the investigators feel contraindicate participation in the study.

Eligibility last updated 12/22/21. Questions regarding updates should be directed to the study team contact.

• Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
• Age 18
  •75 years.
• BMI between 18 and 40 kg/m^2.
• Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
• If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
• If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication before starting new medication.

• Any change to medication(s) within the last 45 days.
• History of chronic alcohol or drug abuse within the prior 12 months.
• Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
• Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit.
• Participation in another study of an investigational drug within the 28 days prior to screening visit or currently.
• Pregnancy and/or breast-feeding.
• Subjects who, in the opinion of the Investigator, may not be suitable for the study.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

• Subject aged 50-80 years at time of consent.
• Increased risk of lung cancer defined by having at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
• Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening.
• Willing to consent to the investigational blood draw during index low dose CT scan screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
• Willing to consent to a 1-year, 2-year and additional follow-up per protocol.

• Subject has not smoked for 15 or more years.
• Subject has less than 20 pack-year smoking history.
• Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
• Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer.
• Preexisting or history of lung cancer.
• Previously diagnosed high-risk lung lesion.
• History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
• Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
• Currently receiving treatment for pneumonia.
• Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
• Additional cohorts: inclusion and exclusion criteria will be specified for each cohort as appendixes.

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

• Eligible patients are females with stage I-III breast cancer taking adjuvant AI (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled. Treating physicians determine if pain is secondary to an AI.  
• ≥ 18 years old.
• Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment.
• Patients should have an ECOG performance score of 0-2. 

•  Age less than 18 years.
• Significant underlying pulmonary disease.

Eligibility last updated 1/14/22.  Questions regarding updates should be directed to the study team contact.

• Able to give informed consent.
• Adults  > 50 years old.
• No prior cancer diagnosis.

• Individuals < 50 years old.
• Unable or unwilling to provide informed consent.

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Age and gender matched to biorepository cohort.
• Population specific: 
  • For the never-COVID group – no history of having contracted COVID;
  • For COVID infection without post COVID cohort (+ COVID,
    •PASC), part of initial acute COVID biorepository;
  • time from onset of symptoms matched to biorepository cohort. 
  • For the + PASC group Included in the PASC biorepository.
• Matched by age, sex and time of onset of symptoms, as appropriate be able to participate fully in all aspects of the study; and  
• Have understood and signed study informed consent. 

• Active persistent COVID infection. 
• < 40 kg in weight have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence. 
• Women with a previously confirmed infection with the novel SARS-CoV-2 virus of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.   

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

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

Eligibility last updated 11/15/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/1/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria;

• Age > 25 or < 65 years.
• HbA1c ≥ 8.5%.
• BMI ≤ 28 Kg/M^2 (for lean participants).
• BMI ≥ 25 Kg/M^2 (for obese participants).
• Use of diet, sulfonylureas or metformin only (for T2DM participants).
• For female subjects: negative pregnancy test at the time of enrollment and study.
• No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• No active systemic illness or malignancy.
• No symptomatic macrovascular or microvascular disease.
• No contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit > 35%.
• TSH > 0.4 or < 5.5.
• Consumption of < 2 alcohol drinks per day or < 14 per week or a negative AUDIT questionnaire.
• No allergy to iodine.

• Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
• HbA1c ≥ 8.5%.
• BMI ≤ 28 Kg/M^2.
• Use of insulin or agents other than sulfonylureas or metformin.
• For female subjects: positive pregnancy test at the time of enrollment or study.
• History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
• Active systemic illness or malignancy.
• Symptomatic macrovascular or microvascular disease.
• Contraindications to MRI (e.g., metal implants, claustrophobia).
• Hematocrit < 35%.
• TSH < 0.4 or > 5.5.
• Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire.
• Allergy to iodine.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.