• Adolescent patients age 13-17 at the time of clinical evaluation.
• Documented COVID infection (positive PCR, rapid COVID test, or positive antibody testing following suggestive clinical syndrome or known exposure).
• Post-COVID symptoms primarily characterized by fatigue, autonomic dysfunction, or pain persisting > 12 weeks from initial diagnosis.
• Access to both patient portal and Zoom, for virtual coaching sessions.
• English speaking.

• Severe anxiety or depression (defined as psychiatric hospitalization in the past 12 months, current or recent suicidal ideation or plan, or anxiety/depression primarily causing missed school or activities, or clinician assessment).
• Prior medical complexity, as defined by clinician.
• Severe COVID illness, with evidence of end-organ damage or requiring hospitalization.
• Acute COVID-19 infection.
• No prior positive SARS-CoV2 testing.
• Age ≥ 18 years at time of initial clinical evaluation.

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

Eligibility last updated 6/9/23. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years old.
• Patients with clinically indicated MRI-PDFF (Proton Density Fat Fraction) for liver imaging.

Exclusion Criteria

• Individuals < 18 years old.
• Vulnerable subjects such as:
  • Prisoners;
  • Adults lacking capacity to consent.
• Patients with liver iron overload, which may confound PDFF measurements.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• BMI ≤ 30.
• No current cardiac medications.
• Systolic BP ≤ 140 mmHg.
• Diastolic BP ≤ 90 mmHg.
• Capacity to consent.

• Age < 18 years.
• To be assessed via EMR screening.
• Patient confirmation during screening visit.
• Screening tests as applicable.
• History of cardiovascular disease.
• eGFR < 30.
• Current orthopedic limitations.

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

• Evaluation for total knee arthroplasty (TKA) at Mayo Clinic (Rochester, MN) or OrthoCarolina (Charlotte, NC).
• Evaluated and scheduled for TKA at Mayo Clinic by Drs. Cody Wyles, Robert Trousdale, Kevin Perry, Corey Couch, or Nic Bedard or at OrthoCarolina by Drs. Thomas Fehring, Bo Mason, Keith Fehring, or Jesse Otero. 
• Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery.
• ≥ 18 years of age at enrollment.

• Previous surgery with hardware on the joint of interest.
• Varus or valgus defor 1mity > 15° or any other preoperative deformity at the discretion of the surgeon portending a risk of needing a constrained or hinged device.
• Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease).
• BMI ≥ 40.
• Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol.
• Contralateral side previously enrolled in this study (i.e., simultaneous bilateral or staged bilateral patients cannot have both sides enrolled).
• Current tobacco use.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

• Age 15-30 years inclusive.
• Male gender.
• Active participation in collegiate level baseball as a batter.
•  Unrestrictive baseball participation.
• No current musculoskeletal complaints for which the subject is being treated.
• Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
• Willingness to participate in the study

• Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
• Known neurological, visual, or vestibular disease affecting balance or coordination.
• Congenital deformity of the neck, upper extremity, or lower extremity.
• Congenital or acquired scoliosis or significant thoracic kyphosis (>30 degrees).
• History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

Eligibility last updated 2/27/23. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years of age.
• Hiccups in the 4 weeks prior to phone contact (patient must confirm).
• Able to speak and read English.
• Has an e-mail address.

• Individuals < 18 years of age.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

• Patients age 1 year through adult.
• Have a documented activating variant of the CASR gene for ADH1 or documented activating variant of the GNA11 gene for ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment.
  • Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
• Be willing and able to provide informed consent or assent after the nature of the study has been explained, and prior to any research-related procedures.
• Be willing to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available.
• Be willing and able to comply with the study visit schedule and study procedures.

• Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures.
• Enrollment in an ADH1/2 interventional clinical study at the time of DMS Screening visit or at any point during the DMS.

Eligibility last updated 3/30/23. Questions regarding updates should be directed to the study team contact.

• Subjects who are ≥ 18 years of age.
• Subjects who are known to be positive for syphilis antibodies using routine, standard of care serologic assays.

• Subjects who are < 18 years of age.
• Subjects who are unable to give informed consent.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/7/23. Questions regarding updates should be directed to the study team contact.

• Positive SARS-CoV-2 PCR in index case or a household contact of index case.

• Hospitalization at the time of diagnosis.
• Inability to perform serial testing.

Eligibility last updated 11/29/21. Questions regarding updates should be directed to the study team contact.

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

• Active disease as defined by SES-CD (PMID: 15472670) > 6 (> 4 if ileal only), AND active symptoms of CD (CDAI score > 220) or full Mayo score for UC ≥ 2 with an endoscopy score of ≥2 (PMID: 31272578) within the past 4-6 weeks. 9,10,11,12,13
• Remission as defined by SES-CD 0-2 and CDAI score ≤150, or full Mayo score for UC 0-2 with endoscopy score < 2.9,10,11,12,13.
• Ability to give informed consent.

Healthy Adults

• ≥ 18 years age.
• No underlying medical illnesses that could serve as confounders with the objectives of the study.  

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

• Less than 18 years of age.
• Prior history gastrointestinal surgeries including IPAA, ileostomy and colostomy.
• Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test.
• Use of osmotic laxatives and unable to unwilling to stop taking one week prior to permeability test.
• Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous two weeks and for the duration of the study.
• Multiple dietary restrictions or unable or unwilling to alter dietary protein or dietary fiber for the permeability testing.
• Unwilling or unable to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
• Bowel preparation for colonoscopy must be completed more than 48 hours prior to completion of permeability test. If intestinal biopsies were performed, 7 days must pass prior to permeability testing.
• Pregnancy or plan to become pregnant during the study time frame.
• Vulnerable adult.

Healthy Adults 

• Less than 18 years of age.

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

Either:

• TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment; or
• TEGSEDI Unexposed Cohort: Patients diagnosed with hATTR-PN who have not taken any dose of TEGSEDI within 25 weeks prior to enrollment and are eligible for TEGSEDI treatment per applicable product label.
• Clinically managed in Canada, Europe, or the US.
• Have provided appropriate written informed consent.

• None.

Eligibility last updated 12/2/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.

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 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.

• Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study.
• Male or female, age ≥ 18 years at the screening visit.
• Have a diagnosis of PBC in line with the AASLD guidelines as demonstrated by having at least 2 of the following:
  • History of sustained increased ALP levels > ULN first recognized at least 6 months prior to the screening visit (sustained ALP elevations at the time of screening is not required, recognizing that the ALP may have decreased on UDCA therapy);
  • Documented positive AMA titer (> 1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific ANA immunofluorescence patterns (multiple nuclear dots and/or punctuate nuclear rim);
  • Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts. Liver biopsy could have been done at any time in the past.
• Those treated with UDCA will be allowed to enroll if they meet one of the following criteria at Visit 1:
  • A minimum of 24 weeks of stable treatment at a dose of ≤ 20 mg/kg/day; OR
  • A minimum of 12 weeks off treatment and consequently determined by the investigator to be clinically stable.
• Systemic therapies intended to address cholestatic pruritus, specifically fibrates, selective serotonin reuptake inhibitors, rifampin/rifampicin, and opioid-receptor antagonists are allowed if one of the following criteria is met at the screening visit:
  • A minimum of 12 weeks of stable treatment; OR
  • A minimum of 4 weeks off treatment.
• Average daily Adult ItchRO score ≥ 4 during screening to be enrolled in the study at Visit 2.
• Overall compliance of ≥ 80% in daily completion of the Adult ItchRO score in the eDiary during:
  • Screening in order to be enrolled in the study at Visit 2;
  • Single-blind, placebo run-in in order to be randomized at Visit 4.
• Willing to maintain an ≥ 80% average in daily completion of the Adult ItchRO between Visits 2 and 10.

• Pruritus associated with an etiology other than PBC.
• Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events (e.g., variceal bleeding, ascites, hepatic encephalopathy, hepatorenal syndrome)
• Current symptomatic cholelithiasis or inflammatory gallbladder disease. Those with history of cholecystectomy ≥3 months before the screening visit may be eligible for enrollment.
• History of small bowel surgery/resection impacting the terminal ileum (e.g., ileostomy, ileo-anal pouch, or other surgeries/conditions) that may disrupt the enterohepatic circulation
• Evidence, history, or suspicion of other liver diseases, including but not limited to:
  • Active hepatitis A or E infection;
  • Active hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) or presence of hepatitis B virus DNA;
  • Hepatitis C as defined by the presence of hepatitis C virus (HCV) antibody and positive HCV RNA. Infection documented to have been cured for > 1 year prior to the screening visit may be eligible;
  • Secondary sclerosing cholangitis, autoimmune hepatitis, PSC, immunoglobulin G4-related cholangitis, Wilson disease, alpha-1-antitrypsin deficiency, or hemochromatosis;
  • Suspected or proven cholangiocarcinoma or hepatocellular carcinoma;
  • History of liver transplantation;
  • Histologically confirmed diagnosis of nonalcoholic steatohepatitis;
  • Alcohol-related liver disease.
• Unstable and/or serious medical disease that is likely to impair the participant’s ability to participate in all aspects of the study, confound efficacy and/or safety assessments, or result in substantially shortened life expectancy (e.g., any malignancy including hematological malignancy, end-stage heart failure, active infection, acute and chronic diarrhea).
• Moderate alcohol consumption as defined for this study by > 1 and > 2 standard drinks on average per day for women and men, respectively, within 24 weeks of screening visit. A standard drink is defined as 1.5 oz (one shot) of liquor, 5 oz of nonfortified wine, or 12 oz of beer (1 oz=29.57 mL).
• Drug abuse within the 24 weeks prior to, or a positive drug screening result, at the screening visit unless it can be explained by a drug prescription:
  • Use of cannabinoids (legal, prescribed, or otherwise) is allowed, provided use is stable for at least 12 weeks prior to screening and throughout the entire study duration.
• Positive for HIV antibody.
• Specific clinically significant ECG abnormalities, including but not limited to:
  • Evidence of acute ischemia;
  • Q-wave infarction identified within 6 months of screening visit;
  • QT interval corrected using Fridericia’s correction formula (QTcF) > 470 msec (unless individual has a pacemaker);
  • Congenital long QT syndrome;
  • Active conduction abnormalities including:
    • Mobits Type II second-degree heart block without a permanent pacemaker;
    • Third-degree heart block without a permanent pacemaker;
    • Untreated supraventricular tachycardia (heart rate ≥ 120 beats per minute);
    • Ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, torsade de pointes);
    • Uncontrolled atrial fibrillation.
• Results provided by the central laboratory for any of the following laboratory parameters collected during the screening visit:
  • Platelet count ≤ 100,000/mm^3;
  • Estimated glomerular filtration rate ≤ 45 mL/min, as calculated by the Chronic Kidney Disease-Epidemiology Collaboration equation;
  • Serum creatinine > 2 mg/dL (178 μmol/L);
  • ALT or AST > 5 × ULN.
  • Note: If ALT at Visit 2 or at an unscheduled visit during the single-blind, placebo run-in is > 5 × ULN, the participant may still be enrolled if the average of the 2 ALT values from the screening visit and the eligible repeat assessment remain ≤ 5 × ULN;
  • Total bilirubin > 2 × ULN, unless the individual has a diagnosis of Gilbert syndrome or hemolytic anemia as confirmed by investigator and direct bilirubin is within normal range (i.e., 0.1–0.3 mg/dL [1.7–5.1μmol/L]).
    • Note: If total bilirubin at Visit 2 or at an unscheduled visit during the single-blind, placebo run-in is > 2 × ULN, he or she may still be enrolled if the average of the 2 total bilirubin values from the screening visit and the eligible repeat assessment remain ≤ 2 × ULN;
    • International normalized ratio (INR) ≥ 1.7 unless due to therapeutic anticoagulation.
• Statin dosing that is not stable for a minimum of 12 weeks prior to the screening visit.
• Use of obeticholic acid treatment within 12 weeks prior to the screening visit.
• Use of an ASBT inhibitor within 24 weeks prior to the screening visit.
• Bile acid sequestrants, including cholestyramine and colestipol, within 4 weeks prior to the screening visit.
• Use of any other prohibited medication including for PBC and cholestatic pruritus as listed in the protocol within 4 weeks or 5 times the half-life, whichever is greater, prior to the screening visit.
• Women who are pregnant or nursing. Specific criteria for defining childbearing potential and acceptable methods of birth control are outlined in the protocol.
• Known intolerance/hypersensitivity to volixibat or its excipients.
• History of nonadherence to medical regimens, unreliability, medical condition, mental instability, or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
• Participation in an interventional clinical study within 4 weeks OR, if applicable, 5 times the half-life, whichever is greater prior to the screening visit. Always adhere to other eligibility criteria that apply to specified concomitant medication.

Eligibility Criteria
•Open-Label Extension:

To maintain eligibility for the OLE, participants must:

• Have successfully completed the 24-week double-blind study drug treatment period.
• Have not experienced an AE(s) or SAE(s) related to volixibat during the double-blind study treatment period that led to permanent discontinuation.
• Have no changes in their medical condition or treatment that would preclude their participation in the OLE.

Eligibility last updated 5/13/22. 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.

• ≥ 18 years.
• Diagnosed myocardial infarction (MI).
• Enrolled in cardiac rehabilitation program to start within 4 weeks from hospital discharge due to MI.
• Owns a smartphone.
• Willing to download and use a smartphone app.
• Able to read, write, and speak English.

• Pregnancy.
• Actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments.
• Cardiac transplant.
• Active substance use.
• Neurocognitive disorder.
• Active psychosis.
• Mania diagnosis.

Eligibility last updated 12/14/21. 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.

Key

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

Eligibility last updated 6/20/23. 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.

• Hospitalization within 3 months for COPD related causes (exacerbation (including COVID) and/or pneumonia)
• Adults 40 years of age or older..

• Individuals not able to be reached by telephone.

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.