• Subject is age 18
  •80 years at the time of screening.
• Subject has type 1 diabetes for more than one year Study specific inclusion criteria.
• Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study.
• Subject is willing and able to perform study procedures as per investigator discretion.
• Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e., co-payments for insulin with insurance or able to pay full amount):
  • Humalog™* (insulin lispro injection);
  • NovoLog™* (insulin aspart).

• Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• Subject is female and has a positive pregnancy screening test.
• Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
• Subject is female and plans to become pregnant during the course of the study.
• Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening.
  • Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
• Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
  • Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization);
  • Coma;
  • Seizures.
• Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
• Subject is unable to tolerate tape adhesive in the area of infusion set.
• Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Subject has infection in the area of infusion set placement at time of screening.
• Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
• Subject is currently abusing illicit drugs.
• Subject is currently abusing alcohol.
• Subject is on dialysis (for renal failure).
• Subject has history of adrenal disorder.
• Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening.
• Subject has any condition that the Investigator believes would interfere with study participation
• Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
• Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening.
• Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia.
• Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
• Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range.

Eligibility last updated 8/2/22. Questions regarding updates should be directed to the study team contact.

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

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

• Age range: 18-60 years old (inclusive).
• BMI ≤ 40 kg/m^2.
• Not a current smoker or tobacco user.
• Gender: Both males and females will be allowed to participate in the study.
• Target disease or condition: Healthy and OSA subjects.
• Absence of any chronic medical conditions other than seasonal or environmental allergies, depression, acid reflux and acne.
• Individuals with untreated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study.
• On no prescription medications other than those medications used to treat asthma, seasonal or environmental allergies (such as Ceterizine, Fexofenadine, Desloratadine, Loratadine, etc., depression, acid reflux (such as antacids or PPIs), topical skin treatment medications or shampoos, contraceptive pills, or intrauterine devices. Other medications may be allowed at the discretion of the study staff.
• Not pregnant or breast feeding and not intending to become pregnant or breast feed.
• Ability to provide written informed consent.
• If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subject does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

• Vulnerable study population will be excluded.
• Presence of chronic kidney disease (creatinine > 2.5 mg/dL) and/or active cancer.
• Pregnancy.
• Anemic (hemoglobin < 12.0 g/dL for men and < 11.0 g/dL for women).
• Smoking.
• Use of chronic medications (statins, anti-inflammatory drugs, angiotensin II receptor blockers (ARBs) and/or angiotensin-converting enzyme (ACE) inhibitors).
• Blood or plasma donation during the past 2 months.

Inclusion Criteria

• Individuals age 18 to 45 years.

• Individuals less than 18 or more than 45 years of age.
• BMI > 32 kg/m^2. 
• Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease.
• Orthopedic problems that would keep them from being able to perform an exercise.
• Medications that are known to impact mitochondrial function: 
  • Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, In, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist). 
• Smoking.
• Pregnancy. 

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

•  ≥  18 years of age. 
• Suspected of having a H. pylori infection and are undergoing or recently have undergone a gastric biopsy.

• On a current antibiotic regimen and negative for H. pylori as tested from a gastric biopsy.

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

• Individuals carrying the OSTEOCALCIN SNP gene and age, sex, and race matched controls.

• Participants with a known diagnosis of type 1 or type 2 diabetes mellitus or those individuals on lipid lowering drugs, as these conditions may alter FGF21 and/or apolipoprotein B levels.

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

Eligibility last updated 10/25/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age with hepatobiliary cancers and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
• Newly diagnosed hepatobiliary cancers.

• < 18 years of age. 

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

Eligibility last updated 12/2/22. Questions regarding updates should be directed to the study team contact.

• 18 years of age and older.
• Without current, confounding cardiorespiratory, metabolic, or musculoskeletal conditions.  

• < 18 years of age. 

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.

• Subject has biopsy-proven papillary or follicular thyroid cancer.
• Subject is indicated for 123I-SPECT/CT total body iodine (TBI) scan.
• Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan.
• Karnofsky performance status of greater than or equal to 50 (or ECOG/WHO equivalent).
• Subject is able to be scanned
  •able to lie still on SPECT/CT and PET/CT scanner table for up to 65 min.
• Age years 18 or older.
• Ability to understand a written informed consent document, and the willingness to sign it.
• Subject is not pregnant.

• Contrast-enhanced CT within 4 last weeks.
• Amiodarone within last 4 months.
• Ingested iodine, kelp tablets, Lugols iodine, or SSKI within 2 weeks. If questionable, then urinary iodine measurement must be performed. Exclude if 24h urinary iodine > 100 microg/d.
• Unable to lie flat, still or tolerate a PET scan.
• Applied betadine, iodoform, or quick tanning products to skin within last two weeks.
• If using medication withdrawal for stimulation, then exclude if TSH level < 25.
• Taken anti-thyroid medication within 1 week.
• Subject is breastfeeding.
• Positive pregnancy test.

• Clinical diagnosis of diabetes based upon an elevated hemoglobin A1C.

• Diagnosis of Diabetic Nephropathy.
• Active or unresolved Diabetic Ketoacidosis (DKA).
• Steroid Induced Hyperglycemia.

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

• Ability to provide informed consent.
• 40 patients:
  • 20 preoperative THA, 20 postoperative THA;
  • Sex: 20 men, 20 women;
  • Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.

• Patients with lumbosacral hardware, contralateral THA.

Eligibility last updated 11/5/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

• Age ≥ 18 years.
• Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold).
• AL amyloidosis with organ disease requiring therapy.
• NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters.
• Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled.
• NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained.
• Patients must have completed 6 cycles of Dara-CyBorD-based induction treatment ≤84 days prior to registration.
• Patients must have achieved a hematological CR (irrespective of organ response achievement) or hematological VGPR (irrespective of organ response           achievement) or hematological low-dFLC PR (irrespective of organ response             achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.
• NOTE: Patients with. baseline dFLC <5 mg/dL, must have achieved hematological CR, or dFLC <1 mg/dL or achieved organ response prior to randomization.
• Patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study.
• NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration.
• ECOG Performance Status (PS) 0, 1, 2 or 3. 
• The following laboratory values obtained ≤28 days prior to registration:
  • Hemoglobin ≥ 8.0 g/dL;
  • Absolute neutrophil count (ANC) ≥1000/mm^3;
  • Platelet count ≥ 50,000/mm^3.
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
• NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Provide written informed consent. NOTE: Informed consent required ≤90 days prior registration.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

• Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
  • Pregnant persons;
  • Nursing persons;
  • Persons of childbearing potential {and persons able to father a child} who are unwilling to employ adequate contraception.
• Received > 1 cycle of daratumumab maintenance after end of induction therapy and prior to registration.
• Multiple myeloma at time of diagnosis as defined by any of the following:
• • Hypercalcemia: Serum calcium > 1 mg/dL higher than upper limit of normal or > 11 mg/dL;
  • Renal insufficiency: Creatinine clearance < 40 mL per min or serum creatinine > 2 mg/dL attributed to high circulating light chains (i.e., cast nephropathy) or hypercalcemia;
  • Anemia: Hemoglobin > 2 g/dL below lower limit of normal, or < 10 g/dL, attributed to high marrow myeloma infiltration;
  • Bone lesions: ≥1 osteolytic lesion on skeletal x-ray, CT, or PET-CT (bone imaging is not mandatory but based on clinical suspicion);
  • Clonal bone marrow plasma cells ≥ 60%;
  • >1 focal lesion on MRI (MRI is not mandatory but based on clinical suspicion);
  • If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease;
  • ≥ 40% BMPCs irrespective of the above;
  • The study will allow patients with Involved: uninvolved sFLC ratio ≥ 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met.
• Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).
• NOTE:  Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
• EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. 
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• Uncontrolled intercurrent illness including, but not limited to:
  • ongoing or active infection;
  • unstable angina pectoris;
  • psychiatric illness/social situations that would limit compliance with study requirements.

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

Eligibility last updated 12/5/23.   Questions regarding updates should be directed to the study team contact.

• Patients treated at Mayo Clinic with Multiple Myeloma and their caregivers.

• < 18 years of age. 

Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

• Age 12-25
• Patients in the 2-day Pediatric Pain Rehabilitation Program

• Don’t speak English as their first language

• Men and women.
• Ages ≥ 18 to ≤ 65 years old.
• Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
• Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).

• No contraindication to MRI.
• No implanted devices within the body (shunts, clips, plates, etc.).
• No dental braces or retainer wires.

• MRI-verified isolated medial meniscus root tear.
• Subject must be 18 years of age or older.

• Concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear).
• Preoperative Kellgren-Lawrence grade of 3 or 4.
• Inability to complete outcome questionnaires or comply with required postoperative imaging or MRI requirements, or
• Medical contraindications to surgery or physical therapy. There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment, however they will be stratified in groups for further analysis (BMI less and over 35 and varus alignment below and over 3º of varus. 
• Pregnancy.
• Subjects < 18 years of age.

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

• Clinical diagnosis of type 1 diabetes.
• Age ≥ 65 years old.
• T1D Duration of at least 1 year.
• HbA1c < 10.0% from point of care or local lab at time of screening visit.
• Insulin regimen involves basal/bolus insulin via insulin pump or multiple daily injections.
• Most recent GFR ≥ 30 ml/min/m2 from local lab within the past 6 months.
• Willingness to use a rapid acting insulin compatible with the Tandem t:slim X2 pump (currently aspart and lispro; other rapid acting insulins likely to be approved for pump use prior to study initiation such as Fiasp).
• Familiarity with and willingness to use a carbohydrate ratio for meal boluses.
• Willing to use study devices and automated insulin delivery features.
• Participant is independently managing his/her diabetes with respect to insulin administration and glucose monitoring (may include assistance from spouse or other caregiver)
• Participant understands the study protocol, agrees to comply with it and is able to successfully pass the consent understanding assessment with no more than 2 attempts. 
• Participant comprehends written and spoken English.
• At least 240 hours of CGM readings available during the end of run-in assessment.
• At least 1.5% of time with CGM glucose levels < 70 mg/dL prior to SAP initiation.

• Use of PLGS technology or HCL insulin delivery in the past 3 months.
• History of 1 or more Diabetic Ketoacidosis episodes in the previous 6 months.
• Clinical diagnosis by a primary care provider, neurologist or psychiatrist of dementia, in the investigator’s opinion a suspected severe cognitive impairment such that it would preclude ability to understand the study or use devices, or ascore of 13 or less on the Montreal Cognitive Assessment (mild cognitive impairment is not an exclusion)
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, including severe vision or hearing impairment and any contraindication to the use of any of the study devices per FDA labeling.  
• Known adhesive allergy or skin reaction during the run-in pre-randomization phase or previous difficulty with pump and CGM insertions that would preclude participation in the randomized trial.
• Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Stage 4 or 5 renal disease.
• The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of < 1 year.

• Any autosomal dominant polycystic kidney disease (ADPKD) patient (ages 5-18 years) with confirmed ADPKD (via a combination of imaging, family history, and/or genetic testing), identified from existing and newly identified families for the proposed study.
• Matched controls will be identified as unaffected siblings, unaffected family members of ADPKD subjects, or children recruited from the outpatient primary care clinics.

• ADPKD patients with liver and or kidney transplant.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

• Males and females over the age of 18 years.
• Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
• Ability to provide written, informed consent.
• Females must be willing to take a pregnancy test if still capable of bearing a child.

• Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
• Patients with esophageal varices that preclude biopsies.
• Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
• Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
• Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
• Patients with known eosinophilic esophagitis.
• Patients who are pregnant.
• Patients with a history of hemostasis disorders.*
  • Patients on anticoagulation undergoing low risk procedures are not excluded.

* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (< 100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.

• 18 years of age or older.
• Biologically female.
• Non-Hispanic Black (NHB).
• Diagnosis of breast and/or ovarian cancer or family history of breast and ovarian cancer.

• Under age of 18.
• Not biologically female.
• Ethnicity other than NHB.
• Has not been diagnosed with breast and/or ovarian cancer and does not have a family history breast and ovarian cancer.

• Patients presenting to the catheterization laboratory to undergo non-emergent cardiac catheterization procedures including coronary angiography, percutaneous coronary intervention, right heart cath, ablation, myocardial biopsy.
• Adult patients (18 years old or older).
• Patient willing and able to give informed consent.

• Emergent procedure.
• ST elevation > 1 mm on any two contiguous ECG leads.
• Hemodynamic instability (SBP > 220 or < 80, HR > 160).
• Patients < 18 years old (children).
• Patients known or suspected to be pregnant.
• Incarcerated patients (FMC patients).
• Patients with a pacemaker or defibrillator.
• Metal implants in the body (that are not MRI safe).
• Patients that are unable to lie down in the MCG machine or stay still.
• Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
• Patients without the capacity to provide written informed consent.

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

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

Affected subjects, healthy family members, and healthy unrelated subjects will be recruited to the study.  In many cases in data analysis the healthy unrelated subjects will be used as the “control” population

Study subjects will inform their family and friends of this type of research.  If those unaffected individuals would like to participate the study subjects will inform their treating physician or the PI.

Subject population - Cardiothoracic transplant patients (pretransplant and follow-up), heart failure patients and patients prior to and on mechanical circulatory support take part in this study.

• Those who have signed informed consent. 

• Those who have not signed informed consent.

Inclusion Criteria for Controls.

• Healthy male (N=30) and female (N=30) volunteers aged 18-80 years.

• Having capacity to provide written informed consent before participating in the study.

• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Inclusion Criteria for Constipated Patients.

• Male and female volunteers aged 18-80 years.

• Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: <3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.

• Having capacity to provide written informed consent before participating in the study.

• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria for Controls (Items indicated with an asterisk are also exclusion criteria for patients).

• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*

• Current symptoms of a functional gastrointestinal disorder assessed by questionnaire [2, 16].

• Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 3rd or 4th degree perineal tear.

• Medications that are likely to alter gastrointestinal motility: e.g., opiates, anticholinergic medications, serotoninergic agents, alpha adrenergic agonists, calcium channel or b blockers; a stable dose of thyroxine will be permitted (i.e. no alterations in dose for the preceding three months).

• Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.*

• Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire [17].

• Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*

• Pregnant women, prisoners and institutionalized individuals.*