• Branch 1: People who are older than 18 years old, with low vision, and those with a stable internet connection.
• Branch 2: People who are older than 18 years old, with VA poorer than or equal to 20/1,000, and those with a stable internet connection.

• Anyone with normal vision will be excluded from branch 1 studies, and anyone with vision better than ULV will be excluded from branch 2 studies.  

Eligibility last updated 5/6/22. Questions regarding updates should be directed to the study team contact.

• Age 18 or older.
• Patients with paroxysmal atrial tachyarrhythmias with and without polyuria as a manifestation of their tachyarrhythmia episode.
• Documentation of their paroxysmal atrial tachyarrhythmia episode.

• Patients who are unable to manage the logistics of participating in the study (coming to Saint Mary’s Hospital ot have their blood drawn and urine sample collected during their atrial tachyarrhythmia episode).
• Chronic kidney disease stage 4 or higher.
• Clinical history of heart failure.

Eligibility last updated 10/1/21. Questions regarding updates should be directed to the study team contact.

• Males or females, ≥ 18 years old.
• Recently underwent parotidectomy at Mayo Clinic Rochester (range: 1 day – 1 year).
• Surgical indication for benign and malignant tumors.

• No concurrent surgeries at the time of parotidectomy.
• No prior parotid surgery.
• No adjuvant radiotherapy or chemotherapy after parotidectomy and before this survey.
• History of Bell’s palsy or other cause of facial nerve dysfunction.
• History of facial cosmetic surgery (EXCEPT rhinoplasty).
• History of chronic salivary disease.

• ≥ 50 years of age.
• Diagnosis of GCA by confirmation of temporal artery biopsy and/or advanced arterial imaging (CT angiogram, MR angiogram, PET-CT) consistent with large vessel vasculitis.
• Treated with tocilizumab (subcutaneous OR intravenous) for ≥ 12 months but < 48 months prior to study entry.
• In clinical remission (that is no symptoms present to suggest active GCA) at study entry.
• Off prednisone or its equivalent for minimum 2 months prior to study entry.
• Access to a computer or smartphone/device.

• Uncontrolled diabetes with inability to control glucose level below 200 mg/dl (requirement for obtaining PET-CT).
• Features of active GCA.
• Treatment of tocilizumab for other etiologic reason (besides GCA) for which continuation of tocilizumab is deemed necessary (e.g., concomitant rheumatoid arthritis).
• Ring size smaller than 6 or larger than 13 on digits 2 or 3 (index or middle, respectively).
• Current (other than non-melanoma skin cancer) malignancy or active infection.

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

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.

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

• Male adults (age ≥ 18 years old).
• Presenting to the Departments of Urology or Radiation Oncology for evaluation either for the possibility of high-risk prostate cancer, those with the tissue diagnosis who are to undergo a radical prostatectomy, or those with a rising PSA following previous treatment for prostate cancer. 
  • For purposes of this study, high risk is defined by, but not limited to: those patients with the worrisome level of PSA (free, total, velocity or density), digital abnormality of prostate examination, or strong family history of prostate cancer. 

• An absolute contraindication to MR examination.
• Urethral stricture.
• Current urinary tract infection or positive Gram stain of the urine.
• Inability to provide consent.

Normal Weight

• Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
• BMI: 18.5-25 kg/m2

Obese

• Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
• BMI: ≥ 30 kg/m2

Both Normal Weight and Obese Participants:

• History of abdominal surgery including cholecystectomy and other than appendectomy, Caesarian section or tubal ligation.
• Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, phentermine.
• Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C) and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The AUDIT-C is a 3-item alcohol screening questionnaire that reliably identifies participants who are hazardous alcohol drinkers or have active alcohol use disorders. In men, a score of 4 or more is above the recommended limits will be reviewed by study personnel. In women, a score of 3 or more is above the recommended limits will be reviewed by study personnel. However when the points are above recommended limits, the provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility..
• Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxin replacement therapy.

• Pregnant women admitted to Rochester Methodist Hospital with an intrauterine pregnancy at term (≥37 0/7 weeks) who are undergoing clinically indicated pelvic examinations and standard fetal monitoring.
• Intact Membranes
• Singleton gestation
• 18 years of age or more
• Willing to give informed consent

• High risk pregnancy specifically
  •incompetent os/placenta previa/PIH/Elderly Primi gravida /previous surgery

• Adult (18 years or older).
• Able to provide informed consent 
• Able to provide samples in English.
• U.S. based patient.

• Age < 18 years of age.
• Unable to provide samples in English (i.e., need for interpreter flag in Epic).
• Nonverbal / No speech.
• HPP (High Profile Patient) status.
• International patient.

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

- Willing and able to comply with the required clinic visits, study procedures and assessments.
- Able to understand and complete study-related questionnaires.
- Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required.
- Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information.

- Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information.
- Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
- Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age and older.
• Previous laboratory confirmed positive COVID-19 test.
• Patient of the Public Health, Occupational Medicine, and Infectious Disease Clinic.
• Patient of the Nurse Practitioner.

• Patients < 18 years of age.
• Patients who are unable to return to work without restrictions and those who have not to return to work.
• Patients who are not currently employed.

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

Healthy Volunteer

Homonymous Field Loss

• Homonymous field loss (homonymous hemianopia, homonymous quadranopia or homonymous scotoma).
• Current driver.
• At least 16 years old.
• English speaking (because the survey will be conducted verbally in English).

Normal Vision

• Normal vision (no significant diagnoses of diseases that could cause visual field loss or otherwise impair vision).
• Current driver.
• At least 16 years old.
• English speaking (because the survey will be conducted verbally in English).

• < 16 years of age. 

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

Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.

• Adult men and women, age 18 or older.
• Previously seen at the Mayo Clinic Fibromyalgia and Chronic Fatigue Clinic (Rochester, MN) and diagnosed with fibromyalgia.
• Able to read and speak English.
• Must be willing and able to provide consent and participate in both portions of the study.

• Minors (under the age of 18).
• Patients not diagnosed with fibromyalgia.
• Patients who cannot provide consent or unwilling to participate in both portions of the study.

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

Eligibility last updated 4/27/23. Questions regarding updates should be directed to the study team contact.

• Patients presenting for evaluation of an ocular tumor.
• Age ≥18 years.
• Any gender.
• Have capacity to consent.

• Inability to provide informed consent.
• Lack of an ocular tumor.
• Lack of evaluation in the Mayo Clinic Rochester clinical practice.

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

Eligibility last updated 3/24/23. Questions regarding updates should be directed to the study team contact.

• Non-obese (BMI 20-25.0 kg/m^2) adults.
• 10 young (18-35y) and 10 older (65-80y) with both age groups balanced for sex (5F and 5M each).
• All subjects will not have cardiometabolic diseases (e.g., T2DM, HTN) and will not be taking anticoagulants, nor prescriptions or supplements that effect adipose tissue metabolism (i.e., statins, Thiazolidinediones, niacin, atypical antipsychotics, or fish oil).

• < 18 years of age.

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

Eligibility last updated 5/15/23. Questions regarding updates should be directed to the study team contact.

1. Willing to give a blood sample
2. Ability to provide informed consent
3. Ability to complete all aspects of this trial
4. At least 18 years of age
5. Have cold agglutin disease with anemia

• None

• Any gender.
• Age over 4 years.
• Have read, understood and signed the approved informed consent form (parent or legal guardian must sign for anyone younger than 18 years).
• Willing to use the Seer EDS as instructed and provide feedback.

• Subjects considered by the participating site to be unable to operate the medical device due to cognitive or physical impairment.

Eligibility last updated 9/16/21.  Questions regarding updates should be directed to the study team contact.

General Eligibility Criteria:

• Assessment for general eligibility criteria is based on medical records of the site and interview with a candidate patient. Patients must meet ALL general inclusion criteria to participate in the clinical investigation. If ANY general exclusion criteria are met, the patient is excluded from the clinical investigation and cannot be enrolled.
• If any clinical and/or laboratory tests are required for patient screening and are not included in a site’s standard tests, they must be completed after written informed consent is obtained.

• Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines.
• Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
• Subject has a life expectancy of at least one year.
• Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
• Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.

• Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor.
• Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period.
• Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU.
• Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis.
• Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments).
• Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device.
• Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP).
• Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)*.
• Subject is unable to read or write.
  • * NOTE:  Does not apply to a medical device with no known impact to the Aveir Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation and the decision to implant the LP should take into account the presence of other active implantable devices and should include consultation with the Sponsor and/or manufacturer of the co-existing device.

Eligibility last updated 11/18/21. Questions regarding updates should be directed to the study team contact.

• Locally advanced, unresectable or metastatic UPS or MFS (or Grade 1 MFS with documented metastases) confirmed by histologic analysis by the treating institution pathologist, including pleomorphic undifferentiated sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphic sarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes) and myxofibrosarcoma located deep to the fascia in muscle (MFS). “MFS” of the retroperitoneum, abdominal cavity and pelvis is not allowed. Pathology report and enrollment checklist will be reviewed by sponsor prior to randomization.
• Documented progression by radiographic criteria (e.g., RECIST, WHO, Choi) on or following chemotherapy.
• Measurable disease by RECIST 1.1.
• Age of > 12 years or older and weight > 40 kg
• Eastern Cooperative.
• Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade -study baseline (except alopecia or neuropathy)
• Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transami 1.5 x upper limit of normal (ULN) where bilirubin < 2.5 x ULN is allowed 0 Absolute lymphocyte count (ALC) > 500/uL randomization) 9.0 g/dL (without transfusion support within 14 days prior to randomization; erythropoietin or darbepoetin permitted) 75 times the upper limit of normal or creatinine clearance > 30 mL/min by Cockcroft-Gault formula 5 unless the patient is receiving a direct Factor Xa inhibitor Serum albumin > 3.0 g/Dl 8. Willingness and ability to consent (and assent if under age 18) for self to participate in study.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• UPS/MFS FFPE tumor specimen or slides thereof (fine needle aspiration is not acceptable), unless archival tissue is unavailable and biopsy is unsafe or unfeasible.
• Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 180 days following last dose of envafolimab or ipilimumab (if applicable) whichever is later.
• Women of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy or hysterectomy) or medicallydocumented ovarian failure confirmed by medical history (i.e., no menstrual bleeding for more than 12 months in women aged 45 years or more), OR women of child bearing potential who test negative for pregnancy at time of enrollment based on serum or urine pregnancy test and agree to use at least 2 acceptable methods of birth control, one of which must be highly effective, during the study and for at least 180 days after stopping envafolimab or ipilimumab (if applicable) whichever is later.

• Prior treatment with a PD-(L)1 or CTLA-4 inhibitor.
• Prior treatment with any immunomodulatory therapy, including T cell therapy.
• QTcF > 480 ms.
• Autoimmune disease requiring systemic treatment within the past twelve months.
  • Note: Vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, and conditions, including eczema, not expected to recur in the absence of an external trigger are permitted.)
• Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to study treatment.
  • Note: Inhaled and topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent or steroids for the treatment of contrast allergies, are permitted in the absence of active autoimmune disease.
• History of or active interstitial lung disease
• More than two prior lines (may be combination regimen) of chemotherapy (not including hormonal treatments) for UPS/MFS (neoadjuvant/adjuvant treatment does not count as a line of treatment if completed > 12 months prior to randomization).
• Current treatment or participation on another therapeutic clinical trial.
• Women who are pregnant or breastfeeding.
• Receipt of systemic anticancer therapy, including investigational agents, within 5 -life or 14 days of starting study treatment, whichever is shorter.
• Major surgical procedure or significant traumatic injury within 4 weeks prior to randomization and must have fully recovered from any such procedure or injury:
  • planned surgery (if applicable) or the anticipated need for a major surgical procedure within the next six months.
  • Note: the following are not considered to be major procedures and are permitted up to 7 days before randomization: Thoracentesis, paracentesis, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, and imaging-guided biopsy for diagnostic purposes.
• Patients who have received days prior to randomization.
• Uncontrolled hypertension defined as systolic > 170 or diastolic > 100 mm Hg on the average of the 3 most recent BP readings. Anti-hypertensives may be started prior to randomization.
• Ascites or pleural effusion that required intervention within three months prior to randomization.
• Pericardial effusion (except clinically insignificant trace or small effusion identified by echocardiogram or another imaging study) within three months prior to randomization.
• History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
• Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, symptomatic pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 6 months prior to randomization.
• Active bleeding. Patients who have been uneventfully anti-coagulated with a direct Factor Xa inhibitor or low molecular weight heparin are eligible
• Hemoptysis (> ½ teaspoon [2.5 mL] of bright red blood) within 6 months prior to randomization, unless definitively treated without recurrence for > 28 days prior to randomization.
• Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomization
• Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
• History of prior malignancy unless the cancer is currently in complete remission per adequately treated basal cell or squamous cell skin cancer, a history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence or prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible.
• Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/µL with an undetectable viral load.
• Active infection that requires systemic treatment.

• Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.

• Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
• Patients on chronic laxatives who cannot stop for at least 24 hours prior to stool collection.
• Patients who are unable to provide a stool sample to Mayo clinic within 24 hours of collection via FedEx overnight mail. (i.e., people overseas who are unable to provide a sample before leaving the USA).

• Adult (18 and older).
• Diagnosed with acoustic neuroma tumors.

• Patients under the age of 18 will be excluded.

• Age 18-80 years.
• Recipient of kidney transplantation 4 or more years.
• Competent and able to provide written informed consent.
• Ability to comply with protocol.

• Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, or stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
• Severe chronic liver, heart, or lung disease.
• Undergoing acute rejection.
• Contra-indication to biopsy; bleeding disorders.
• Chronic infection.
• Any active malignancy and undergoing therapy.
• Kidney or ureteric stone.
• Unable to give valid informed consent.
• Known pregnancy or intent to conceive during the study period.
• Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia, or other contraindication to MRI.
• Federal medical center inmates.

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

• Diagnosis of an eosinophil-associated cardiovascular, gastrointestinal, hematologic, and/or respiratory disorder. 

• None.

• T1D
• eGFR ≥ 60 ml/mt
• Capable of providing informed consent

• eGFR ≤ 60 ml/mt
• Pregnancy

- Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g.,
NeuroPace RNS, Medtronic PC+S, Medtronic RC+S).
- Pediatric subjects 7 years of age or older.

- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
- Presence of open or healing wounds near monitoring sites (infection risk).

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age
• Completed mammography appointment at Mayo.
• Patients who enrolled in the STRIVE Study IRB#16-008471 previously consented to long-term follow-up. 

• < 18 years of age.

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

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

• Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy.
• Confirmed fibroblast growth factor receptor 2b (FGFR2b) overexpression by immunohistochemistry (IHC) (central testing result).
• Eastern Cooperative Oncology Group (ECOG) less than or equal to 1.
• Measurable, evaluable, or non-evaluable disease as long as evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Participant has no contraindications to mFOLFOX6 chemotherapy.
• Adequate organ and bone marrow function:
  • absolute neutrophil count greater than or equal to 1.5 times 10^9/L;
  • platelet count greater than or equal to 100 times 10^9/L;
  • hemoglobin greater than or equal to 9 g/dl;
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement).
  • total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease);
  • calculated or measured creatinine clearance (CrCl) of greater than or equal to 30 mL/minute calculated using the formula of Cockcroft and Gault -international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment.

• Prior treatment for metastatic or unresectable disease.
  • Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose.
• Prior treatment with any selective inhibitor of fibroblast growth factor.
• ibroblast growth factor receptor (FGF-FGFR) pathway.
• Known human epidermal growth factor receptor 2 (HER2) positive.
• Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
• Peripheral sensory neuropathy greater than or equal to Grade 2.
• Clinically significant cardiac disease.
• Other malignancy within the last 2 years (exceptions for definitively treated disease).
• Chronic or systemic ophthalmological disorders.
• Major surgery or other investigational study within 28 days prior to first dose of study treatment.
• Palliative radiotherapy within 14 days prior to the first dose of study treatment.
• Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Available for testing performed in Rochester, MN.
• Willing to undergo both an echocardiogram with RTMPE and CMR.
• Study subject providing consent.

• Adults < 18 years.
• BMI <30 kg/m^2.
• Hypertension.
• Diabetes Mellitus.
• Stroke.
• Cardiomyopathy or structural heart disease.
• Known coronary artery disease or history of myocardial infarction.
• Contraindication to echo enhancement agent or gadolinium administration such as an allergy.
• Renal GFR < 50 mL/mL.
• Females who are pregnant.
• Subject unwilling to consent.

• Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
• Age: 18-75 years old.
• Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
• Women of childbearing potential must agree to use a method of effective contraception during study participation.
• Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
• Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.

• History of Abdominal bariatric surgery.
• Weight is greater than 450 lbs. (204 kg).
• Recent use (within the last three months) of any antiobesity medication.
• Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
• Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
• Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
• Hypersensitivity or contraindication to the study medication.
• Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
• Principal Investigator discretion.