• Patients who underwent primary surgery performed by an expert gynecologist oncologist at Mayo Clinic, Rochester, MN.
• Research authorization.
• Patients with endometrioid EC FIGO stage IB G1-2-3 and stage II G1-2-3 disease.
• Patients who had confirmed negative lymph nodes with pelvic lymph node assessment.

• Presence of synchronous cancers, or previous neoadjuvant therapies.
• Slides not available for pathologic review.

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

Eligibility last updated 12/30/22. Questions regarding updates should be directed to the study team contact.

• Self-identify as Hispanic, Latino/a/x/e, or Chicano/a/x.
• For breast cancer screening: age 50-74 years; for cervical cancer screening: age 21-65 years; for colorectal cancer screening: age 45-75 year.
• Receive primary care at either HH or MPHC.
• At least one office visit within the previous 12 months to the primary care site.
• Eligibility for breast, cervical, or colorectal cancer screening documented in the electronic medical record (EMR).
• Intention to continue to receive medical care at HH or MPCHC for the next three months.
• If a potential participant is eligible for more than one screening, they will be given the option of participating in multiple versions of the intervention.

Exclusion Criteria: 

• Individuals with previous breast, cervical, or colorectal cancer diagnoses.
• For the participants in the colorectal cancer screening intervention, those under surveillance (i.e., did not have a cancer diagnosis but did have polyps) will also be excluded.

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

Eligibility last updated 2/22/23. Questions regarding updates should be directed to the study team contact.

• Positive SARS-CoV-2 PCR in a Mayo Clinic Employee.
• Able to complete swab within five days of initial positive test.

• Hospitalization at the time of diagnosis.
• Inability to complete nasopharyngeal and mid-turbinate swabs.

Eligibility last updated 12/29/23. Questions regarding updates should be directed to the study team contact.

• Patients with a presumptive diagnosis of EPH determined by the group of clinicians who participate in patient management conference.
• Ability to comply with test directions and provide informed consent or assent to the study; i.e. cognitively able to participate in studies (typically IQ of 65 or above).
• Relatively preserved verbal memory – as determined via formal neuropsychological evaluation performed by the neuropsychologist. The values must within 1 SD of the mean for verbal memory.
• Proficient in English, as all of our tasks and consent forms will be in English and the inclusion of non-English speakers will introduce another confound in this small sample size and preclude grouped analysis.
• Age 18 – 65 years (we expect the trial to take 5 years and wish to target patients with minimal medical comorbidities).
• Must have a minimum of 2 seizures per month
  •this is essential to be able to detect the impact of neuromodulation on the epilepsy over relatively short intervals of time.

• Impaired reading and cognitive functions (more than 3 standard deviations below the mean, usually an IQ < 60), as determined by preoperative neuropsychological testing.
• Patients with gross structural abnormalities (hamartomata, tumors, vascular malformations, diffuse malformations of cortical development) in the brain that raise the possibility of dual pathology resulting in the epilepsy and by derivation, a larger epilepsy network.
• Patients with uncontrolled prominent psychiatric comorbidity that will preclude their meaningful participation.
• Patients who are unable to speak or comprehend English. The inclusion of multiple languages will make task development and grouped comparisons of neuro-psychology data difficult.
• Patients with cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices that are deemed MRI incompatible by the manufactures – The absence of high resolution structural imaging precludes appropriate targeting of the regions of interest.
• Classic hippocampal sclerosis (equivalent to ILAE type 1) by imaging.
• Prior brain surgery for any reason or failed prior brain neuromodulation (prior VNS therapy is acceptable so long as it is held constant for the duration of the trial).
• History of or current non-epileptic spells (will confound accuracy of seizure detection with ANT Percept PC and the precision of the estimate of the neuromodulation effect).
• Patients who are pregnant. 

Eligibility last updated 8/26/22. Questions regarding updates should be directed to the study team contact.

• Patients 3
  •110 days old with drug resistant focal and generalized epilepsy and normal cognitive function undergoing intracranial EEG recording as part of their evaluation for epilepsy surgery.
• Patients that are anticipated to undergo intracranial EEG electrodes will be prioritized for the study. This includes patients with stereoEEG electrodes, depth electrodes, and subdural neocortical strips or grids.

• Patients believed to be at increased risk of infection or hemorrhage.
• Exclude if cognitive abilities of patient preclude performed required study tasks.

• Subjects older than 18.

• Vulnerable subjects such as prisoners and adults lacking capacity to consent.
• Subjects with low B-mode ultrasound image quality due to factors such as narrow rib gap space or excessive body fat.

• Male or female adults, ≥ 18 years of age.
• Patients with unilateral or bilateral cochlear implants that were implanted at Mayo Clinic, Rochester.

• Not able to provide consent for self to participate.
• Patients that declined MN research authorization.
• Additional handicap that would limit the patient from being able to follow study instructions.

• Healthy, pregnant women 26 – 36 weeks gestation with a singleton pregnancy and accurate dating (last menstrual period confirmed by 1st or 2nd trimester ultrasound).
• Currently receiving routine prenatal care will be recruited.

Any medical/obstetrical contra-indication to exercise during pregnancy per ACOG guidelines, including:

• • • • •  
• Hemodynamically significant heart disease.
• Restrictive lung disease.
• Incompetent cervix/cerclage.
• Increased risk for premature labor .

• Patients with Barrett's Esophagus (BE) undergoing endoscopic surveillance.

• Patients with contraindications to endoscopic resection and/or volumetric laser endomicroscopy (VLE) imaging.

• Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
• Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
•  Admission to the system within one year of injury.
• Discharge from the System Rehab as:
  • Having completed inpatient acute rehabilitation;
  • Deceased.
• Signed informed consent and HIPAA authorization forms.
• Reside in the geographic catchment area of the system at the time of the injury.  Patients may be injured outside of the catchment area.
• A US citizen or non-US citizen who is expected to stay in the catchment area.

• Must not have previously been treated at another model system for the injury.
  • Ensures that patients are enrolled into the database by only one model system.
• Must not have completed an organized rehabilitation program prior to the admission to the system.

Eligibility last updated 1/24/22. Questions regarding updates should be directed to the study team contact.

- CHA2DS2-VASc ≥ 4 with age ≥ 65;
- CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP;
- CHA2DS2-VASc = 3 with age ≥ 75
- CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or
elevated NT-proBNP.

- Anytime in the past; and
- Documented by an electrocardiographic recording; and
- Episode lasting 6 minutes or longer1*.

- Prior procedure involving opening the pericardium or entering the pericardial space.
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous).
- Planned cardiac surgical procedure using non-sternotomy approaches.
o Partial sternotomies will be allowed.
- Patients whose planned procedure is a heart transplant or implantation of any
ventricular assist devices.
- Active endocarditis.
- Active systemic infection at the time of cardiac surgery requiring antibiotics,
including known SARS-CoV2 infections regardless of symptoms.
- Known allergy to Nitinol or nickel sensitivity.
- Known medical condition with expected survival of less than 1 year.
- Other comorbidities that in the investigator's opinion make the subject unsuitable
candidate to complete the protocol required visits.
- Current enrollment in an investigation or trial or an investigational devices or
investigational drug that would interfere with this trial.
- Mental impairment or other psychiatric conditions which may not allow the patient to
understand the nature, significance, and scope of the trial.
- Pregnancy.
- Known severe symptomatic carotid disease.

Clinical

• Signs and symptoms consistent with an acute posterior circulation ischemic stroke.
• Baseline modified Rankin Scale (mRS) score ≤ 2 prior to qualifying stroke.
• Subjects age is 18-89 years.
• Baseline National Institutes of Health Stroke Scale Score > 4 and remains > 4 immediately prior to thrombectomy treatment.
• Stroke symptoms began within 48 hours of thrombectomy treatment. Stroke onset is defined as the time the patient was last known to be at his/her neurologic baseline. Wake-up strokes are eligible if they meet the above time limits.
• Endovascular thrombectomy for PCLVO planned as standard-of-care therapy.
• Time of arterial puncture (femoral or radial artery) occurred (or expected to occur) within 90 minutes of CT or MR imaging study completion.
• Patient or Legally Authorized Representative has signed the study Informed Consent form.

Imaging

• Planned to undergo standard neuroimaging evaluation by computed tomography (CT) or magnetic resonance (MR) imaging that includes CT or MR angiography or the intracranial circulation and cerebral perfusion imaging prior to thrombectomy.
• .Vertebral artery or basilar artery occlusion on CTA or MRA. (Alternative assessment (if MRA/CTA technically inadequate or > 90 minutes old): Tmax>6s perfusion deficit consistent with a vertebral or basilar artery occlusion).

Clinical

• Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional outcomes evaluation.
• Endovascular treatment that primarily involves angioplasty or stent placementt.
• Any condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

Imaging

• Acute symptomatic arterial occlusions in more than one vascular territory on CTA (ie – associated anterior circulation LVO of the internal, middle, or anterior cerebral artery.
• Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm or arteriovenous malformation.
• Mass effect with significant herniation above the cerebral tentorium or below the foramen magnum.
• Intracranial stent implanted in the same vascular territory that precludes safe deployment/removal of neurothrombectomy device.

Eligibility last updated 8/1/22. Questions regarding updates should be directed to the study team contact.

• Adult patients who have clinical indication for limited liver MRI study that includes PDFF estimation.

• Contra-indications to MRI study.
• Participants who are unable to undergo MR (claustrophobia, implanted device, etc.), pregnancy, obesity (> 400 lb).

• Possible or Probable MSA (regardless of type).
• At least one other supporting test (CSF, imaging, RT-QuIC, smell test, autonomic testing). Does not have to be uniform but at least one supporting test is required. If any additional information supporting the diagnosis is available, please add to the accompanying data.

• N/A

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

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

- Age ≥ 18 years.

- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) and eligible for treatment in the first line or second line settings.

- Acceptable histologies include adenosquamous carcinoma, mucinous adenocarcinoma, hepatoid carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated
carcinoma, and undifferentiated carcinoma with osteoclast-like-cells, and adenocarcinoma. Pancreatic neuroendocrine tumors (PNET) are excluded.

o Note: prior adjuvant or neoadjuvant chemotherapy is permitted if the last dose was > 12 months prior to the diagnosis of metastatic disease.

- Radiographically measurable disease of at least one site by computed tomography (CT) scan (or magnetic resonance imaging, if allergic to CT contrast media) as defined by
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 21-day window, prior to randomization.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- Adequate organ function (lab results must be obtained within the 21-day window prior to randomization)

- Absolute neutrophil count ≥ 1500/mm^3.

- Hemoglobin ≥ the lower limit of normal (LLN) or 9g/dL.

- Platelets ≥ 100,000/mm^3.

- Serum creatinine ≤ 1.0 x upper limit normal (ULN), or calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault).

- Albumin ≥ 3.0 g/dL.

- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN (up to ≤ 5 x ULN in presence of liver metastasis).

- Total bilirubin ≤ 1.5 x ULN.

- INR ≤ 1.5 x ULN (up to ≤ 2 x ULN for subjects on anticoagulation therapy).

- Subjects must be willing to provide protocol-mandated tissue and blood samples for diagnostic and research purposes as a condition of enrollment into the trial.

- Able to swallow pills, capsules or tablets.

- Able to adhere to study visit schedule and other protocol requirements.

- Females of childbearing potential [defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy
(the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the
preceding 24 consecutive months)] must:

- Have a negative serum or urine pregnancy test (?-human chorionic gonadotropin [?-hCG]) as verified by the study doctor within 14 days prior to randomization;

- Commit to complete abstinence from heterosexual contact or agree to use medical doctor-approved contraception throughout the study without interruption while receiving study treatment and for at least 6 months following last dose of study treatment.

- Males must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with a pregnant female or a
female of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.

- HIV-infected subjects on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HIV viral load test should be performed at screening and be negative (i.e., undetectable).

- HBV-infected subjects are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HBV viral load test should be performed at screening and be negative (i.e., undetectable).

- Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured. Subjects with HCV infection who are currently on treatment are eligible if
the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HCV viral load test should be performed at screening and be negative (i.e., undetectable).

- Subjects with a history of brain metastases are eligible provided they show evidence of stable lesions (and no new lesions) with no evidence of tumor progression for at
least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. In addition, any neurological
symptoms that developed either as a result of the brain metastases or their treatment, must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed > 7 days prior to the first dose of trial therapy.

- No known leptomeningeal disease.

- Subjects with a prior or concurrent malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational
regimen are eligible. Subjects receiving any active therapy for a concurrent secondary malignancy are excluded.

- Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using New York Heart Association Functional Classification. To be eligible for this trial, subjects should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.

- Understands the nature of the study and has agreed to participate by voluntarily signing the IRB approved informed consent.

CASES: Heavy drinkers with alcoholic hepatitis.

• A clinical diagnosis of alcoholic hepatitis.
• Serum total bilirubin >3 mg/dL.
• Subject or guardian ability to understand and willingness to provide written consent.
• Age greater or equal to 21 years.
• Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study.

• Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis.
  • NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation).
• Pregnant or breast feeding.
• Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements.

CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria

• History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. 
• Subject or guardian ability to understand and willingness to provide written consent.
• Age greater or equal to 21 years.

• Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past).
• Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis.
  • NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.
• Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days.
• If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa.
• Pregnant or breast feeding.
• Any of the following laboratory abnormalities within 90 days prior to signing the consent:
  • Total bilirubin: >ULN* 2.
  • INR: > 1.4 5
    • *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation.

HEALTHY CONTROLS

• AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse).
• Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment.
• Ability to understand and willingness to provide written consent.

• Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. 
• Presence of diabetes (requiring treatment with oral agents or insulin). 
• Significant heart disease (prior history of heart disease, other than hypertension).
• Chronic lung disease (requiring chronic treatment).
• Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.).
• Known infection with HIV.
• Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days.
• BMI>35.
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
• Pregnant or breast feeding.
• Any of the following laboratory abnormalities within 90 days prior to signing the consent:
  • Hemoglobin: <10 g/dL;
  • Conjugated bilirubin: > ULN;
  • INR: > 1.4;
  • AST: >40 IU/mL;
  • ALT: >40 IU/mL.
• Based on the judgment of the investigator, subject is not capable of complying with the study requirements.

• Age ≥ 18 years.
• No use of opioids for 6 months prior to the issuance of the initial opioid prescription.
• At least 1 dose of the initial opioid prescription was taken.
• Willingness to participate in all aspects of the study including use of the mobile health platform on their personal smartphone.
• Patients meeting these inclusion criteria will be further categorized based on CONSORT criteria.

Criteria for the long-term CONSORT category includes:

• Episodes of opioid prescribing lasting longer than 90 days and including 120 or more total days’ supply or 10 or more prescriptions.

Criteria for the short-term CONSORT category includes:

• Episodes of opioid prescribing lasting 90 days or less.

• Cancer-associated pain.
• Concurrent treatment for cancer (e.g., chemotherapy, radiation therapy).
• Residence in an extended care facility.
• Mental health disorders that could impede functioning in an ambulatory care setting (e.g., schizophrenia, dementia).
• Non-English speaking individuals.
• Although study participation will be limited to adults who own a smartphone, recent data from January 2018 demonstrate 77% of U.S. residents own a smartphone.
• An iPad will be available for use by adults not wanting to utilize their smartphone, or for those not owning a smartphone.

• Between the ages of 18-50 years old.
• Are of moderate to high fitness level and participate in regular physical activity.
• Must have a body mass index (BMI) less than 31 kg/m^2.
• Must be able to provide clear informed written consent.

• History of chronic respiratory, cardiovascular, metabolic disease or neural/cognitive disorders.
• Anemia (< 12 g/dl for males, < 11 g/dl for females).
• Migraines.
• Active smoker (smoke within the past 6 years), or have more than 5 pack-years of smoking history
• Females who are pregnant or trying to become pregnant.

Task 1 Specific:

• History of pneumothorax, functionally limiting barotraumas or any inability to equalize tympanic pressure (e.g., during diving, swimming or flying).
• Current dental abscesses or jaw pain consistent with severe dental caries.
• Prior allergies or serious side effects from vasoconstrictors such as Afrin™ (oxymetazoline hydrochloride) utilized for sinus decongestion.
• Hyperbaric exposure within the last 24 hours (for chamber visits).

• ≥ 30 years of age.
• Either gender.
• Any self-declared ethnicity-race.
• Open-angle with one of the following:
  • Untreated OHT ≥ 21mmHg;
  • Treated OHT with history of IOP ≥ 21 mmHg on 2 prior clinic visits or IOP ≥ 21 mmHg at screening;
  • Mild-to-moderate stage open-angle glaucoma based on history of untreated IOP ≥ 21 mmHg.
• Reliable Humphrey visual field test result within previous 1 year.
• Open on gonioscopy within previous 1 year.
• At least one eye must be phakic.
• Able to cooperate for aqueous humor dynamic procedures.
• Able to participate on site over the multi-visit study period.
• Contact lenses must be removed before topical fluorescein instillation and remain out until study testing the following day is completed.
• Contact lenses must be removed for the entire duration of the study visits.
• All study medication must be used without contact lenses in the eyes.

• Women who are pregnant or breastfeeding.
• IOP ≥ 38 in study eye(s) or at discretion of the clinician.
• Refusal to remove contact lenses.
• Advanced visual field loss (MD ≤ -16 dB) or threat to fixation in study eye(s) or at discretion of the clinician.
• Study eye(s) with CCT < 480 microns or > than 620 microns.
• Study eye(s) with any sign of Fuchs cornea dystrophy as noted clinically with guttae and corneal edema.
• Narrow angle of ≤ Shaffer grade 2 for 180o, peripheral synechiae, or peripheral iridotomy in either eye.
• History of acute angle closure crisis in either eye.
• History of glaucoma incisional surgery (e.g., trabeculectomy, glaucoma drainage implant, Xen gel stent) in study eye(s).
• History of minimally invasive glaucoma surgery (MIGS, e.g., angle surgery, Cypass) in study eye(s).
• History of any cycloablation surgery (e.g., micropulse or diode transcleral or endoscopic cyclophotocoagulation) in study eye(s).
• Study eye cannot have history of any past SLT or ALT glaucoma laser treatments.
• Study eye(s) cannot have any history of refractive surgery.
• Study eye(s) cannot have any history of herpetic infection of the cornea.
• Study eye(s) cannot have chronic or recurrent inflammatory eye disease.
• Study eye(s) cannot have ocular trauma within the past 6 months, other than uncomplicated cornea abrasion.
• Study eye(s) cannot have ocular infection in the past 3 months.
• Study eye(s) cannot have clinically significant retinal disease that includes proliferative diabetic retinopathy, vein occlusion, cystoid macular edema, wet age-related macular degeneration.
• History of intraocular or peri-ocular injections in study eye(s) within 3 months.
• History of oral steroid use within 30 days of screening Visit 1.
• Any abnormality preventing reliable fluorophotometry (e.g., corneal scarring or severe dry eye with fluorescein staining).
• Serious hypersensitivity to any components of study medications or risk from treatment (e.g., sulfa drug allergy, bradycardia, severe asthma, or emphysema).
• Participants must be on minimum 30-day stable regimen prior to Visit 1 for a systemic medication that may affect IOP (i.e., sympathomimetics, beta-blockers, alpha-adrenergic agonists and blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.).  Any change of such medication during the study will result in exclusion.
• Prohibited meds during study: cannabis products, brimonidine 0.025% (Lumify), bimatoprost 0.03% for eyelash growth (Latisse), topical ocular and peri-ocular steroids, oral steroids.

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

Eligibility last updated 10/17/22. Questions regarding updates should be directed to the study team contact.

• Mayo Clinic patients with positive COVID-19 test who agreed to follow up through video visit by Mayo COVID-19 Virtual Clinic providers.

• Non Mayo Clinic patients.
• Patients with negative COVID-19 result

• Patients with MSAC (patients with cerebellar ataxia as the predominant symptom) or MSA-P (patients with predominantly parkinsonian features) subtypes.
• Willing and able to provide informed consent.

• Patients who participated in the Phase 3 study BHV3241-301.
• Patients with a clinically significant history of underlying neurological diseases beyond MSA.

• To be eligible for this project, a patient must currently be enrolled in an applicable DRCR.net study or previously been enrolled in an applicable DRCR.net study.
• The DRCR.net procedures manual will indicate which DRCR.net protocols are applicable for study enrollment.

• Clinician Participants: All clinicians who are affiliated with a participating primary care practice and care for adult patients eligible for CV prevention will be invited to participate.
• Patient Participants: Adult patients (ages 40-75 years) with or without diabetes who have not experienced an atherothrombotic clinical event and receive preventive care at a participating primary care practice will be eligible to participate.

• Individuals who do not speak English or have any sort of cognitive deficit that would impact their ability to consent to participate in the study will not be invited to participate.

Index Participants will be eligible if they:

• Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
• Are aged ≥ 21 years (legal smoking age in Alaska).
• Self-report smoking in the past 7 days, biochemically verified with breath expired air carbon monoxide (CO) > 4 ppm and saliva cotinine > 30 n/ml (positive Alere iScreen result).
• Smoked > 3 cigarettes per day (cpd) over the past 3 months.
• If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
• Are considering or willing to make a quit attempt.
• Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration.
• Nominate one adult family member who will enroll.

• Used pharmacotherapy or a stop smoking program within the past 3 months.
• Another person in the household is enrolled as the index participant.

Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:

• Are ≥ 21 years old.
• Are defined as family by the index participant.
• Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration.
• Both men and women and those from non-ANAI racial/ethnic groups.
• Family members may only support one index participant to mitigate concern about lack of independence of household or other support networks, and potential for crosstreatment contamination, which could attenuate effects in the RCT.

Alaska Tribal Health System stakeholders:

• Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

• Age 18 and older.
• Willing to provide consent.
• Men or women.
• Stable weight for 3 months prior to study entry.

• Individuals who are unable to sign consent (e.g., mentally challenged, those declared legally incompetent).
• Recent use of weight loss medications (< 6 months).
• History of abdominal GI surgery other than appendectomy.
• Bleeding disorder.
• Pregnancy.
• 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.
• Subject has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.
• Any contraindications to MRI.
• Claustrophobia.

• Adults age 18 or older.
• Have already received a cochlear implant.
• Must be able to provide consent to participate.

• Additional handicap that would limit the patient from being able to follow study instructions.