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

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

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

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

• Patients who have not undergone open prophylactic NSM surgery.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Inclusion Criteria;

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

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

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

• 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.

• Participants from birth to age 90 years must meet all the following criteria for inclusion during screening:
  • 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 8/4/22. 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.

• Signed informed consent must be obtained prior to participation in the study.
• Patients must be adults ≥ 18 years of age.
• Patients must have an ECOG performance status of 0 to 2.
• Patients must have a life expectancy > 9 months as determined by the study investigator.
• Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site).
• Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader.
• Patients must have documented metastatic disease to bone and/or soft tissue/visceral sites documented in one of the following manners within 28 days prior randomization:
  • Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans; OR
  • Lymph node metastases of any size or distribution. If lymph nodes are the only site of metastasis, then at least one must be at least 1.5 cm in short axis AND outside of the pelvis; OR
  • Visceral metastases of any size or distribution. If a subject has a history of visceral metastases at any time prior to registration, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes).
• Patients must have adequate organ function:
  • Bone marrow reserve ANC ≥ 1.5 x 10^9/L;
  • Platelets ≥100 x 10^9/L;
  • Hemoglobin ≥ 9 g/dL;
  • Hepatic Total bilirubin ≤ 2 x the institutional upper limit of normal (ULN);
  • For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases;
  • Renal eGFR ≥ 50 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation.
• Albumin ≥ 2.5 g/dL.
• Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial.
• Patients must be:
  • Treatment naïve OR minimally treated with:
  • Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of therapy.
  • If received, prior LHRH agonist/antagonist use in the adjuvant/neo-adjuvant setting must have been discontinued > 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy;
  • Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No exposure for earlier stages of prostate cancer is allowed.

• Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy.
• Any systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria 11), including chemotherapy, PARP inhibitors, immunotherapy or biological therapy (including monoclonal antibodies).
• Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
• Ongoing participation in any other clinical trial.
• Use of other investigational drugs within 30 days prior to day of randomization.
• Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
• Transfusion for the sole purpose of making a subject eligible for study inclusion.
• Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (magnetic resonance imaging (MRI) preferred or CT with contrast).
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.
  • Note: Patients with a history of CNS metastases that have received prior therapy and are neurologically stable, asymptomatic and not receiving corticosteroids are allowed.
• Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance) and had no symptoms for at least 28 days before the first dose of study medication.
• No active clinically significant cardiac disease defined as any of the following:
  • NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45% with improvement in symptoms to class < 3;
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as:
  • Concomitant clinically significant cardiac arrhythmias; e.g., sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block);
  • History of familial long QT syndrome or known family history of Torsades de Pointes;
  • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature .
• History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
• Any condition that precludes raised arms position.
• Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
• Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 6 months after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

Eligibility last updated 1/17/22. 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 12/13/22. 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 18 years and older.
• Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician.
• IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy.
• Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures .

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

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

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

• Patients with TOF or TOF-related variants.
• Age ≥ 18 years.
• Planned transcatheter valve placement in native RVOT.

• Individuals < 18 years.
• Non-TOF related variants (i.e., pulmonary stenosis, PA-IVS, etc.).
• Prior catheter or surgical ablation of ventricular tachycardia (VT).

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

• 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.

• Is 18 years old or older.
• Self-identifies as a member of the LGBTQ community or self-identified as such at the time of their admission or is the spouse, partner, or family member who identifies as a member of the LGBTQ community.
• Has been on a ventilator in the intensive care unit or is the spouse, partner, or family member of a patient on a ventilator in the intensive care unit between 1/2016 and 2/2022.

• Does not meet the above criteria for age, LGBTQ identity, relationship to an LGBTQ identifying individual, and past mechanical ventilation.

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

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.

• All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
• If patients declined MN research authorization, they may be contacted for consent for approval.

• Patients that did not undergo cochlear implantation at the Mayo Clinic.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.