• Diagnosis of Chronic Hypersensitivity Pneumonitis (CHP) defined from the first instance in which a patient was informed of having CHP for at least 3 months.
• Age 18 through 85 years.
• Diagnosis of CHP by HRCT:
  • Typical CHP: Evidence of lung fibrosis (reticular abnormality and/or, traction bronchiectasis and/or, architectural distortion, and/or honeycombing), lack of features suggesting an alternative diagnosis and one or more of the following:
    • Profuse poorly defined centrilobular nodules of ground-glass opacity affecting all lung zones;
    • Inspiratory mosaic attenuation with three-density sign.
  • Compatible CHP*: Evidence of lung fibrosis (as above) lack of features suggesting an alternative diagnosis and one or more of the following:
    • Patchy or diffuse ground-glass opacity;
    • Patchy, non-profuse centrilobular nodules of ground-glass attenuation;
    • Mosaic attenuation and lobular air-trapping that do not meet criteria for typical fibrotic HP.

* These patients are required to have a known or indeterminate (suggestive) antigen exposure and/or BAL lymphocytosis (≥ 20%) and/or lung histology consistent with HP (e.g., transbronchial biopsies demonstrating non-necrotizing granuloma(s) or lymphocytosis and/or wedge biopsy or cryobiopsy with a typical, compatible or indeterminate pattern for HP).

•  
• Indeterminate CHP**:  CT signs of fibrosis without other features suggestive of HP.

** These patients are required to have a known or indeterminate (suggestive) antigen exposure and/or BAL lymphocytosis (≥ 20%) and/or lung histology consistent with HP (e.g., transbronchial biopsies demonstrating non-necrotizing granuloma(s) or lymphocytosis and/or wedge biopsy or cryobiopsy with a typical, compatible or indeterminate pattern for HP).

• Able to understand and sign a written informed consent form.
• Able to understand the importance of adherence to the study protocol and willing to follow all study requirements (e.g., completing procedures such as 6-min walk and questionnaires).

• Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study (e.g., unstable or deteriorating cardiac disease such as congestive heart failure requiring hospitalization or unstable angina).
• Known explanation for the interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, pneumoconiosis.
• Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, and rheumatoid arthritis.
• Expected to receive a lung transplant within 4 months from enrollment.
• Pregnant women.

Eligibility last updated 9/27/21. 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.

• Male or female subjects ≥ 50 years of age scheduled to undergo single level posterolateral lumbar spinal fusion surgery in conjunction with local autograft bone for degenerative spondylolisthesis, spondylosis, and/or stenosis.
• Psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
• Willing and able to undergo diagnostic imaging, inclusive of X-rays and CT scans with contrast.
• Persistent, disabling pain after at least 6 months of non-surgical intervention (e.g., anti-inflammatory medication, physical therapy, chiropractic care) prior to providing informed consent.
• Pre-operative Oswestry Disabilty Index (ODI) Score ≥ 30.
• Grade 1 or less spondylolisthesis or retrolisthesis.
• Absence of neurological motor deficit.
• Agree to use a highly reliable method of birth control (male and female subjects) for at least 9 months after administration of IP.
• Women of childbearing potential must have a negative pregnancy test at screening and again ≤ 7 days prior to surgery. Perimenopausal women must be amenorrheic for at least 12 months prior to the time of providing informed consent to be considered of non-childbearing potential.
• Agree to remain nicotine-free for the duration of their participation in the study.

• Multiple level spondylolistheses or a primary diagnosis of low back pain syndrome secondary to diseases other than degenerative spondylolisthesis
• Unwillingness or inability to abstain from medications that affect bone homeostasis including, but not limited to, bisphosphonates and other forms of bone anabolic medications (e.g., Forteo, Reclast, Fosamax, etc.).
• Unwillingness or inability to abstain from non-steroidal anti-inflammatory medications/arthritis medicines (such as Advil, Aleve, Ibuprofen, Motrin, Clinoril, Indocin, Daypro, Naprosyn, Celebrex, Vioxx, etc.) from 5 days before surgery until the end of the study.
• Ongoing / existing infections in or around the surgical site or spine
• Prior lumbar spine arthrodesis.
• Concurrent clinically significant autoimmune disorder or systemic inflammatory disease
• Known hypersensitivity to recombinant Wnt proteins.
• Use of tobacco; subjects must be nicotine-free at screening and agree to remain nicotine free for the duration of the study.
• Use of medications that may impair cell proliferation and bone healing including: chemotherapy, radiation, chronic steroids and immunosuppressive drugs.
  • NOTE: Medications that may impair cell proliferation are to be discussed with the protocol medical monitor prior to enrollment.
• Severe established osteoporosis requiring active treatment; e.g., with bone density more than 2.5 standard deviations below the young adult mean with one or more osteoporotic fractures.
• A Body Mass index (BMI) ≥ 40 unless documentation clearly demonstrates why BMI is not a primary factor in the subject’s decreased mobility.
• Chronic opioid use.
• History of deep vein thrombosis (DVT) or blood clotting abnormalities.
• Uncontrolled diabetes mellitus.
• Uncontrolled hypertension, defined as average systolic blood pressure ≥ 140 mm Hg or an average diastolic blood pressure ≥ 90 mmHg.
• Diagnosed renal and/or liver failure.
• History of systemic infection with HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
• Chronic alcohol abuse, defined as consistent consumption of 8 drinks or more per week for women and 15 drinks or more per week for men.
• Poor nutritional status (e.g., malnourished, undernourished).
• Chronic Obstructive Pulmonary Disease with forced expiratory volume less than 80% of normal.
• Connective tissue disorders (e.g., Ehlers-Danlos Syndrome).
• Peripheral Vascular Disease.
• Pre-operative/anesthesia evaluations deeming the subject ineligible for surgery.
• Female subjects who are pregnant or intend to become pregnant during the course of the study.
• Male subjects, if not infertile or surgically sterilized, who will not agree to use highly-effective contraception or to not donate sperm from screening until at least 9 months  after receiving IP.
• Active malignancy ≤ 5 years prior to providing informed consent.
  • EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix.
  • NOTE: If there is a history of prior malignancy, the subject must not be receiving other specific treatment for their cancer.
• Concurrent participation in another investigational drug, biologic or device study that could confound study data.
• Involvement in or plans to engage in litigation or receiving Worker's Compensation related to neck, back, or leg pain.

Eligibility last updated 8/10/23. Questions regarding updates should be

• Female, age 18 or older.
• Currently pregnant or pregnant within the past 12 months.
• English or Spanish speaker.

• Under the age of 18.
• Not currently pregnant or pregnant within the past 12 months.
• Does not speak English or Spanish.

• Individuals aged 12
  •100+. 
• Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
• Participants also must have a normal (18.5-24.9kg/m^2) or overweight BMI (25-29.9kg/m^2).
• Participants must be able to speak, listen, read, and understand sentences written in English.

• Participants will be excluded who:
  • display more than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease;
  • have a history of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke);
  • take medications that cause dizziness or slow movement;
  • smoke;
  • have a body mass to height squared ratio greater than 30kg/m^2 or less than 18.4kg/m^2;
  • blood pressure greater than 140/90 mmHg;
  • history of heart conditions.
• Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions.

• Individuals aged 12
  •100+. 
• Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
• Participants also must have a normal (18.5-24.9kg/m^2) or overweight BMI (25-29.9kg/m^2).
• Participants must be able to speak, listen, read, and understand sentences written in English.

• Participants will be excluded who:
  • display more than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease;
  • have a history of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke);
  • take medications that cause dizziness or slow movement;
  • smoke;
  • have a body mass to height squared ratio greater than 30kg/m^2 or less than 18.4kg/m^2;
  • blood pressure greater than 140/90 mmHg;
  • history of heart conditions.
• Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions.

• Patients who are ≥ 18 years of age.
• Patient must have SM, confirmed by Central Pathology Review of BM biopsy, and ISM or SSM subtype, as confirmed by WHO diagnostic criteria. In Part 1 of the study, only patients with a diagnosis of ISM are eligible.
• Patient must have moderate-to-severe symptoms based on minimum mean TSS over the 14-day eligibility screening period for assessment of TSS and ≥ 1 symptom in skin or GI domains of the ISM-SAF at Baseline. Minimum TSS for eligibility is ≥ 28.
• Patient must have failed to achieve symptom control for 1 or more Baseline symptoms, as determined by the Investigator, with at least 2 of the following symptomatic therapies administered at optimal (approved) dose and for a minimum of 4 weeks (28 days) before starting the ISM-SAF for determination of eligibility: H1 blockers, H2 blockers, proton-pump inhibitors, leukotriene inhibitors, cromolyn sodium, corticosteroids, or omalizumab.
• The patient’s SM symptomatic therapies (e.g., H1 and H2 blockers) must be stable (same dose, no new medications for SM) for ≥ 14 days before starting the ISM-SAF for determination of eligibility.
• If the patient is receiving corticosteroids, the dose must be ≤ 20 mg/d prednisone or equivalent, and the dose must be stable for ≥ 14 days before starting the ISM-SAF for determination of eligibility.
• Patient must have an Eastern Cooperative Oncology Group Performance Status of 0 to 2.
• Patient must be able to give written informed consent.

• Patient must not have received prior treatment with avapritinib.
• Patient must not have had any cytoreductive therapy including but not limited to masitinib and midostaurin, or investigational agent for < 14 days or 5 half-lives of the drug (whichever is longer), and for cladribine, interferon alpha, pegylated interferon, or antibody therapy < 28 days or 5 half-lives of the drug (whichever is longer), before starting the ISM-SAF for determination of eligibility.
• Patient must not have received radiotherapy or psoralen and ultraviolet A (PUVA) therapy < 14 days before starting the ISM-SAF for determination of eligibility.
• Patient must not have received any hematopoietic growth factor < 14 days before starting the ISM-SAF for determination of eligibility.
• Patient must not require therapy with a concomitant medication that is a strong inhibitor, strong inducer, or moderate inducer of cytochrome P450 3A4 (CYP3A4).
• Patient must not have a QT interval corrected using Fridericia’s formula (QTcF) of > 480 msec.
• Patient must not have a history of a seizure disorder (e.g., epilepsy) or requires antiseizure medication.
• Patient must not have a history of a cerebrovascular accident or transient ischemic attacks within 12 months before the first dose of study drug.
• Patient must not have a known risk or recent history (12 months before the first dose of study drug) of intracranial bleeding (e.g., brain aneurysm).

• ≥ 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.

• Adults ≥ 18 years of age.
• Current and former HIMS participants at a U.S. based international medical center.

• Under 18 years of age.

• Age ≥ 50 years old OR primary healthcare professional (defined as having a job that has had direct patient contact during the COVID-19 pandemic) and ≥ 18 years old.
• No symptoms of COVID-19 (a fever of 100.0 degrees F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation) in the past 7 days.
• Have a negative Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening .
• Have not had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 (Close contact is defined by CDC as:  being within approximately 6 feet of a COVID-19 patient for a prolonged period of time (more than 5 minutes) or having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on)) in the last 14 days.
• Mayo Clinic patient who has a patient online account set up or is willing to set up an online account.
• Must have a valid email address and internet service

• History of positive or indeterminate COVID PCR test prior to screening or positive or indeterminate Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening.
• Active symptoms of COVID ((a fever of 100.0 degrees F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation)) in past 7 days.
• Known intolerance to Centrum multivitamins or Zinc supplement from prior exposure.
• Inability to complete follow-up questions or grant access to electronic health record for surveillance.
• Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in past 14 days.
• Current or former smoker less than 5 years ago.
• Pregnant or breastfeeding.
• Prisoner.
• Any subject with known immunosuppressed state, including:
  • A history of solid organ or bone marrow transplantation;
  • Subjects currently receiving chemotherapy;
  • Current rheumatologic or autoimmune illness requiring treatment with glucocorticoids, antimetabolite agents (methotrexate, azathioprine, mercaptopurine, fluorouracil, mycophenolate, leflunomide), IMIDs (lenalidomide, thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine), mTOR inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs (including any drug given intravenously or subcutaneously) for the purpose of immunosuppression;
  • Subjects with HIV or primary immunodeficiency syndromes.

• Adult patients, ≥ 18 years of age.
• Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital to patient's home or assisted living facility.
• Patients or their legally authorized representative provides consent to participate in the study.

• Patients discharged from Hospital Service Meds 1-4 and Med 17.
• Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility.
• Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure).
• Patient/legally authorized representative is Non-English speaking.
• Patient leaves the hospital Against Medical Advice (AMA).
• No access to mobile technology/laptop/computer for post-discharge follow-up.
• Patient with an active diagnosis Covid-19 infection.
• Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment.

• Adult patients, ≥ 18 years of age.
• Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital to patient's home or assisted living facility.
• Patients or their legally authorized representative provides consent to participate in the study.

• Patients discharged from Hospital Service Meds 1-4 and Med 17.
• Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility.
• Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure).
• Patient/legally authorized representative is Non-English speaking.
• Patient leaves the hospital Against Medical Advice (AMA).
• No access to mobile technology/laptop/computer for post-discharge follow-up.
• Patient with an active diagnosis Covid-19 infection.
• Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment.

• Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.
• Hypogammaglobulinemia (IgG levels < 5 g/L) as confirmed by the Central Laboratory.
• ≥ 18 years of age.
• Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.

• IgG treatment within 3 months prior to Screening.
• Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the exception of trimethoprim-sulfamethoxazole [TMP/SMX], diaminodiphenyl sulfone [dapsone] and pentamidine inhalation).
• Current major infection or > 1 major infection in the previous 6 months before Baseline.
• History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component.
• History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years.
• Severe liver disease, with signs of ascites and/or hepatic encephalopathy.
• Severe kidney disease (as defined by estimated glomerular filtration rate [eGFR] 140 kg.
• Eastern Cooperative Oncology Group (ECOG) performance score of > 2.
• Female patients of childbearing potential unwilling to use a protocol-required method of contraception from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug.
• Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test).
• Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while undergoing CLL therapy, and patients with active HBV, defined as high HBV titers.
• Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C [HCV] polymerase chain reaction [PCR]).
• Pregnant and lactating women.
• Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) within 6 months before Baseline.
• Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment.
• Participation in another interventional clinical trial that is either blinded or involves an investigational (not approved) product within 3 months before Baseline or during the course of the clinical study. Participation in observational clinical trials or open-label trials involving an approved product may be permitted after consultation with the medical monitor.

Eligibility last updated 3/18/22. Questions regarding updates should be directed to the study team contact.

• Adults age 75 years or older.
• Community-dwelling adults.

• Clinically evident CVD, defined as prior MI, prior stroke, prior revascularization  procedure, or a secondary prevention indication for a statin as determined by their  clinician.  
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months
  • Note:  History of heart failure without clinically evident cardiovascular disease is not an  exclusion).
• Dementia (clinically evident and/or previously diagnosed).
• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of  urinary or bowel continence).
• Severe hearing impairment (preventing phone follow up).
• Severe visual impairment (preventing cognitive testing).
• Statin use in the past year or for longer than 5 years previously (participant  reported).
• Ineligible to take atorvastatin 40 mg (clinician determined).
• Documented intolerance to statins.
• Active liver disease.

Eligibility last updated 7/11/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Adults > 18 years of age regardless of medical condition.
• SARS-CoV-2 nasopharyngeal PCR testing prior to gastrointestinal endoscopy as part of routine clinical care. 
• Undergoing an upper gastrointestinal endoscopic procedure (e.g, EGD, EUS, ERCP, upper enteroscopy), lower endoscopy (colonoscopy, flexible sigmoidoscopy, lower EUS), or ERCP.
• Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.  

• Seizure refractory to at least three standard antiepileptic medications at adequate doses, failed for lack of effectiveness. This may include a rescue medication designated use as PRN.
• A minimum of 3 seizures per month for 2 months by patient diary started at intake interview.
• Subjects should have partial-onset seizures with or without secondary generalization.
• Subjects should have evidence suggesting the target lesion is the source of seizures by standard clinical criteria including at least the description of seizures, physical examination, neuroimaging, and video EEG monitoring capturing at least one seizure.
• Subjects must be taking 2 medications during the Baseline period and the dosage must be stable.
• A diagnosis of intractable epilepsy secondary to a dysplastic subcortical lesion which would include: Hypothalamic hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial tumor (DNET), Cortical dysplasia, or Tuberous sclerosis.

• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.).
• Patients with malignant brain tumors.
• Patients with a known history of psychogenic non-epileptic spells in the last three years.
• Patients with a vagal nerve stimulator, deep brain stimulator, other implanted electronic device, or prior radiofrequency lesion techniques.
• Lesions in the brainstem or cerebellum.
• Subjects with symptomatic generalized epilepsy.
• Subjects with only simple partial seizures.
• Subjects who have had convulsive status epilepticus within 12 months prior to baseline.
• Subjects with a prior diagnosis of psychogenic/non-epileptic seizures within the last 5 years.
• Subjects who are candidates for traditional open surgery or elect to receive traditional open surgery are excluded.

• Diagnosis of multiple system atrophy (possible or probable) based on autonomic reflex screen.
• Females only, age 40-80 years.

• Clinical evidence of untreated endocrine disorder (hypothyroidism, hyperthyroidism).
• Current use of glucocorticoid hormones (prednisone, prednisolone).

Participants who were previously included in a chart review study (IRB# 19-003546, Brachial Plexus Injury Patterns in Shoulder Arthroplasty study) will be invited to participate in the survey.

Inclusion Criteria
•COVID-19 Cohort:

• Patient age: 60-85 years old.
• SARS-CoV-2 infection confirmed by PCR.
• Need for hospitalization due to COVID-19 pneumonia.
• Need for ≥ 2L supplemental oxygen at any point during hospitalization.

Inclusion Criteria
•CONTROL Cohort:

• Patient age: 60-85 years old.
• No pre-existing history of interstitial lung disease or chronic lung disease, except for mild COPD with FEV1 > 80% predicted and FEV1/FVC < 0.7.
• Absence of lung infiltrate, fever or any signs or infection.
• Undergoing bronchoscopy for evaluation of lung nodule or adenopathy.

Exclusion Criteria
•COVID-19 and CONTROL Cohorts:

• Unable to provide consent to participate in the study.
• Patient under guardianship or curatorship.
• Pre-existing interstitial lung disease, pulmonary fibrosis or chronic lung disease, except for mild COPD as outlined in “inclusion criteria.”
• Active cigarette smoking, vaping or other inhalation use (former smoker providing quit > 90 days prior to admission acceptable).
• > 20 pack years.
• Immunocompromised host status due to ongoing therapy with methotrexate, cellcept, azathioprine, prednisone dose > 15 mg daily, rituximab, cyclophosphamide or other biologic agents.
• Chemotherapy or Radiation therapy in last 2 years.

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

Eligibility last updated 1/16/23. Questions regarding updates should be directed to the study team contact.

• Children ages 3-18 years old.
• Clinical diagnosis of Type 1 diabetes.

• Newly diagnosed with Type 1 diabetes within the past month of study date.
• Contraindications to receiving 23 valent pneumococcal vaccines.
• Other conditions associated with compromised immunity and vaccine response.
• Primary or Secondary Immune deficiency.
• Previous receipt of PPSV-23 vaccination.

• 18 years of age or older at the time of consent.
• Frontline healthcare professional.
• Have access to an Apple or Android device.
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have no contraindicating comorbid health condition as determined by the clinical investigators.

• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
• Currently (within the past 3 weeks) been undergoing an additional program (e.g., CAM) to improve quality of life or sleep.
• Currently (within 3 weeks) been enrolled in another clinical or research program (e.g., CAM) which intervenes on the patients’ QOL, stress or sleep.
• An unstable medical or mental health condition as determined by the physician investigator.

• Must be 55 years of age or greater.
• Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation.

• Failure to obtain consent.
• Vulnerable study population.
• Any need for chronic anticoagulation.
• Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma.
• Glasgow Coma Scale (GCS) less than 8.

• Age ≥ 22 years old.
• English-speaking.
• Planned for outpatient direct current cardioversion for atrial fibrillation or atrial flutter.
• Participant is willing and able to read and sign consent and participate in study.
• Participant lives independently and does not require continuous care.
• Participant has an email account (or is willing to create one).
• Participant has a compatible smartphone (iPhone 6s or later).
•  
• Participant is willing to wear only the device they are randomized to receive for the study period for as many hours during the day as they are able, except for the time spent charging the device or in the environments that may be suboptimal for the device.
• Participant is willing to use the Hugo mobile health platform and Apple Watch Series 5 or Withings Move.
• Participant has cardiology care at Mayo Clinic and primary care in a health system with a patient portal.

• Do not meet all inclusion criteria as listed above
• Unable to provide informed consent.

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

Inclusion Test:

• Adult patients, 18 years or older.
• Current order for SARS-CoV-2 testing to be collected at one of two participating collection sites in SW or SE MN.
• Provide verbal consent for an additional nasal swab collection (15 seconds each nostril) for research use only.

Exclusion Test:

• Children (patients under age 18).
• Patients who do not give verbal consent for collection of additional nasal swab specimen.

• Adults, age 18 or older.
• Having sign/symptoms of COVID-19 and/or prior diagnosis of COVID-19.
• Willing and able to participate in the study.

• Individuals less than 18 years old.
• Enrolled patients will not be health care workers or have prior training in collecting a Mid-Turbinate (MT) nasal swab.
• Non-English speaking

• 22
  •80 years of age.
• Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
• Pathologic reflux while off PPI based on Lyon criteria by either of the following:
  • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
  • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
• Commitment to long-term study.
• Ability to give consent individually or by a legally authorized representative.

• Hiatal hernia > 5 cm.
• Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
• Pregnancy (in females) at time of procedure.
• Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
• Subjects requiring mesh treatment at time of procedure.
• Provider discretion.
• BMI > 35.

• ≥ 18 years of age.
• Either gender.
• Any self-declared ethno-racial category.
• Subjects with two healthy eyes with the crystalline lens, without glaucoma or any other clinically significant eye diseases.
• Open angles in both eyes.
• Intraocular pressure less than 22 mmHg in either eye.
• Be able and willing to provide signed informed consent and follow study instructions.
• Ability to cooperate for the examinations required for study and be able to attend all study visits.
• Contact lenses removed before the study visit.
• Best-corrected visual acuity (BCVA) in each eye of 20/50 or better.

• Under 18 years of age.
• Narrow angle of < Shaffer grade 2, peripheral synechiae, or peripheral iridotomy in either eye.
• Subjects with a central corneal thickness less than 480 µm or greater than 620 µm in either eye.
• Chronic or recurrent inflammatory eye diseases.
• Ocular infection or ocular inflammation in the past 3 months.
• Ocular trauma other than corneal abrasion within the past 6 months.
• Clinically significant retinal disease (eg, diabetic retinopathy, exudative or severe non-exudative macular degeneration).
• Cornea pathologic changes preventing reliable measurement (eg, scarring, opacity) in either eye.
• Previous intraocular surgery or laser procedure in either eye.
• Myopia greater than -6.00D, or hyperopia greater than +2.00D.
• Moderate to severe dry eye in either eye.
• Serious hypersensitivity to topical anesthetic eye drops.
• Use of any topical ophthalmic medications other than lubricants and artificial tears within the past 30 days.
• Use of any products of cannabis (THC or CBD compounds) within the past 30 days.
• Lack of suitable episcleral vein for EVP measurement.

PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA

• Pathologically (histologically or cytologically) confirmed diagnosis of epithelioid or biphasic malignant pleural mesothelioma (MPM) within 90 days prior to Step 1 Registration -Imaging proof of clinical stage (American Joint Committee on Cancer [AJCC] 8th edition) I-IIIA MPM by PET/CT within 42 days prior to Step 1 Registration.
• MPM is amenable to resection by P/D as determined by a thoracic surgeon within 42 days prior to Step 1 Registration.
• History/physical examination within 42 days prior to Step 1 Registration.
• Karnofsky performance status ≥ 80 within 42 days prior to Step 1 Registration.
• Pulmonary function tests within 42 days prior to Step 1 Registration:
  • ≥ 40% predicted post-forced expiratory volume in 1 second (FEV1);
  • ≥ 40% predicted post-operative diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin [Hgb]).
• Leukocytes ≥ 3000 cells/mm^3 (within 30 days prior to Step 1 Registration).
• Absolute neutrophil count ≥ 1500 cells/mm^3 (within 30 days prior to Step 1 Registration).
• Platelets ≥ 100,000 cells/mm^3 (within 30 days prior to Step 1 Registration)..
• Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 30 days prior to Step 1 Registration).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine a minotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 X ULN (within 30 days prior to Step 1 Registration).
• Glomerular filtration rate (GFR): ≥ 50 mL/min/1.73 m^2 (must be calculated using estimated creatinine clearance [CrCl] by the Cockcroft-Gault [C-G] equation [Nephron 1976;16:31-41]) (within 30 days prior to Step 1 Registration).
• Negative serum pregnancy test within 14 days of Step 1 Registration for pre-menopausal women of childbearing potential.
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
• EORTC QLQ-C30 and QLQ-LC13 within 42 days prior to Step 1 Registration.

PRIOR TO STEP 2 RANDOMIZATION INCLUSION CRITERIA

• Patients must have received at least 2 cycles of pemetrexed/platinum chemotherapy and undergone a pleurectomy/decortication with the goal of macroscopic complete resection following step 1 Registration.
• Karnofsky performance status ≥ 70 within 30 days prior to Step 2 Randomization.
• History/physical examination within 30 days prior to Step 2 Randomization.
• EORTC QLQ-C30 and QLQ-LC13 within 30 days prior to Step 2 Randomization.

PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA

• Pregnant or lactating women, or sexually active men or women not using effective contraception (risk for fetal defects from teratogenic chemotherapy and radiation therapy) within 14 days prior to Step 1 Registration
• Diagnosis of sarcomatoid mesothelioma.
• Severe, active co-morbidity defined as follows:
  • New York Heart Association (NYHA) class III or IV heart failure;
  • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed;
  • Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months;
  • Interstitial lung disease;
  • Hemodialysis or peritoneal dialysis;
  • Concurrent active malignancy (with the exception of current or prior non-melanomatous skin cancer or low-grade malignancies followed observantly for which treatment has not or does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen).
• If evidence of disease < 3 years, institution must consult with the principal investigator, Andreas Rimner, Doctor of Medicine (MD)
• Hepatic impairment defined by ChildPugh class (ChildPugh class B & C);
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated.
  • Note: HBV viral testing is not required for eligibility for this protocol.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
• For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 30 days prior to registration.
• Active tuberculosis.
• Patients on immunosuppressive therapy, for example history of organ or bone marrow transplant or chronic lymphocytic leukemia (CLL).
• CD4 count < 200 cells/microliter.
  • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count  200 cells/microliter within 30 days prior to registration.
  • Note also that HIV testing is not required for eligibility for this protocol.
• Prior nephrectomy on the contralateral side of MPM.
• Ipsilateral thoracic electronic implant; e.g., pacemaker, defibrillator, unless switched to the contralateral side prior to initiation of radiation therapy (RT).
• Prior thoracic radiation therapy (patients with prior thoracic RT cannot be planned to 50-60 Gy without exceeding normal tissue constraints).

PRIOR TO STEP 2 RANDOMIZATION EXCLUSION CRITERIA

• Progressive disease.
• Supplemental oxygen use.
• Third space fluid that cannot be controlled by drainage or insufficient lung expansion after P/D (this prevents targeting the pleura without exceeding normal tissue constraints).
• Prior intrapleural therapy (i.e., intrapleural chemotherapy, photodynamic therapy); pleurodesis is permitted.
• Bulky residual disease in the major fissure preventing pleural IMRT.
• Patients who have undergone extrapleural pneumonectomy.
• Patients with active infection that requires systemic I.V. antibiotics, antiviral, or antifungal treatments.