• Have had a prior surgery.
• Possess implants (i.e., dental).
• May be receiving subsequent radiotherapy treatments at their local clinic.
• May be receiving full treatment at Mayo.
• May be referred by the regional practice.

• None.

• Male and female subjects aged 18 to 75 years, inclusive.
• IPAA for UC completed at least 1 year prior to screening.
• Active signs and symptoms of pouchitis, as follows:
  • Modified Pouchitis Disease Activity Index (mPDAI) score ≥ 5; and
  • Increased stool frequency, defined as 3 more stools per day above “normal” (after IPAA) and an absolute total of ≥ 6 stools per day.
• Chronic or recurrent pouchitis, defined by:
  • ≥ 2 episodes within 1 year prior to or including the screening period treated with antibiotic or other prescription therapy; or
  • Maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the screening endoscopy.
• Antibiotic-resistant pouchitis, defined as disease remaining active despite at least 2 weeks of antibiotic therapy.
• Histologic inflammation in the pouch, defined by a Geboes score of 3.1 or greater.
• Unlikley to conceive.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit prior to the first dose of study drug.
• Able to participate fully in all aspects of this clinical trial.
• Written informed consent must be obtained and fully documented.

• Known Crohn’s disease (CD) or suspected CD of the pouch, defined as complex perianal/pouch fistula and/or extensive length of pre-pouch ileitis with deep ulceration.
• Diagnosed or suspected irritable pouch syndrome (IPS).
• Isolated or predominant cuffitis.
• Mechanical complications of the pouch such as stricture or fistula(e) that preclude evaluation of the pouch and terminal ileum.
• Fecal incontinence due to anal sphincter dysfunction.
• Pelvic sepsis within 12 months prior to screening.
• Planned surgery for UC, or any other elective surgery within the time frame of the study.
• Diverting stoma.
• Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, active tuberculosis infection, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 6 months prior to screening, any infection requiring antimicrobial therapy within 2 weeks prior to screening, history of more than 1 episode of herpes zoster or any episode of disseminated zoster.
• Prior biologic use restrictions and exclusions:
  • No more than 25% of enrolled subjects (in each phase) may have prior failure of any biologics;
  • Subjects who have used prior biologic therapies must have discontinued within 8 weeks of screening (or within 4 weeks if drug levels are undetectable).
• Use of any of the following prohibited therapies, except under the stated conditions (if applicable):
  • Opioids within 4 weeks prior to screening;
  • Chronic use of nonsteroidal anti-inflammatory drugs;
  • Oral 5-aminosalicylate (5-ASA), unless the dose is ≤ 4.8 g/day and has been stable for at least 4 weeks prior to screening;
  • Oral budesonide within 6 weeks of screening;
  • Other oral corticosteroids at daily doses > 20 mg prednisone or equivalent, or who started oral corticosteroids within 6 weeks prior to screening; stable doses < 20 mg prednisone or equivalent for at least 4 weeks prior to screening are permitted;
  • Any rectal compounds;
  • Immunosuppresant therapy (azathioprine, 6-mercaptopurine, methotrexate, cyclosporin) within 8 weeks prior to screening;
  • Fecal transplant within 12 weeks prior to screening;
  • Any investigational therapy within 4 weeks prior to screening.
• Diagnosed with any immune deficiency.
• History of malignancy, except for basal cell carcinoma, nonmetastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence. 
• Clinically meaningful laboratory abnormalities at screening that would affect subject safety, as judged by the investigator from local testing.
• A concurrent, clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitoruinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound study results, pose additional risk to the subject, or interfere with the subject’s ability to participate fully in the study.
• Current or recent history of alcohol dependence or illicit drug use that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures.
• Pregnant or lactating females.
• Any surgical procedure requiring general anesthesia within 1 month prior to screening, or planned elective surgery during the study.
• Mental or legal incapacitation or a history of clinically significant psychiatric disorders at the time of the screening visit that would impact the ability to participate in the trial according to the investigator.
• Concurrent participation in any other interventional study or received any investigational therapy within 1 month prior to screening.
• Previous exposure to AMT-101.
• A known hypersensitivity to AMT-101 or its excipients.

• Adults, ≥ 18 years of age.
• Willing and able to provide informed consent.
• Patients who have undergone unilateral scleral buckle only surgery (i.e., no vitrectomy) with a 360° encircling band.

• Individuals < 18 years of age.
• Diagnosis of glaucoma or glaucoma suspect.
• Unilateral ocular hypertension.
• Difference in lens status (i.e., pseudophakic vs phakic) between the two eyes.
• Preoperative (pre-buckle) anisometropia > 2.5 D.
• Current use of steroid medications (oral, topical, inhaled, injected, or other).
• Use of IOP-lowering medications.
• Active or chronic uveitis.
• Diseases or processes which affect the iridocorneal angle, including but not limited to neovascular glaucoma, iridocorneal endothelial syndrome, peripheral anterior synechiae, etc.
• Monocular status (enucleated or phthisical fellow eye, or fellow eye with visual acuity less than 20/100).
• History of previous vitreoretinal surgery in either eye.
• Inability to lay completely supine for the required time period.

• Adults, ≥ 18 years if age.
• Subjects who have respiratory tract specimens positive for the SARS-CoV-2 virus.

• Individuals < 18 years of age.
• Unable to provide consent.

• Aged ≥ 18 years of age.
• Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the site investigator.
• Disease duration of > 1 year.
• Fluent in English (capable of consenting to the study and following task instructions in English).
• Participant understands the ecological momentary assessment and agrees to comply with it to the best of their ability.
• Has 24-hour access to a smart phone with reliable internet access.

• Individuals < 18 years of age.
• Unable to complete cognitive assessments due to significant visual, motor or hearing impairment.
• Any medical or psychiatric condition or treatment (via clinic medical records) that is judged by the PIs to interfere with the completion of the study (e.g., active dialysis or chemotherapy, recent myocardial infarction, inpatient psychiatric admission, organ transplant, acute neurological insult, terminal medical condition).
• Clinical diagnosis of dementia based on clinic medical record data.
• Current use of real-time continuous glucose monitoring.
• Unable to complete EMA assessments between 9am – 9pm through the study period (e.g., night shift work, planned travel across time zones, or occupation that does not reliably allow breaks to complete assessments within a reasonable period; e.g., within an hour).

• Post-lingually deafened adults (age ≥ 18 years).
• < 10 years duration of deafness.
• Likely to meet audiologic candidacy criteria for cochlear implant (CI) (based on screening of audiologic testing performed locally).
• Normal inner ear anatomy.
• Access to appropriate technology (computer, tablet or mobile phone) for videoconference.
• All patients who do not require prior written authorization from their insurers for this procedure.

• Individuals < 18 years of age.
• Comorbidities or cognitive deficits that prevent participation in the telehealth component and preference for non-Cochlear brand devices, non-English speaking, or deafness caused by pathology that would significantly impact outcomes such as significant head trauma, certain brain tumors, revision CI. Those patients who continue to undergo CI through the traditional care delivery model will serve as the “control” group for comparison purposes. 
• Additional exclusion criteria for the traditional control group include non-English speaking, a revision CI, deafness due to a tumor, single-sided deafness, or any patients that have a cause of hearing loss that the study staff consider “non-traditional”, as this would not be a good patient to compare to the subjects in the other study arm.

Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.

• Adult transgender women and men, ≥ 18 years of age. 
• Diagnosis of gender dysphoria according to DSM-V.
• Able and willing to provide informed consent.

• Previous use of cross sex hormone therapy:
  • Estrogen;
  • Testosterone;
  • Progesterone;
  • Spironolactone;
  • 5-Alpha Reductase Inhibitor (Finasteride, Dutasteride);
  • Anti-Androgen (such as Leuprolide, Bicalutamide, Cyproterone Acetate).
• Previous fracture within 12 months of study.
• Tobacco users.
• Presence of clinical diagnosis of any of the following:
  • Significant liver or renal disease;
  • Malignancy (including myeloma);
  • Malabsorption (as defined by clinical diagnosis);
  • Hypoparathyroidism;
  • Hyperparathyroidism;
  • Acromegaly;
  • Cushing’s Syndrome;
  • Hypopituitarism;
  • Severe Chronic Obstructive Pulmonary Disease.
• Heart failure history.
• Use of medications affecting bone turnover:
  • Oral or systemic glucocorticoids ≥ 3 Months;
  • Anticonvulsant therapy for seizures in past year;
  • Thiazolidinediones;
  • Thyroid Hormone (causing suppression of thyroid stimulating hormone below normal).
• Use of previous and current bone modulating therapy:
  • Bisphosphonates;
  • Denosumab;
  • Teriparatide;
  • Abloparatide;
  • Selective Estrogen Receptor Modulators;
  • Romosozumab.

• Age ≥ 18 years old.
• Suspected of having bacteremia or septicemia.

• Age < 18 years old.
• Pregnancy.
• Inability to provide consent.

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

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

Eligibility last updated 11/28/22. Questions regarding updates should be directed to the study team contact.

• Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is > 18 years old, at the time of signing the informed consent.
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

RRMM Patients:

• Must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
• Must have received their last dose of prior anti-CD38 therapy within 12 months prior to the first dose of SAR442257;
• Must be refractory to anti-CD38 antibody (e.g., daratumumab or isatuximab), characterized by progression within 60 days of the last dose of anti-CD38, regardless of which line it was given;
• Must be either relapsed or refractory to all established therapies with known clinical benefit in RRMM where approved and available, or are intolerant to those established therapies, based upon investigator’s clinical judgement;
• Must not be candidates for regimens known to provide clinical benefit based upon investigator’s clinical judgement.
• Patients with RRMM must have measurable disease as per the following:
  • Serum M protein ≥ 0.5 g/dL (≥ 5 g/L); or
  • Urine M protein ≥ 200 mg/24 hours; or
  • Serum free light chain (FLC) assay: involved FLC assay ≥ 10 mg/dL and an abnormal serum FLC ratio (< 0.26 or > 1.65).
• Patients with RR-NHL must be relapsed or refractory to all established therapies with known clinical benefit where approved and available, or are intolerant to those established therapies.
• Patients with RR-NHL must have measurable disease of at least one lesion ≥ 1.5 cm as documented by computed tomography (CT) scan, including the following subtype of disease:
  • Diffuse large B-cell lymphoma (DLBCL);
  • Transformed follicular lymphoma (tFL);
  • Follicular lymphoma (FL);
  • Mantle cell lymphoma (MCL);
  • Marginal zone lymphoma (MZL);
  • Lymphoplasmacytic lymphoma;
  • Small lymphocytic lymphoma (SLL).
• Patients with RR-NHL subtype T cell lymphoma (TCL): histopathologically confirmed mycosis fungoides or Sézary syndrome (cutaneous T cell lymphoma [CTCL] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (i.e., refractory) as determined by the Investigator.
• Patients with lymphoma must have availability of lymphoma tissue for biomarker testing: either archived tissue or a fresh biopsy as a part of screening. On-treatment biopsy (Cycle 2 or beyond) is also expected if disease location is in a superficial lymph node. Excisional biopsy or resected tissue is required if clinically feasible; otherwise, core needle biopsy is acceptable. Fine needle aspirates are not acceptable.
• Patients with lymphoma must have a ≥ 50% left ventricular ejection fraction (LVEF) and no pericardial effusion, as measured by echocardiogram (ECHO).
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants are eligible to participate if they agree to the following starting from the time of informed consent, during the treatment period, and for at least 180 days after the last dose of study intervention:
  • Refrain from donating sperm.  Plus either: Be abstinent from heterosexual intercourse (abstinent on a long term and persistent basis) and agree to remain abstinent; OR
  • Must agree to use contraception/barrier;
  • Agree to use a male condom when having sexual intercourse with a woman of childbearing potential who is not currently pregnant;
  • Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential; OR
  • Is a woman of childbearing potential and agrees to use two highly effective contraceptive methods with a failure rate of < 1% per year starting from the time of informed consent, during the treatment period, and for at least 180 days after the last dose of study intervention;
  • A woman of childbearing potential must have a negative highly sensitive pregnancy test (serum) within 7 days before the first dose of study intervention.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Capable of giving signed informed consent of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

• Diagnosed or treated for another malignancy within 3 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
• Amyloidosis, leukemic manifestations of lymphoma, chronic lymphocytic leukemia, and prolymphocytic leukemia.
• Known CNS involvement by myeloma, lymphoma or other CNS disease such as neurodegenerative condition or CNS movement disorder.
• Has congestive heart failure (New York Heart Association) Grade ≥ II; cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method > 480 msec (Grade ≥ 2). Acute myocardial infarction within 6 months before start of study treatment.
• Has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
• Clinically-not controlled chronic or ongoing infectious disease requiring treatment at the time of first dose or within the 14 days before first dose.
• Active hepatitis A, B, and C as defined below: active hepatitis A (defined as positive IgM), active hepatitis B (defined as either positive hepatitis B surface antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay, and hepatitis B core antibodies), or C infection (defined as a known positive hepatitis C antibody result and known quantitative hepatitis C [HCV] ribonucleic acid [RNA] results greater than the lower limits of detection of the assay). E 08. Known positivity for Human Immunodeficiency Virus (HIV). E 09. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE Version 5.0 Grade 1 or to levels dictated in the eligibility criteria with the exception of Grade 1 peripheral neuropathy, alopecia or toxicities from prior anticancer therapy that are considered irreversible (defined as having been present and stable for > 4 weeks) which may be allowed if they are not otherwise described in the exclusion criteria.
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
• Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment, or any prior allogeneic SCT or solid organ transplantation, any one or more of the following: systemic immunosuppressive therapy within 3 months prior to start study treatment, any active acute graft versus host disease (GvHD), Grade 2-4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment.
• Systemic radiation therapy < 28 days and focal radiotherapy < 14 days prior to the first dose administration of SAR442257.
•  Major surgery, defined as surgery requiring general anesthesia with endotracheal intubation within 28 days prior to the first dose administration of SAR442257, unless discussed with and eligibility approved by sponsor medical monitor.
• Participant received any investigational drug within 5 half-lives (of the investigational drug) or within 21 days of the first dose of SAR442257, whichever is shorter.
• Dexamethasone at cumulative doses of greater than 160 mg or equivalent < 3 weeks prior to the first dose administration of SAR442257 is not allowed. Use of topical or inhaled steroids is acceptable.
• Concomitant oral anticoagulant therapy or low molecular weight heparin (LMWH) (low dose aspirin is allowed).
• Participants are excluded if they received a live vaccine within 6 weeks prior to the first SAR442257 administration.

Eligibility last updated 1/11/22. Questions regarding updates should be directed to the study team contact.

• Signed Informed Consent Form.
• Age 18-65 years at time of signing Informed Consent Form.
• Body mass index (BMI) of 18-35 kg/m^2.
• Physician-diagnosed asthma for at least 12 months prior to screening.
• Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen.
  • If no historical documentation is available, the skin test or in vitro reactivity to a perennial aeroallergen will need to be performed during screening.
• Eligibility per the study drug-dosing table (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg) and ability to be dosed per the USPI dosing table.
• Able to comply with asthma control medication adherence, physical activity and sleep monitoring data collection, and eDiary requirements during screening period. Compliance will be assessed during the last 2 weeks prior to study enrollment and non-compliance is defined as:
  • Asthma control medication use < 70% of the time during the 2 week period before study enrollment;
  • Wearing the physical activity and sleep monitor less than approximately 80% of the time (approximately 90 hours during the day and approximately 44 hours at night) for each week during the 2 week period before study enrollment);
  • Using the eDiary < 5 out of 7 days for each week during the 2 week period before study enrollment.
• Able to safely complete incremental exercise tolerance at screening.
• Able to comply with the study protocol for the duration of the study, in the investigator's judgment, including but not limited to:
  • Able and willing to use a wrist-worn physical activity and sleep monitor every day and night for the duration of the study;
  • Able and willing to use eDiary device throughout the duration of the study.
• Pre-bronchodilator FEV1 of 40%-80% of predicted at screening..
• Documented history of variable airflow obstruction or hyper-responsiveness within 12 months of study entry via at least one of the following criteria:
  • FEV1 bronchodilator response ≥ 12% and ≥ 200 mL with up to 400 mg albuterol;
  • Concentration of methacholine needed to produce a 20% decrease in FEV1 from baseline (PC20 ≤ 8 mg/mL or PD20 ≤ 200 mg);
  • In patients with a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70%, FEV1 variability should be ≥ 12% spontaneously (e.g., between clinic visits) or in response to oral corticosteroids.
  • If no documented history is available, an assessment will need to be performed during screening.
• On inhaled corticosteroid (ICS) therapy at a total daily dose ≥ 500 mg of fluticasone propionate or equivalent and at least one second controller (long-acting beta agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA]) for ≥ 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the study.
• Uncontrolled asthma during the screening period, defined as an Asthma Control Questionnaire 5 (ACQ5) ≥ 0.75 score and both of the following symptoms that are not controlled according to EPR (2007) and GINA (2019).
  • Night time awakening due to asthma in the past 4 weeks;
  • Activity limitations due to asthma in the past 4 weeks.
• Sleep disturbance due to asthma (e.g., cough, wheezing, etc.) in the opinion of the investigator.
• Medical Research Council Dyspnoea scale ≥ 2 at screening.
• Impaired exercise capacity defined as VO2 max % of predicted ≤ 80% of healthy volunteers (Koch et al. 2009) during the incremental exercise test at screening.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use adequate contraception during the treatment period and for 60 days after the final dose of study drug.
• A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
• The following are examples of adequate contraceptive methods: bilateral tubal ligation; male sterilization; hormonal contraceptives; hormone-releasing intrauterine devices; copper intrauterine devices; male or female condom with spermicide; and cap, diaphragm, or sponge with spermicide.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.  If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.

• Known history of anaphylaxis/hypersensitivity to omalizumab.
• Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening.
• Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening.
• Treatment with non-steroid immunosuppressants (e.g., cyclosporine, methotrexate, azathioprine, mycophenolate, sirolimus, tacrolimus) within 2 months or 5 half-lives, whichever is longer, prior to screening.
• Asthma exacerbation, defined as new or increased asthma symptoms that require use of systemic corticosteroids for ≥ 3 days and/or hospitalization or emergency visit with systemic corticosteroid administration within 4 weeks prior to screening.
• Intubation for respiratory failure due to asthma within 12 months prior to screening.
• Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period.
• Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period for any reason, including an acute exacerbation event.
• Inability to withhold short acting bronchodilators for a period up to 6 hours.
• Isolated diagnosis of exercise induced asthma without chronic symptoms.
• History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma.
• Current participation or participation in the last 6 months in pulmonary rehabilitation prior to screening.
• Current malignancy or history of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been treated or excised and is considered resolve.
• Any serious medical condition (including but not limited to significant arrhythmia, uncontrolled hypertension) or abnormality in clinical laboratory tests that precludes the patient’s safe participation in and completion of the study in the opinion of the investigator.
• Elevated IgE due to hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis.
• Unable to complete cardiopulmonary exercise testing and/or perform physical activity due to underlying cardiac, neurologic or orthopedic conditions.
• Ongoing physician-treated sleep disorder that is unrelated to asthma within 6 months prior to screening.
• Use of any prescription or over-the-counter sedative sleep medication for the duration of the study (e.g., zolpidem)
• Physician determination of patient lifestyle that can interfere with study endpoints, (e.g., rotating shifts, any prescription or over the counter medical cannabis, use of recreational drugs, etc.).
• Planned major surgery during the course of the study.
• Current smoker or past smoker with > 10 pack years
• Known HIV infection at screening.
• Known acute or chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
• Infection that meets any of the following criteria:
  • Resulted in hospital admission within 4 weeks prior to screening;
  • Required treatment with intravenous or intramuscular antibiotics within 4 weeks prior to screening;
  • Any active infection that required treatment with oral antibiotics within 2 weeks prior to screening.
    • Note: Antibiotics are considered to include any antimicrobial therapy used to treat bacterial, fungal, parasitic, viral, or other infections.
• Active parasitic infection, including nematodes (e.g., Ascaris, Ancylostoma), platyhelminths (e.g., Schistosoma), or Listeria monocytogenes infection within 6 months prior to screening.
• Active tuberculosis requiring treatment within 12 months prior to screening:
  • Patients who have completed treatment for tuberculosis at least 12 months prior to screening and have no evidence of recurrent disease are permitted.
• Initiation of or change in allergen immunotherapy within 3 months prior to screening.
• Initiation of or change in aspirin desensitization within 4 months prior to screening.
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab:
• Women of childbearing potential must have a negative serum pregnancy test result during the screening period.
• History of alcohol, drug, or chemical abuse within 6 months of screening.

• Participation in the BCT-002-US study, completed all study visits and have received three IT treatments.
• Able to provide to the Investigator written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the participant has provided such consent.
• Able to safely undergo a bone marrow aspiration.
• Feeding tube use is permitted.

• Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow aspiration, or inability to tolerate treatment procedures for any other reason (lying flat with BiPAP or NIV is not exclusionary).
• History of clinically significant autoimmune disease (excluding thyroid disease) myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
• Any unstable clinically significant medical condition other than ALS (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the Investigator, would compromise the safety of the Participant.
• Any history of malignancy within the previous 5 years, with the exception of nonmelanoma localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline).
• Current use of immunosuppressant medication or use of such medication within 4 weeks of the screening visit.
• Any history of acquired or inherited immune deficiency syndrome.
• Tracheostomy and/or mechanical ventilation (BiPAP or NIV are not exclisonary).
• Pregnant women or women currently breastfeeding or unwilling to use effective birth control methods during the treatment (if of childbearing age).
• Positive test result for Hepatitis B virus (HBV; surface antigen (HBsAg) and IgM antibodies to core antigen (IgM anti-HBc)), Hepatitis C virus (HCV), Human Immune deficiency virus (HIV) 1 and 2.

• All patients with RA diagnosed after 1995:
  • Diagnosis defined as a clinical diagnosis by a rheumatologist.
• Active disease (CDAI > 2.8).
• Participants who are following up with Mayo Clinic rheumatology providers in Rochester, MN.

• None for main study cohort.
• Subaim:
  • No prior anti-inflammatory treatment (conventional DMARDs, targeted synthetic DMARDs and biologic DMARDs);
  • No exposure to metformin
  • Prednisone dose > 15mg per day within 7 days of blood draw.

• Adult patients ≥ 18 years old.
• Willing and able to consent.
• Admitted to a hospital ward or ICU for greater than 24 hours with cirrhosis.
• Patients with cirrhosis admitted to the general ward or intensive care unit may be enrolled.
• Patient must undergo 1 or more invasive non-surgical procedures at admission or during the hospitalization.

• Age < 18 years old.
• Prisoner.
• Pregnant.
• Previously enrolled in this study.
• Unable to consent.

• Male and female adults, ≥ 18 years of age.

• Individuals < 18 years of age.
• Participants who are unable to undergo MR (claustrophobia, implanted device, etc.), pregnancy, obesity (> 400 lbs.).

• Adult patients (≥ 18 years).
• Known or suspected brain tumor.
• Willing and able to consent to a research-only procedure for Cerebrospinal  Fluid (CSF) collection.

• Patients < 18 years old.
• Member of a vulnerable population.
• Unable to provide written, informed consent.

• Participants must be classified with a diagnosis of chronic low back pain.
• 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; or
  • 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, or a history of heart conditions.
• Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions will also be excluded.

Inclusion Criteria - Patients:

• Age 18-65 years.
• Currently depressed patients [n=100 major depressive disorder (MDD), n=100 bipolar (50 BPI, 50 BII)] confirmed by Mini International Neuropsychiatric Interview (MINI) active in clinical care.
• Use a compatible smartphone. If participant has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, a smartwatch will be offered for the 12 week trial.

Inclusion Criteria
•Healthy Controls:

• Age 18-65 years old.
• 100 age- and sex- matched controls as confirmed by Mini International Neuropsychiatric Interview (MINI).
• Use a compatible smart phone. If participating has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, an accelerometer will be offered for the 12 week trial.

Exclusion Criteria
•Patients:

• Inability to understand written or spoken English.
• Inability to provide valid written informed consent because of an identified/diagnosed intellectual disability, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
• Primary reasons for treatment are not related to depression  (e.g., are due to an adjustment disorder, personality disorder  effect of substances or substance abuse, or exacerbation of a comorbid psychiatric disorder) based on available information, review of EHR, and/or investigator judgement.
• Psychotic disorder or Current psychotic features;
• Active suicidal ideation (QIDS-C question 12 score of > 2 and investigator judgement).
• Women with known pregnancy at time of enrollment.*

Exclusion Criteria
•Healthy Controls:

• Inability to understand written or spoken English;
• Inability to provide valid written informed consent because or mental retardation, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
• Has had a current  psychiatric diagnosis within the last year.
• Currently taking a psychotropic medication.
• Women with known pregnancy at time of enrollment.*

* Healthy controls will not be receiving any psychiatric treatment during the study. For depressed female patients of child bearing potential who will be followed naturalistically, it is possible they may receive pharmacotherapy or other clinical intervention from her mental health provider. It will be up to the clinician providing care to determine the need to clarify the pregnancy status.

* If a patient or healthy control becomes pregnant at anytime throughout the study, the patient will be withdrawn from the study.

Eligibility last updated 6/7/22.  Questions regarding updates should be directed to the study team contact.

• Participants < 21 years AND meets one or more of the following criteria:
  • SARS-CoV-2 detection from a respiratory specimen; and/or
  • Meets criteria for MIS-C; and/or
  • Meets criteria for MIS-C, except has involvement of only 1 organ system.
• Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as participants. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C.
• If SARS-CoV-2 antibody testing is negative, participants will be labeled at the end of the study as suspected/not confirmed MIS-C.

• Participant and/or parent/guardian who is not able to understand or be willing to provide informed consent and where applicable assent.
  • Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
  • Nonetheless, blood draw restrictions will be strictly adhered to.

• Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations.  
• Age 18 through 89.
• Able to provide informed consent.

• Anyone not meeting inclusion criteria.
• Anyone unable or unwilling to provide informed consent.
• Anyone unable to complete questionnaires or participate in voice recording.
• Anyone with severe neurological voice or speech disorders. 
• Moderate or severe dysphagia for thin liquids.
• Non-English speakers (English as a second language may be included).
• Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.

• Adults, ≥ 18 years of age.
• Chronic asthma on maintenance therapy with an inhaled corticosteroid or ICS-LABA.

• Use of oral or IV antibacterials within last 30 days.
• Current treatment with asthma biologic therapy (mepolizumab, benralizumab, omalizumab, or dupilumab).

Inclusion Criteria
•Registration:

• Age ≥ 18 years old.
• Diagnosis of multiple myeloma who have not received more than 3 lines of therapy.
• Currently on treatment with a daratumumab containing combination.
• Have received at least 4 doses of daratumumab.
• Intent to convert to SC version of daratumumab.
• Provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria
•Registration:

• Individuals < 18 years old.
• Last dose of IV dara received > 90 days prior to day of questionnaire administration.

• Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
• Be appropriate for the PADC standard outpatient therapy program, and c) be interested in starting outpatient therapy,
• Have the anxiety disorder as their primary diagnosis, d) if taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study.
• Agree to no changes during the 12 weeks of the study.

• History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
• Current positive diagnosis in the child’s caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
• Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.

Up to 500 patients will be recruited for this study. Patients presenting for drive-through or walk-in tent specimen collection for RT-PCR testing for SARS-CoV-2 at one or more of the following SE or SW Minnesota testing sites would be enrolled:

SWMN

Mankato Eastridge

101 Martin Luther King Jr. Drive

SWMN

New Prague

212 10th Ave NE

SWMN

Fairmont

800 Medical Center Drive

SEMN

Owatonna

2200 26th St NW

SEMN

Austin

510 2nd St NW

SEMN

Albert Lea

1705 SE Broadway Ave

SEMN

Red Wing

1407 West 4th Street

The drive-thru or tent collection sites would be selected based upon testing volumes and percent positive tests in the week preceding study commencement, in order to maximize the number of positive SARS-CoV-2 PCR results.

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

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

Inclusion Criteria
•Aim 1:

• Women aged 30-65 years old.
• Qualify for average risk cervical cancer screening; research authorization status; identified as empaneled in the Mayo Clinic Midwest Primary Care database.

Exclusion Criteria
•Aim 1:

• S/P hysterectomy, in utero DES exposure, history cervical cancer, HIV+, S/P solid organ transplant, on immunosuppressant medication.

Inclusion Criteria
•Aim 2:

• FM and IM clinicians (MD/DO, APP) and FM residents (MD/DO) in Mayo Clinic Midwest Primary Care practices at time of study administration.

Exclusion Criteria
•Aim 2:

• Clinicians who do not perform cervical cancer screening tests in their clinical practice.

Inclusion Criteria
•Aim 3:

• Primary care physician leaders within Mayo Clinic (department chair of Family Medicine, division chair of Community Internal Medicine, director of southeastern Minnesota Primary Care, vice president of operations Mayo Clinic Health System) and national thought leaders in cervical cancer screening identified by their roles in USPSTF, ASCCP and CDC.

Exclusion Criteria
•Aim 3:

• Conflict of interest related to primary HPV testing platforms.

• Age ≥18 years.
• Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
• Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
• Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
• Ability to understand and the willingness to sign a written informed consent document.
• Patient is willing to have their Ommaya sampled on at least 2 future occasions.
• Patients is willing to have cerebrospinal fluid (CSF) banked through the neuro-oncology biorepository (requires a separate signature).

• Vulnerable populations: pregnant women, prisoners, or the mentally handicapped.
• Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
• Prior history of any wound infection.
• Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may (but need not necessarily) include surgical anatomy clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns. 

• Individuals age ≥ 18 years old. 
• Able to give informed consent.
• Patients with the diagnosis of bladder cancer.
• Patients treated with radical cystectomy.

• Individuals < 18 years old.
• Unable or unwilling to provide informed consent.