• Patient with ICD (including CRT devices) for > 5 years.
• Age ≥ 65 years.
• Englishspeaking (instruments only available/validated in English).
• Sufficient cognitive ability to provide consent (i.e., answer simple questions about participation, study purpose, and procedures).
• Participation in remote monitoring (the standard of care; necessary for comprehensive data collection).
• Has an informally or formally designated proxy (i.e., family member) who agrees to participate in study interviews if the patient becomes incapacitated (e.g., cannot participate due to mental of physical disability) or dies.

• < 65 years of age. 

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

Eligibility last updated 10/31/2022. Questions regarding updates should be directed to the study team contact.

• Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy.
• The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (< 25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
  • Herniated nucleus pulposus;
  • Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
  • Facet joint degeneration/osteophyte formation;
  • Spondylosis (defined by the presence of osteophytes);
  • Disc degeneration and/or annular degeneration; and/or
  • Lumbar stenosis defined by spinal cord or nerve root compression.
• Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency.
• Preoperative Oswestry Disability Index score > 40/100 at baseline.
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
• Signed informed consent.

• More than one vertebral level requiring treatment.
• Previous instrumented surgery (i.e., anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level.
• Degenerative or lytic spondylolisthesis greater than Grade 1 (< 25% translation).
• Rotatory scoliosis at the level to be treated.
• Congenital bony and/or spinal cord abnormalities at the level to be treated.
• Subcaudal defect, disrupting the integrity of the pedicle.
• Clinically compromised vertebral bodies at the involved level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion.
• Disrupted anterior longitudinal ligament at the index level.
• Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated.
• Back pain of unknown etiology without leg pain.
• Severe spondylosis at the level to be treated as characterized by any of the following:
  • Autofusion (solid arthrodesis) determined radiographically (CT);
  • Totally collapsed disc, or;
  • Vertebral body that cannot be mobilized.
• Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E.
• Unable to undergo an MRI scan, CT scan or other radiograph assessments.
• Osteopenia: The SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening.
• Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta).
• Insulin-dependent diabetes mellitus.
• Lactating, pregnant or interested in becoming pregnant in the next 3 years; 18. Active infection – systemic or local.
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
• Body Mass Index > 40.
• Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease.
• Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation.
• Spinal tumor.
• Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
• Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease.
• Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
• In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
• Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code.
• Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered ‘current’).
• Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation.
• Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results.
• Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

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

Clinical

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

Imaging

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

Clinical

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

Imaging

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

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

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

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact.

• Transgender and gender diverse (TGD) identifying patients.
• Patients ≥ 18 years old.
• Patients who are seeking or have sought gender-affirming care or fertility preservation.
• Willingness to provide informed consent and allow recording of the interview.
• Speaks and understand English language proficiently.

• Patients who are not transgender or gender diverse or have not received gender-affirming care or counseling.
• Participants under 18 years old.

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact.

Eligibility last updated 8/8/23. Questions regarding updates should be directed to the study team contact.

• Infants born via vaginal delivery at Mayo Clinic Rochester.
• Infants must be followed by the Division of Pediatrics with follow-up routine prenatal care to be completed at Baldwin Building.
• 25 infants will be at high risk for development of atopic dermatitis. High risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) of one of the following: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
• 25 infants will be at low risk for development of atopic dermatitis. Low risk for development of atopic dermatitis is determined by an immediate family history (parent or sibling) without the presence of any of the following medical conditions: atopic dermatitis, asthma, allergic rhinitis, or food allergy.
• No underlying medical conditions at birth including underlying congenital medical conditions.

• Infants born via cesarean section delivery.
• Infants followed by the Division of Family Medicine with routine follow-up prenatal care to be completed outside of Baldwin Building.
• Presence of underlying medical conditions at birth including congenital medical conditions.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

• Females ≥ 25 and ≤ 60 years of age.
• Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
• Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion). 

• Excluded if pregnant.
• Excluded if no cervix (history of total hysterectomy).
• Excluded if moderate to heavy vaginal bleeding on the day of the visit.
• Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.

Eligibility last updated 8/11/22. Questions regarding updates should be directed to the study team contact

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

Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.

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

• Adult 21 years and older.
• English speaking.
• Able to provide consent.
• Clinically diagnosed stable heart failure with NYHA Class I-III symptoms.

• Patients who are unable to engage in a regularly structured exercise training program.
• History of dangerous arrhythmias.
• BMI > 40 kg/m^2
• Current smokers or smoking history of > 20 pack years
• Pregnant women, implanted pacemaker and/or ICD, cochlear implants, drug infusion pump, or any other implanted metal objects.

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

Inclusion Criteria
•Childre:

• Ages 3-7.
• Outpatients.
• Any gender, race, or ethnicity.
• Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent.
• EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).
• Families approached for participation will be asked to commit to complete the treatment:
• At least one primary caregiver and the identified child will have to be able to speak and understand English;
• Must have the ability, technology, and internet access for remote therapy/research visits.   

Inclusion Criteria
•Adults:

• Agree to wear Garmin watch.
• Ages 18-99.
• Any gender, race, ethnicity.
• Able to provide informed consent.
• Able to speak and understand English.
• Has the ability, technology, and internet access for remote therapy/research visits.

Exclusion Criteria
•Children: 

• Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
• Parents not consenting to the study.
• Parents or child is not able to adhere to the study protocol.
• A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator’s discretion.
• Unable to speak and understand English.
• Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
• Children in foster care.
• Does not have the ability, technology, and/or internet access for remote therapy/research visits.
• Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.

Exclusion Criteria
•Adults:

• Unable to speak and understand English. 
• Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Eligibility last updated  10/19/22. Questions regarding updates should be directed to the study team contact.

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

Inclusion Criteria
•General: 

• The subject (or, when applicable, the subject’s legally acceptable representative) signs an informed consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
• The subject is an outpatient of either sex, at least 40 years old, at the time of consent.
• Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including neuroimaging brain scans and lumbar punctures.
• The subject has a body mass index (BMI) ≥ 18 and ≤ 35 kg/m^2 at screening.

Inclusion Criteria
•Diagnostic:

• The subject has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria (Gilman et al. 2008).
• The subject’s onset of first MSA symptoms (including parkinsonism, cerebellar symptoms, orthostatic or urinary symptoms) occurred ≤ 4 years before screening, as assessed by the investigator.
• The subject’s anticipated life expectancy is ≥ 3 years, per investigator judgment.
• The subject has an UMSARS Part I score of ≤ 21 (excluding Item #11, sexual function), and additionally has:
  • Severity score ≤ 2 on the swallowing item (#2);
  • Severity score ≤ 2 on the ambulation item (#7);
  • Severity score ≤ 2 on the falling item (#8).
• The subject has an UMSARS Part IV disability score ≤ 3.
• Subject has a MoCA ≥ 18. Additionally, subject has sufficiently intact cognition to complete study assessments and follow study instructions, per investigator's judgment.
• A male subject who is nonsterilized and sexually active with a female partner of childbearing potential is eligible to participate if he agrees to use a barrier method of contraception (i.e., condom with or without spermicide) from the signing of informed consent throughout the study and for 90 days plus 5 half-lives (total of 190 days) after the last dose.
• Female subjects are eligible to participate if:
  • they are not pregnant or nursing; and
  • they are of nonchildbearing potential or agree to use highly effective contraception from the signing of informed consent throughout the study and for 30 days plus 5 half-lives (total of 130 days) after the last dose of study drug.

Exclusion Criteria
•Medical History:

• The subject has serious or unstable clinically significant illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune (e.g., multiple sclerosis), hematologic, or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromises the subject’s safety or ability to complete the study, or compromises the interpretation of the study results.
• The subject has other medical problems (neurological, visual, orthopedic, psychiatric) that, in the opinion of the investigator, may significantly interfere with completion of the study or interpretation of study endpoints.
• The subject has a disorder that is likely to interfere with drug disposition and elimination.
• In the opinion of the investigator, the subject has a diagnosis of depression or other psychiatric disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), AND this disorder is poorly controlled AND of sufficient severity to interfere with completion of the study or interpretation of the endpoints.
• The subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year before screening. Subjects who have positive answers on Item 4 or 5 on the C-SSRS (based on the past year) before randomization are excluded.
• The subject has a history of alcohol or substance use disorder (except tobacco use disorder), as defined by the DSM-5, within 1 year before screening or between screening and randomization, or, in the opinion of the investigator, the subject’s current or past use of substances may interfere with performance on the assessments.
• The subject has a positive finding on an alcohol or illicit drug screen. A positive result for cannabis or prescription medications does not require exclusion.
• The subject has undergone surgery for the treatment of MSA (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation).
• The subject has a history of epilepsy or seizures, except self-limited febrile childhood seizures.
• The subject has any contraindication to lumbar puncture including but not limited to thrombocytopenia or other coagulation disorders (including subjects who are receiving anticoagulants and cannot safely stop them), the absence of cutaneous or soft-tissue infection overlying or adjacent to the site of lumbar puncture, previous spinal surgery that could complicate access to the subarachnoid space, or conditions associated with raised intracranial pressure such as a closed head injury within 3 months or benign intracranial hypertension, or any spinal abnormality or other aspects (e.g., tattoos in the midline lumbar area) or other clinical findings (papilledema seen with ophthalmoscopy) that may complicate or contraindicate lumbar puncture, as judged by the investigator. Subjects who are using low-dose aspirin, low molecular weight heparin, coumadin, or other anticoagulants may still participate if use of these medications can be safely suspended before lumbar puncture, per investigator judgment and local medical practices.

Exclusion Criteria
•Diagnostic Assessments:

• Any clinically significant abnormality as determined by investigator at screening or between screening and randomization in physical examination findings, vital signs, ECGs, or clinical laboratory test results that may compromise the subject’s safety or ability to complete the study or compromise the interpretation of the study results.
• Presence of any of the following contraindications to MRI:
  • claustrophobia that would contraindicate brain MRI or the presence of a pacemaker;
  • cardiac defibrillator; spinal cord or vagus nerve stimulator;
  • aneurysm clip;
  • artificial heart valve; recently placed (within 1 year) coronary or carotid stent; ear implant;
  • CSF shunt; other implanted medical device (e.g., insulin pump); or
  • metal fragments or foreign objects in the eyes, skin, or body.
• Ophthalmic abnormalities. The following are considered exclusionary:
  • Ophthalmic abnormalities and conditions that, in the judgment of the investigator and/or ophthalmologist, would affect subject safety and/or impair the ability to perform a quality ophthalmological evaluation;
  • Congenital or acquired ophthalmic conditions (primary or secondary) that are considered poorly controlled within the last 12 months before screening, with or without treatment, or otherwise expected to lead to significant deterioration in visual acuity in the next 12 months after randomization;
  • Any ocular opacities that may prevent quality fundus assessment;
  • Neovascular or exudative (wet) form of age-related macular degeneration.
• The subject has any of the following at the screening visit:
  • estimated glomerular filtration rate (determined with the Chronic Kidney Disease Epidemiology Collaboration equation) < 50 mL/min; QT interval with Fridericia correction method > 450 ms for male subjects and > 470 ms for female subjects;
  • a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 1.5 × the upper limit of normal (ULN).
• Clinically significant vital sign abnormalities at screening, defined as:
  • Systolic blood pressure ≥ 160 mm Hg;
  • Diastolic blood pressure ≥ 90 mm Hg (blood pressure assessed with the subject at rest in the seated position; may be repeated up to 3 times), or;
  • Pulse rate 100 beats per minute (subject at rest in the seated position).
• The subject has a positive hepatitis B surface antigen test result, known or suspected active hepatitis C infection, or known history of HIV infection:
  • Note: Subjects with positive hepatitis C virus (HCV) serology results may be enrolled if results from a quantitative polymerase chain reaction for HCV RNA is negative, to exclude active hepatitis C infection, and if the investigator agrees that the subject can safely participate in the study.
• The subject has a brain MRI that shows clinically significant evidence of malignant, ischemic, demyelinating, structural, or degenerative brain disease (other than MSA) that may confound diagnosis or subject safety during the study, or the subject has findings that compromise the safety of lumbar puncture per investigator judgment.
• The subject has a current blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory tests of coagulation.

Exclusion Criteria
•Other:

• The subject has poor venous access such that IV drug delivery or PK/safety blood sampling would be difficult.
• The subject has participated in another study investigating active or passive immunization against αSYN for PD or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
• The subject’s participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee. For example, subjects who participated in a study of gene therapy and antisense oligonucleotides (or other disease-modifying treatment) and received active treatment would be excluded.
• The subject has received any investigational compound that, in the opinion of the investigator or sponsor, may not have completely washed out before the screening visit or may affect the safety or efficacy evaluations.
• The subject has a positive pregnancy test result at screening.
• The subject is an immediate family member, is a study site employee, or is in a dependent relationship (e.g., as a spouse, parent, child, or sibling) with a study site employee who is involved in the conduct of this study.
• The subject has donated 400 mL or more of his or her blood volume within 90 days before the start of the screening visit.  

Eligibility last updated 8/10/22. Questions regarding updates should be directed to the study team contact.

• Individuals carrying the OSTEOCALCIN SNP gene and age, sex, and race matched controls.

• Participants with a known diagnosis of type 1 or type 2 diabetes mellitus or those individuals on lipid lowering drugs, as these conditions may alter FGF21 and/or apolipoprotein B levels.

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

Eligibility last updated 10/25/22. Questions regarding updates should be directed to the study team contact.

• Wrestlers on roster from Rochester Community and Technical College.
• ≥ 18 years of age. 

• Any athlete with a known cardiac condition will be excluded.

Eligibility last updated 8/23/22. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 and < 70 years.
• Any gender.
• Patients with physician-diagnosed AERD (including a physician diagnosis of bilateral nasal polyposis, and at least one NSAID-induced reaction that caused respiratory symptoms).
• Patients with nasal polyps and no AERD (with and without asthma).
• Patients who require endoscopic sinus surgery (ESS) for treatment of chronic rhinosinusitis and sinonasal polyposis as part of their standard of care treatment.

• Patients under the age of 18 years and above 70 years.
• Patients who are or intend to get pregnant during the course of the study or those who are breastfeeding.
• Patients with mental or legal incapacitation.
• Patients with acute of chronic kidney or liver disease either self-reported or physician-diagnosed.
• Patients with anemia requiring work-up up (hemoglobin < 10 mg/dL).
• Patients with an active peptic ulcer disease.
• Patients with bleeding-disorder or G6PD deficiency.
• Patients with a planned surgical procedure during the 1-year study period.

Eligibility last updated 8/16/22. Questions regarding updates should be directed to the study team contact.

Adult Patients With Two or More Chronic Conditions

• Members of Mayo Clinic Connect, the online community of patients facilitated by the Mayo Clinic Center for Social Media, who have received care in multiple settings and organizations.

People Living With One or More Chronic Conditions

•  Individual with one of more chronic conditions.

International Experts in Shared Decision Making (SDM)

• Participants will be adults that have published, peer reviewed, SDM related manuscripts.
• Affiliated with institutions eligible to support a research collaborator status with Mayo Clinic and willing to become Mayo Clinic research collaborators for the duration of their participation in this study.

Primary and Specialty Care Clinicians

• Clinicians included in the KER Unit database as having expressed interest in SDM, having participated in prior focus groups, or contributed to our work as clinical content experts in developing SDM tools.

Adult Patients With Two or More Chronic Conditions

• Minors, those with cognitive issues and/or non-English speaking.

People Living With One or More Chronic Conditions

• Minors, those with cognitive issues and/or non-English speaking.

International Experts in Shared Decision Making (SDM)

• No expertise in SDM or ability to enter into research collaborator status with Mayo Clinic , Minors, those with cognitive issues and/or non-English speaking.

Primary and Specialty Care Clinicians

• Minors, those with cognitive issues and/or non-English speaking.

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.

• Primary care clinicians in Rochester/Kasson who complete the pre/posttests, dermoscopy education and conducts skin lesion visits in their practice.  

• Patient refusal for dermoscopy skin lesion photo (skin lesion would then be excluded), dermoscopy image not captured by clinician at visit.

Eligibility last updated 8/18/22. Questions regarding updates should be directed to the study team contact.

• Any autosomal dominant polycystic kidney disease (ADPKD) patient (ages 5-18 years) with confirmed ADPKD (via a combination of imaging, family history, and/or genetic testing), identified from existing and newly identified families for the proposed study.
• Matched controls will be identified as unaffected siblings, unaffected family members of ADPKD subjects, or children recruited from the outpatient primary care clinics.

• ADPKD patients with liver and or kidney transplant.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

• English speaking subjects with a suspected CVF, known CVF, or healthy control subjects.

• Subjects who are not English speaking.

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

• The participant must have a family member that has been diagnosed with one of the following forms of dementia:
  • Parkinson’s/Lewy body dementia;
  • Any frontotemporal lobar degeneration dementia; or
  • Alzheimer’s dementia.
• The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
• The participant must have been caring for their loved one with dementia for at least 3 months. 
• All participants must have access to a computer and be able to use the internet.
• All participants must be English speaking.
• All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief “virtual” interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
• All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.

• Care Partner’s loved one does not have a confirmed diagnosis of dementia.
• Care Partner is unable to provide consent.
• Care Partner was or has been in that role for less than 3 months.

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

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age. 
• Patients with known genetic predisposition to pheochromocytomas and paragangliomas (PPGL) development.
• Patients with history of (PPGL).

• < 18 years of age. 

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

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

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

Eligibility last updated 9/15/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

- Clinical diagnosis of focal epilepsy.

- Estimated to have at least 2 countable seizures per month.

- Has not had control with at least 2 anti-seizure medicines.

- Able to maintain a constant medication for duration of the study (rescue meds
allowed).

- Subject or legally authorized representative is able to understand consent and keep a
seizure diary in English.

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

Eligibility last updated 3/15/23. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

• Male or female adults ages 21 and older at the time of enrollment.
• Received at least one COVID-19 vaccination (Johnson &Johnson, Pfizer, Moderna, Novavax; subjects with any number of prior vaccine doses are eligible) and would like to receive an mRNA booster vaccine.
• No immunosuppression or immunodeficiency.
• Determined by medical history and clinical judgment to be eligible for the study, by being generally healthy, with no autoimmune or immunosuppressive conditions and having stable current medical conditions (subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the booster vaccine, will be eligible. A change in dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g., surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease. A change to a new therapy category caused by worsening disease is considered significant and therefore ineligible for enrollment.
• Patients with diabetes mellitus are eligible for inclusion if they have had a hemoglobin A1c measurement of < 8.0 within the past 6 months prior to enrollment. These hemoglobin A1c measurements are recommended at least twice yearly by the American Diabetes Association (ADA), and the target levels here are representative of the goals of the ADA. These hemoglobin A1c levels will ensure that these participants have good glycemic control. (American Diabetes Association. American Diabetes Association Position Statement: Standards of Medical Care in Diabetes— 2015. Diabetes Care 2015;38(Suppl. 1): S1–S94).
• Able to follow study procedures in the opinion of the investigator.
• Expected to be available for the duration of the study.
• Weighs > 110 lbs.

• Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents (e.g., for cancer, HIV, or autoimmune disease).
• Subjects on corticosteroids will be excluded if ≥ 20mg of Prednisone (or equivalent drug) has been (or will be) administered daily for 2 weeks or more. Subjects will be eligible if corticosteroid therapy has been discontinued for at least 30 days.
• Serious chronic medical conditions including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator’s opinion, precludes the subject from participating in the study. Diabetic patients will be excluded if they do not have a hemoglobin A1c measurement within the past 6 months or if they had a hemoglobin A1c measurement of an A1c  > 8.0.
• Receipt of any blood products, including immunoglobulin, within 6 months of study enrollment.
• Current anticoagulant therapy or a history of bleeding diathesis that would contraindicate intramuscular (IM) injection:
  • Note: antiplatelet drugs such as aspirin and clopidogrel are permitted.
• Receipt of any COVID-19-specific monoclonal antibodies within the past 90 days prior to enrollment.
• Any acute illness within the last 30 days.
• Blood donation within the last 56 days prior to study enrollment and within 56 days following the last study visit.
• Pregnancy, Nursing or trying to conceive at the time of the study or for 28 days following the baseline visit.
• Currently taking antibiotics to treat a serious infection. Preventative use of antibiotics (i.e. oral surgery) is not an exclusion criterion.
• Diagnosis of a cognitive disorder (e.g., Alzheimer’s, Dementia).
• Anemia.
• Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.

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

Eligibility last updated 1/25/23. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 6/13/23. Questions regarding updates should be directed to the study team contact.