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

Eligibility last updated 10/9/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Children:

• Ages 3-7.
• Outpatients or Inpatients.
• 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).
• Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
• 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.   

 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.

Inclusion Criteria
•Adults:

• Agree to wear Garmin watch.
• Ages 18-99.
• Any gender, race, ethnicity.
• Able to provide informed consent.

Exclusion Criteria
•Adults:

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

• Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either radiofrequency (RF) or microwave (MW) energy.
• At least 21 years of age.
• Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician’s discretion.
• Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician’s discretion.
• Single ablation, using a single ablation needle, per tumor.
• Able and willing to give informed consent.

• Liver tumor that cannot be ablated with a single ablation needle, according to the investigator’s clinical discretion.
• Subject cannot tolerate/undergo contrast-enhanced CT.
• Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
• Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
• Pregnant or lactating.
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
• Unable or unwilling to give informed consent.

Eligibility last updated 5/24/22. Questions regarding updates should be directed to the study team contact.

• English speaking.
• Ability to complete a questionnaire.
• ≥ 18 years of age.
• Patients treated for endometrial cancer from 2013-2018 (about 590 patients treated between 2013-2018 per Rad Onc Outcomes):
• Status post-surgery +:
  • Pelvic +/- para-aortic external beam radiotherapy;
  • External beam radiotherapy +/- vaginal cuff brachytherapy;
  • Brachytherapy alone.
• Patients treated for cervical cancer from 2013-2018 (62 definitive or adjuvant treated between 2015-2018 per Rad Onc outcomes):
  • Status post-surgery and external beam radiotherapy +/- chemotherapy;
  • Definitive radiotherapy +/- chemotherapy.
• Patients treated for vulvar cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (40 treated between 2013-2018 per Rad Onc outcomes).
• Patients treated for vaginal cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (34 treated between 2013-2018 per Rad Onc outcomes).
• Patients treated for anal cancer from 2013-2018 receiving radiotherapy +/- chemotherapy +/- surgery (243 treated between 2013-2018 per Rad Onc outcomes).

• Females < 18 years of age.
• Any exception to above Inclusion Criteria.

Eligibility last updated 11/18/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• Moderate-severe to severe TR due to atrial enlargement.
• Ambulatory (not wheelchair/scooter dependent).
• Ejection fraction > 40%.

• Systolic pulmonary artery pressure > 70 mmHg. with a fixed pulmonary vascular resistance > 7 Wood units by catheterization.
• Ejection fraction < 40%.
• Obstructive hypertrophic cardiomyopathy.
• Constrictive pericarditis or tamponade.
• Active myocarditis.
• Complex congenital heart disease.
• Other valve disease requiring surgical intervention.
• Terminal illness (other than HF) with expected survival of less than 1 year.
• Pregnancy or breastfeeding mothers.

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

• Subject must be ≥ 18 years and ≤ 75 years of age.
• Body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF)/assent form.
  • Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to 17 years inclusive) will only enroll subjects who are 18 years of age or older. Enrollment of adolescent subjects will begin only after the applicable regulatory requirements for enrolling subjects in that age group have been satisfied and the necessary health authority approvals have been granted. Where national or regional guidelines for the definition of adolescence differ from the definition stated above, the national or regional guidelines may be used to determine eligibility.
• Subject has histologic evidence of EoE, defined as a peak count of ≥ 15 eosinophils per high-power field (hpf) at any 2 levels of the esophagus (proximal, mid, and/or distal) when off anti-inflammatory therapy (eg, corticosteroids, see Exclusion Criterion 7) for EoE. The histologic criterion for diagnosis of EoE must be confirmed by a centrally read histological assessment of an EGD specimen during the Screening Period prior to randomization.
• Subject has symptoms of dysphagia of at least 4 DD, as assessed with the mDSD instrument, over the last 2 consecutive weeks (14 days) prior to Day 1 when off anti- inflammatory therapy (eg, corticosteroids, see Exclusion Criterion 7) for EoE. Subjects are required to have at least 11 days of diary data out of the final 14-day period of screening mDSD collection in order to be enrolled in the study. During these 11 days, responses to questions 2 through 5 of the mDSD instrument must be complete.
• Subject must have previously received an adequate trial of proton-pump inhibitor (PPI) medication (8 weeks per guidance, Dellon, 2013) that did not provide complete response to EoE, or the subject remains symptomatic with continued use (Dellon, 2018b; Lucendo, 2017). Prospective subjects who discontinued use of a PPI must not have received a PPI for at least 4 weeks before their first Screening Visit and must agree not to restart a PPI during the study.  If a prospective subject is receiving a PPI medication at screening, he or she must have been receiving a stable dose for at least 4 weeks prior to the first Screening Visit and agree to continue the same dose throughout the study.
• Subject must either:
  • be naïve or have had an adequate response to corticosteroid therapy (i.e., classified as Steroid Responders/Naïve); or
  • have had an inadequate response to corticosteroid therapy and is not considered to be a candidate for continued corticosteroid therapy, or is intolerant to corticosteroid therapy. For subjects who have previously received systemic or swallowed topical corticosteroids for EoE, designation of the status of Steroid Inadequate Responders/Intolerant will include either of the following definitions. Note that if any of the below criteria are met, a subject will be deemed Steroid Inadequate Responders/Intolerant (approximately 70% of the study population) and cannot be classified as Steroid Responders/Naïve (approximately 30% of the study population).
    • Inadequate response to corticosteroid therapy (failed to respond or lost response) and not considered a candidate for continued corticosteroid therapy: subjects who have had a trial of at least 6 weeks of swallowed topical corticosteroid treatment; or
    • 4 weeks of systemic corticosteroids at doses in accordance to published guidelines for the management of EoE (Lucendo, 2017), or a trial for the treatment duration specified in the prescribing information for approved products and judged by the treating physician as not achieving clinical improvement or having clinical improvement initially but lost response while on therapy;
• • Intolerant to corticosteroid therapy: subjects who initiated systemic or swallowed topical corticosteroid treatment but were unable to achieve treatment durations or dose levels due to intolerance because of side effects, including intolerance from use of corticosteroids for conditions other than EoE, or subjects with underlying conditions in which corticosteroid use is not recommended or contraindicated.
• Documentation of type of therapy, treatment duration, and outcome details will be collected when possible.
• Subjects must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or EoE) from the first Screening Visit and throughout the duration of the study, and subjects must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit. Subjects must agree not to introduce any changes in their diet while participating in the study.
• Subjects currently receiving inhaled corticosteroids, leukotriene receptor antagonists (e.g., montelukast), or mast cell stabilizers (e.g., cromolyn sodium) for indications other than EoE, or medium potency topical corticosteroids (eg, mometasone furoate cream or lotion) for dermatologic conditions, must maintain stable doses/regimens for at least 4 weeks prior to the first Screening Visit and regimens must remain stable throughout the duration of the study. If recently discontinued, the medication must have been discontinued at least 4 weeks prior to the first Screening Visit.
• Female subjects of childbearing potential must agree to practice a highly effective method of contraception. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
• A female of childbearing potential (FCBP) is a female who:
  • has achieved menarche at some point;
  •  has not undergone a hysterectomy or bilateral oophorectomy; or
  •  has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:
• • Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study and through the Final 16-week Safety Follow-up Visit. This applies even if the subject practices true abstinence* from heterosexual contact;
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, highly effective contraception without interruption throughout the study and for 5 months after the last dose of IP. Acceptable methods of birth control in this study are the following (birth control must be effective by the time the FCBP subject is randomized into the study [e.g., hormonal contraception should be initiated at least 28 days before randomization]):
    • combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal;
    • progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable placement of an intrauterine device (IUD);
    • placement of an intrauterine hormone-releasing system (IUS);
    • bilateral tubal ligation; or bilateral tubal occlusion (if an implantable device was recently placed, the subject must use an additional effective method of birth control until full occlusion has been confirmed and documented);
    • vasectomized partner (vasectomized partner is a highly effective birth control method provided that the partner is the sole sexual partner of the FCBP and has received medical assessment of the surgical success);
    • sexual abstinence.
• Subject is willing to receive weekly SC injections throughout the study.
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• True abstinence is acceptable when this is the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), and lactational amenorrhea method are not acceptable methods of contraception.

• Subject has clinical or endoscopic evidence of the presence of any other disease that may interfere with or affect the histologic, endoscopic, and clinical symptom endpoints for this study (eg, erosive esophagitis Los Angeles [LA] classification Grade B or above, Barrett's esophagus, esophageal lichen planus, upper gastrointestinal bleed, achalasia, inflammatory bowel disease, diagnosed eosinophilic gastroenteritis [clinical symptoms and/or EGD findings and confirmatory eosinophilia in gastric and/or duodenal mucosa], or significant hiatal hernia [> 3 cm], etc.).
• Subject demonstrates presence of esophageal varices.
• Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition.
• Subject has evidence of a severe endoscopic structural abnormality in the esophagus (e.g., high-grade stenosis where an 8- to 10-mm endoscope could not pass through the stricture without dilation at the time of the screening EGD).
• Subject had esophageal dilation for symptom relief during the Screening Period or within 8 weeks prior to the first Screening Visit, or esophageal dilation is anticipated to be performed within 48 weeks of dosing during the study.
• Subject demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs (e.g., anti-IL-13 antibodies [except IP in this study], IL-4 receptor alpha antagonist antibodies [eg, dupilumab], anti-IL-5 antibodies, anti-IL-17 antibodies, anti-immunoglobulin E [IgE] antibodies, α4β7 integrin inhibitor antibodies, or any other monoclonal antibody, methotrexate, cyclosporine, azathioprine, mercaptopurine, interferon alpha [IFNα], tumor necrosis factor alpha [TNFα] inhibitors, etc.) within 5 drug half-lives prior to the first Screening Visit. Any use of these medications will be prohibited during the study.
• Subject is currently receiving systemic or swallowed topical corticosteroid medication. Prospective subjects with EoE previously treated with a corticosteroid must not have received a systemic corticosteroid within 8 weeks or swallowed topical corticosteroid within 4 weeks of the first Screening Visit.
• Subject is currently receiving a high potency topical corticosteroid (e.g., augmented betamethasone dipropionate, clobetasol propionate, etc.) for dermatologic use. Prospective subjects must not have received a high potency topical corticosteroid for dermatologic use within 8 weeks of the first Screening Visit. Any use will be prohibited during the study.
• Subject is currently receiving a leukotriene receptor antagonist (e.g., montelukast) or mast cell stabilizer (e.g., cromolyn sodium) for the indication of EoE. Subjects must not have received a leukotriene receptor antagonist or mast cell stabilizer for EoE within 4 weeks of the first Screening Visit. Any use for the treatment of EoE during the study will be prohibited.
• Subject is currently successfully treated for EoE with dietary modifications (e.g., food elimination diet) and is able to fully adhere to the diet resulting in a complete response to EoE (i.e., the subject does not meet the symptoms of dysphagia requirement of at least 4 DD and histologic criterion for diagnosis of EoE per Section 4.2, Inclusion Criteria 2 and 3).
• Subject has received oral or sublingual immunotherapy within 6 months of the first Screening Visit; any use will be prohibited during the study. Subjects receiving SC immunotherapy may participate but must be on stable doses for at least 3 months prior to the first Screening Visit and during the study.
• Subject is receiving concurrent treatment with another IP, including through participation in an interventional trial for COVID-19. Prospective subjects may not participate in a concurrent IP study or have received an IP within 5 drug half-lives prior to signing the ICF/assent for this study. Further, for subjects who received an investigational COVID-19 vaccine as part of a clinical trial prior to the first Screening Visit, enrollment must be delayed until the biologic impact of the vaccine is stabilized, as determined by discussion between the Investigator and the Clinical Trial Physician.
• Subject has received a live attenuated vaccine within one month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the course of the study. Administration of any live attenuated vaccine will be prohibited during the study through the Final 16-week Safety Follow-up Visit.
• Subject has previously received CC-93538 treatment (formerly known as RPC4046 and ABT-308) through participation in the Phase 2 Study, RPC02-201, or any Phase 1 clinical study.
• Subject has any other disease that would make conduct of the protocol or interpretation of the study results difficult or that would put the prospective subject at risk by participating in the study (eg, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, gastritis, colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE).
• Subject has liver function impairment or persisting elevations of aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) that are 2 times the upper limit of normal (ULN), or total bilirubin 1.5 times the ULN. Subjects with elevations that are not clinically significant in total bilirubin associated with Gilbert’s syndrome may participate.
• Subject has an active parasitic/helminthic infection or a suspected parasitic/helminthic infection. Subjects with suspected infections may participate if clinical and laboratory assessments, if needed, rule out active infection prior to randomization.
• Subject has an ongoing infection (e.g., hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines).
• Subject had a previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening. Symptoms must have completely resolved and based on Investigator assessment in consultation with the Clinical Trial Physician, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
• Subject has known hereditary fructose intolerance (HFI).
• Subject is pregnant or lactating.
• Subject has a history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent.
• Subject has a history of cancer or lymphoproliferative disease, other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or adequately treated cervical carcinoma in situ, within 5 years of screening.
• Subject has a history of alcohol or drug abuse within 5 years prior to initiation of screening.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.

• Subject must be ≥ 18 years or older.
• Male or female.
• Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration.
• Must be in AF at time of surgery, or inducible using manual or electrical stimulation.
• Subject is willing and able to provide written informed consent.
• Subject has a life expectancy of at least 1 year.

• Long-standing AF (duration > 1 year).
• Prior AF ablation.
• Left main coronary artery occlusion > 70%.
• Critical aortic stenosis (gradient > 50mm HG).
• Inability to induce patient into AF without drugs at time of surgery.
• Female subjects who are pregnant at time of surgery.
• Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study.
• Permanent pacemaker or implantable cardioverter defibrillator.
• Current cancer treatment that includes radiation of the heart.
• Inability to give informed consent.
• Significant intra-cardiac thrombus
• Subjects not eligible for or considered high risk for anticoagulation

• All adults, aged 18-40 years old at time of surgical intervention.
• Had a distal ulnar resection (CPT 25240 or 25150) 5 or more years ago.

• Individuals less than 18 or over 40 years of age at time of surgery.

• Males, age 18-40 years old.
• Staff members and trainees within the Sports Medicine Division and Physical Medicine and Rehabilitation Departments of Mayo Clinic.

• Individuals under 18 or over 40 years old.
• Prior or current history of elbow joint pain, injury, or surgery such as elbow joint arthritis, prior/current elbow ulnar collateral ligament injury that required subject to take time off from sport, or history of any elbow surgery.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria

• Age ≥ 18 years old
• Diagnosis of Brain Metastases
  • Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.).
  • Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
• Size of Brain Metastases
  • At least one intact metastasis (not previously treated with radiosurgery) must measure > 2.0 cm and < 4.0 cm in maximal extent on the contrasted pre-treatment MRI brain scan obtained ≤ 28 days prior to registration.
  • If the largest lesion measures ≥ 2.0 to < 4.0 cm in maximal extent the patient will be randomized.
• Able to undergo contrast enhanced MRI Brain
• Negative urine or serum pregnancy test completed ≤7 days prior to registration, for women of childbearing potential only
• Patient willing and able to provide written informed consent
• Karnofsky Performance Status (KPS) ≥ 50
• ECOG Performance Score of (PS) ≥ 2
• Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations.
  • Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol.

Exclusion Criteria

• Any patient who has received previous whole brain radiation
• Any brain metastasis that is located in the brainstem measuring ≥ 2.0 cm in maximal extent.
• Any patient with definitive evidence of leptomeningeal metastasis (LMD).

NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator’s discretion based on level of clinical suspicion.{Kim, 2017 #2840}

• Any patient with an intact brain metastasis measuring > 4.0 cm

• Adults over the age of 18 and who are willing and able to give informed consent.
• Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
• Volunteers of any race, any gender.
• Range of physiques.

• Injury or skin disturbance in the area of the test device.
• Pregnant.
• Currently smokes cigarettes.
• Has known respiratory conditions such as:
  • Flu;
  • Pneumonia/bronchitis;
  • Shortness of breath/respiratory distress;
  • Respiratory or lung surgery;
  • Emphysema, COPD, lung disease.
• Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function.
• Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask).

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

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

• Primary liver diseases.
• Diagnosis of suspected kidney function insufficient with laboratory test.
• Age ≥ 18 years.

• Patients with kidney congenital diseases, such as renal agenesis, hypoplasia, horseshoe kidney, abnormal location kidney, etc.
• Patients with transplant kidney.
• Patients with HIV infection (lower immune activity).
• History of liver transplantation or hepatic resection.
• Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, a deep brain stimulator, and severe claustrophobia.
• Women who are pregnant or breastfeeding.
• Any severe medical condition that, in the opinion of the Principal Investigator, would serve as exclusion criteria for study enrollment.

• Age: 18 and over.
• 30 days after a clinical or laboratory diagnosis of COVID-19.
• Willingness and ability to provide written informed consent.
• Generally healthy, as determined by study investigators, and not meeting any of the exclusion criteria listed below.

• Individuals under 18 years of age.
• Currently pregnant.
• Immunocompromising medical conditions (diabetes mellitus, autoimmune diseases, chronic kidney disease, liver disease, HIV infection, malignancy, or other conditions deemed by the study investigators to be immunocompromising).
• Subject has current anticoagulant therapy or history of bleeding diathesis.
• Weighs ≤ 110 lbs.
• Receipt of oral prednisone or other immunosuppressive medications within 30 days prior to the study blood draw (inhaled, intranasal, or intra-articular corticosteroids are permitted).
• Transgender women/men will be excluded due to the potential impact of this status on immune response.
• Recipient of any blood/blood product transfusion within the last 30 days.

• Body Mass Index (BMI) ≥ 18.0 to < 35 kg/m^2.
• HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 12 weeks prior to screening.
• Meets HIV-specific laboratory parameters as below:
  • Plasma HIV-1 RNA below lower limit of detection (LLOD) at screening and at least 6 months prior to screening;
  • CD4+ T cell count ≥ 500 cells/uL at screening and at least once during the 12 months prior to screening;
  • CD4+ T cell nadir of ≥ 350 cells/uL during chronic infection.
• Willing to undergo ART interruption.
• Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study

• Known resistance to ≥ 2 classes of ART.
• History of AIDS-defining illness.
• Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
• History of or active immunodeficiency (other than HIV).
• Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
• Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 6 months prior to the first dose of study drug.
• Current hepatitis B virus or hepatitis C virus infection.
• Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

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

Eligibility last updated 7/27/22. Questions regarding updates should be directed to the study team contact.

• 18 years of age or older.
• Patients who are able and willing to sign the informed consent.
• A negative urine pregnancy test within 48 hours prior to PET imaging procedures in females of childbearing potential.
• Patients who are scheduled and considered eligible (according to MRI safety policies) for a clinically-indicated PET/MR epilepsy or dementia study.

• Individuals < 18 years of age.
• Patients who are unable to lay still for an additional 15 minutes.

Eligibility last updated 1/26/22. Questions regarding updates should be directed to the study team contact.

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

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

• Age 18 or older.
• Patients with paroxysmal atrial tachyarrhythmias with and without polyuria as a manifestation of their tachyarrhythmia episode.
• Documentation of their paroxysmal atrial tachyarrhythmia episode.

• Patients who are unable to manage the logistics of participating in the study (coming to Saint Mary’s Hospital ot have their blood drawn and urine sample collected during their atrial tachyarrhythmia episode).
• Chronic kidney disease stage 4 or higher.
• Clinical history of heart failure.

Eligibility last updated 10/1/21. Questions regarding updates should be directed to the study team contact.

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

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

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