• Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable. 
• Males and females. 
• Subjects of age 18 years and older. 
• Subjects with both Diabetes Mellitus AND BMI ≥ 30 OR Diabetes Mellitus/BMI ≥ 30 AND at least one of the following: 
  • Current/Previous smoking history ≥ 30 pack year;
  • Chronic Obstructive Pulmonary Disease (COPD).
• Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
  • Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study. 
• Subject is willing and able to provide a signed Informed Consent Form and is willing and able to comply with study's procedures including follow-up visits.

• Subjects undergoing partial sternotomy. 
• Subjects with any preoperative active significant infection. 
• Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening. 
• Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients. 
• Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled during the screening process). 
• Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic/hypersensitivity reactions. 
• Subjects with uncontrolled Asthma (GINA III-IV). 
• Subjects with chronic urticaria. 
• Immunocompromised subjects from any reason, at screening. 
• Subjects with renal failure requiring dialysis. 
• Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure. 
• Subjects scheduled for mechanical assist device. 
• Subjects scheduled to be treated with preventive negative pressure devices.
• Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization. 
• Subjects that have undergone previously, any cardiac surgery through sternotomy. 
• Subjects with active or previous malignancy in the chest area. 
• Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin, are eligible. 
• Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide). 
• Subjects enrolled in any intervention study with an investigational medicinal product and/or received any investigational medicinal product within 30 days or 5½ half-lives of the product prior to enrollment (whichever is longer). 
• In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g., due to a cognitive, medical condition or residency distanced from site that may jeopardize Follow-Up visits attendance etc.).

• Age greater than 18 years or older.

• Age < 18 years.
• Having received any investigational drug or device within 30 days prior to entry into the study.
• Clinically unstable patients (e.g. systolic blood pressure < 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
• Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.
• Prior organ transplantation or being on a waiting list for organ transplantation.
• Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).
• History of blood pressure > 190/115 mmHg or unexplained syncope within the past 3 months.
• Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months.
• Clinically significant intrinsic renal disease (eGFR <15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries.
• Baseline hemoglobin < 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal.
• History of alcohol abuse within the past 6 months.
• Women who are pregnant, or breast-feeding.

Inclusion Criteria

• A patient with at least one soft-tissue liver lesion ≤ 5 cm undergoing MWA using the NEUWAVE Microwave Ablation System. Note: A patient cannot have more than three lesions ablated during the procedure.
• Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
• Written informed consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor.
• Patients ≥ 22 years old.
• Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG]).
• Class A or B functional hepatic reserve based on the Child-Pugh score.
• Lesion must be visualized by non-contrast enhanced CT scan -or- the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).

• Active bacterial infection or fungal infection on the day of the ablation.
• Patients with implantable pacemakers or other electronic implants.
• Platelet count < 50,000/mm^3  
• Patients with uncorrectable coagulopathy at the time of ablation.
• Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
• Physical or psychological condition which would impair study participation.
• ASA (American Society of Anesthesiologists) score of ≥ 4.
• Use of hydrodissection.
• Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, within 30 days prior to the study ablation procedure.
• Systemic Chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
• INR > 1.85.
• Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
• Patient judged unsuitable for study participation by the performing physician for any other reason.

Eligibility last updated 9/7/21. Questions regarding updates should be directed to the study team contact.

• Age 18-55 years old.
• BMI 21.0 – 32.0 kg/m^2.

• BMI > 32.0 kg/m^2.
• For the 20 participants who are involved in training - participation in structured exercise (>2 times per week for 30 minutes or longer).
• For the 10 participants in the aerobic arm
  •do not participate in structured exercise > 5 times per week.
• For all participants
  •cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease, orthopedic problems that would keep them from being able to perform leg extensions; medications that are known to have an impact on mitochondrial function: 
  • Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist), smoking, pregnancy. 
  •  

Participants must be adults with the ability to provide cosent

• Male or female between 6 months through 36 months of age at the time of informed consent as clinical diagnosis of IS, confirmed by video-electroencephalogram (EEG) analysis, and hypsarrhythmia on EEG at screening according to the Burden of Amplitudes and Epileptiform Discharges (BASED) scale score.
• As assessed by the investigator has no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or has no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and is contraindicated to and/or refused by the patient’s legal representative(s) for treatment with one or both other 2 therapies.
• Patient has general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on physical and neurological examinations, medical history, normal renal function and electrocardiogram (ECG), and clinical laboratory values completed during the Screening Period visit (Visit 1).

• Patient considered by the investigator, for any reason (including, but not limited to, the risks described as precautions and warnings in the current version of the investigator’s brochure for investigational product) to be an unsuitable candidate to receive the investigational product.
• Patient has known or suspected allergy to the investigational product or apple juice.
• Patient has clinically significant renal impairment, defined as creatinine > mg/dL or blood urea nitrogen > 2 × upper limit of normal (ULN); clinically significant liver dysfunction, defined as total bilirubin ≥ 2 × ULN, or aspartate aminotransferase or alanine aminotransferase ≥ 3 × ULN; has clinically significant abnormal laboratory values; the investigator may deem the patient eligible if he/she judges the laboratory values to be not clinically significant.
• Patient has an ongoing or known history of human immunodeficiency virus infection, or chronic hepatitis B or C.
• Patient has a clinically significant abnormality on ECG that, in the opinion of the investigator, increases the safety risks of participating in the study.
• Patient has a neurodegenerative disorder as the underlying cause of IS.
• Patient has a known history of aspiration pneumonia within the past year.
• Patient has previously participated in another clinical study of the investigational product or received any investigational drug or device or investigational therapy within 30 days of study entry.
• Patient has received therapy with felbamate, cannabinoids, ketogenic diet or vagus nerve stimulation within 14 days of screening.
• Patient has received therapy with a medication known to be a CYP3A4 substrate and whose PK has been shown to be impacted in the presence of a CYP3A4 inhibitor within 14 days impacted in the presence of a CYP3A4 inhibitor within 14 days of screening.
• Patient has not remained at stables doses of all drugs used for treating epileptic seizures for at least 14 days prior to screening (except for rescue medications used for acute treatment of breakthrough seizures which are not known to be CYP3A4 substrates and whose PK has not been shown to be impacted in the presence of a CYP3A4 inhibitorist of CYP3A4 substrates]).
• Patient has a lethal or potentially lethal condition other than infantile spasms, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia.
• Patient has an underlying metabolic disease associated with glucose intolerance (e.g., glucose transporter deficiencies).
• Patient has a body weight below 5 kg.

• Male and female subjects between the ages of 18 and 70 years, inclusive.
• Diagnosis of Crohn's disease localized in the ileum and/or colon, with active mucosal inflammation and visible lesion(s), documented by centrally read ileocolonoscopy and a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥ 6 (≥ 4 for isolated ileal disease). 
• Subjects who do not have an optimal response (daily stool frequency > 3 and pain score > 1) to their current ongoing treatment of biologics (e.g., first anti-tumor necrosis factor-alpha [TNF-α] monoclonal antibody), immunosuppressants, low-dose steroids, or 5-aminosalicylic acid (5-ASA) formulations.
• Subjects who are on stable Crohn's disease medications for at least 4 weeks. 
• Subjects with a CDAI score between 180 and 450 points, inclusive.
• Subjects who are willing and able to follow the trial protocol and have signed informed consent.

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP. 
• Sexually active males or WOCBP who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control depot injection, condom with spermicide, or sponge with spermicide. 
• Subjects taking any nonsteroidal anti-inflammatory drugs that cannot be stopped or replaced.
• Use of prednisone or prednisolone > 30 mg/day or budesonide > 9 mg/day within 4 weeks prior to screening; or intravenous steroids within 4 weeks prior to screening.
• Subjects taking blood thinners. 
• Subjects with bowel stenosis > 5 mm, fistula, or stoma; or with 2 or more bowel resections. 
• Subjects with a history of upper gastrointestinal involvement of Crohn's disease or perianal Crohn's disease. 
• Subjects with prior surgery that removed the ileocecal valve or resections that led to short bowel syndrome. 
• Subjects with known existing aortic aneurysm, or who are at risk for an aortic aneurysm, such as subjects with peripheral atherosclerotic vascular diseases, uncontrolled hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly subjects (over the age of 70). 
• Subjects with known or suspected (family history, unexplained syncope) long QT syndrome or QTcF > 470 msec for females or > 450 msec for males at baseline. 
• Subjects with inadequate organ function, as follows:
  • Serum creatinine > 1.5 x the upper limit of normal (ULN);
  • Aspartate aminotransferase or alanine aminotransferase levels > 1.5 x ULN;
  • Total bilirubin > 1.5 x ULN; Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
• Use of antibiotics (e.g., metronidazole, rifaximin, tinidazole, ciprofloxacin, clarithromycin) within 15 days prior to screening or for greater than 2 months within the past year. A short course (maximum of 5 days) of antibiotics will be permitted during the trial, as needed, for indications other than Crohn's disease. 
• Known hypersensitivity to quinolones or other significant adverse reaction to quinolones. 
• Conditions or circumstances that could prevent completion of the trial according to the judgment of the investigator, including an uncontrolled comorbidity, heart condition, or dysfunction of any other organ; peripheral neuropathy; known arrhythmias, atrial fibrillation, or paroxysmal tachycardia; history of myasthenia gravis; history of drug or alcohol abuse, mental illness, or noncompliance with treatments or visits; or known immune-deficiency. 
• HIV infection, viral hepatitis, prior organ transplant, or malignant disease that is not in remission for at least 3 years, with the exception of basal cell carcinoma. 
• Subjects who have used any investigational drug within 2 months prior to screening. 
• Blood donation in the last 2 months. 
• Use of inhibitors of UGT1A1 and UGT1A9 (e.g., Silybin, diclofenac, mycophenolic acid, efavirenz, regorafenib) and BCRP (eg, Estrone, 17β-estradiol, flavonoids, herb extracts, gefitinib, imatinib, tamoxifen, novobiocin, nelfinavir, ritonavir, dipyridamole, fumitremorgin C, Ko143, cyclosporine, curcumin, eltrombopag, omeprazole, ivermectin). 
• Subjects with a history of treatment failure with 2 or more biologics. 
• Subjects with risk factors for tendon rupture (i.e., psoriasis, ankylosing spondylitis, competitive athletes, renal failure, diabetes mellitus) or who have a history of tendon rupture and/or ongoing tendinopathy.
• Subjects with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg.
• Subjects taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol, amiodarone, ibutilide, dronedarone, or propafenone.

Inclusion Criteria:

• English s.peaking
• Willing and able to communicate and participate.
• ≥ 18 Years of Age.
• Admitted to one of the ICUs described in the Setting section.
• ICU admission > 24 hours.
• CAM-ICU negative (delirium absent), RASS 0 (calm and cooperative) as documented by the patient-care nurse during the most recent documented assessment that calendar day.

• Non-English speaking.
• Not willing to communicate or participate.
• < 18 years of age.
• CAM-ICU positive (delirium present) or RASS other than 0 (Not calm and cooperative) as documented by the patient-care nurse during the most recent documented assessment that calendar day.
• Not admitted to one of the ICUs described in the Setting section.
• ICU admission < 24 hours.
• Documented as a threatening/verbal abuse.
• Documented cognition or communication problems (i.e., admission for treatment of active substance abuse/withdrawal, codependence, Traumatic Brain Injury,  developmental delay, Alzheimer’s disease, dementia).
• Prisoners.

• Able and willing to provide informed consent.
• Postmenopausal women (FSH > 20 IU/L).
• Aged 50-80 years old.
• Lean control subjects:  BMI < 25, Hemoglobin A1c <or= 5.9%
• Obese, non-diabetic subjects:  BMI ≥ 30, Hemoglobin A1c <or= 5.9%
• Obese, T2DM subjects:  BMI ≥ 30, Hemoglobin A1c > 6.5% (for at least the past 5 years).

• Clinical significant abnormality in any of the screening laboratory studies (see below).
• Presence of (documented clinical diagnosis of any of the following):
  • Significant liver or renal disease;
  • Malignancy (including myeloma);
  • Malabsorption (as defined by clinical diagnosis);
  • Hypoparathyroidism (as defined by clinical diagnosis);
  • Hyperparathyroidism (as defined by clinical diagnosis);
  • Acromegaly;
  • Cushing’s syndrome;
  • Hypopituitarism;
  • Severe chronic obstructive pulmonary disease;
  • History of cardiac failure;
  • Bleeding disorders or current use of therapeutic doses of anticoagulants other than aspirin.
• Undergoing treatment with any medications that affect bone turnover, including the following:
  • corticosteroids > 3 months at any time (inhaled steroids acceptable unless used year-round);
  • anticonvulsant therapy for seizures (carbamazepine or phenytoin within the previous year);
  • pharmacological doses of:
    • thiazolidinediones;
    • thyroid hormone (causing decline of thyroid stimulating hormone below normal);
    • Bisphosphonates (within the past 3 years);
    • denosumab, estrogen therapy or treatment with a selective estrogen receptor modulator, or teriparatide (within the past year).
  • Any history of fracture prior to screening.

• Adolescent patients between 12 and 18 years old, inclusive.
• Patients being evaluated at the Pediatric Diagnostic Referral Clinic for symptoms of suspected orthostatic intolerance (OI), postural orthostatic tachycardia syndrome (POTS), or autonomic dysfunction or already carry diagnosis of OI, POTS, or autonomic dysfunction. Identified with pre-appointment triaging to have any of the following symptoms: dizziness, lightheadedness, fainting, heart racing, shortness of breath, vision changes, fatigue, exercise intolerance, and chest pain when standing.

• Age not within 12-18 years old.
• Lack of assent from child to participate/wear actigraph.

Patients or adult caregivers with severe cognitive disabilities; patients or adult caregivers who otherwise meet study criteria but do not fall within above inclusion criteria.

• Adult subjects undergoing MR imaging for radiation therapy planning.

• Patients 3 years old and older.
• May undergo or have undergone intracranial EEG recordings as part of their clinical evaluation for medically intractable partial epilepsy, pain, brain tumor, deep brain stimulation or amyotrophic lateral sclerosis
• A healthy control group of subjects age 18-65.

• Patients who are unable to go into the MRI scanner; for example, when they have MRI contraindications (e.g., metal implants, claustrophobia or pregnancy).

Inclusion criteria:

- Patients must be ≥18 years of age (≥20 years of age in Japan). All genders are
permitted.

- Histologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC
harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity and
permitted in the osimertinib national label (such as either exon 19 deletion and/or
L858R) which is not amenable to curative therapy.

- Documented radiologic disease progression on 1L osimertinib.

- MET amplification and/or overexpression (FISH10+ and/or IHC90+) as determined by FISH
(central) and IHC (central) testing on tumour sample collected following progression
on 1L osimertinib treatment.

- Available tumour sample for central MET FISH and IHC analysis or willingness to
collect additional sample for central testing which fulfils the following
requirements:

Obtained following progression on previous osimertinib therapy;

obtained within 2 years of submission for MET analysis;

sufficient tissue to meet the minimum tissue requirement defined in the current Laboratory
Manual.

- At least 1 lesion, not previously irradiated, not biopsied during the screening
period, that can be accurately measured at baseline as ≥10 mm in the longest diameter
(except lymph nodes which must have short axis ≥15 mm) with CT or MRI which is
suitable for accurate repeated measurements. If only 1 measurable lesion exists, it is
acceptable to be used as long as baseline tumour assessment scans are done at least 14
days after the screening tumour sample collection is performed.

- Prior lines of therapy in locally advanced/metastatic setting: Only prior 1L
osimertinib treatment in metastatic setting is permitted.

- Adequate haematological function defined as:

- Absolute neutrophil count ≥1500/?L

- Haemoglobin ≥9 g/dL (no transfusion in the past 2 weeks)

- Platelets ≥100,000/?L (no transfusion in the past 10 days)

- Adequate liver function

- ALT, AST ≤2.5 x ULN with TBL ≤ ULN OR

- TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN

- Adequate renal function
•defined as a serum creatinine <1.5 times the institutional
ULN OR a glomerular filtration rate ≥50 mL/min. Confirmation of creatinine clearance
is only required when creatinine is only required when creatinine is >1.5 times ULN.

- Adequate coagulation parameters: INR <1.5 and activated partial thromboplastin time
<1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects
these parameters.

- Patients with known tumour thrombus or deep vein thrombosis are eligible if clinically
stable on low molecular weight heparin for ≥2 weeks. The use of direct oral
anticoagulants such as apixaban/rivaroxaban will be accepted as treatment for cancer
related thromboembolism treatment. The use of warfarin for oral anticoagulation is not
recommended.

- ECOG/WHO performance status of 0 or 1 with no deterioration over the previous 2 weeks
and a minimum life expectancy of 12 weeks.

- Females must be using highly effective contraceptive measures, should not be breast
feeding and must have a negative pregnancy test if of childbearing potential, or must
have evidence of non-childbearing potential.

- Males with a female partner of childbearing potential should be willing to use barrier
contraception during the study and for 6 months following discontinuation of study
drug.

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

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

Eligibility criteria
•Inclusion: 

Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction.

Eligibility criteria
•Exclusion: 

Exclusion criteria include lack of consent, contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.

Patients will undergo both CT and ZTE within a 6 week time period (though attempting with each patient to schedule on the same day). ZTE MRI examinations will be added, when possible, to a patient’s already scheduled MRI or will take place as a standalone appointment without sedation.

• All female patients undergoing radical cystectomy for bladder cancer.

• Inability to provide informed consent.
• Non-English speaking.
• Life expectancy less than 2 years.

• Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e., unstable angina).
• Age: 18-65 years old. 
• Gender: Men or women.

• Weight change greater than 3% in the previous 3 months (weight stable).
• History of bariatric surgery including lap band and bariatric endoscopy. 
• Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
• Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM.
• A positive score on the AUDIT-C questionnaire as judged by an investigator. 
• Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.

• Study participant must be ≥ 18 years of age at the time of signing the informed consent.
• Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations.
• Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Visit 1.
• Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1.
• Study participant with a MG-ADL score of at least 3 (with > 3 points from non-ocular symptom) AND a QMG score of at least 11 at Visit 1 and at Baseline (Visit 2).
• Study participant is considered for additional treatment such as IVIg or PEX by the Investigator.
• Body weight ≥ 35kg at Visit 1.
• A male study participant must agree to use contraception as detailed in this protocol during the Treatment Period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
• Female study participants of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of at least 90 days after their final dose of study medication. According to the ICHM3 (R2), highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
• A female participant is eligible to participate if she is not pregnant), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP); OR
  • A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 90 days after the last dose of study treatment. The study participant must have a negative serum pregnancy test at Visit 1, which is confirmed to be negative by urine testing prior to the first dose of study medication at Visit 2.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

• Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
• Study participant has a history of alcohol use disorder or other substance use disorder (as per Diagnostic and Statistical Manual of Mental Disorders-5) within 12 months prior to Visit 1. 3.
• Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol.
• Study participant has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.
• Study participant has a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP.
• Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) will be excluded.
• Study participant has been previously received rozanolixizumab drug product.
• Study participant has received a live vaccination within 8 weeks prior to Visit 2; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of IMP.
• Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within timeframe shorter than no-treatment period.
• Study participant has been treated with any biological agent in the past 3 months or within 5 half-lives prior to Visit 2, whichever was longer.
• Study participant has prior treatment with rituximab in the 6 months prior to Visit 2 or study participant has prior treatment with rituximab in the 12 months prior to Visit 2 and B cells monitoring have shown they did not return to normal range.
• Study participant had a thymectomy in the past 6 months or a thymoma at any time that required chemotherapy and/or radiotherapy prior to Visit 1. 13a.Study participant has active inflammatory bowel disease (IBD), diverticular disease, or GI ulceration or history thereof in past 6 months prior to Visit 1.

• Age ≥ 18 years.
•  Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus.
• Note: patients undergoing concurrent chemotherapy are eligible.
• Able to provide informed written consent.
• Willing to consent for photography of radiation field.
• Receiving a dose ³ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison.

• Patients with active rash, pre-existing dermatitis, lupus, tattoos,scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.
• Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields.
• Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study.
• Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit.
• The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable).

• Signed informed consent.
• On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue.

• Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2.
• Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires ≥ 36-hour washout before baseline visit).
• History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan.
• Renal vascular hypertension (including renal artery stenosis).
• Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula < 30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder.
• History of angioedema.
• Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures.
• Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study.
• Other protocol defined inclusion/exclusion criteria may apply.

• Adult patients (> 18 years old) undergoing elective planned percutaneous coronary intervention (PCI) of one coronary artery territory.
• Target coronary lesion is suitable for robotic PCI at discretion of the primary operator.
• Either femoral or radial approach planned for procedure.
• Patient must be able to tolerate dual antiplatelet therapy and give written informed consent.

• Hemodynamic instability, cardiogenic shock or anticipated need for hemodynamic support device use.
• Severely calcified coronary lesion or anticipated need for rotational atherectomy.
• Chronic total occlusion.
• Unrevascularized multivessel coronary artery disease.
• Left ventricular ejection fraction < 35%.
• Advanced renal dysfunction (defined as GFR < 30 ml/min).

• Patients ≥ 18 years of age.
• All patients coming to Ambulatory infusion center in the Mayo Clinic Cancer Center to receive treatment for hematological or oncology diagnosis.

• Under 18 years of age.

• Potential participants must be age 18 years old or older.
• Able to read, comprehend, and complete the informed consent form (provide informed consent).
• Willing to participate in a long-term follow-up at least 5 years.
• Has symptoms or signs of chronic GERD (including heartburn, regurgitation, atypical chest pain, dysphagia or trouble swallowing, sore throat, voice hoarseness, cough, asthma), or a confirmed diagnosis of GERD, laryngopharyngeal reflux, Barrett’s esophagus, eosinophilic esophagitis, reflux esophagitis, reflux-related esophageal stricture).

• None.

• Women ages 35-55 years old.
• Female patients with abnormal uterine bleeding within the menopause transition.

• Women outside of the ages of 35-55 years old.
• Women who have undergone hysterectomy,

• For 20 healthy controls, individuals without a history of easy bruising/bleeding who have not consumed aspirin-containing prescription or over-the-counter medications or prescription anti-platelet agents for 10 days prior to study enrollment. 
• For the 20 volunteers in the anti-platelet agent group, 20 non-acutely ill volunteers or patients who have taken either clopidogrel alone (10 volunteers) or both aspirin and clopidogrel (any doses) for the 10 consecutive days prior to study enrollment.

• History of easy bruising/bleeding.
• Taking over-the-counter or prescription aspirin or anti-platelet medication (group 1).
• Not taking either clopidogrel alone or the combination of aspirin and clopidogrel for each of the prior 10 days (group 2). 

• Age 18 years or older.
• Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with endoscopic therapy with negative surveillance endoscopy for at least one year from endoscopic therapy.
• Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with initial endoscopic therapy with remission across two subsequent surveillance endoscopies but evidence of recurrence of intestinal metaplasia, dysplasia, or EAC by the third surveillance endoscopy.
• Tolerance of endoscopy.
• Ability to give informed consent.

• Age < 18 years old.
• Pregnancy.
• Prior gastric surgery.
• Use of any bile acid sequestrants (cholestyramine, colestipol, and colesevelam) at the time of enrollment.
• Evidence of biliary obstruction or cholestasis due to any reason, defined as total bilirubin above the upper limit of normal, alkaline phosphatase above the upper limit of normal, and/or clinical evidence of jaundice.
• Active esophagitis or stricture precluding passage of endoscope and completion of endoscopic procedure.
• Coagulopathy, defined as INR > 1.5 or platelet level 50,000 precluding completion of endoscopic procedure.

• Biopsy confirmed CD diagnosis.
• Seropositive.
• Gluten free diet (12 months minimum).
• Experienced at least one self reported moderate or greater severity symptom during the last 28 day period.
• Willing to take study treatment daily.
• Must sign informed consent.

• Wheat allergy.
• History of peptic ulcer disease, esophagitis, IBS, IBD.
• Active colitis, dermatitis herpetiformis.
• Diagnosed with Type 1 Diabetes.
• Patients with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery).
• Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening.
• Known refractory celiac disease (RCD1 or RCD2).
• Inability to give informed consent.

• No fall history in the past 6 months.
• Independent in their daily life.

• Participants with chronic or current pain.
• Particiupants using prostheses or assistive devices.
• Participants with visual abnormality, proprioceptive loss, or peripheral neuropathy.