• 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.

• At screening, female participants must be nonpregnant and nonlactating.
• In good physical health on the basis of no clinically significant findings from medical history, PEs, laboratory tests, ECGs, and vital signs.
• Participant is a carrier of a loss of function GRN mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation.

• Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. 
• History of alcohol abuse or substance abuse.
• Participant resides in a skilled nursing facility, convalescent home, or long term care facility.

• Aged 18 years and older.
• Normal subjects must not have any confounding medical conditions.

Exclusion Criteria:

• Any ‘undefined’ metallic implants or foreign bodies inside the body.
• Implanted active devices such as cardiac defibrillators/pacemakers, deep brain stimulators, vagus nerve stimulators, intrathecal pumps, cochlear implants.
• Devices, or residual parts thereof left in the body such as cardiac pacer wires, which provide life assist, bone growth or pain management.
• Structural support devices, screws, or wires in bone that are near the spinal cord or temperature sensitive organs.
• Reconstructive metallic implants near the orbits.
• External devices, medicinal patches, piercings, jewelry, clothing or hair accessories (such as wigs, weaves and extensions) within to the radiofrequency coil that cannot be removed from the body.
• Pregnancy.
• Prisoners.
• Tattoos located within or near the radiofrequency coil.
• Permanent facial makeup (for brain scanning).
• Metallic fragment in the eye.
• Colored contact lens.
• Fever / elevated temperature.
• Suffer from claustrophobia.

• Patients ≥ 18 years old.
• Patients undergoing plasma exchange therapy for a medical indication.

• Age < 18 years old.

• Patients older than 18 years old.
• Males or females.
• Patients who came in for cardioversion for atrial fibrillation.

• Poor image quality.

Inclusion Criteria - For Roll-over Patients from Trial HS-18-633:

• Patients who attend the Week 24 visit of the preceding trial (HS-18-633) and are willing to continue their participation in this trial.
• Written informed consent of the patient.
• Patients must be willing to use an acceptable method of contraception during the entire trial.

Inclusion Criteria - For New Patients:

• Able to provide written informed consent to participate in the trial prior to any
  trial-related procedures are performed .
• Willingness and ability to comply with the requirements of the protocol.
• Male or female patients, ≥ 18 years at screening.
• Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
  as documented by:
  • IGF-1 levels > 1 x ULN;
  • Pituitary adenoma on magnetic resonance imaging (MRI) or pathology report Computerized tomography (CT) is accepted if MRI could not be performed;
  • IGF-1 levels >1 x ULN measured at least 3 months after the surgery for patients who have undergone pituitary surgery.
• Treatment with a stable dose of octreotide LAR (10 mg, 20 mg, 30 mg or 40 mg) or
  lanreotide ATG (60 mg, 90 mg or 120 mg) for at least 3 months as monotherapy prior to
  screening.
• IGF-1 levels >1 x ULN and ≤ 2.0 x ULN at screening (adjusted for age and sex; mean
  value of the first measurement at screening and the second measurement at 2 weeks
  before Day 1) with or without prior pituitary radiotherapy (at least 3 years prior to
  screening), or IGF-1 levels ≤ 1 x ULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1), with prior pituitary radiotherapy at least 3 years prior to screening and confirmed disease activity defined as IGF-1 levels > 1 x ULN during drug holiday 3 to 9 months prior to
  screening.
• Patients must have adequate liver, pancreatic, renal and bone marrow functions:
  • Adequate liver function:
    • Total serum bilirubin ≤ 1.5 x ULN*;
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x ULN;
    • International normalized ratio (INR) < 1.3.
  • Adequate pancreatic function:
    • Amylase and lipase ≤ 2 x ULN.
  • Adequate renal function:
    • Estimated glomerular filtration rate ≥ 60 mL/min by the Modification of Diet in Renal Disease formula.
  • Adequate bone marrow function:
    • Platelets ≥ 100 x 10^9/L;
    • Hemoglobin > 9 g/dL;
    • White blood cells > 3.0 x 10^9L.

*Patients with previous diagnose of Gilbert’s syndrome may be included if the disease is not
accompanied by other hepatobiliary disorders and if the total bilirubin is < 3 mg/dL
(< 51.3 μmol/L) and the direct bilirubin is ≤ ULN.

• Normal ECG defined as the following as determined by the mean value of a triplicate ECG:
  • Resting heart rate 50-105 bpm;
  • QTc interval corrected by Fridericia’s formula (QTcF) <450 msec.
• Female patients of childbearing potential must be willing to use an acceptable method of contraception during the entire trial.
• Male patients must be willing to use condoms throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).

For Roll-over Patients from Trial HS-18-633

• Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633).
• Patients who, based on the Investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by physical examination, laboratory tests or ECG.
• Pregnancy.

For New Patients

• Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]).
• Currently receiving other treatments known to affect GH or IGF-1 concentration (including oral estrogens for e.g. contraception or replacement treatment in hypogonadism or during menopause).
• Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks).
• Compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
• Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening. Patients who have undergone surgery more than 1 month from screening must have recovered from the treatment and be in good clinical condition.
• Patients who have undergone pituitary surgery within 6 months prior to screening
• Patients who have received prior pituitary irradiation within 3 years prior to screening
• A history of another primary malignancy except the following:
  • Stable and well-differentiated microcarcinoma of the thyroid
  • Non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast from which the patient has been disease-free for ≥3 years
  • A primary malignancy that has been completely resected and in complete remission for ≥5 years.
• Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening
• Patients with poorly controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >8.0%
• Patients with diabetes mellitus who have initiated treatment with insulin or who have changed the insulin treatment regimen within 6 weeks prior to screening
• Hepatic/pancreatic-related exclusion criteria
  • Presence of hepatitis B surface antigen
  • Current hepatitis C virus infection
  • History of alcohol/drug misuse within the past 12 months
  • Patients with symptomatic cholelithiasis within 3 months from screening (patients with non-symptomatic cholelithiasis/sludge and patients who have undergone cholecystectomy more than 1 month from screening can be included in the trial)
• Patients with presence of active or suspected acute or chronic uncontrolled infection or
• immunocompromised patients, including patients with positive human
• immunodeficiency virus (HIV) test result
• Cardiac exclusion criteria: cardiac or cardiac repolarization abnormality, including any
• of the following:
  • a. History of myocardial infarction, angina pectoris or coronary artery bypass graft
  • within 6 months prior to screening
  • b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete
  • left bundle branch block, high-grade atrioventricular (AV) block (e.g. bifascicular
  • block, Mobitz type II and third-degree AV block)
  • c. Long QT syndrome, family history of idiopathic sudden death or congenital long
  • QT syndrome, or any of the following:
  • i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or
  • hypomagnesemia, history of cardiac failure or history of clinically
  • significant/symptomatic bradycardia
  • ii. Concomitant medication(s) with a “Known risk of Torsades de Pointes” that cannot be discontinued or replaced by
  • safe alternative medication/s. A wash-out of 5 half-lives or 7 days
  • (whichever is longer) from previous treatment with drugs with a known
  • risk of Torsades de Pointes is required prior to the first dose of CAM2029
  • iii. Inability to determine the QTcF interval
• Uncontrolled hypertension defined by a systolic blood pressure >160 mmHg and/or
• diastolic blood pressure >100 mmHg. The patient needs to be on a stable dose of
• antihypertensive medication for at least 4 weeks before screening
• Untreated or uncontrolled hypothyroidism, hypoadrenalism or diabetes insipidus.
• Patients must be adequately treated with stable doses of replacement therapy for a
• minimum of 3 months prior to screening
• Any other current or prior medical condition that may interfere with the conduct of the
• trial or the evaluation of its results in the opinion of the Investigator or the Sponsor’s
• Medical Monitor
• Pregnant, lactating or planning to be pregnant during the trial
• Clinically significant laboratory abnormalities, which in the opinion of the Investigator
• may prevent the patients from safely participating in the trial
• Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or
• history of any drug hypersensitivity or intolerance which in the opinion of the
• Investigator, would compromise the safety of the patient or the trial
• Any other contraindicated serious medical condition, which in the opinion of the
• Investigator may prevent the patients from safely participating in the trial.
• Unwilling or unable to comply with the requirements of the protocol or in a situation or  condition that, in the opinion of the Investigator, may interfere with participation in the trial.
• On the staff, affiliated with, or a family member of the personnel directly involved with this trial.

• Age 18 or older.
• Scleral lens wearers with a history of 6 months of at least 5 hours of scleral lens wear at least 5 days/week are invited to participate.

• Patients with active infections or unstable inflammation of the eyes are not eligible to participate.
• Patients who have been refit into a different scleral lens design during the past 6 months.
• Patients who are actively participating in the scleral lens fitting process.

• Patients 18 years and older.
• Patients who are undergoing elective defibrillation threshold testing of their transvenous ICD or defibrillation threshold testing of the subcutaneous ICD at the time of implantation.

• Patients under age 18 years old.
• Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks.
• Pregnant patients.
• Patients who cannot provide informed consent because of cognitive dysfunction.

• Age 18-80 years.
• Recipient of kidney transplantation 4 or more years.
• Competent and able to provide written informed consent.
• Ability to comply with protocol.

• Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, or stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
• Severe chronic liver, heart, or lung disease.
• Undergoing acute rejection.
• Contra-indication to biopsy; bleeding disorders.
• Chronic infection.
• Any active malignancy and undergoing therapy.
• Kidney or ureteric stone.
• Unable to give valid informed consent.
• Known pregnancy or intent to conceive during the study period.
• Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia, or other contraindication to MRI.
• Federal medical center inmates.

Eligibility last updated 9/13/22. Questions regarding updates should be directed to the study team contact.

• Patients with epilepsy having previously undergone brain imaging using a 7T MRI scanner as part of their diagnostic evaluation.

• Patients in which a prior 3T brain MRI was diagnostic for an epileptogenic lesion at the time of initial interpretation.
• Prospective patients who do not sign and return the HIPAA use consent form.
• Patients with large, confounding cerebral pathologies such as large infarcts or brain tumors.
• Patients with poor 7T image quality due head motion or other technical issues

• Individuals between 18 and 65 years of age.
• Individuals who have undergone surgical reconstruction of the brachial plexus.
• Individuals in good neuromuscular health with no previous musculoskeletal disease

• Individuals under 18 or over 65 years of age

• Adult patients 18 years or older. 
• Patients with Glasgow coma scale score (GCS) ≤ 8
• Patients having neuroimaging concerning for ICP crises or have active ICP treatment may undergo non-invasive NIRS monitoring and invasive LICOX intraparenchymal brain tissue oxygen monitoring once study consent is obtained.

• Patients with CNS infection.
• Patients with bleeding diathesis or thrombocytopenia < 50,000 platelets.
• Patients with subdural hematomas who have had surgical decompression and bone flap removal.
• Each patient will undergo 3 to 10 days of monitoring (depending on pathology; i.e., patients with poor-grade aneurysmal subarachnoid hemorrhage may undergo longer monitoring to assess for delayed cerebral ischemia during the time window of vasospasm risk).
• Pregnant individuals.
• Children.
• Prisoners.
• Institutionalized individuals.
• Others who are likely to be vulnerable.

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact

• Bone marrow hypocellular for age.
• Moderate or severe aplastic anemia defined by one of the following: peripheral blood neutrophils < 0.5 x 10^9/L; platelets < 30 x 10^9/L or platelet transfusion dependence; reticulocytes < 50 x 10^9/L in anemic patients or red cell transfusion dependence.
• Diagnosis of dyskeratosis congenita based on clinical triad of abnormalities of skin pigmentation, nail dystrophy, oral leukoplakia; OR one of clinical triad and presence of two or more associated features; OR a pathogenic mutation in DKC1,TERC, TERT, NOP10, NHP2, TCAB1, TINF2, CTC1, PARN, RTEL1, or ACD as reported by a CLIA-approved laboratory; OR age-adjusted mean telomere length < 1%ile in peripheral blood lymphocytes as reported by a CLIA-approved laboratory; OR Hoyeraal-Hreidarsson syndrome; OR Revesz syndrome
• Availability of a related or unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1.
• Patient and/or legal guardian must be able to sign informed consent.
• Donor must provide a marrow allograft.
• Diagnosis of Fanconi anemia must be excluded by mitomycin C or diepoxybutane chromosomal breakage testing on peripheral blood at a CLIA-approved laboratory (not required for patients with a genetic mutation consistent with DC).
• Adequate renal function with glomerular filtration rate equal to or greater than 30 ml/min/1.73 m2.

• Clonal cytogenetic abnormalities associated with MDS or AML on bone marrow examination.
• Karnofsky/Lansky performance status < 40.
• Uncontrolled bacterial, viral or fungal infections.
• Positive test for the human immunodeficiency virus (HIV).
• Pregnancy or breastfeeding.
• Known severe or life-threatening allergy or intolerance to fludarabine, alemtuzumab, cyclosporine, or mycophenolate mofetil.
• Positive patient anti-donor HLA antibody, which is deemed clinically significant.
• Prior allogeneic marrow or stem cell transplantation.
• Prior solid organ transplantation.

• Adult patients (age >= 18 years old).
• Suspected WHO grade II or III infiltrating glioma based on standard MR imaging.
• No previous tumor treatment or surgery.
• Surgery for definitive diagnosis anticipated to occur within 3 months of study imaging.

• Inability to undergo MR imaging for any reason (claustrophobia, habitus, implanted devices, etc.).
• Previous cranial surgical operations if metallic plates or grafts are near the area of tumor.
• Predominantly ring-enhancing disease on anatomic MR.
• Pregnancy.