• DBS in one of the defined nuclei of interest during the period of the study.
• Male or female, aged 18 years and above.
• Be willing and able to give written and oral informed consent.
• Ability to complete all required study procedures including travelling to Mayo Clinic  and staying overnight.
• All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study.  This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence.

• Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
• Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate.
• Pregnancy test positive.

• Subjects are scheduled for a clinically indicated cardiac ultrasound examination at the site.
• Subjects are over the age of 18.

Exclusion Criteria:

• Subjects under the age of 18.
• Women who are currently pregnant.
• Subjects with any known contraindications for ultrasound scanning.
• Philips employees and their family members.

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

Eligibility last updated 9/2922. Questions regarding updates should be directed to the study team contact.

• Group 1: children 5-7 months of age receiving the 3rd scheduled DTap-IPV/Hib+PCV13 dose.
• Group 2: children 10-18 months of age receiving the 1st scheduled MMR+VZV dose.
• Group 3: children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose.
• Group 4: children 0-12 years of age receiving the influenza vaccine or nasal mist.
• Group 5: children 0-12 years of age receiving the SARS-CoV-2 vaccine.
• Group 6: children in any of the above groups that were scheduled for a clinical vaccination after their first research blood collection, but it was cancelled by the provider for any reason.
• Group 7: young adults 18-21 years of age receiving the influenza vaccine or nasal mist or SARS-CoV-2 vaccine.

• History of autoinflammatory or autoimmune disease.
• History of genetic or metabolic disorder.
• History of hematological disorder.
• History of malignancy or active malignancy undergoing suppressive treatment.
• Blood donation or collection within 8 weeks of the study.
• Signs or symptoms consistent with severe infection at the time of first visit.
• Weight less than 6 kg in group 1, less than 7.5 kg for group 2, less than 12 kg for group 3 and less than 6 kg for groups 4 & 5.
• Additional vaccination within 3 weeks prior to baseline blood draw.

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

• Age 18 years of age or older.
• Able to provide informed consent.

• None.

• Patients with TJA and matched controls.

• None.

• Age ≥ 18 years old.
• At least one ambulatory visit in one of the participating study sites during the past year.
• SBP > 145 mmHg at most recent clinic visit (may be treated with BP meds already or not), as reported by the participant.
• A self-reported commitment to “work on lowering your blood pressure by 10 points or more to reduce your risk of heart attack and stroke."
• Owns a Smartphone (Android or iOS) and has an email address.
• Willing to receive text messages from the study.
• Can read/write English well enough to use English-based Smartphone apps and fill out online surveys in English.

• Has an arm circumference < 22 cm or > 42 cm.
• Owns a functioning Home Blood Pressure Monitor (HBPM) and has used it in the last 3 months.

• Patients 18
  •65 years of age.
• Diagnosed with primary IgAN.
• Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or an ARB or a direct renin-inhibitor.
• Has urine protein greater than or equal to 1 gram/24-hour. 
• Has hematuria (blood cells present in urine).

• Patients less than 18 years or older than 65 years old.
• Has renal disease other than IgAN.
• Has a diagnosis of rapidly progressive glomerulonephritis. 
• Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis).
• Has poor kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2. 
• Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection.
• Has on-going high blood pressure.
• Treated with systemic corticosteroids or any immunosuppressant agents in the past 12 months .
• Received an organ transplant.

• Male or female gender.
• Adults aged 18-100 years old.
• Isolated medial knee pain secondary to medial meniscal pathology or medial compartment osteoarthritis.
• Willingness to trial a medial knee unloader brace for symptomatic improvement.
• Ability to ambulate 100ft without an assistive device.

• No medial knee joint pain.
• Lateral knee joint pain.
• History of knee arthroplasty on affected side.
• Prior meniscal surgery.
• Prior use of a medial knee unloader brace.
• Knee xrays taken greater than 6 months prior to study enrollment.

Patient

• Adolescents and young adults age 12 to 21 years at time of consent who have had NYHA Class II or higher heart failure in the preceding two years.
• Actively being followed by a pediatric heart failure specialist with at least one visit in the past year, or actively being followed by a pediatric cardiologist with Heart Failure as an active diagnosis and history of consultation with a pediatric heart failure specialist.
• English speaking.
• Inpatient or outpatient.
• Any etiology of heart failure including but not limited to cardiomyopathy, myocarditis, and congenital heart disease, unless mentioned in Exclusion Criteria.
• May have systolic or diastolic heart failure, or Fontan/single ventricle heart failure.
• May have had advanced cardiac therapies including pacemakers, ICDs, ventricular assist devices, or cardiac transplant as long as other Inclusion Criteria are met.

Caregiver

• Parent(s)/guardian(s)/caregiver(s) of participating adolescent/young adult subjects with heart failure.
• Age 18 or older.
• English speaking.
• Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
• Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Patient

• Significant co-morbidities that may greatly impact their ability to distinguish symptoms of heart failure, such as: muscular dystrophy, active malignancy, or primary non-cardiac organ failure (e.g., renal failure with uremic cardiomyopathy).
• Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

Caregiver

• Clinical condition that would interfere with their ability to participate in a focus group or interview (e.g., severe developmental delay or other cognitive impairment).

   

• Full term newborns, approximately equal number of male and female newborn, age <28 days.
• Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth <37 weeks or birth weight <1500 grams.

• Infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past. 
• Infants with major congenital anomalies that may affect bone health or structure. 
• For full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (<10th percentile for weight) at birth.

• Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
• Male or female subjects of 12 years of age or older, at the time of informed consent and body weight greater than or equal to 40 kg. Adolescent subjects below the age of 18 years old will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years and older will be enrolled.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Must have completed the full treatment period of a qualifying Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 study (if applicable).
• Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
  • Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
  • Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
• Female subjects of non childbearing potential must meet at least 1 of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure; or
  • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
• Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
• Must agree to avoid use of prohibited medications throughout the duration of the study.

• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Currently have active forms of other inflammatory skin diseases; i.e., not AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
• Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at any point during the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
• Ongoing adverse event in the qualifying Parent study which in the opinion of the investigator, or sponsor, is an ongoing safety concern.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Cases

1) Males and females ages 18 years or older.

2) Treatment-naïve HCC as defined by LI-RADS LR-5 or OPTN 5 CT or MRI criteria (all lesions must exhibit arterial phase hyper-enhancement), or histologic evidence.

3) Early-stage HCC defined by single lesion ≤5 cm or ≤ 3 lesions ≤3 cm determined at enrollment or within 100 days prior without vascular invasion.

4) Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.

5) Child-Pugh score A–B8.

6) Subject must be able to understand and provide informed consent.

Controls

1) Males and females ages 18 or older.

2) Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.
3) Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or within 100 days prior based on one of the following:
a. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
b. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
c. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit.
4) Child-Pugh score A–B8.
5) Subject must be able to understand and provide informed consent

Cases

1) Uncontrolled ascites.

2) Uncontrolled encephalopathy.

3) History of liver transplant.

4) Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment, including mixed HCC-CCA (if diagnosed with previous malignancy, subject must be in remission for at least 5 years prior to enrollment). Prior history of HCC, including resection of HCC at any time, is excluded.

5) Prior treatment of tumor.

6) Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Controls

1) Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria.

2) Uncontrolled ascites.

3) Uncontrolled encephalopathy.

4) History of liver transplant.

5) Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if diagnosed with previous malignancy, subject must be in remission for at least 5 years prior to enrollment). History of HCC, including resection of HCC at any time, is excluded.

6) Any significant non-liver-related medical condition in which expected survival is less than 1 year.

• Age 18 years or older.
• Indicated for CRT, with QRS duration ≥ 130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
• Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB.
• LVEDD ≥ 55 mm, as determined by site.

• Permanent/persistent AF or presenting with AF.
• Pre-existing or previous LV lead or other confounding devices; e.g., Left Ventricular Assist Device, Vagal Nerve Stimulator.
• Currently implanted with IPG or ICD with > 10% RV pacing.
• Permanent complete AV block.
• Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study. 
• Less than 1 year life expectancy.
• Vulnerable adults.
• Younger than 18 years of age.

• Subject and/or legally authorized representative is willing and able to provide consent prior to study participation.
• Subject is ≥ 18 years of age.
• Subject is undergoing or a candidate for routine SOC monitoring per the collection sites’ CMV management protocol.
• Subject meets one of the following two criteria:
  • Subject is a kidney, liver, lung, or heart transplant recipient; or
  • Subject is an allogeneic or autologous HSCTR.
• Subject is serotype D+/R-, D-/R+ or D+/R+.
• Subject has a positive CMV result of equal to or above the LLOQ (≥LLOQ) within 10 days prior to enrollment with no intervening negative CMV result below the LLOQ (<LLOQ) and/or TND by SOC viral load testing.

• Subject already participated in this study.
• Subject is unsuitable for study participation based on the PI’s decision (e.g., unlikely to comply with study procedure(s), significant medical complication).
• Subject is participating in another investigational study that the PI believes might interfere with the subject’s participation in this study.

• 18 years of age or older.
• Kidney transplant recipient.

• Neuropsychiatric condition causing patient to be unable to provide consent.
• Non-English speaking patient.
• Failed kidney transplant defined as return to dialysis.

• Adults between 18 and 65 years of age.
• Bipolar I or II disorder as confirmed by structured clinical interview for DSM-IV-TR.
• Major depressive episode unresponsive to steady and stable (i.e., at least 2 weeks) mood stabilization (e.g., lithium, valproate, lamotrigine, carbamazepine/oxcarbamazepine, and/or atypical antipsychotic therapy) and non-psychotropic medication.
• Antidepressant therapy is allowed in the study as long as patients are also on a mood stabilizer. Patients will be enrolled provided that any needed modifications to the antidepressant would be made at least two weeks prior to randomization.
• Patients receiving psychotherapy will be allowed to be randomized provided therapy frequency does not change during the 8-week blinded phase.  
• Symptom severity score on the Quick Inventory for Depressive Symptomatology – Clinician (QIDS-C16) ≥ 9, and the Clinical Global Impression for Bipolar Illness (CGI-BP) Depression Severity Scale ≥ 3.
• Patients on stimulants for comorbid attention deficit disorder (ADHD) and/or binge eating disorder (BED) will be enrolled provided that the stimulant can be tapered and discontinued at least one week prior to randomization; symptom severity inclusion criteria must be met again prior to randomization.
• Patients with a prescribed opiate (e.g.. hydroxicodone) or other pain intervention for acute or chronic pain management will be allowed provided they:
  • use a prescribed opiate or other pain intervention at a recommendation dose and established duration;
  • show no evidence of prescription misuse;
  • do not meet abuse or dependence criteria by SCID;
  • no known significant pharmacological interactions.
• Ability to travel for the assessment visits.  

• Inability to provide written informed consent.
• Inability to understand English.
• Score less than 86% correct (i.e., one wrong) on comprehension assessment that reviews study goals.
• Clinically significant signs of acute suicidality from any of the following assessments:
  • Response of > 2 on question #12 of QIDS-C; or
  •  Response = 3 on the SCID Module A- #A19.
• Suicide attempt within the past year.
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs); also, within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor.
• Baseline Young Mania Rating Scale (YMRS) score ≥ 12.
• Patients with active psychosis (measured by a score > 4 on YMRS question #8) or a diagnosis of schizophrenia, schizoaffective disorder, delusional, or schizophreniform disorder identified by structured clinical interview for DSM-IV-TR.
• Active abuse or dependence of alcohol, opiates, or cannabis (nicotine dependence will be an exception) by structured clinical interview for DSM-IV-TR; patients meeting full remission for at least 3 months can be randomized. 
• Positive toxicology screen for drugs of abuse (i.e., cocaine, methamphetamine, illegal opiates).
• Positive toxicology screen for cannabis and a cannabis use disorder by structured clinical interview for DSM-IV-TR.  Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.
• Known lifetime history of cocaine or methamphetamine abuse or dependence identified by structured clinical interview for DSM-IV-TR.
• Active stimulant prescription abuse or dependence by structured clinical interview for DSM-IV-TR; patients meeting full remission for at least 6 months can be randomized.
• Known lifetime history of stimulant-induced mania.
• Known hypersensitivity, such as angioedema or anaphylaxis, to amphetamines or other ingredients of MYDAYIS.
• Clinically unstable medical disease.
• Known history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problems.
• ECG with clinically significant arrhythmias, conduction abnormalities, or voltage criteria met for left ventricular hypertrophy (unless cleared by cardiology consultation).
• Uncontrolled hypertension (> 160/100) or tachycardia (heart rate > 110).
• History of grand mal seizure; history of febrile seizure as infant permitted.
• Established vasculopathy or history of Raynaud’s phenomena.
• Narrow angle glaucoma.
• Chronic kidney disease (CKD) > stage IIIa (GFR 40-59).
• Tourette syndrome.
• Women who are pregnant, lactating or of child-bearing potential not using at least one adequate contraceptive measure (i.e., hormonal contraception-birth control pills, intrauterine devices (IUD), tubal ligation or condoms during sexual intercourse).
• Current positive test for SARS-CoV-2; those with previous COVID-19 illness and those who test positive for SARS-CoV-2 any time after starting study drug or placebo will be included.
• Otherwise excluded for administrative reasons and/or clinician judgment.

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

Inclusion Criteria
•Database Registry: 

• Patients aged  ≤ 26 years who present with a curve large enough that a definitive fusion for idiopathic scoliosis would be considered an option.
• Male or female.
• Diagnosis of idiopathic scoliosis for which definitive fusion surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
• Curve cobb of any magnitude – operative range.
• Spina bifida Oculta is permitted.
• Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
• Non-operative idiopathic scoliosis patients:
  • Aged  ≤ 26 years, male or female, curve cobb of ≥40º, whom elected not to proceed with surgery; or
  • Aged  ≤ 26 years, male or female, Curve cobb ≥ 30º and approaching skeletally mature (defined as Age:  girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 or sanders ≥7).

Execlusion Criteria
•Database Registry:

• Prior spinal surgery.
• MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
• Neuromuscular or other serious co-morbidities.
• Thoracogenic or cardiogenic scoliosis.
• Associated syndrome or developmental delay.
• Unable or unwilling to firmly commit to returning for required follow-up visits.

• The subject is of legal age to participate in the study per the laws of their respective geography. 
• Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant). 
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females. 
• The subject is deemed to be suitable for the defined protocol pharmacologic regimen. 
• The subject is able to undergo TEE examinations. 
• The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial. 
• The subject is able and willing to return for required follow-up visits and examinations.

• The subject is currently enrolled in another investigational study that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed. 
• The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy). 
• The subject is deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons. 
• The subject had or is planning to have any cardiac or major non-cardiac interventional or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30 days prior to or 60 days after randomization [including, but not limited to: percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.), etc.]. 
• The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization. 
• The subject had a prior major bleeding event per ISTH definition within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event. 
• The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
• The subject has a history of atrial septal repair or has an ASD/PFO device. 
• The subject has an implanted mechanical valve prosthesis in any position. 
• The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
• The subject has a documented life expectancy of less than two years.
• The subject has a cardiac tumor. 
• The subject has signs/symptoms of acute or chronic pericarditis. 
• There is evidence of tamponade physiology. 
• Contraindications (anatomical or medical) to percutaneous catheterization procedures. 
• The subject has documented NYHA Class IV heart failure. 
• The subject has documented surgical closure of the left atrial appendage. 
• The subject has an active infection.

• Participants must be adults ≥ age 21 years old.
• Self-report as the primary caregiver of an adult (≥ age 21 years old) outpatient palliative care patient.
• Care recipients must be residing at home (not in a nursing home or memory care facility; however, may reside in an assisted living facility).
• Participants must be living with the patient at least 50% of the time.
• Participants must be able to read and speak English
• Participants must be cognitively intact.
• Participants are also required to be in possession of an iPhone 6 or newer model for use of the health monitor application, and have access to wifi at least once per day during the two weeks of wearing the device (to allow for transfer of data to the researcher team’s portal).

• As determined through self-report, FCGs with a history of head trauma, panic attacks, diagnosed with a major mental health condition, or who are unwilling to participate.  

• Patients that are undergoing liver tumor treatment with microwave ablation therapy.

• Pregnant women.
• The liver tumor cannot be easily identified on a contrast-enhanced CT scan.
• There are contraindications to the use of contrast required in the study.
• Treatment of 4 or more liver tumors.

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: 
  • Fusiform aneurysm diameter ≥ 5 cm;
  • Saccular aneurysm (no diameter requirement); 
  • Rapid aneurysm growth (≥ 5 mm in one year).
• Aortic aneurysm includes most or all or the entire abdominal aorta, including the renal arteries with aneurysmal extension as far as 65 mm proximal to the celiac artery.
• Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required).
• Age ≥ 19 years at the time of informed consent signature.
• Male or infertile female.
• Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician.
• Capable of complying with protocol requirements, including follow-up.
• An Informed Consent Form signed by Subject or legal representative.
• Sufficient distal landing zones in both iliac arteries to permit all EXCLUDER components to land proximal to the internal iliac bifurcation on each side.
• Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:
  • For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm;
  • Proximal seal zone ≥ 20 mm in length
    •Aortic neck angle ≤ 60°;
  • Distal landing zone (iliac arteries) 8-25 mm;
  • Distal seal zone in iliac arteries of at least 10 mm in length;
  • Renal artery landing zone diameters between 4-10 mm;
  • Celiac and superior mesenteric artery landing zone diameters between 5-12 mm;
  • Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed. 

Patent left subclavian artery Secondary Study Arm Only:

• If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm.
• The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery.
• The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported.
• At least one patent internal iliac artery, without planned occlusion or embolization or the placement of a branched iliac device in order to achieve adequate distal seal concomitant with the TAMBE procedure.

The patient is / has:

• Prior open, aortic surgery of the ascending aorta or aortic arch.
• Ruptured or leaking aortic aneurysm.
• Aneurysmal dilatation due to chronic aortic dissection.
• Infected aorta.
• Mycotic aneurysm.
• Life expectancy < 2 years.
• Myocardial infarction or stroke within 1 year of treatment (staged or index procedure).
• Systemic infection which may increase risk of endovascular graft infection.
• Degenerative connective tissue disease; e.g. Marfan's or Ehler-Danlos Syndrome.
• Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening.
• History of drug abuse; e.g., cocaine or amphetamine or alcohol, within 1 year of treatment.
• Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access.
• A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow.
• Known sensitivities or allergies to the device materials.
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin.
• Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.
• Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis).

• Age between 18 years old and 79 years old.
• Ability to provide consent for surgery.
• Patients who undergo a free flap procedure.

• Age under 18 years old or above 80 years old.
• Inability to provide consent for surgery.

• Age ≥ 18 years.
• In the second or third trimester of  healthy pregnancy
• Must meet all tissue donor eligibility criteria (as defined by 21CFR1271).
• Full understanding of the requirements of the study and willingness to comply.
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.

• Abnormal pregnancy that my include:
  • Birth defects of the fetus;
  • Maternal complications with the placenta or umbilical cord anatomy;
  • Any complications during the birthing process;
  • History of malignancy or transplant;
  • Any long term use of steroids;
  • Autoimmune disorders;
  • Any chronic infections (i.e., HIV, MRSA, VRE, Hepatitis, TB, etc.);
  • Any other significant medical history that in the opinion of the PI would deem the donor ineligible.

• Age 18 years or older at the time of enrollment on Segment A.
• Patients with acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow.
• Patients with myelodysplasia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with <5% vs. 5-10% blasts in this disease).
• Patients with relapsed chronic lymphocytic leukemia with chemosensitive disease at time of transplantation.
• Patients with lymphoma with chemosensitive disease at the time of transplantation.
• Planned reduced intensity conditioning regimen.
• Patients must have a related or unrelated peripheral blood stem cell donor as follows:
  • Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
  • Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C and –DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.
• Cardiac function: Left ventricular ejection fraction at least 45%.
• Estimated creatinine clearance acceptable per institutional guidelines.
• Pulmonary function: DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%.
• Liver function acceptable per institutional guidelines.
• Karnofsky Performance Score at least 60%.
• Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant (see Section 2.6.4 for definition of postmenopausal).
• Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception (see Section 2.6.4 for list of barrier methods), or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.
• Plans for the use of post-transplant maintenance therapy must be disclosed upon enrollment and must be used irrespective of the outcome of the randomization.
• Voluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

• Prior allogeneic transplant.
• Active CNS involvement by malignant cells.
• Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including CMML.
• Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
• Presence of clinically significant fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated.
• Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible.
• Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• Female patients who are pregnant (as per institutional practice) or lactating.
• Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patients with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the Protocol Officer or Chairs.
• Planned use of ATG or alemtuzumab in conditioning regimen.

• Adults and children with a confirmed molecular diagnosis of cystic fibrosis.

• No confirmed diagnosis of CF.

• Congenital hemophilia A; FVIII ≤ 5% or congenital hemophilia B; FIX ≤ 5%.
• Birth date on or after January 1, 2010.
• Care established at one of the participating HTCs.
• Co-enrollment in the ATHNdataset.
• Parent or authorized guardian can provide informed consent.

• Patients who are referred to the HTC with no record of bleed and factor utilization data.

• Medical students and interns of the department of general surgery with experience of having placed <5 central venous catheters.

• Participants who do not consent to participate in the study.

• Patients with gastroparesis or functional dyspepsia
• Age 18-70 years
• Patients will be identified from among Mayo Clinic patients.
• Patients will have symptoms consistent with gastroparesis based on a national guideline for gastroparesis (symptoms PLUS delayed gastric emptying of solids).
• Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:
  • Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis;
  • One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning;
  • Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal);
  • No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations;
  • Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
• Ability to provide informed consent
• Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
• Body mass index of 18-35 kg/m2
• Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are permissible.

Exclusion Criteria:

• Patients with current H. pylori infection will be excluded.
• Pregnancy or lactation.
• Rapid metabolizers for CYP3A4 or CYP2C19 [estimated prevalence of 17% and 18% respectively based on literature review (36)] will be excluded since this could impact assessment of effects of cannabidiol.
• Patients with abnormal baseline liver transaminases (any value above UNL), since up to 3-fold, dose-related elevations of liver transaminases (ALT and/or AST) occur in 13% of treated patients (vs. 1% placebo).
• Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX.
• Concomitant use of valproate, CNS depressants and alcohol, other hepatotoxic drugs.
• The subject has HbA1c > 12%
• The subject is unable to withdraw any of the following medications listed in table 1a 48 hours prior to the study
• The subject has participated in another interventional clinical study within the past two weeks.
• History of recent surgery (within 60 days of screening)
• The subject has a history diagnosis of post-surgical gastroparesis
• A subject who in the determination of the investigator, possesses any condition that the investigator believes would put the subject at risk or would preclude the subject from successfully completing all aspects of the study.
• Concomitant use of CNS depressants and/or alcohol within 48 hours of GI testing, unless able to maintain a consistent dosage throughout the study.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

• All adult patients (≥ 18 years old) who are referred for invasive hemodynamic assessment of chronic dyspnea.
• Patients who have the capacity to understand and consent for the research study.

• Patients with known interstitial lung disease or pulmonary fibrosis.

• Patients over the age of 3 years with CHD HF who are candidates for MCS will be prospectively identified at the participating centers.

• Any CHD-HF patient unable to tolerate a CMR or cardiac CT will be excluded.