• Children aged 12-17.
• Adults of all ages.
• Patients with probable REM Behavior Disorder (RBD), RBD, and REM Sleep Without Atonia (RSWA) or Parkinson’s disease (PD), parkinsonism, mild cognitive impairment, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure seen in the Mayo Center for Sleep Medicine or Mayo Clinic Department of Neurology.
• Control subjects matched for age and gender with primary snoring or obstructive sleep apnea (matched for AHI of RBD/RSWA) without polysomnographic RSWA will also participate.

• Children less than 12 years of age.
• Those with developmental delay.

Eligibility last updated 12/27/22. Questions regarding updates should be directed to the study team contact.

• Male and female volunteers aged 18-80 years old.
• Persistent upper gastrointestinal symptoms (nausea, vomting, bloating, post prandial fullness or post prandial pain) for > 6 months.
• Having capacity to provide written informed consent before participating in the study.
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
• Undergoing a clinically indicated a gastric emptying study or having completed a gastric emptying study.

• Severe nausea or vomiting, which may preclude study assessments.
• Use of medications that, in the opinion of the investigator have the potential, to alter GI motility (e.g., narcotics, medications with significant anticholinergic effects, prokinetic agents) and which cannot be discontinued for 4 half-lives prior to the imaging studies.
• Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  A history of inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis).  However, participants with microscopic or collagenous colitis will be eligible to participate.
• Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy).  Appendectomy, cholecystectomy, tubal ligation,  hysterectomy, herniorrhaphy, and limited colonic resection are permissible.
• Participants who are allergic to eggs or decline to consume milk.
• History of radiation therapy to the abdomen.
• Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire 11.
• Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*
• Pregnant women, breast-feeding women, prisoners and institutionalized individuals.*
• Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain.
• Positive tissue transglutaminase antibodies (TTG).
• Poor peripheral venous access, if central venous access is not available.
• Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.

• Adults, ≥ 18 years old.

• Children under 18 years of age.
• Adults lacking capacity to consent.
• Adults with impaired decision making.

Inclusion Criteria
•Patients with Active Recurrent Pericarditis:

• Physician-confirmed (or confirmation in medical records) diagnosis of Recurrent Pericarditis (RP) defined as an initial acute, episode and at least one pericarditis recurrence after the initial acute episode.
• Experienced at least one pericarditis episode in the 3 years prior to inclusion.
• Under the care of a physician for the treatment and management of RP.
• Currently prescribed medication for RP.
• Able to read and understand English or Spanish.
• Have access to technology to complete ePROs.
• Provided informed consent or assent, as required by local regulations.

Inclusion Criteria
•Patients with Inactive Recurrent Pericarditis:

• Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial, acute episode.
• Patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion.
• Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment.

Exclusion Criteria
•Patients with Active Recurrent Pericarditis:

• Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post-thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases, except SJIA and adult Still’s disease, HIV.
• Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient English or Spanish proficiency that could interfere with ability to complete patient-completed assessments.
• Currently enrolled in a therapeutic investigational drug or device study.

Exclusion Criteria
•Patients with Inactive Recurrent Pericarditis:

• Experienced a pericarditis episode within 3 years from enrolling in the registry.
• Currently receiving RP treatment prescribed by a treating physician (e.g., CS, colchicine).
• Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post-thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases except SJIA and adult Still’s disease, HIV.
• Enrolled in a therapeutic investigational clinical trial during the observation period.

• Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves.
• Cobb angle between 40-60 degrees (inclusive).
• Flexible curve that that reduces to ≤ 30 degrees on lateral side bending radiographs or as evident by traction x-ray.
• Kyphosis angles of ≤ 55 degrees measured from T5 to T12.
• Appropriate candidate for posterior surgical approach.
• Patient has good general health.
• Patient has no known hypersensitivity or allergies to titanium.
• Patient’s guardian signs a written informed consent form (ICF).

• Any type of non-idiopathic scoliosis.
• Any main thoracic deformity that includes vertebral levels and cranial including to T2.
• Known history of existing malignancy, or any systemic or local infection.
• Spinal cord abnormalities that require treatment.
• Known neurological deficit (defined as motor grade < 5/5).
• Known poor bone quality defined as T score -1.5 or less.
• For female patient, pregnancy.
• Previous spine surgery.
• Active systemic disease, such as AIDS, HIV, or active infection.
• Active infection or the skin is compromised at the surgical site.
• Systemic disease that would affect the Patient’s welfare or overall outcome of the study.

• Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves.
• Cobb angle between 40-60 degrees (inclusive).
• Flexible curve that that reduces to ≤ 30 degrees on lateral side bending radiographs or as evident by traction x-ray.
• Kyphosis angles of ≤ 55 degrees measured from T5 to T12.
• Appropriate candidate for posterior surgical approach.
• Patient has good general health.
• Patient has no known hypersensitivity or allergies to titanium.
• Patient’s guardian signs a written informed consent form (ICF).

• Any type of non-idiopathic scoliosis.
• Any main thoracic deformity that includes vertebral levels and cranial including to T2.
• Known history of existing malignancy, or any systemic or local infection.
• Spinal cord abnormalities that require treatment.
• Known neurological deficit (defined as motor grade < 5/5).
• Known poor bone quality defined as T score -1.5 or less.
• For female patient, pregnancy.
• Previous spine surgery.
• Active systemic disease, such as AIDS, HIV, or active infection.
• Active infection or the skin is compromised at the surgical site.
• Systemic disease that would affect the Patient’s welfare or overall outcome of the study.

• Mayo Clinic patients with a previously confirmed infection with the novel SARS-CoV-2 virus who have been seen in the PCCOC, CARP, Pulmonary for post COVID clinic, Neurology, or approval by MAGPIES research group.
• Aged 5 years and older.
• All racial and ethnic groups are eligible.

• Lacking the capacity to consent.
• Prisoners and institutionalized individuals.

Eligibility last updated 9/8/21. Questions regarding updates should be directed to the study team contact.

.

1. Diagnosis and/or management of AAOCA at a CHSS member institution from January 1, 1998 forward
2. Male or female age 0-30 years at time of diagnosis
3. If surgical repair:
   1. Performed from January 1, 1998 to study initiation (January 20, 2009) for retrospective subjects
   2. Performed from January 21, 2009 forward for prospectively identified subjects
   3. Completed operative note
4. Structurally normal heart or with small, hemodynamically insignificant lesion, including:
   1. Patent ductus arteriosus 
   2. Atrial septal defect 
   3. Ventricular septal defect
   4. Mild pulmonic valvar stenosis 
   5. Bicuspid aortic valve without aortic stenosis
5. Parental/guardian permission (informed consent, and authorization as applicable) 
6. Subject consent, and authorization as applicable if ≥ 18 years of age and if appropriate, child assent for the observational/questionnaire portion of the study.

1. Anomalous coronary from the pulmonary artery, coronary artery atresia, or other coronary artery anomalies (e.g., coronary-cameral fistula, coronary aneurysms, myocardial bridging)
2. Hemodynamically significant structural heart disease, except as outlined above.

• Provisions of signed and dated informed consent form.
• Patient is 18 years of age and older.
• Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
• Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
• Maximum axial and anterior to posterior tumor dimension of ≤ 3.5cm after SOC.
• Patient has received 3 months of SOC per each participating institution’s guidelines.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4.
• Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System.
• Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC.

• Participation in an interventional trial for pancreatic cancer during the study data collection period.
• Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy.
• Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade.
• Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.

• Age ≥ 18 years old.
• Known cardiac ischemia, who are non revascularizable, or have not and will not be undergo coronary intervention for the duration of their participation in the study.
• Evidence of ischemia from previous clinical tests (echo, nuclear, standard ECG from past 6 months).
• Left Ventricular Ejection fraction > 40% by echo (evaluated last 3 months).
• Able to complete a cardiopulmonary exercise test without significant non cardiac limitations, primarily orthopedic.
• On guideline directed optimal therapy for stable ischemia.

• Anemia (< 7 mg/dl).
• Low potassium (< 3 mmol/L).
• Creatinine (> 5.0 mg/dl or < 0.6 mg/dl).
• Unable to exercise due primarily to orthopedic limitation.
• Severe lung disease.
• Morbid obesity (BMI > 42).
• Pregnant.
• Breast feeding.
• Significant arrhythmia (Vtach, Vfib, frequent PVCs, persistent afib, or 2nd or 3rd degree AV block).
• Seizures.
• Unstable angina.
• Coronary spasm.
• Recent MI (< 90 days).
• Recent PTCA (<90 days).

Inclusion Criteria

• For the HUMIRA treatment group
  • Children between the ages of 6 and 17 years inclusive at the time of enrollment
  • Diagnosed with moderately to severely active Crohn's Disease
  • Has been prescribed Humira therapy according to the local approved Humira product label
• For the immunosuppressant therapy treatment group
  • Children between the ages of 6 and 17 years inclusive at the time of enrollment
  • Diagnosed with moderately to severely active Crohn's Disease
  • Has been prescribed azathioprine, 6-mercaptopurine or methotrexate
• Parent or guardian or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric Crohn's Disease investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data informed consent form after the nature of the registry has been explained and there has been the opportunity to ask questions

Exclusion Criteria

• Cannot be treated in accordance with the local Humira product label
• Is currently being treated with any investigational agents or is receiving any investigational procedures
• Should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA

• Ages 18-60
• Able to provide written consent

• Renal Failure
• Pregnancy
• Active steroid use
• Active liver Disease
• Anemia (Hemoglobin < 12.5 g/dL in men and < 11.5 g/dL in women)
• H/O alcohol use (average > 2 drinks per day)
• BMI > 30

Inclusion Criteria

• Allogeneic HSCT patients surviving ≥ 1 year post-HSCT
• Diagnosis of both malignant and non-malignant conditions as HSCT indications
• HSCT survivors receiving any type of conditioning chemo/radiotherapy for HSCT
• Ability to provide written and verbal informed consent
• Age ≥ 18 years
• Adequate blood counts; i.e., platelets > 50,000 per microliter; HB > 9/dL, and ANC > 1000 per microliter

Exclusion Criteria

• HSCT survivor with human immunodeficiency virus (HIV) infection
• HSCT survivor with active hepatitis B or C HSCT survivor on any TKI for either Philadelphia chromosome positive cancers or for GVHD treatments or for any other indication (e.g., imatinib for GIST, sorafenib for FLT3+ AML etc.)
• HSCT survivor with any post-transplant maintenance chemotherapy
• Post-transplant relapse of cancer
• Active progressive CHRONIC chronic or overlap GVHD (per the NIH chronic GVHD criteria)
• Presence of uncontrolled psychiatric disorder
• Patient unable to give informed consent
• Extremely poor overall prognosis (< 6 months as deemed by the primary transplant physician)
• HSCT survivors with confirmed drug addiction
• HSCT survivors with active coronary artery disease (CAD) [including angina] or active congestive heart failure (CHF)
• International HSCT survivors in whom loss to follow-up would be a concern as deemed by primary transplant physician
• Known hypersensitivity or allergy to dasatinib, or quercetin
• Presence of uncontrolled lupus
• Presence of uncontrolled pleural/pericardial effusions or ascites
• Presence of active new cancer (solid or hematologic) except non-melanoma skin cancers
• Presence of progeroid syndromes in family
• Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
• Creatinine clearance < 60 mL/min/1.73 m^2 based on the Cockcroft-Gault
• Inability to tolerate oral medications
• Total bilirubin >2 x upper limit normal (unless deemed to be due to Gilbert's syndrome); AST/ALT >2.5 x ULN
• Active progressive ACUTE graft-versus-host disease
• Active progressive OVERLAP graft-versus-host disease
• Patients taking medications that are sensitive substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from infectious disease perspective, then they will be allowed only if the levels are therapeutic. Levels will be checked at baseline and also at day +4 post intervention.
• Patients taking H2-antagonists or proton pump inhibitors
• Patients on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors etc.)
• On antiplatelet agents (e.g., full dose aspirin, clopidogrel etc.). Baby aspirin if absolutely necessary from cardiac perspective will be allowed.
• On any quinolone antibiotic therapy for treatment or for prevention of infections.
• QTc > 450 msec. Common drugs that are well known in prolonging QTc include azithromycin, citalopram, escitalopram, fluconazole, and pentamidine. Baselines EKG will be obtained in each patient and if QTc > 450 msec, then they will be excluded from the trial.

• Subject is at least 18 years of age.
• Subjects is indicated for a routine ultrasound examination at the site, including with or without examination with contrast.
• Subject is willing and capable of providing informed consent and participating in this study.

• Subjects who are pregnant will be excluded from the study.
• Subjects with a limited capacity to consider being scanned on an additional ultrasound system will be excluded. 

1. Participants with chronic pancreatitis.

Inclusion Criteria:

• Age (years) ≥ 18.
• Able to provide Written Informed consent.
• Systemic sclerosis as defined by VEDOSS or ACR/EULAR 2013 Classification criteria.

• Individuals < 18 years.
• History of IBD (Crohn’s disease or ulcerative colitis), microscopic colitis, or celiac disease.
• Pregnancy.
• Prior abdominal surgery (except hernia, fundoplication, C-section, hysterectomy, appendectomy, and cholecystectomy).
• Prior antibiotic use or new probiotic use in the last 2 weeks.

• Subject must have a disease of interest. Specifically, subject must have one of:
  • head and neck squamous cell carcinoma (HNSCC);
  • non-small-cell lung cancer (NSCLC);
  • small cell lung cancer (SCLC);
  • urothelial carcinoma (UCC);
  • gastric or gastroesophageal junction adenocarcinoma;
  • cervical cancer;
  • esophageal squamous cell carcinoma (ESCC);
  • triple-negative breast cancer (TNBC); 
  • hepatocellular carcinoma (HCC);
  • renal cell carcinoma (RCC);
  • colorectal cancer (CRC).
• Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
• Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
• Subject must have undergone, or will undergo, medical imaging (e.g., CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
• Willing to provide electronic informed consent per IRB-approved protocol.
• Able to speak, read, and comprehend English fluently.
• Subject is 18 years of age or older.
• Subjects must have sufficient tissue available to fulfill the specimen requirements of the study, as defined in the SPECIMENS TO BE COLLECTED section of this protocol.

• Inability or unwillingness to provide informed consent.
• Subject who does/did not have one of the cancers listed above (other histologies).
• Subject has already participated in this trial.

• Subjects with hereditary eye disease.
• Subjects with a family history of hereditary eye disease.
• Subjects without hereditary eye disease and no family history of hereditary eye disease who would serve as a control in specific case-control experiments.
• Ability to understand and willingness to sign the informed consent documents.

• Unable or unwilling to sign or understand the informed consent documents.
• Unwilling to participate in the research.
• Unwilling to allow genetic testing.
• Unwilling to allow samples to be sent to other institutional for testing.
• Not meeting the inclusion criteria.

• Females and males between the ages of 18 and 90. 
• Family or personal history of cancer and/or a family or personal history of genetic variants (deleterious or variant of unknown significance) in cancer predisposition genes.
• Participants may also be those who have tested negatively for genetic variants in cancer predisposition genes.

• This project does not involve prisoners or children.

• Subjects with an ocular tumor.
• Subjects with a family history of an ocular tumor.
• Subjects without an ocular tumor and no family history of ocular tumor who would serve as a control in specific case-control experiments.
• Subjects within the United States who are not currently Mayo Clinic patients.
• Ability to understand and willingness to sign the informed consent documents.

• Unable or unwilling to sign or understand the informed consent documents.
• Unwilling to participate in the research.
• Unwilling to allow genetic testing.
• Unwilling to allow samples to be sent to other institutions for testing.
• Not meeting the inclusion criteria.

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

Eligibility last updated 11/2/23. Questions regarding updates should be directed to the study team contact.

• Male or female, age 55 to 80 years, inclusive, at the time of informed consent:
  • Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity of amyloid positivity < 65 years:
    • First degree relative diagnosed with dementia onset before age 80; or
    • Known to possess at least 1 apolipoprotein є4 variant (APOE4) allele; or
    • Known before screening to have elevated brain amyloid according to previous PET or CSF testing. Individuals with historical amyloid PET scans with Aβi (e.g., from preclinical AD studies such as A4 or EARLY) are eligible to be screened provided the subject did not participate in any clinical studies involving antiamyloid therapies subsequent to the PET assessment.
• Global CDR score of 0 at Screening.
• Mini Mental State Examination (MMSE) score ≥ 27 (with educational adjustments) at Screening.
• Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at Screening of ≥ 6.

A45 Trial:

Elevated brain amyloid pathology by amyloid PET: Elevated amyloid is defined as approximately > 40 centiloids on Screening scan.

A3 Trial:

• Intermediate levels of brain amyloid pathology by amyloid PET: Intermediate amyloid is defined as approximately 20 to 40 centiloids on Screening scan.
• Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject’s daily function.
• Provide written informed consent.
• Willing and able to comply with all aspects of the protocol.

• Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test witha minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). For women of childbearing potential, a separate baseline assessment is required if a negative Screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
• Females of childbearing potential who:
  • Within 28 days before study entry, did not use a highly effective method of contraception,which includes any of the following:
    • total abstinence (if it is their preferred and usual lifestyle);
    • an intrauterine device or intrauterine hormone-releasing system;
    • a contraceptive implant o an oral contraceptive (with additional barrier method) (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation);
    • have a vasectomized partner with confirmed azoospermia.
  • Do not agree to use a highly effective method of contraception (as described above) throughoutthe entire study period and for 28 days after study drug discontinuation For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception; i.e., double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide.
    • NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age range, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
• History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
• Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures.
• Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRIscanners), or exhibit other significant pathological findings on brain MRI at Screening, including but not limited to: more than 4 microhemorrhages (defined as 10 mm or less at the greatest diameter); a singlemacrohemorrhage greater than 10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations that are at high risk for hemorrhage, or infective lesions; evidence of multiple lacunar infarcts (that in the opinion of the investigator, may impact cognition) or stroke involving a major vascular territory, severe small vessel, or severe diffuse white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not beexclusionary).
• Hypersensitivity to any monoclonal antibodytreatment.
• Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study.
• Bleeding disorder that is not under adequate control (including a platelet count 1.5) at Screening.
• Results of laboratory tests conducted during Screening that are outside the following limits:
  • Thyroid stimulating hormone (TSH) above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all subjects whether or not they are taking thyroid supplements
  • Abnormally low (below lower limit of normal [LLN]) serum vitamin B12 levels for the testing laboratory (if subject is taking vitamin B12 injections, level should be at or above the LLN for the testing laboratory). A low vitamin B12 is exclusionary, unless the required follow-up labs (homocysteine and methylmalonic acid [MMA]) indicate that it is not physiologically significant.
• Known to be human immunodeficiency virus (HIV) positive.
• Any other clinically significant abnormalities that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety, such as:
  • Physical examination or vital signs at Screening; 
  • Laboratory tests or ECG at Screening;
  • Other medical conditions (e.g., cardiac, respiratory, gastrointestinal, psychiatric, renal disease), which are not adequately and stably controlled;
  • Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.
• Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male subjects with treatment cycles completed at least 6 months before Screening). Subjects who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
• Answer “yes” to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at Baseline, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.
• Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening. Subjects who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse.
• Taking prohibited medications. 
• Participation in a clinical study involving:
  • Any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before Screening (anti-amyloid therapies within 1 year before Screening), unless it can be documented that the subject was randomized to placebo or never received study drug;
  • BAN2401;
  • Any new chemical entities or investigational drug for AD within 6 months before Screening unless it can be documented that the subject received only placebo;
  • Any other investigational medication or device study in the 8 weeks or 5 half-lives (whichever is longer) of the medication before randomization unless it can be documented that the subject was in a placebo treatment arm.
• Planned surgery during the Pre-randomization Phase or within 3 months of Randomization, which requires general anesthesia.

• Age greater than 28 days and less than 85 years.
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass.

• Expected order for washed or volume reduced platelets.
• Patient with known anti-platelet antibodies.
• Platelet transfusion refractoriness due to anti-HLA antibodies.
• Known or suspected pregnancy.
• Previously randomized in this study.
• Conscious objection or unwillingness to receive blood products.
• Known IgA deficiency.
• Known congenital platelet disorder.
• Known congenital bleeding disorder.
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis.
• Patients intended to receive whole blood either intra-operative or post-operative for bleeding.
• Platelet transfusion (of any type) within 24 hours prior to receiving study platelets.
• Pre-operative thrombocytopenia.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

• Diagnosed with ADPKD prior to 18 years of age.
• Demonstration of ADPKD by clinical information, imaging studies, biopsy, autopsy, or genetic testing.

• Patients with autosomal recessive polycystic kidney disease (ARPKD), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.   

Inclusion Criteria
•All Groups:

• All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes.
• Meet one set of group-specific inclusion criteria listed below.
• All participants must be ≥ 18 years old and ≤ 75 years at the time of enrollment.

Inclusion Criteria
•No Pancreas Disease Controls:

• No personal history or symptoms of pancreatic disease.
• No upper abdominal symptoms
• *Participant will answer “No” and “None” to below questions to meet this criterion:
  • Have you had a stomach ache or pain more than SIX times in the past year?
  • □ YES            □ NO
• How many times have you had a feeling of WANTING TO THROW UP (nausea) in the last year?
  • □ NONE        □ ANY
• No family history of pancreatic disorders, celiac disease, cystic fibrosis.
• No history of acute infectious or inflammatory conditions requiring medical treatment or evaluation in the preceding 6 months (per provider clinical judgment).
• No history of cancer, except for non-melanoma skin cancers.
• No known pregnancy at the time of enrollment.
• No solid organ transplant or history of HIV/AIDS.
• Able to provide an informed consent.
• Not currently incarcerated.
• ASA 1-2.

Inclusion Criteria - Chronic Upper Abdominal Pain of Suspected Pancreatic Origin:

• Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration for which a pancreatic origin is clinically considered in the differential diagnosis.*

* Pancreatic type pain is defined as epigastric pain that is often constant, often worsens post-prandially, and may radiate to the back. This can often be associated with lipase/amylase elevations that do not meet the threshold for diagnosis of AP (i.e. <3-fold upper limit of normal).

• No history of AP or CP.
• No prior endoscopic sphincterotomy or pancreatic surgery.
• Normal cross-sectional abdominal imaging (CT and MRI/MRCP).**

** CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment as “Chronic Abdominal Pain – Undifferentiated”. The second imaging study can be performed in this situation after the enrollment and the final assignment into the appropriate subgroup can be done after review of the imaging results.

• If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation and attempts will be made to complete this during follow-up as feasible. If the second study could not be performed, the subject will be assigned to Chronic upper abdominal pain group if the available study was normal or as Indeterminate CP if the available study shows Cambridge 1-2 findings.

Inclusion Criteria - Indeterminate CP with no history of AP:

• Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration for which a pancreatic origin is clinically considered in the differential diagnosis*

* Pancreatic type pain is defined as epigastric pain that is often constant, often worsens post-prandially, and may radiate to the back. This can often be associated with lipase/amylase elevations that do not meet the threshold for diagnosis of AP (i.e. <3-fold upper limit of normal).

• No history of AP or CP.**

**AP is defined as compatible symptoms (upper abdominal pain) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR).

• Cambridge grade I-II changes of CP# on cross-sectional imaging (CT or MRI/MRCP).***

*** CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment.  CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment as “Chronic Abdominal Pain – Undifferentiated”. The second imaging study can be performed in this situation after the enrollment and the final assignment into the appropriate subgroup can be done after review of the imaging results.

• If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation and attempts will be made to complete this during follow-up as feasible. If the second study could not be performed by month 6 after enrollment, the subject will be assigned to Chronic upper abdominal pain group if the available study was normal or as Indeterminate CP if the available study shows Cambridge 1-2 findings. 
• No prior endoscopic sphincterotomy or pancreatic surgery.

Inclusion Criteria - Acute Pancreatitis (AP):

•  History of one documented attack of AP in the preceding 18 months.*

* AP is defined as compatible symptoms (upper abdominal pain) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR). Patient should not have had an attack of AP in the month prior to enrollment.

• Patients should not have had an ERCP prior to the episode of AP.
• Pancreatitis episode is not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
• Pancreatic necrosis, if present, is <50% (to be verified by a CPDPC site radiologist).
• Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP).***

*** CT and MRI/MRCP must be performed ≤ 24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study  can be performed in this situation after the enrollment.

• If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation. Final group assignment in this situation will be based on the available study.   
• No prior pancreatic surgery.

Inclusion Criteria - Recurrent Acute Pancreatitis (RAP):

• Two or more documented attacks of AP* separated by at least 1 month, with complete symptom resolution between the attacks.

* AP is defined as compatible symptoms (epigastric pain with nausea or vomiting) together with A) ≥ 3-fold elevation of serum amylase and/or lipase above upper limit of normal, AND/OR B) features of AP on cross-sectional imaging (CT and/or MR).

• Patient should not have had an ERCP prior to having first documented attack of pancreatitis.
• Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP)**

**CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study can be performed in this situation after the enrollment.

• Cambridge grade < III changes of CP# on cross-sectional imaging (CT or MRI/MRCP).**

**CT and MRI/MRCP must be performed ≤24 months prior to enrollment OR within 6 months after study enrollment. CT and MRI scans must be intravenous contrast-enhanced and MRCP with secretin (a non-contrast MRI and MRCP without secretin prior to enrollment is acceptable at baseline to be used for enrollment). If the patient has had only one imaging study, the patient is eligible for enrollment. The second study can be performed in this situation after the enrollment.

• If the second study was planned within 6 months after enrollment but could not be completed, it will not be considered as eligibility violation. Final assignment in this situation will be based on the available study.
• In a rare circumstance, the last imaging patient had was >24 months prior to enrollment. In this circumstance, the patient is still eligible for enrollment, and can undergo CT scan first, and if there is no evidence of Cambridge 3-4 findings, undergo an MRI/MRCP to fulfill entry criteria. If the planned studies could not be completed within 6 months after enrollment, the final group assignment will be in this situation will be based on the available study.
• Pancreatitis episodes are not attributable to gallstones, medications, trauma or autoimmune pancreatitis.
• No prior pancreatic surgery.

Inclusion Criteria - Definite Chronic Pancreatitis

• Presence of unequivocal CP (i.e., Cambridge grade ≥ 3) and/or parenchymal and/or ductal calcifications by cross-sectional imaging (IV contrast-enhanced MRI/MRCP or CT) verified by the CPDPC site radiologist.*

* Must exclude the possibility that calcifications are vascular. Calcifications noted by EUS only (and not correlated with CT) are not included as definite CP. A non-contrast CT scan or MRI/MRCP documenting definite CP as per criteria is acceptable for enrollment.

• Pancreatic histology diagnostic of CP (including findings of fibrosis [Ammann’s ≥ 6], chronic inflammation, and acinar loss) as verified by a CPDPC site pathologist, if pathology slides are available for review.

• History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which   results in suspected disconnected duct syndrome.
• Primary pancreatic tumors
  •pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 
• Pancreatic metastasis from other malignancies.
• History of solid organ transplant, HIV/AIDS.
• Known isolated pancreatic exocrine insufficiency (e.g., in the absence of any eligible inclusion criteria).
• Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator’s opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
• Patients with known abnormal creatinine (GFR < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP (yellow) subgroups).
• Failure to agree for longitudinal follow-up.
• Known Pregnancy. All participants of childbearing potential, except if post-menopausal [i.e., no menses for ≥ 2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
• Currently incarcerated.
• Inability to get MRI/MRCP in patients with chronic abdominal pain of suspected pancreatic origin (Green II) or Suspected CP (Yellow groups) at baseline (e.g., metal object in the body which precludes performance of MRI).

• Adult subject 18 years or older.
• Scapula and proximal humerus must have reached skeletal maturity.
• Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy.
• Willing and able to comply with the protocol.
• Willing and able to sign the informed consent form.
• Patients with an adjusted Constant Score ≤ 65.

• Active local or systemic infection, sepsis, or osteomyelitis.
• In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
• In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
• In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
• In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
• Metabolism disorder that could compromise bone formation, or Osteomalacia.
• Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
• Known allergy or suspected allergy to the materials.
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Medical condition(s) or balance impairments that could lead to falls (e.g., epilepsy not well-controlled with medication, Multiple Sclerosis, etc).
• Previous failed arthroplasty.
• Nonfunctional deltoid muscle.
• Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
• Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
• Currently, or within the last six months, or planning to be on chemotherapy or radiation.
• Recent or ongoing alcohol or drug abuse as determined by the investigator.
• Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
• Currently enrolled in any clinical research study that might interfere with the current study.
• Known history of severe depression.
• Primary insurance is Workers’ Compensation.
• The study has completed 109 implant attempts for the randomized treatment arm.
• Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
• Chronic shoulder dislocation with or without fracture, > 6 weeks.
• Parkinson’s disease.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.