• 18 years of age or older.
• Biologically female.
• Non-Hispanic Black (NHB).
• Diagnosis of breast and/or ovarian cancer or family history of breast and ovarian cancer.

• Under age of 18.
• Not biologically female.
• Ethnicity other than NHB.
• Has not been diagnosed with breast and/or ovarian cancer and does not have a family history breast and ovarian cancer.

• Children age 2-18 years old.
• Seen on Mayo 16 for an outpatient clinic appointment.

• Participant unable to stand for stadiometer height.
• Pregnant patients.

• Admission to PICU or SDU at any point during illness due to severity (not due to bed availability).
• ≤ 21 years old on admission.
• Influenza-associated LRTI:
  • Positive influenza test (rapid antigen, DFA or PCR); and
  • > 1 sign of acute respiratory illness: cough, shortness of breath, tachypnea or retractions, invasive or non-invasive mechanical ventilation, need for FiO2 to maintain SpO2 > 92%, pulmonary infiltrate or hyperinflation on chest imaging.
• At least 1 parent or legal guardian able and willing to provide permission.

• Previous enrollment in this study during the current season.
• Hospital acquired influenza infection as determined by site hospital infection control experts.
• Pre-existing conditions that are known risk factors for severe influenza infection (with the exception of asthma or reactive airways disease (RAD).  Exclusions include:
  • Chronic pulmonary (except asthma/RAD) or upper airway disorders;
  • History of prematurity in patients < 1 year of age;
  • Known immune disorders;
  • Cardiac disease with compromise requiring medications or alterations in activities;
  • Neurologic disorders impairing respiratory muscle strength or secretion management;
  • Sickle cell disease;
  • Complex genetic disorders impairing multiple organ systems; AND
  • Metabolic disorders that may be worsened by infection including diabetes mellitus.

• Patients presenting to the catheterization laboratory to undergo non-emergent cardiac catheterization procedures including coronary angiography, percutaneous coronary intervention, right heart cath, ablation, myocardial biopsy.
• Adult patients (18 years old or older).
• Patient willing and able to give informed consent.

• Emergent procedure.
• ST elevation > 1 mm on any two contiguous ECG leads.
• Hemodynamic instability (SBP > 220 or < 80, HR > 160).
• Patients < 18 years old (children).
• Patients known or suspected to be pregnant.
• Incarcerated patients (FMC patients).
• Patients with a pacemaker or defibrillator.
• Metal implants in the body (that are not MRI safe).
• Patients that are unable to lie down in the MCG machine or stay still.
• Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
• Patients without the capacity to provide written informed consent.

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

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

• Age 18-65 years.
• Patients with injuries resulting in loss of elbow flexion, in particular a traumatic brachial plexus injury.
• Functional passive range of motion of the involved upper extremity.
• Able to follow simple directions.
• Willingness to participate in the study.
• No restriction will be placed on gender, race, or ethnicity.

• Under 18 and over 65 years of age.
• Closed head injury with resultant inability to follow commands.
• Soft tissue or skeletal injuries which preclude use of an orthosis.
• Non-functional passive range of motion.
• Neuropathic pain which prevents use of a powered exoskeleton.
• Unwillingness or inability to comply with test procedures.

• Subject aged 50-80 years at time of consent.
• Increased risk of lung cancer defined by having at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
• Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening.
• Willing to consent to the investigational blood draw during index low dose CT scan screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
• Willing to consent to a 1-year, 2-year and additional follow-up per protocol.

• Subject has not smoked for 15 or more years.
• Subject has less than 20 pack-year smoking history.
• Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
• Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer.
• Preexisting or history of lung cancer.
• Previously diagnosed high-risk lung lesion.
• History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
• Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
• Currently receiving treatment for pneumonia.
• Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
• Additional cohorts: inclusion and exclusion criteria will be specified for each cohort as appendixes.

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

• Over 18 years old.
• Fusion of the MCP joint at Mayo Clinic between January 01, 1990- December 31, 2020.

• Individuals under 18 years old.

Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.

• Patients with adequate clinical residual serum ( ≥ 0.5 mcL) or prospectively drawn blood obtained within 10 days of native renal biopsy, and prior to initiation of immunosuppressive therapy. 
• The glomerular diseass of interest occur in varied patient populations; therefore, both adult and pediatric patients will be enrolled.   

• Does not meet Inclusion Criteria.

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

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

• Living kidney donors > 18 years.

• Anyone not meeting the inclusion criteria including liver donors.

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

Eligibility last updated 8/10/23. Questions regarding updates should be directed to the study team contact.

• Provide written informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age ≥ 18 years.
• Diagnosed with MACS:
  • At least 2 abnormal post-dexamethasone cortisol results:
    • 1 mg post-dexamethasone cortisol > 1.8 mcg/d;  or
    • 8 mg post-dexamethasone cortisol > 1 mcg/dL;
  • Historical dexamethasone suppression test results can be used if performed within 6 months prior to enrollment.
• Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia).
• At least one of the following comorbidities:
  • Obesity (BMI > 30 kg/m^2);
  • Dysglycemia;
  • Dyslipidemia;
  • Hypertension;
  • Osteopenia;
  • Osteoporosis;
  • Fragility fractures.
• Ability to take oral medication and be willing to adhere to the study intervention regimen.
• For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study.
• For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <5% per year during the treatment period and for 6 months after the last dose of study treatment.
• Stable timing for bedtime for at least one week prior to on-site study visits

• Planned alternative therapy for MACS within 6 months after joining the study.
• Current use of oral exogenous glucocorticoid therapy.
• Current use of opioid therapy > 20 MME/day.
• Planned use of oral exogenous glucocorticoid therapy.
• Planned use of opioid therapy > 20 MME/day.
• Use of injectable glucocorticoid within the last 6 weeks.
• Investigator’s judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome.
• Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection;
  • Symptomatic congestive heart failure;
  • Unstable angina pectoris;
  • Cardiac arrhythmia;
  • Psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy or lactation.
• Known allergic reactions to metyrapone.
• Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone.
• Treatment with another investigational drug or other intervention within lower than specific therapy washout period.

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

Eligibility last updated 8/14/23. Questions regarding updates should be directed to the study team contact.

• 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.

• 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.

• Patients 18 years of age and older.
• Undergoing a cardiac surgery at participating centers.
• Intraoperative team members involved in cardiac surgery at participating centers.

• Individuals under 18 years of age.
   

• Plain film skeletal survey is the universal screening examination all cases of suspected child abuse in patients aged 24 months and younger.
• All patients who fit these criteria and present to the Rochester, Mayo Clinic site are routinely evaluated by the Child Abuse Team, led by coinvestigators Drs. Arne Graff and Chris Derauf.
• The non-contrast ultra-low dose chest CT will be performed the same day as the plain film skeletal survey, or less optimally within 48 hours. Logistically, many of these patients also receive head CT as part of the initial work-up, which would be the ideal time to add this additional examination, as it would add just seconds to the examination already being performed.
• A follow-up ultra-low dose chest CT will also be performed at the time of follow-up plain film skeletal survey. Follow-up imaging is typically recommended at about 2 weeks, but a wider window of 1-4 weeks will be allowed to capture this patient population, which is a reasonable time-period to evaluate for healing changes of occult fractures on x-ray.

• Patients older than 24 months.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

• Adult women, ≥ 18 years of age.
• Breast lesion and are scheduled for clinically-indicated biopsy.

• < 18 years of age.
• Previous breast surgery or breast implant.
• Lacking capacity to consent.
• Pregnant or lactating.
• Receiving cancer therapy such as chemotherapy or radiation therapy.

Female patients with breast lesions scheduled for clinically indicated biopsy; age of 18 or above.

Inclusion Criteria
•RBD Group:

• All participants must have polysomnogram-confirmed RBD by ICSD-3 criteria [AASM 2014]. An EDF of a polysomnogram demonstrating RSWA must be available from NAPS1 or obtainable from elsewhere to verify this entry criterion.
• Capable of providing informed consent at time of NAPS2 study enrollment, unless the participant previously enrolled in NAPS1:
  • For individuals previously enrolled in NAPS1 who developed cognitive decline and are no longer able to provide informed consent prior to enrollment in NAPS2, informed consent will be obtained from the legally authorized representative, and written assent obtained from the participant;
  • Individuals who enroll in NAPS2 will identify a proxy at initial enrollment. If a participant subsequently develops cognitive decline and is no longer able to provide informed consent for revised consent documents during follow-up visits, the proxy or legally authorized representative (depending on local regulations) will be asked to provide informed consent, and written assent obtained from the participant.
• Age ≥ 18 years.

Exclusion Criteria
•RBD Group:

• PD, dementia of any type, or MSA unless the individual was previously enrolled in NAPS1. Participants who phenoconvert during NAPS2 will be eligible to continue participation if they enrolled at a time when they were capable for providing informed consent.
  • Coexisting cognitive, motor, or autonomic symptoms are permitted in the RBD group provided that a diagnosis of dementia, PD, MSA, or any other overt neurodegenerative phenotype is not present;
  • The presence of “soft” cognitive, motor, autonomic, or other neurologic symptoms are appropriate for inclusion since 1) such features are common among RBD patients in the clinical setting, 2) such features are common in NAPS1participants,3) the NAPS2 program is designed to mimic recruitment of RBD patients who may be appropriate for participation in clinical trials, and 4) a primary goal of NAPS2 is to identify those at short-term risk of phenoconversion since clinical trials will focus on such RBD patient.
• Narcolepsy-associated RBD.
• RBD secondary to any known cause except prodromal synucleinopathy.
• Participation in a clinical trial, except by specific permission by the Executive Committee.
• In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol. 

Exclusions for Specific Procedures - RBD Group:

RBD participants will not be excluded from NAPS2 for the following exclusions; they will be excluded from undergoing the specific procedure(s).

• Exclusions specific for MRI include any of the following:
  • metal implant or pacemaker;
  • Pregnancy;
  • Head/shoulder or body girth/weight unable to fit in the MRI scanner and coils;
  • Note that RBD participants who have claustrophobia or other issues completing MRI will not be excluded necessarily from MRI;
• Exclusions specific for DaTscan SPECT include any of the following:
  • Pregnancy;
  • Head/shoulder or body girth/weight unable to fit in the SPECT scanner;
  • Note that RBD participants who have claustrophobia or other issues completing DaTscan will not be excluded necessarily from DaTscan;
  • Note that RBD participants who take concomitant medications that are potentially interfering for DaTscan as listed in the NI Manual of Procedures will not be excluded necessarily from DaTscan, but the specific medication(s) will be held if possible per site-specific protocols and at the discretion of the local Site Investigator. Any such medications will be noted in source documents at the time of scan.
  • History of an allergic reaction to iodine and iodine-containing products such as IV contrast dye (used for CT scans, IVPs, etc.). An allergy to shellfish is not exclusionary.
• Exclusions specific for lumbar puncture include any of the following:
  • Diagnosis of a bleeding disorder;
  • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Inclusion Criteria
•Control Group:

• Ability to provide written consent.
• Age ≥ 18 years
• Must meet age, sex, and race matching criteria per the DMS core recommendations for the site.
• Must be willing and able to undergo all testing procedures, including neuroimaging and lumbar puncture.
• Normal capacity to perform complex activities of daily living independently based on informant or physician report.

Exclusion Criteria
•Control Group:

• History of dream enactment behavior to suggest RBD
• Parkinsonism, MSA, dementia, or mild cognitive impairment
• Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning:
• • Since the goal is to include typical normal persons, the Controls may include participants with adequately controlled medical and psychiatric conditions (based on physician determination and stratification in the RBD cohort);
  • This includes the use of stable doses of antidepressant medications, and their presence will be factored into any RBD vs Controls analyses.
• Contraindications to complete MRI, including any of the following:
  •  
  • metal implant or pacemaker;
  • too claustrophobic to complete MRI scans;
  • previous issue completing an MRI;
  • Pregnancy;
  • Head/shoulder or body girth unable to fit in the MRI scanner and coils;
  • Body mass index > 35 kg/m^2 or weight > 300 lbs, due to neuroimaging scanner limits;
  • Participation in a clinical trial, except by specific permission by the Executive Committee;
  • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition.
• Contraindications to complete lumbar puncture:
  • Diagnosis of a bleeding disorder;
  • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Eligibility last updated 1/14/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria:

For controls:

• The study participants must be between the ages of 12—60;
• The study participants must read and speak English.

For patients recovering from ACL injury or ACLr:

• Unilateral ACLr or unilateral ACL injury with no surgical intervention. As is common, injuries may include disruption of the meniscus, articular cartilage, or subchondral bone. Surgery may include meniscus repair or partial meniscectomy as this is a common associated finding in the setting of an ACL injury in young athletes;
• Included physical therapy interventions: Therapist will follow their own standard, typical protocol for recovery after ACL injury or ACLr;
• Between the ages of 12—60 yrs. of age;
• Testing at the time of clearance for sport or within 1 year of such clearance. There are reports that return-to-sport takes up to 2 years.

For controls:

• Study participants will be excluded if any of the following are present:
  • Neurological disorders;
  • No history of lower extremity injury in the past 6 months that has prevented you from participating fully in sports activities;
  • Presence of any medical condition that would impair the participant’s ability to perform the tasks proposed in this study;
  • Study participants will be excluded if a self-reported medical condition would impair the participant’s ability to perform the tasks proposed in this study.

For patients recovering from ACL injury or ACLr:

• Excluded surgical interventions: None, consistent with inclusion criteria.
• Other:
  • Less than 2 months post-injury if no surgery was done, or less than 2 months post-surgery if surgery was done;
  • Moderate pain: Pain > 4/10 visual analog score (VSA);
  • Inability to flex affected leg between 60 and 120 degrees to achieve testing position.

Eligibility last updated 3/29/22. Questions regarding updates should be directed to the study team contact.

Patients undergoing gracilis transfer surgery

• Mayo Clinic patients diagnosed with or suspected to have COVID-19 (infection with SARS-CoV-2).

• None.

• Adults, ≥ 18 years if age.
• Subjects who have respiratory tract specimens positive for the SARS-CoV-2 virus.

• Individuals < 18 years of age.
• Unable to provide consent.

Inclusion Criteria:

• Diagnosis of Type 1 Diabetes Mellitus.

• Diagnosis of Diabetic Nephropathy.

• Healthy volunteers
  aging from 25 to 65 years (male or female).
• Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
• With a body mass index (BMI) comprised between 18 and 35 kg/m^2 and weight > 50 kg at Screening.
• Able to comply with study requirements and to provide signed informed consent.
• Has signed the informed consent form before beginning any study procedure.
• Regular defecation (frequency and stool consistency, with at least about three bowel movements a week).
• For women of childbearing potential :
  • A negative urine pregnancy test immediately prior to starting the study treatment;
  • Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal; i.e., 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
    • Surgical sterilization;
    • Hormonal contraception (implantable, patch, oral, intra-muscular);
    • Intra-uterine device;
    • Double barrier method (diaphragm plus condom);
    • At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance.

• History of hypersensitivity to the study treatments (active substance or excipients), brewer’s or baker’s yeast.
• Contraindication and special warning to the study treatments according to the Summary of Product Characteristics (SmPCs).
• History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average.
• History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily.
• Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago).
• History of Clostridium difficile infection.
• Active gastrointestinal disease.
• Known chronic or recurrent systemic disorder (including diabetes and hypertension)  that may interfere with the study treatment evaluation.
• Associated immune deficiency.
• Severe hepatic or renal impairment.
• Clinically relevant abnormalities in results of laboratory tests as per Investigator’s judgement.
• Patients with a central venous catheter.
• Oral or systemic antibacterial therapy during the 3 months prior to study enrollment.
• NSAIDs and proton pump inhibitor treatment longer than 1 week, within 3 months prior to study enrollment.
• Steroids within 6 weeks prior to study enrollment.
• Use of medications affecting gastrointestinal transit or permeability within 7 days prior to the testing.
• Use of artificial sweeteners, lactulose, mannitol within 2 days prior to the testing and during the 24 h testing period.
• New prescription medications during the 2 weeks prior to study enrollment.
• Use of probiotics or drugs that alters gut microbiota or function, during 4 weeks prior to study enrollment.
• Intake of antifungals within 14 days prior to study enrollment.
• Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator.
• Current smoker.
• History or presence of drug or alcohol abuse.
• Inability to abstain from intensive muscular effort the day before the intestinal permeability test.
• Breast-feeding woman.
• Patients enrolled in another clinical trial where they received an investigational treatment within the past 30 days.
• Patients not able to fill in the study questionnaires.
• Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Eligibility last updated 8/11/23. Questions regarding updates should be directed to the study team contact.

• Patients (≥ 18 years of age) with a solid pancreas tumor requiring a clinical endoscopic ultrasound for diagnostic and staging purposes. 
• Freely of their own will, able to complete a written informed consent.

• Patients under 18 years of age.
• Pregnant.

• All patients ≥ 16 years old.
• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN), and Mayo Clinic Orthopedics and Sports Medicine (Minneapolis, MN). 

• Patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
• Substantial alcohol or drug abuse.
• History of narcotics within 6 months of surgery.
• Pregnancy.
• Renal impairment.
• Peptic ulcer disease.
• GI bleeding.

• All patients ≥ 16 years old.
• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN), and Mayo Clinic Orthopedics and Sports Medicine (Minneapolis, MN). 

• Patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
• Substantial alcohol or drug abuse.
• History of narcotics within 6 months of surgery.
• Pregnancy.
• Renal impairment.
• Peptic ulcer disease.
• GI bleeding.

• Adult (≥18 years of age) donors recruited for lymphoid tissue biopsy by the principal investigator, co-investigators, study coordinators, Infectious Disease clinic nurses, or clinic phlebotomists.
• Required to have a platelet count >50,000/mm³ documented in the medical record within 30 days prior to the procedure.
• Eligible participants may have HIV infection, or another infection or inflammatory condition that may affect the content or structure of lymph nodes, or no known disease if used as a normal control. 

• Inability to provide informed consent
• Self-reported or clinically documented pregnancy
• Known allergy to local anesthetic
• Significant bleeding diatheses
• Active bacterial infection
• Any other condition that in the opinion of the principal investigator would increase the risk of the adverse events associated with the surgical procedure.

• ≥ 18 years of age.
• Second or third trimester of healthy pregnancy.
• Meet all tissue donor eligibility criteria (as defined by 21 CFR 1271 donor eligibility criteria).
• Planning to deliver her infant at Mayo Clinic Rochester via Cesarean Section.
• Able and willing to provide written informed consent.

• Failure to meet 21 CFR 1271 donor eligibility criteria based on responses to a Tissue Donor History Questionnaire (administered at the time of enrollment), including but not limited to: history of malignancy (including melanoma and any form of other skin cancer <6 months from diagnosis*), transplant, long-term use of steroids, autoimmune disorders, or chronic infections such as HIV, Hepatitis, TB, MRSA etc.
• Positive infectious disease result on any test in the infectious disease screening panel collected during Visit 1 or post-operatively with the exception of CMV** (including HBsAg Screen, HBc Total Ab, HBV NAT, HCV NAT, HIV-1 NAT, HCV Ab Screen, HIV-1/-2, plus O Ab Screen, HTLV-I/-II Ab Screen, T. cruzi Total Ab, Syphilis Ab Screen, West Nile Virus NAT, ZIKA NAT).
• Abnormal pregnancy that may include:
  • Birth defects of the fetus;
  • Maternal complications with the placenta or umbilical cord anatomy;
  • Any complications during the birthing process.
• Vaginal delivery.
• Excluded after medical records review or physical exam.

NOTE: Enrolled subjects will be excluded from the study if, at the time of delivery, any of the below occur. In these situations, tissue and cord blood will not be collected, and the subject will be withdrawn from the study. Tissue will be given to clinical pathology for review post-delivery as standard procedure.

Exclusion Criteria Post Enrollment:   

• Placentas with Apgar test < 7 at 5 minutes.
• Gestation period of < 37 weeks.
• Multiple gestation (twins or greater).
• Suspected chorioamnionitis.
• Time between membrane rupture and delivery > 18 hours.
• Any significant fetal medical history including: stillborn, respiratory distress, ominous heart tracing, fetal anomaly, oligohydramnios, transfer to NICU, and IUG.
• Any significant maternal medical history including: recurrent reproductive complications, unexplained maternal fever, collagen vascular disease, hypertension/preeclampsia, diabetes, and substance abuse.
• Unusual anatomic findings (placental mass, true knots, or unusual findings per the obstetrician).
• SARS-CoV-2 (COVID-19) infection during pregnancy.

* Melanoma is excluded, any skin cancer diagnosis > 6 months from resection is acceptable.

**Donors who test positive for CMV will remain eligible for participation. Should MSCs and/or derivatives of be successfully isolated and included in the biorepository, a disclaimer disclosing positive CMV status of the tissue donor will be included on the Certificate of Analysis for future considerations. 

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

Eligibility last updated 9/5/23. Questions regarding updates should be directed to the study team contact.

• Adult individuals seeking  or receiving composite tissue allotransplantation at Mayo Clinic.

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.