• Discharged from hospital in the past 7 days or observation status.
• Age ≥ 18 years.
• LACE+ score ≥ 59 and at least two chronic conditions.
• Index hospitalization with discharge directly to community dwelling (home, assisted living).
• English speaking.
• Discharge to home (residential dwelling) or assisted living, as appropriate and determined by the study coordinator.
• Normal cognitive function. Mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment.
• Mayo Clinic or Mayo Clinic Health System provider managing the patient’s care (e.g. primary care).  Patient is paneled to a Mayo Clinic MD/NP/PA.
• Access to and ability to communicate via telephone and/or video (either patient or caregiver).

• Psychiatric hospital admission.
• Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient’s clinic.
• Untreated active substance or alcohol abuse.
• Dementia or moderate to severe cognitive impairment.
• Discharged to one of the following:
  • Rehabilitation unit;
  • Skilled nursing facility;
  • Assisted living memory unit;
  • Group home;
  • Transitional care unit.
• Pregnancy.
• Active treatment for cancer.
• Receiving dialysis or transplant services.
• Life expectancy < 6 months or enrolled in hospice or palliative care programs.
• Patient is unwilling to sign a Release of Information (ROI) – (ROI allows those providing care, internal and external to be actively involved in patient’s care coordination).
• Patients with active tuberculosis (TB).
• Violent patient flag noted in Epic.
• Patient is already enrolled in Remote Patient Monitoring or the Care Transitions Program (CTP), Palliative Care Homebound Program (PCHP), or Primary Care House Calls Program (PCHP), Advanced Care at Home (ACH) Program (NW WI).
• Recent or active COVID patient (i.e., discharged from COVID admission, active COVID event)
• Religious Sisterhood living at Mayo Clinic Hospital
  •St. Mary’s Campus or Assisi Heights (Rochester only).
• Permanently living in a long-term care facility or a memory unit of an assisted living facility.
• Chronic pain syndrome if chronic pain is the only diagnosis and no chronic medical condition exists.

• Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

• Exclusion criteria include inability to provide informed consent, medical or surgical history precluding breast reduction, history of significant chronic pain requiring daily use of opioid or nonopioid analgesics, pregnancy, concomitant non-breast surgical procedure, previous chest wall irradiation, previous breast implant, breast reduction or breast lift surgery, known allergy to bupivacaine or liposomal bupivacaine, liver or kidney dysfunction, use of antiplatelet or anticoagulation therapy.

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

Eligibility last updated 1/11/23. Questions regarding updates should be directed to the study team contact.

Patients undergoing gracilis transfer surgery

• Premenopausal women, ages 18-50 years old.
• Uterine fibroid group (n≈20): These participants will have had a previous or current diagnosis of UF determined by ultrasound, hysteroscopy, or MRI, confirmed with medical documentation within one year of recruitment.
• Control (non-fibroid) group (n≈20): These participants will not have evidence of UF (confirmed by imaging) at the time of study participation.

• History or evidence of:
  • hepatic, renal, or hematological disease;
  • peripheral vascular disease;
  • stroke/neurovascular disease;
  • diabetes;
  • dyslipoproteinemia;
  • hypertension (> 130/80 mmHg brachial cuff pressure); 
  • lung disease;
  • arthritis affecting ability to exercise; or
  • a body mass index > 30 kg/m^2. 
• Participants also will be excluded if taking antihypertensive medication or medication that alters autonomic or vascular function (e.g., tricyclic antidepressants, alpha-blockers, beta-blockers, etc.). 
• Participants will be non-smokers. 
• Subjects must have a negative pregnancy test in order to participate in the study. 
• Participants who are breastfeeding will be excluded.
• Women who have undergone hysterectomy will be excluded.

Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.

• 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.

• For Enrollment to Phase 1b: Participants must have histologically confirmed advanced or metastatic soft-tissue sarcoma and no curative multimodality treatment options available.
• For Enrollment to Phase 2: Participants must have histologically confirmed advanced or metastatic leiomyosarcoma (LMS) and no curative multimodality treatment options available.
• Participants must have measurable disease per RECIST 1.1 criteria.
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lurbinectedin in combination with doxorubicin in participants < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%).
• Participants must have adequate organ and marrow function as defined below:
  • Absolute Neutrophil Count ≥ 1,500/mcL;
  • Hemoglobin (Hgb) ≥ 8 g/dl (transfusion support permitted);
  • Platelet Count ≥ 100,000/mcL;
  • Total Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN);
  • AST (SGOT) / ALT(SGPT) ≤ 2.5 × institutional ULN, OR ≤ 5 × institutional ULN if elevation is a result of metastases;
  • Creatinine ≤ 1.5 × institutional ULN, OR Creatinine Clearance ≥ 60 mL/min/1.73 m^2 for participants with creatinine levels above 1.5 × institutional normal (calculated via the Cockcroft-Gault equation);
  • Creatine Phosphokinase (CPK) < 2.5 × institutional ULN on two different determinations performed one week (± 1 day) apart.
• For participants with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Left ventricular ejection fraction (LVEF) ≥ 50% on screening echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
• The effects of lurbinectedin or doxorubicin on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study agent administration.
• Ability to understand and the willingness to sign a written informed consent document.
• Participants must have archival tissue available for analysis in the form of a formalin-fixed paraffin embedded (FFPE) block or unstained slides. Participants without archival tissue available may be enrolled with approval of the Sponsor-Investigator. Note: confirmation of availability of archival tissue is the only requirement for eligibility, archival tissue does not need to be received by the study team or site prior to enrollment.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator may be included with the approval of the Sponsor-Investigator.

• Participants who have received prior anthracycline or trabectedin (Yondelis, ET-743), including prior exposure to doxorubicin or liposomal doxorubicin.
• Participants who have received more than 2 prior lines of cytotoxic chemotherapy for the phase 1b study and no more than 1 prior line of cytotoxic chemotherapy for the phase 2 study. There is no limit on the number of prior lines of non-cytotoxic chemotherapy (e.g., pazopanib, immunotherapy).
• Prior exposure to lurbinectedin (PM01183).
• Participants who have received or undergone prior chemotherapy within 14 days of cycle 1 day 1, therapeutic radiation therapy within 21 days of cycle 1 day 1 or major surgery within 21 days of cycle 1 day 1.
• Participants who have received prior palliative radiation therapy within 7 days of cycle 1 day 1.
• Participants who have received prior antibody-based therapy (e.g., nivolumab) within 4 weeks or 3 half-lives (whichever is shorter) of cycle 1 day 1.
• Participants who have received prior oral small molecule or tyrosine kinase inhibitor (TKI) therapy within 2 weeks or 3 half-lives (whichever is shorter) of cycle 1 day 1.
• Participants who have not recovered to ≤ Grade 1 or baseline from adverse events attributed to any prior anti-cancer therapy, with the exceptions of alopecia, controlled endocrine toxicity (e.g., hypothyroidism), and cutaneous toxicity which will be permitted at Grade 2.
• Participants who are receiving any other investigational agents.
• Participants with known CNS disease involvement, with the exception of patients with brain metastases that have been previously treated and have remained stable on MRI ≥ 28 days prior to cycle 1 day 1 without use of steroids or anti-epileptic medications.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to lurbinectedin or doxorubicin. 
• Participants receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP3A, CYP2D6, or P-gp are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant must be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic indwelling drains, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of interstitial pneumonitis or pulmonary fibrosis.
• Known cardiomyopathy.
• Pregnant women are excluded from this study because lurbinectedin and doxorubicin are anti-cancer agents with the potential for teratogenic or abortifacient effects.  Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lurbinectedin or doxorubicin, breastfeeding must be discontinued if the mother is treated with lurbinectedin or doxorubicin. A negative pregnancy test is required for women of childbearing potential prior to the first dose of study medication.
• Immunocompromised patients, including patients who are known to be seropositive for human immunodeficiency virus (HIV) due to the increased risk of lethal infections when treated with marrow-suppressive therapy. HIV testing is not required as part of screening. 

Eligibility last updated 8/17/23. Questions regarding updates should be directed to the study team contact.

• Age 0 or older 
• Females in the second or third trimester of pregnancy.
• Females planning to deliver her infant at Mayo Clinic Rochester.
• Females able and willing to provide informed consent.

• Females unable or unwilling to provide consent for self or infant.
• Females planning to commercially or publically bank infant cord blood.

• symptoms of gastroesophageal reflux
• presence of Zenker's diverticulum or cricopharyngeal hypertrophy
• undergoing surgery for Zenker's diverticulum or cricopharyngeal hypertrophy with endoscopic laser cricopharyngeal myotomy
• at least 18 years old

• pregnant women
• children
• prisoners
• adults lacking capacity to consent

• Clinical diagnosis of type 1 diabetes.

• Refusal of permission to use medical records for ongoing research.

• Clinical diagnosis of type 1 diabetes.

• Refusal of permission to use medical records for ongoing research.

• No abdominal surgery (except appendectomy and cholecystectomy)
• Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter

• History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.
• History of gastroenteritis in six months prior to Campylobacter enteritis
• Pregnancy

• Midlife women, ages 45-60 years old.
• Non-smokers.
• Non-obese.
• Have at least one ovary.
• Free from cardiovascular disease.
• Not taking medications influencing cardiovascular function.

• None.

• Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.

• Multiple pregnancy.
• Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
• Intrauterine growth retardation or fetal macrosomia.
• Maternal age under 18 or over 50.
• Maternal body mass index (BMI) of less than 18 and more than 40.
• Pregnancy less than 37 weeks of completed gestation.

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

• Any adult over the age of 18.
• Any patient able to walk unassisted with or without a gait aid.

• Individuals under the age of 18.
• Individuals who are immobile (defined as unable to walk with or without a gait aid).

Eligibility last updated 6/5/23. Questions regarding updates should be directed to the study team contact.

• Mayo Clinic patients scheduled for or being seen in the Healthy Longevity Clinic in the Division of General Internal Medicine.
• 18 years of age or older at time of consent
• Have the ability to provide informed consent
• Have the ability to complete all aspects of this trial.

• < 18 years of age. 

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

Eligibility last updated 4/6/23. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Challenge Study:  

• Males or females 18 to 70 years of age, inclusive.
• Subjects demonstrate willingness to participate in the study and to perform all required procedures as documented by signed informed consent.
• Subjects must have a diagnosis of celiac disease CeD by intestinal biopsy at least 12 months and positive celiac serology at some point in their evaluation, prior to screening as confirmed by medical records or written physician statement.
• Subjects must have reported following a strict GFD for at least the 12 consecutive months and must be willing to maintain their current diet for the duration of study participation while being in gluten challenge.
• Patients who don’t show mucosal healing with a VH:CD ratio < 2 at the baseline endoscopy will enter the GFD non-healed cohort (see below) and will not undergo gluten challenge.   Ninety percent of patients who are asymptomatic, adhere to GFD and are seronegative have achieved histologic healing.

Exclusion Criteria
•Challenge Study:

• Current diagnosis of any severe complication of CeD, such as refractory CeD (RCD) type I or II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or GI perforation.
• Diagnosis of any chronic, active GI disease other than CeD, such as active, untreated peptic ulcer, eosinophilic esophagitis, erosive esophagitis , ulcerative colitis or Crohn’s disease, microscopic colitis, irritable bowel syndrome, small intestinal bacterial overgrowth, tropical sprue, or other GI and non-GI disorder or prior GI surgery that may, in the Investigator’s opinion, interfere with the assessment of symptoms of abdominal pain, diarrhea, or other components of CeD.
• Selective IgA deficiency, defined as having undetectable levels of serum IgA.
• History of severe reaction to gluten exposure that is considered incapacitating or life-threatening.
• Known or suspected exposure to COVID-19 infection in the 4 weeks before the screening.
• History or presence of any clinically significant disease that, in the opinion of the Investigator may confound the subject’s participation and follow-up in the clinical trial or put the subject at unnecessary risk, including but not limited to: uncontrolled hypertension (BP ≥180/110 mm/Hg), unstable angina, Class II congestive heart failure or major fluid overload, coronary angioplasty or myocardial infarction within the past 6 months, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, severe chronic pulmonary disease, or any renal, hematologic, GI, immunologic, dermatologic, neurologic, or psychiatric disease.
• History of significant substance or alcohol abuse during the 12 months prior to screening as obtained by medical record and/or subject report.
• Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding.
• Participation in another investigational drug or device study or treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening.
• Individuals with uncontrolled clotting disorders or on anti-coagulants that they can’t safely hold prior to endoscopy.
• Participation in clinical trial within 30 days prior to consenting, and 12 months for a clinical trial including a biologic agent.
• Participation in clinical trial with tolerogenic agents.

Inclusion Criteria
•De-challenge Study:

• Males or females, 18 to 70 years of age, inclusive.
• Subjects demonstrate willingness to participate in the study and to perform all required procedures as documented by signed informed consent.
• Newly suspected subjects of CeD, either typical symptoms of CeD or referred to celiac clinic due to positive CeD serology undergoing upper endoscopy. Patients with weak positive serology will not be included in order to maximize the likelihood of the patients qualifying for the dechallenge study.    
• Subjects who are currently not on GFD.

Exclusion Criteria
•De-challenge Study:

• Has a history of chronic inflammatory gastrointestinal disease (example, inflammatory bowel disease, extensive colitis, ulcerative jejunitis, drug induced enteropathy) (Microscopic colitis is not an exclusion criteria).
• Has chronic infectious gastrointestinal illness, or acute infectious gastrointestinal illness within the 4-week period prior to screening.
• Known history of lymphoproliferative disease, including monoclonal gammopathy of unknown significance, lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
• Individuals with uncontrolled clotting disorders or on anti-coagulants that they can’t safely hold prior to endoscopy.
• Known or suspected exposure to COVID-19 infection in the 4 weeks before the screening.
• History or presence of any clinically significant disease that, in the opinion of the Investigator may confound the subject’s participation and follow-up in the clinical trial or put the subject at unnecessary risk, including but not limited to: uncontrolled hypertension, unstable angina, Class II congestive heart failure or major fluid overload, coronary angioplasty or myocardial infarction within the past 6 months, clinically significant arrhythmias or ECG abnormalities, severe chronic pulmonary disease, or any renal, hematologic, GI, immunologic, dermatologic, neurologic, or psychiatric disease.
• History of significant substance or alcohol abuse during the 12 months prior to screening as obtained by medical record and/or subject report.
• Participation in another investigational drug or device study or treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening.
• Participation in clinical trial within 30 days prior to consenting, and 12 months for a clinical trial including a biologic agent.
• Participation in clinical trial with tolerogenic agents
• Participants whose initial biopsies do not reveal villous atrophy will not be followed in the de-challenge group but may be recruited into the potential celiac disease cross sectional group so long as they meet the criteria for inclusion into that group.

Inclusion Criteria
•Controls:

• Subjects (both cases and controls) will include males and non-pregnant females, aged 18-70 years.
• Females of reproductive age or capacity (i.e. not having had tubal ligation or sterilization) will have a pregnancy test performed.

Exclusion Criteria
•Controls:

• Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation within 4 weeks of the studies, and smokers
• Subjects will be asked not to take any probiotics in the week before testing.
• Any known intestinal inflammation such as GERD, eosinophilic esophagitis, and inflammatory bowel disease.
• Prior gastrointestinal surgery (other than appendectomy)
• Ongoing use of antiplatelet agents or anticoagulants.
• Controls should not have a prior history of or family history of CD.
• Subjects unable to provide informed consent
• The presence of any medical or psychological condition could interfere with the safe performance of the upper endoscopy.

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

Eligibility last updated 9/19/23. Questions regarding updates should be directed to the study team contact.

• Age: 18 to 65 years old (inclusive).
• Gender: both males and females.
• Body mass index (BMI): 18.5-34.9 kg/m^2.
• Habitual sleep duration < 7 hours.
• Presence of either:
  • Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg;
  • Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg.
• Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions.
• Not pregnant or breast feeding and not intending to become pregnant or breast feed.
• Not a current smoker or tobacco user.
• Ability to provide written informed consent.

• Vulnerable study populations will be excluded.
• Pregnancy.
• Smoking.
• Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders.
• If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month.
• Habitual sleep duration ≥ 7 hours.
• Excessive alcohol (≥ 15 drinks/week in men and ≥ 8 drinks/week in women) and/or excessive caffeine intake (> 400 mg).
• Currently on a diet and/or actively trying to lose weight.
• Currently or previously (during the past 2 months) participation in any other research study at the discretion of study personnel.
• Blood/plasma donation during the past 2 months.
• Unwillingness or inability to adjust sleep schedule.

• Adults, age ≥ 18 years.
• Any concomitant malignancy being treated with any PD-1 inhibitor (pembrolizumab, nivolumab or cemiplimab) as monotherapy and the presence of inflammatory arthritis defined by:
  • provider documented inflammatory arthritis (meet 2010 EULAR/ACR classification criteria of RA) in one or more large or small joints; and at least one or more of the following:
  • elevated inflammatory markers;
  • supportive imaging and/or supportive synovial fluid analysis.

• Active infection.
• Prior history of the rheumatic disease.
• Any B cell depletion therapy.
• PActive use of high (≥ 30 mg daily) of prednisone or steroid equivalent.
• Clinical features suggestive of non-RA autoimmune rheumatic disease (e.g., lupus, Sjogren’s, psoriatic arthritis, etc.) or axial spondyloarthropathy.

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

Inclusion Criteria

- Adult patients ≥ 18 years of age undergoing primary liver transplant

- Ascites-adjusted BMI ≥ 25 kg/m2

- Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with
patent hepatic artery, hepatic veins and portal veins)

Exclusion Criteria

- Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant
histology

- Untreated post-transplant vascular complications or biliary strictures

- Multi-organ transplantation

- Urine protein excretion ≥2.0 g/day

- Uncontrolled diabetes mellitus (HbA1c > 10%)

- Associated medical conditions incompatible with safe participation in a nutritional
intervention study, including digestive diseases with fat intolerance, neurological,
psychiatric or endocrine disorders

- Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)

- History of bariatric surgery

- Pregnancy or planning on pregnancy in the next year

• Community dwelling adult patients 18 years and older.
• Diagnosis of hypertension defined as bp of > 140/90, who would benefit from BP management.
• Paneled in Onalasca Primary care practice.
• Has established a patient online secured account.
• Has a compatible mobile device (with Bluetooth connectivity).
• Able to give consent to participate in research study (consent and HIPAA form).

• Non-English speaking.
• Residing in skilled care facilities.
• Has cognitive impairment.

Mayo Site

• Children born in four southeast MN counties including Olmsted, Dodge, Goodhue, or Wabasha County between Jan 1st, 1997–Dec 31st, 2020 with age of 3-26 years old.
• Research authorization for using medical record for research.
• Children who have received medical care at only Mayo Clinic. 

Sanford Children's Hospital (for Aim 4 only)

• Children who were born between November 1, 2011, and December 31, 2018.

• No research authorization for using medical record for research.
• Residents living in non-Olmsted, Dodge,Goodhue or Wabasha county address in medical record within one year prior to last follow-up date as of data abstraction.
• Insufficient medical record to ascertain asthma status or other variables.
• Children who left the community before the age of 3 years because API requires medical history at least during the first 3 years of life.
• Adopted children (lack of information on a family history of parents which is one of API criteria).
• Conditions making asthma ascertainment difficult (tracheobronchial foreign body at or about the incidence date of asthma, bullous emphysema or pulmonary fibrosis, PiZZ alpha1-antitrypsin, cystic fibrosis, hypogammaglobulinemia (IgG < 2.0 mg/mL), other immunodeficiency disorder (or conditions identified by the International Union of Immunological Societies at index date of AIICs), primary ciliary dyskinesia, bronchiectasis, or COPD if it is present) and other major chest disease (severe kyphoscoliosis or bronchiectasis) which will be identified by ICD code and free text search.
• Immunodeficiency or immunosuppressive therapy:  Patients who had received immunosuppressive or immunoglobulin therapy or transfusion within twelve months prior to index date of AIICs except corticosteroid burst therapy for asthma exacerbation. 
• Children who weigh below 17 kg (the volume of blood taken from the donors is minimized to be less than 3 mL/kg bodyweight for a venipuncture).
• A history of malignancy at index date of AIICs.

• Diagnosis of fibromuscular dysplasia (FMD), segmental arterial mediolysis, and/or spontaneous coronary artery dissection (SCAD)

• Missing records to determine whether or not they have FMD

• Patients who do not accept to participate in research studies.

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

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.

1. Parous women with a history of cornary artery disease (CAD)
2. Women without CAD

1. Women without pregnancies

• Adults ≥ 18 years old.
• Undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

• Patients who require Intensive Care Unit admission after surgery.
• Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

Eligibility last updated 8/26/21. Questions regarding updates should be directed to the study team contact.

• Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems
• Ability to provide informed written consent
• Known paternity for pregnancy
• Singleton pregnancies

• Mothers < 18 years of age
• Multiple fetuses

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.