• 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:

• Males or females ≥ 40 years of age.
• Willingness to undergo the required clinical assessments and biopsies.
• Clinical diagnoses as DLB, PD and PDD.

• Are being treated with chemotherapy for cancer.
• Are known to have a structural brain lesion or other CNS disease process or symptoms.
• Have a clinically significant infectious disease, such as HIV, hepatitis or prion disease.
• Have suspected encephalopathy due to alcoholism or end-stage liver disease.
• Have a bleeding diathesis, are on anticoagulant therapy, or have severe medical illness.
• Have skin disease in the posterior cervical area.

1. Adult Participants, non-HFpEF (25 prospectively enrolled)
   1. Adult controls (>18 years) age, sex, and BMI matched without signs or symptoms of heart failure, confirmed via limited echocardiogram and physical examination.
2. Data retrospectively collected from 25 Adult Participants with HFpEF (≥3 months), age 40-85 years who were enrolled in study 16-001467, defined by:
   1. Signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF as met by at least 1 of the following 4 criteria:
      1. Hospitalization for decompensated HF in the past year but not within the past 30 days;
      2. Invasively-documented elevated pulmonary capillary wedge pressures (PCWP) at rest (>15 mmHg) or with exercise (≥25 mmHg) at catheterization performed in the evaluation of dyspnea;
      3. Elevated NT-proBNP (>400 pg/mL) or BNP (>200 pg/mL);
      4. Echocardiographic evidence of HFpEF based upon current diagnostic guidelines(≥2 of the following: [a] E/e’≥15, [b] ≥moderate left atrial enlargement, [c] PASP >35 mm Hg).

1. Adult Participants, non-HFpEF
   1. Signs and symptoms of HF (dyspnea, fatigue), reduced left ventricular (LV) EF (≤50% within 12 months of enrollment), and objective evidence of HF as met by at least 1 of the following 4 criteria:
   2. Hospitalization for decompensated HF in the past year but not within the past 30 days;
   3. Invasively-documented elevated pulmonary capillary wedge pressures (PCWP) at rest (>15 mmHg) or with exercise (≥25 mmHg) at catheterization performed in the evaluation of dyspnea;
   4. Elevated NT-proBNP (>400 pg/mL) or BNP (>200 pg/mL);
   5. Echocardiographic evidence of HFpEF based upon current diagnostic guidelines40 (≥2 of the following: [a] E/e’≥15, [b] ≥moderate left atrial enlargement, [c] PASP >35 mm Hg).
2. Data retrospectively collected from 25 Adult Participants with HFpEF (≥3 months), age 40-85 years who were enrolled in study 16-001467, defined by:
   1. Inability/unwillingness to engage in ET 
   2. Recent (<1 months) HF hospitalization 
   3. Concomitant treatment with organic nitrates or phosphodiesterase 5 inhibitors 
   4. Prior EF <50%, BMI <20 or >50 kg/m2 
   5. Acute coronary syndrome or revascularization within 3 months
   6. Infiltrative, hypertrophic, or radiation-induced cardiomyopathies 
   7. Constrictive pericarditis 
   8. Dyspnea felt to be due to primary lung disease or myocardial ischemia 
   9. Severe anemia (Hgb <8.0) 
   10. Systolic BP <110 mm Hg at consent  
   11. Recent (<30 day) change in diuretics/vasoactive medications 
   12. Significant left-sided valvular heart disease (>mild stenosis, >moderate regurgitation) 
   13. Complex congenital heart disease 
   14. Severe renal (estimated GFR<30) or hepatic disease

Inclusion Criteria
•Database Registry: 

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

Execlusion Criteria
•Database Registry:

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

• Consenting individuals age 18 or older.
• Have received a lung transplant within the last 36 months at Mayo Clinic Rochester MN or Mayo Clinic Jacksonville FL.
• Have received or are receiving outpatient antifungal chemoprophylaxis. 

Exclusion Criteria: 

• Under the age of 18 years old.
• Multiple organ transplantations or re-transplantation.
• Requires language interpreter.

• Adult patients, 18 years of age or older.
• Renal transplant recipients undergoing renal biopsy to evaluate for graft function

• Patients under 18 years of age.

• Age 18+ Years Old.
• Diagnosis of Chronic Lymphocytic Leukemia (B-CLL).

• Pregnant.

• Age ≥ 18 years old.
• Capable of giving consent.
• Established diagnosis of Multiple Sclerosis according to McDonald Criteria (2018). Patients may be diagnosed with any of the conventional phases of MS, primary progressive, relapsing remitting, secondary progressive etc.
• Willing to participate in a 7T MRI examination within a few days of their clinical 3T or 1.5T examination.

• Age < 18 years old.
• Any metallic implant, device implant, ventriculoperitoneal shunt, cardiac valve, pacemaker which would constitute a contraindication to 7T imaging.
• Previous craniotomy.
• Permanent facial makeup (for brain scanning).
• Suffer from claustrophobia.
• Pregnancy.
• Fever / elevated temperature.

• Fuchs Endothelial Corneal Dystrophy (FECD): Presence of central or paracentral corneal guttae with or without corneal edema. (Controls will not have any guttae).
• Any age (expected range will be 40-90 years).
• Any sex or race.
• Subjects who have previously undergone uncomplicated cataract surgery (to eliminate the confounding effect of cataract on vision) at least 2 months prior to enrollment.

• Any ocular disease that is known to affect vision (e.g., cataract, macula/retinal disease, amblyopia, etc.).
• Previous corneal transplantation in both eyes.

• The subjects will be between 45-90 years old for both genders.
• Post-menopausal women.
• Subjects must be able to provide written informed consent.

• Subjects younger than 45 years old.
• Subjects with a BMI > 40.
• Subjects with a history of bariatric surgery.
• Subjects with a history of carotid surgery.
• Subjects not able to provide written consent.
• Vulnerable populations such as neonates, children, pregnant women, and prisoners.

• Adults, ≥ 18 years of age.
• Willing and able to provide informed consent.
• Patients who have undergone unilateral scleral buckle only surgery (i.e., no vitrectomy) with a 360° encircling band.

• Individuals < 18 years of age.
• Diagnosis of glaucoma or glaucoma suspect.
• Unilateral ocular hypertension.
• Difference in lens status (i.e., pseudophakic vs phakic) between the two eyes.
• Preoperative (pre-buckle) anisometropia > 2.5 D.
• Current use of steroid medications (oral, topical, inhaled, injected, or other).
• Use of IOP-lowering medications.
• Active or chronic uveitis.
• Diseases or processes which affect the iridocorneal angle, including but not limited to neovascular glaucoma, iridocorneal endothelial syndrome, peripheral anterior synechiae, etc.
• Monocular status (enucleated or phthisical fellow eye, or fellow eye with visual acuity less than 20/100).
• History of previous vitreoretinal surgery in either eye.
• Inability to lay completely supine for the required time period.

• 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.

• Age 18 years or older.
• Histologic evidence of breast cancer with known hormone receptor and HER2 status.
• Initiation of new systemic therapy for recurrent or progressive metastatic disease or unresectable locally recurrent disease within four weeks of the blood draw.
• An understanding of the protocol and its requirements, risks, and discomforts.
• The ability and willingness to sign an informed consent.

• Pregnancy or lactation (for females).
• Inability on the part of the patient to understand the informed consent or be compliant with the protocol.

• Male or female, 18 years of age or older.
• Recent transplantation (< 1 year).
• Diagnosis of type 2 diabetes pre-transplant.
• Recipient of a first time, solitary kidney transplant between August 1, 2020 and January 1, 2021.

• Individuals < 18 years of age.
• Prior transplants and/or combined organ transplant.
• Type 1 diabetes.
• No documented follow-up.

Inclusion Criteria
•All Subjects:

• ≥ 50 years of age
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

• Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
• Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

• Prior or concurrent cancer diagnosis defined as:
  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
  • Recurrence of the same primary cancer within any timeframe; OR
  • Concurrent diagnosis of multiple primary cancers.
• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
• Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
• IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
• Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
• Participant has an active febrile infection prior to blood draw.
• History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•All Subjects:

• ≥ 50 years of age
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

• Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
• Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

• Prior or concurrent cancer diagnosis defined as:
  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
  • Recurrence of the same primary cancer within any timeframe; OR
  • Concurrent diagnosis of multiple primary cancers.
• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
• Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
• IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
• Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
• Participant has an active febrile infection prior to blood draw.
• History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•All Subjects:

• ≥ 50 years of age
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information or personal data to the study investigator.

Inclusion Criteria
•Cancer Subjects Only:

• Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian, esophageal cancer, head and neck squamous cell, thyroid, small intestine, cervical, anal, vulva, or testis confirmed through pathology reports and/or clinical/radiographic data; or
• Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

• Prior or concurrent cancer diagnosis defined as:
  • Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
  • Recurrence of the same primary cancer within any timeframe; OR
  • Concurrent diagnosis of multiple primary cancers.
• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
• Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
• IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
• Individual has a condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
• Participant has an active febrile infection prior to blood draw.
• History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

• Infants (Day 0
  •5 years).
• Long QT Syndrome(LQTS).
• Newborns without LQTS (Controls).
• Parental willingness to provide informed consent and follow the study protocol.

• Children > 5 years old.
• Those with genetically elusive LQTS.
• Infants with congenital heart disease.
• Infants born < 32 weeks EGA.
• Patients with a cardiac device implant (pacemaker/ICD).

• Is able to provide written informed consent.
• Willing to comply with all study procedures and be available for the duration of the study.
• Ability to take oral medication.
• Male or female, at least 18 years of age.
• Is a solid organ transplant (SOT) recipient.
• Has recurrent C. difficile infection. A C. difficile recurrence is defined as:
  •  Positive C. difficile testing in stool (confirmed via medial record review) AND
  •  Diarrhea (≥3 loose stools over 24 hours) during the 180-day period following completion of treatment for prior CDI episode.
• History of positive IgG testing to cytomegalovirus (CMV) and Epstein Barr Virus (EBV) for subject.
• Clinical response to 4-10 days of C. difficile treatment for the current CDI episode. Clinical response is defined as ≥5% reduction of diarrhea.
• Females of childbearing potential must have a negative urine or serum pregnancy test at baseline and prior to randomization. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception.
  • Note: Acceptable method of contraception is defined as those, alone or in combination, that result in a low failure rate [i.e. less than 1% per year] or in conjunction with their sexual partner(s), use 2 forms of medically acceptable contraceptive methods that have a reported failure rate of >1% per year. Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.

• Major bowel resection surgery within 90 days of randomization.
• Active chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis).
• History of total colectomy or bariatric surgery.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Presence of colostomy or ileostomy.
• Concomitant antibiotic use within 48 hours of Visit 2. Topical antibiotics and SOT prophylaxis (e.g., trimethoprim-sulfamethoxazole) are permitted.
• Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS), or patient shows evidence of dysphagia when the ‘safety test’ capsule is administered.
• Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT.
• Active, severe gastroparesis
• Unwilling to withhold probiotics for duration of study. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are permitted.
• Neutropenia, ≤500 neutrophils/mL [abstracted from the medical record and resulted within 7 days of Visit 2].
• Symptomatic co-infection with another intestinal pathogen as determined by chart review.
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor.
• Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions.
• Expected life expectancy <6 months.
• Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
• Women who are pregnant, lactating or planning on becoming pregnant during the study.
• Not suitable for study participation due to other reasons at the discretion of the investigators        

• Age ≥ 18 years.
• Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
• The ability to read and respond to questions in English or Spanish.
• Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
• Life expectancy at least 6 months.

• Individuals < 18 years.
• Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Eligibility last updated 12/21/21. Questions regarding updates should be directed to the study team contact.

• 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.

• Be female, age 0-17 years.
• Be undergoing an elective laparoscopic oophorectomy or oophorectomy done via laparoscopy as part of their clinical care.
• Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

• Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.

• Adult patients, ≥ 18 years of age.
• Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital to patient's home or assisted living facility.
• Patients or their legally authorized representative provides consent to participate in the study.

• Patients discharged from Hospital Service Meds 1-4 and Med 17.
• Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility.
• Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure).
• Patient/legally authorized representative is Non-English speaking.
• Patient leaves the hospital Against Medical Advice (AMA).
• No access to mobile technology/laptop/computer for post-discharge follow-up.
• Patient with an active diagnosis Covid-19 infection.
• Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment.

• Adult patients, ≥ 18 years of age.
• Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital to patient's home or assisted living facility.
• Patients or their legally authorized representative provides consent to participate in the study.

• Patients discharged from Hospital Service Meds 1-4 and Med 17.
• Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility.
• Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure).
• Patient/legally authorized representative is Non-English speaking.
• Patient leaves the hospital Against Medical Advice (AMA).
• No access to mobile technology/laptop/computer for post-discharge follow-up.
• Patient with an active diagnosis Covid-19 infection.
• Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment.

​​​​​​

• Adults ≥ 18 years of age.
• Post-Fontan palliative surgery and who currently have heart failure, or are at a high risk for heart failure post Fontan surgery.
• Patients with post-Fontan palliative surgery status, heart failure and able to provide informed consent.

• Individuals < 18 years of age.
• Inability to speak English.
• Inability or unwilling to provide informed consent.

Incusion Criteria:

• A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site.
• Age 18+.
• NRS pain score of a 5+ out of 10.
• Pain that developed (onset) or significantly worsened since cancer diagnosis.
• Malignant Hematology including:
  • Lymphoma;
  • Myeloma;
  • Chronic Leukemias.

• PHQ8 score of 14 or more.
• Life expectancy less than 12 months.
• Hospice enrollment.
• SNF/Long term care placement.
• Acute Leukemias.

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.

• Adult participants (≥ 25 years of age).
• PLS diagnosis is based on the new PLS diagnostic criteria.
• Symptom onset was no more than 15 years prior to baseline.
• Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation.
• In cases where a molecular test has been done prior to enrollment in this study, HSP or HSP- related mutations are negative.
• Expected to have at least some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect); however, the absence of these symptoms will not exclude participants when molecular testing is negative for known HSP.
• UMN symptoms and signs in a region other than the legs.
• Normal brain and spinal cord neuroimaging except for changes expected for PLS.
• No active major neurological diseases other than PLS and no history of major neurological diseases.
• No major unstable medical diseases that require treatment (e.g., active cancer, dialysis) in the past 6 months.
• Participant is residing within a commutable distance to the study site and is willing to visit the study site as required.
• No history of ALS or PLS in immediate family and no family history of hereditary spastic paraplegia (HSP).
• gia (HSP) If disease duration is less than 5 years, no significant lower motor neuron (LMN) degeneration upon the EMG examination within 12 months before enrollment (evident entrapment neuropathy or radiculopathy are acceptable). If EMG tests were not done in this period, an EMG test should be obtained through regular patient care (through insurance) in order to make a diagnosis of PLS (this cost will not be covered by this research study). If disease duration is more than 5 years and at least one EMG was performed post-diagnosis, an EMG examination 12 months prior to enrollment is not required.
• Participant understands the study’s purpose, has capacity to consent, and is willing to sign the informed consent form.

• Unwilling or unable to give informed consent.
• UMN symptoms and signs only in the legs.
• Unwilling or unable to visit the study site as required.
• Clinically obvious cognitive impairment that precludes obtaining informed consent, as determined by the site PI.
• Participating in clinical treatment trials.

Eligibility last updated 5/3/22. Questions regarding updates should be directed to the study team contact.

• Males and Females ages 10-21 years.
• Cystic Fibrosis (CF) must be diagnosed.
• Ability to sign informed consent if they are 18 years or older.
• Written parental permission if age 10-17 years old.

Exclusion criteria:

• Active CF flare as determined by the primary CF team .
• Use of steroids.
• Inability to tolerate oral feedings.
• Prior intestinal surgery.
• Concern for allergy or intolerance to dextrose, fructose, or corn derivatives.