• 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.

• Diagnosed with Opioid Use Disorder (OUD).
• Willing to participate and follow MAT program rules or enrolled in a residential treatment program.
• Willing to wear an armband device and answer questionnaires.
• Cellphone capable of downloading application (those in residential treatment will download upon discharge from the program).

• Active untreated comorbid mental health symptoms.
• Unable to understand or sign informed consent.
• History of heart disease.
• Women currently pregnant.

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

Eligibility last updated 11/6/23. Questions regarding updates should be directed to the study team contact.

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.

• Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.

• Patients undergoing surgery with an expected blood loss of less than 135cc.
• Provisions for inclusion of minorities: 
  • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

• Ulnar nerve injuries:
  • High ulnar nerve traumatic injuries: proximal to the junction of the proximal and middle thirds of the forearm;
  • Severe compression injuries: intrinsic muscle weakness and atrophy.
• Treated with anterior interosseous to ulnar motor branch nerve transfer performed at Mayo Clinic.
• More than 1 year follow-up.

Exclusion Criteria: 

• Nerve transfer performed at a different hospital.
• Insufficient follow up and data.

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

Eligibility last updated 12/9/22. 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 males and females, ages 40 to 85 years.
• Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years until discontinuation of treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit.  Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
• All skin phototypes ≥ grade I of Fitzpatrick’s classification.
• Mild-to-moderate global face wrinkles and mild-to-moderate global fine lines based on a modified Griffiths’ 10-point scale.
• Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
• Volunteer willingness to discontinue any other anti-aging topical or parenteral treatments for the duration of the study.
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related treatment.
• Can provide written informed consent to being photographed for purposes of treatment for medical, scientific purposes.

• Pregnant or nursing, or planning on becoming pregnant during the study period.
• Subjects who have had an antiaging or esthetic treatment prior to the study: Botox or Botox‐like products, peelings, plastic surgery, resurfacing with Laser, IPL, threats, radiofrequency treatments, hyaluronic acid treatment, Plasma‐Rich Platelets treatment, or any other specific treatments prone to change the skin aspect during the last 6 months.
• Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies, collagen diseases, or skin cancer involving the treated sites within the past 6 months.
• Cutaneous marks on the experimental area which could interfere with the assessment of skin reactions (pigmentation problems, scar elements, over‐developed pilosity, ephelides, and nevi in too great quantity, sunburn, beauty spots, freckles, etc.).
• Participants with asymmetric photodamage on dorsal hands due to environmental exposures (i.e., golfing) and/or other skin lesions including burns or scars resulting in significant skin surface variability between dorsal hands.
• Eczematous reaction still visible, scar, or pigmentary sequelae of previous tests on the experimental area.
• Allergy to colophony or nickel.
• Allergy or reactivity to drugs, food or cosmetic products previously observed, including perfumes or cologne products.
• Skin hyper‐reactivity.
• Forecast of intensive sun, tanning bed use or UV phototherapy during the test period.
• Treatment with Vitamin A acid or its derivatives within 3 months before the beginning of the study.
• Treatment with topical corticoids on the experimental area within 16 days before the study.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Preop:

• ECOG performance status 0-1 or KPS >70%
• Age ≥ 18 years
• Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage confirmed at the enrolling institution
• No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and pelvic +/- abdominal imaging)
• Suitable candidate for surgery
• Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
• No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
• Approved and signed informed consent
• No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
• No history of prior pelvic or abdominal radiotherapy

Exclusion Criteria
•Preop:

• Extrauterine disease, gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I).
• Contraindication for SLN mapping.
• The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy.

Inclusion Criteria
•Postop:

• Hysterectomy.
• Bilateral salpingo-oophorectomy, unless already previously performed.
• Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy).
• Final pathology must show Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with < 50% myometrial invasion, including non-invasive disease).
• Final pathology must show negative pelvic peritoneal cytology.
• Adjuvant treatment as recommended by the multidisciplinary team must be
  as follows:
  o No adjuvant treatment; or
  o Intravaginal radiation only.

Exclusion Criteria
•Postop:

• There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes.
• Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC).
• Hysterectomy is not performed.
• Bilateral salpingo-oophorectomy is not performed, unless already previously performed.
• Failed unilateral or bilateral SLN mapping.
• Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy.
• Patient undergoes a radical type C hysterectomy.
• Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion < 50%.
• Stage IB Grade 3 endometrioid cancer.
• Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology.
• Empty unilateral or bilateral sentinel lymph nodal packet(s).
• Positive peritoneal cytology.

• 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.

• Inclusion of Legacy PH patients from two previous Mayo Clinic Hyperoxaluria Center registry protocol databases will be rolled into the 6401 PH Registry.
• Patients < 18 years with a history of kidney stones, and/or nephrocalcinosis; OR
• Patients > 18 yrs with a history of kidney stones, and/or nephrocalcinosis and at least one of the following:
  • Family history of stones or nephrocalcinosis or unexplained kidney failure;
  • Growth retardation due to metabolic bone disease and/or renal failure;
  • Crystals of unusual type;
  • Mild to moderate proteinuria;
  • Elevated serum creatinine and/or reduced GFR;
  • Hypomagnesemia;
  • Increased urinary calcium excretion; 
  • Increased urinary oxalate excretion; or
  • Renal cysts.
• Family member of a patient who meets any of the above inclusion criteria

• Any patient unwilling to sign a consent.

• Male patients.
• Age 45-80 years, with > 10 years life expectancy.
• Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
• Stage ≤ T2c, N0, M0.
• ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
• PSA ≤ 20 ng/mL reported within 3 months of baseline.
• Treatment naïve.
• Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.  

• Inability to undergo MRI or general anaesthesia.
• Suspected tumour > 30 mm from the prostatic urethra.
• Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:                
  • Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
• Unresolved urinary tract infection or prostatitis.
• History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
• Artificial urinary sphincter, penile implant or intraprostatic implant.
• Less than 10 years life expectancy.
• Patients who are otherwise not deemed candidates for RP.
• Inability or unwillingness to provide informed consent.
• History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.

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

• Patients 3 years old and older.
• May undergo or have undergone intracranial EEG recordings as part of their clinical evaluation for medically intractable partial epilepsy, pain, brain tumor, deep brain stimulation or amyotrophic lateral sclerosis
• A healthy control group of subjects age 18-65.

• Patients who are unable to go into the MRI scanner; for example, when they have MRI contraindications (e.g., metal implants, claustrophobia or pregnancy).

• Adult males and females over the age of 18.
• Subjects living at Acacia Creek Retirement Community who use a Sleep Number® bed.

• Individuals under the age of 18.
• Subjects who do not have a Sleep Number® bed.
• Subjects without an internet connection to transmit nightly SleepIQ® data.

Eligibility last updated 1/31/22. Questions regarding updates should be directed to the study team contact.

• Age 1-65 years at the time of kidney transplant.
• Biopsy proven diagnosis of primary FSGS or minimal change disease.
• History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia).
• First kidney transplant OR second or third kidney transplant with a history of recurrent FSGS in the first or second transplant
• The patient (if  ≥ 18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if < 18 years old will be required per local IRB requirements. 
• Negative urine pregnancy test prior to randomization (for females who are post-menarche). 
• Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study: 
  • Known genetic cause of FSGS;
  • Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.);
  • Received rituximab within 1 year prior to transplant;
  • Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins;
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
  • Known active bacterial, viral (e.g., HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit;
  • Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer);
  • ANC < 1.5 x 10^3;
  • Hemoglobin: < 8.0 gm/dL;
  • Platelets: < 100,000/mm;
  • AST or ALT > 2.5 x Upper Limit of Normal at the local institution's laboratory;
  • History of drug, alcohol, or chemical abuse within 6 months prior to screening visit;
  • Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential;
  • Concomitant malignancies or previous malignancies; 
  • History of psychiatric disorder that would interfere with normal participation in this protocol;
  • History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease);
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
  • Inability to comply with study and follow-up procedures.

• Known genetic cause of FSGS.
• Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.).
• Received rituximab within 1 year prior to transplant.
• Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
• Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer)
  • ANC < 1.5 x 10^3;
  • Hemoglobin:  < 8.0 gm/dL;
  • Platelets:  < 100,000/mm;
  • AST or ALT  > 2.5 x Upper Limit of Normal at the local institution’s laboratory.
• History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
• Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential.
• Concomitant malignancies or previous malignancies.
• History of psychiatric disorder that would interfere with normal participation in this protocol.
• History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease).
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
• Inability to comply with study and follow-up procedures.

• Capable and willing to provide informed consent.
• Confirmed or suspected physician diagnosis of Primary Immunodeficiency.

• Not willing to provide consent.
• Not diagnosed with Primary Immunodeficiency.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

• Adult male or female between 18 and 65 years of age.
• Adult male or female who is scheduled to receive a knee MRI at our facility. 

• Prior history of knee surgery.
• Inability to WB
• MRI incompatibility (e.g., presence of ferromagnetic implants, claustrophobia, etc.). 

• Children, 1-17 years of age.
• Presence of Cystic Fibrosis (CF):
  • Sweat tests > 60mEq/L or presence of 2 CF causing mutations;
  • Non-CF bronchiectasis or other clinical indications for chest CT;
  • Patients who did not sign Minnesota research authorization will be contacted by study PI and phone consent will be obtained.

• Over 17 years of age.
• Acute respiratory distress.
• Unstable cardiovascular status.
• hypoxia (SaO2 less than 93% in room air).
• Pneumothorax.
• Pulmonary edema.
• Pulmonary emboli.
• Fractured ribs or other chest trauma.
• Recent bronchoscopy.

• Adult and pediatric patients will be considered eligible for accrual.
• Pediatric patients (Age < 18 years) must weigh ≥ 10 kg for consideration.
• Diagnosis of previously untreated or progressive sarcoma who will receive systemic chemotherapy.
• Willing and able to provide written informed consent and age appropriate assent for minors.
• Planned clinical biopsy/surgery or available archived tumor tissue.

• Pediatric sarcoma patients weighing < 10 kg.
• Unable/unwilling to provide written informed consent.

Eligibility last updated 1/13/22. 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.

• All patients who meet the diagnostic criteria for CVID  

• Infants below 6 months of age
• Subjects unable to provide a research blood sample for any medical reason             

1. Willing to give a blood sample
2. Ability to provide informed consent
3. Ability to complete all aspects of this trial
4. At least 18 years of age
5. Have cold agglutin disease with anemia

• None

• Any gender.
• Age over 4 years.
• Have read, understood and signed the approved informed consent form (parent or legal guardian must sign for anyone younger than 18 years).
• Willing to use the Seer EDS as instructed and provide feedback.

• Subjects considered by the participating site to be unable to operate the medical device due to cognitive or physical impairment.

Eligibility last updated 9/16/21.  Questions regarding updates should be directed to the study team contact.

General Eligibility Criteria:

• Assessment for general eligibility criteria is based on medical records of the site and interview with a candidate patient. Patients must meet ALL general inclusion criteria to participate in the clinical investigation. If ANY general exclusion criteria are met, the patient is excluded from the clinical investigation and cannot be enrolled.
• If any clinical and/or laboratory tests are required for patient screening and are not included in a site’s standard tests, they must be completed after written informed consent is obtained.

• Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines.
• Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
• Subject has a life expectancy of at least one year.
• Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
• Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.

• Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor.
• Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period.
• Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU.
• Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis.
• Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments).
• Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device.
• Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP).
• Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)*.
• Subject is unable to read or write.
  • * NOTE:  Does not apply to a medical device with no known impact to the Aveir Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation and the decision to implant the LP should take into account the presence of other active implantable devices and should include consultation with the Sponsor and/or manufacturer of the co-existing device.

Eligibility last updated 11/18/21. Questions regarding updates should be directed to the study team contact.