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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

• Adult (18-90), male/female/other.
• Self-reported racial/ ethnic minority.
• Internet access via mobile device and/or computer/tablet.
• Able to read and write in English or Spanish.

• Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature.
• Under the age of 18 years old.
• Identified as non-underrepresented racial/ethnic minority or medically underserved minority.
• Unable to read and write in English or Spanish.

Eligibility last updated 11/8/21. Questions regarding updates should be directed to the study team contact.

• English speaking.
• Ability to complete a questionnaire.
• ≥ 18 years of age.
• Patients treated for endometrial cancer from 2013-2018 (about 590 patients treated between 2013-2018 per Rad Onc Outcomes):
• Status post-surgery +:
  • Pelvic +/- para-aortic external beam radiotherapy;
  • External beam radiotherapy +/- vaginal cuff brachytherapy;
  • Brachytherapy alone.
• Patients treated for cervical cancer from 2013-2018 (62 definitive or adjuvant treated between 2015-2018 per Rad Onc outcomes):
  • Status post-surgery and external beam radiotherapy +/- chemotherapy;
  • Definitive radiotherapy +/- chemotherapy.
• Patients treated for vulvar cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (40 treated between 2013-2018 per Rad Onc outcomes).
• Patients treated for vaginal cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (34 treated between 2013-2018 per Rad Onc outcomes).
• Patients treated for anal cancer from 2013-2018 receiving radiotherapy +/- chemotherapy +/- surgery (243 treated between 2013-2018 per Rad Onc outcomes).

• Females < 18 years of age.
• Any exception to above Inclusion Criteria.

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

• Age ≥ 18 years old; AND
• Were treated with curative intent; AND
• Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site; AND
• Provided written informed consent to participate in the study; AND
• Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent; AND
• Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent; AND
• Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer.
• Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts:

• Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III).
• Cohort 2: Non-small cell lung cancer (stage II-III).
• Cohort 3: Invasive breast carcinoma with all of the following:
  • Clinical stage T1-4/N0-3/M0 at presentation; AND
  • Completed preoperative systemic chemotherapy-containing regimen; AND
  • Underwent definitive surgical resection of the primary tumor; AND
  • Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes; AND
  • Hormone receptor and HER2 status are known.

Exploratory Cohorts:

• Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent.
• Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III).
• Cohort 6: Gastric adenocarcinoma (stage II-III).
• Cohort 7: Surgically resected pancreatic adenocarcinoma.
• Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers).
• Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology).
• Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)).
• Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent).
• For the purposes of this study, participants receiving extended (> 6 months planned duration) non-chemotherapy systemic treatment will be considered in their end of primary treatment phase after the initial planned surgery, chemotherapy and/or radiation.
• Determination of stage for eligibility assessment and enrollment should be based on pathologic stage unless the participant received pre-surgical/neoadjuvant therapy, in which case standard pre-treatment clinical staging will be used to determine eligibility.

• History of allogeneic organ or tissue transplant.
• Index cancer has neuroendocrine histology.
• History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
• Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC).
• Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.

• Mayo Clinic clinicians (MD, DO, or equivalent).

• None.

Eligibility last updated 4/27/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria
•Clinician:

• All clinicians responsible for caring for eligible patients will be considered for inclusion in the qualitative research. 

Exclusion Criteria
•Clinician:

• If the clinician declines to participate, the patient is still eligible for the study, but qualitative evaluations will be omitted.

Inclusion Criteria
•Patient:

• Participants will be recruited from those identified by a developed electronic health record list of patients with AKI. 
• Included individuals that populate the list are those with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.

Exclusion Criteria
•Patient: 

• Dementia.
• Non-English speaking.
• Expected to be dismissed to a skilled nursing facility or hospice at discharge.
• Expected to need dialysis at discharge.
• Primary Care Transitions Program enrollment.
• Transplant recipients within 100 days of transplant.
• Can only have one time enrollment.  

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

• Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy.
• Confirmed fibroblast growth factor receptor 2b (FGFR2b) overexpression by immunohistochemistry (IHC) (central testing result).
• Eastern Cooperative Oncology Group (ECOG) less than or equal to 1.
• Measurable, evaluable, or non-evaluable disease as long as evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Participant has no contraindications to mFOLFOX6 chemotherapy.
• Adequate organ and bone marrow function:
  • absolute neutrophil count greater than or equal to 1.5 times 10^9/L;
  • platelet count greater than or equal to 100 times 10^9/L;
  • hemoglobin greater than or equal to 9 g/dl;
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement).
  • total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease);
  • calculated or measured creatinine clearance (CrCl) of greater than or equal to 30 mL/minute calculated using the formula of Cockcroft and Gault -international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment.

• Prior treatment for metastatic or unresectable disease.
  • Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose.
• Prior treatment with any selective inhibitor of fibroblast growth factor.
• ibroblast growth factor receptor (FGF-FGFR) pathway.
• Known human epidermal growth factor receptor 2 (HER2) positive.
• Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
• Peripheral sensory neuropathy greater than or equal to Grade 2.
• Clinically significant cardiac disease.
• Other malignancy within the last 2 years (exceptions for definitively treated disease).
• Chronic or systemic ophthalmological disorders.
• Major surgery or other investigational study within 28 days prior to first dose of study treatment.
• Palliative radiotherapy within 14 days prior to the first dose of study treatment.
• Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria Part 1 and Part 2:

- Adult with unresectable, locally advanced or metastatic (not amenable to curative
therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Measurable disease or non-measurable, but evaluable disease, according to Response
Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)

- Participant has no contraindications to mFOLFOX6 chemotherapy or nivolumab

- Adequate organ function as follows:

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior
to the first dose of study treatment

- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper
limit of normal (ULN) (or < 5 x ULN if liver involvement)

- Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's
disease)

- Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated
using the formula of Cockcroft and Gault

- International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except
for participants receiving anticoagulation, who must be on a stable dose of
anticoagulant therapy for 6 weeks prior to enrollment

Additional Inclusion Criteria Part 2:

- No prior treatment for metastatic or unresectable disease except for a maximum of 1
dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and
peri-operative therapy is allowed, provided it has been completed more than 6 months
prior to the first dose of study treatment

- Fibroblast growth factor receptor 2b (FGFR2b) ≥ 10% 2+/3+ tumor cells (TC) as
determined by centrally performed immunohistochemistry (IHC) testing, based on tumor
sample either archival (obtained within 6 months/180 days prior to signing
pre-screening informed consent) or a fresh biopsy.

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

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

• Male and female patient’s age ≥ 18 at the time of informed consent.
• Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

• Pulmonary nodules of 8-50mm in largest dimension.

• Patients with known bleeding diathesis; Platelet count < 50,000.
• Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
• Inability or unwillingness to give informed consent.
• Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
• Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
• Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
• International Normalized Ratio (INR) < 1.5.
• Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Eligibility last updated 10/20/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years and ≤ 80 years.
• High risk myeloma, which is untreated, defined as any of:
  • ISS stage 3 and gain of chr1q or del17p);
  • bi-allelic deletion of TP53;
  • t(4;14) or t(14;16) and gain of chr1q;
  • t(4;14) or t(14;16) and presence of del17p; or
  • presence of a high-risk gene expression signature on Sky92 assays (Skyline Diagnostics).
• The following laboratory values obtained ≤ 14 days prior to registration.
  • Calculated creatinine clearance (using Cockcroft-Gault equation below)* ≥ 30 mL/min;
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3 (without the use of growth factors);
  • Platelet count ≥ 75000/mm^3;
  • Hemoglobin ≥ 8.0 g/dL;
  • Total bilirubin ≤ 1.5 x ULN;
  • ALT and AST ≤ 3 x ULN;
  • *Cockcroft-Gault Equation:
  • Creatinine clearance for males =
  • (140
    •age)(actual body weight in kg)/ (72)(serum creatinine in mg/dL)
  • Creatinine clearance for females =
  • (140
    •age)(actual body weight in kg)(0.85)/(72)(serum creatinine in mg/dL).
• LVEF ≥ 40%.
• ECOG performance status (PS) 0 or 1.
• Provide informed written consent. 
• Negative pregnancy test done ≤ 14 days prior to registration, for women of childbearing potential only.
  • Note: All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
  • Note: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• Willing to follow strict birth control measures as outlined in the protocol.
• Female subjects: If they are of childbearing potential, agree to one of the following:
  • Practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of trial drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
• Male subjects: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
  • Agree to practice effective barrier contraception during the entire trial treatment period and through 90 days after the last dose of trial drug, OR
  • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 
• Willing to return to enrolling institution for follow-up during the Active Treatment Phase of the trial.
• Able to take aspirin (325 mg) daily as prophylactic anticoagulation. 
  • Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.
• Male subjects must agree not to donate sperm for at least 90 days after the last dose of study treatment.
• Willing to provide blood and bone marrow samples for planned research.
• Life expectancy > 6 months.
• Able to take aspirin (325 mg) daily as prophylactic anticoagulation.  Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.

• MGUS, smoldering myeloma, light chain amyloidosis with organ involvement
• Diagnosed or treated for another malignancy ≤ 1 year prior to registration or previously diagnosed with another malignancy and have any evidence of residual disease.  Note: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women;
  • Nursing women;
  • Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol).
• Other co-morbidity which would interfere with subject's ability to participate in trial; e.g., uncontrolled infection, uncompensated heart or lung disease.
• Other concurrent chemotherapy, or any ancillary therapy considered investigational. 
  • NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
• Peripheral neuropathy ≥ Grade 3 on clinical examination or grade 2 with pain ≤ 30 days prior to registration.
• Major surgery ≤ 14 days prior to registration.
• Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.  Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
• Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
• NYHA II, III, IV heart failure
• Known human immunodeficiency virus (HIV) positive.
• Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).  Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.  Those who are PCR positive will be excluded. 
  • EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
• Known or suspected active hepatitis C infection.
• Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
• Prior radiation therapy for bony lesions or plasmacytomasKnown allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
• Inability to comply with protocol/procedures.

Eligibility last updated 3/9/22. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated12/22/22. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria;

• Pre-menopausal (21
  •50 years of age).
• Study group will consist of women seeking hysterectomy for possible adenomyosis adenomyomectomy.
• Controls will consist of women seeking hysterectomy for uterine prolapse or pelvic pain or transgender men prior to androgen treatment and whose pathology shows a uterus < 100 grams with no evidence of adenomyosis, endometriosis, or leiomyomas.

• No ua\se of GnRH analogues, aromatase inhimitors, selective E2 or P4 receptor modulators, oral contraceptives, or immunotherapy within 3 months prior to surgery in any patient.
• No history /confirmation or suspicion of autoimmune disease, fibromyalgia, endometriosis, or leiomyomas in any patient.
• No current or previous history of STDs, pelvic inflammatory disease, endometrial/cervical cancer in any patient.
• Women who do not exhibit menstrual cycles.

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

• Demographic characteristics: ≥ 18 and ≤ 65 years of age.
• Required laboratory results: negative pregnancy test for those with female sex assigned at birth (contraception will not be required to participate in the study).
• Health status: Schizophrenia spectrum disorder (as defined by the DSM-5; Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia, Schizoaffective Disorder, Catatonia, Other Specified Schizophrenia Spectrum Disorder, Unspecified Schizophrenia and Other Psychotic Disorder; but NOT Substance/Medication-Induced Psychotic Disorder or Psychotic Disorder Due to Another Medical Condition) for case group; control group can have any non-schizophrenia spectrum psychiatric illness with exceptions listed below  
• Ability to understand study procedures and to comply with them for the entire length of the study.
• Has an established mental health provider (e.g. ,integrated behavioral health, Mayo W11 psychiatric longitudinal clinic) or a follow up appointment with a new mental health provider within 2 weeks of study appointment.

• Demographic characteristics: < 18 or  ≥ 65 years of age.
• Any legal history of violence, or self-reported personal history of violence in the past 10 years (history of violence is routinely checked in everyday clinical work at the time of admission, and should be apparent in medical records).
• Any active movement disorder that would interfere with quality TMS-EEG.
• Any confirmed or suspected history of a seizure.
• Any major neurocognitive disorder.
• Current diagnosis of Bipolar Disorder with psychotic features or Major Depressive Disorder with psychotic features.
• Current diagnosis of Autism Spectrum Disorder.
• No follow up appointments with a primary care physician or mental health provider.
• Positive pregnancy test
• Positive or presumptive positive urine drug screen test for alcohol or any illicit substance (with the exception of cannabis) at time of recruitment.
• Those with female sex assigned at birth with negative pregnancy test actively trying to become pregnant. Women who are lactating will be included, as long as the infant/toddler can be away from mother for the duration of the study (per mother’s judgement).
• Use of benzodiazepines; any antiepileptic drugs (including gabapentin, valproate, topiramate, carbamazepine, lamotrigine, etc.), opioids, and opioid antagonists.
• TMS or electroconvulsive treatment within the past 12 months, and any past significant adverse events with TMS exposure.
• Any past neuroanatomic findings of gross structural abnormalities; or such findings detected on the MRI. Gross structural abnormalities of the brain include aneurysms, tumors, encephalomalacia and other anatomic sequalae of trauma, infarcts, etc. Of note, in routine clinical practice significant anatomic abnormalities are rarely discovered in patients undergoing workup for psychosis.
• Any active substance use disorder, apart from cannabis and nicotine use disorder.
• Claustrophobia and inability to tolerate MRI (including MRI non-compatible implants, and movement disorders that would interfere with obtaining a quality MRI image).
• Inability or unwillingness of individual to give written informed consent.
• Individual has a legal guardian (any legal guardian) or is in the process of awaiting court hearing for potential guardianship.
• Current involuntary hospitalization as evidenced by active 72h hold; any type of ongoing commitment process (including provisional discharge, stay of commitment, awaiting commitment hearing, etc.).
• Insufficient knowledge of English.
• Any metal, electronic, or other implant that is incompatible with TMS or MRI technology.

Eligibility last updated 5/31/22. Questions regarding updates should be directed to the study team contact. 

Inclusion Criteria
•Overactive Bladder:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent.
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation.
• For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion).
• For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria
•Non-Obstructive Urinary Retention:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent..
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation.
• Have a diagnosis of non-obstructive urinary retention as demonstrated by a urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-day period; and chronic non-obstructive urinary. retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria - Fecal Incontinence:

• 18 years of age or older.
• Candidate for or undergoing Medtronic InterStim lead implant labeled indication* requiring an advanced evaluation.
• Willing and able to provide signed and dated informed consent.
• Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
• Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation.
• Have a diagnosis of fecal incontinence as demonstrated by a bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate, or severe soiling) per week.
• *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria
•Overactive Bladder:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• History of diabetes unless the diabetes is well‐controlled through diet and/or medications.
• Have symptomatic urinary tract infection (UTI).
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component.
• Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study.
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
• Women who are pregnant or planning to become pregnant.
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria - Non-Obstructive Urinary Retention:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• History of diabetes unless the diabetes is well‐controlled through diet and/or medications
• Have symptomatic urinary tract infection (UTI)
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
• Women who are pregnant or planning to become pregnant
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria
•Fecal Incontinence:

• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
• Implanted with a neurostimulator, pacemaker or defibrillator.
• Pelvic floor muscle dysfunction due to surgical intervention or injury.
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• Have uncorrected high grade internal rectal prolapse.
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
• Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
• Women who are pregnant or planning to become pregnant.
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years old and residing in the US.
• Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
• Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ).
• Total daily insulin dose ≤ 200 units/day.
• Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin.
• For females, not currently known to be pregnant If female of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study as documented in the study records. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• HbA1c ≥ 7.5% and ≤ 12% at screening.
• Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one).
• Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study.
• Has the ability to read and understand written English.
• Investigator believes that the participant has capacity such that they can provide informed consent and can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.

• Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology.
• Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months.
• History of inpatient psychiatric treatment in the past 6 months.
• History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
• History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe.
• History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system.
• Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in section 8.3 of the protocol or determined by investigator to interfere with the study.
• Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication or starting a new glucose lowering agent during the trial.
• Unstable dose of any medication used for weight loss or starting a new medication for weight loss during the trial.　
• Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (> 450 ms).
• History of hemodialysis.
• History of adrenal insufficiency.
• Uncontrolled hypo- or hyperthyroidism.
• Significant diabetes related complications, based on investigator assessment.
• Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:  

• B-Cell Lymphoma:
  • Histologically documented lymphomas expected to express CD19;
  • Relapsed/refractory disease following at least 2 prior lines of multi-agent  immunochemotherapy.
• Chronic Lymphocytic Leukemia (CLL):
• Diagnosis of CLL per iwCLL guidelines;
  • Relapsed/refractory disease following at least two prior systemic treatment regimens.
• Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
  • Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics;
  • Relapsed/refractory disease after at least 2 cycles of standard multiagent induction  chemotherapy.
  • For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen.

ALL SUBJECTS

• Capable of giving signed informed consent.
• Age ≥ 18 years old.
• Stated willingness to comply with study procedures and duration.
• Contraceptive use for women and men as defined in the protocol.

ALL SUBJECTS

• Females who are pregnant or breastfeeding.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2.
• Body weight < 50 kg.
• Evidence of insufficient organ function.
• Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is  shorter; or any investigational therapy within 28 days prior to Day 1.
• Currently receiving or likely to require systemic immunosuppressive therapy.
• Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T.
• Receipt of an allograft organ transplant.
• Known active central nervous system (CNS) involvement by malignancy.
• Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or  neurodegenerative disease.
• Clinically significant cardiovascular disease.
• Positive serologic test results for HIV infection.
• Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B  (HBV) infection.
• Positive serologic and PCR test results for Hepatitis C (HCV) infection.
• Live vaccine < 6 weeks prior to start of lympho-conditioning.
• Known allergy to albumin (human) or DMSO.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

• ≥ 18 years of age.
• Capacity to consent.
• Patients undergoing a clinically indicated.

• Unable or not willing to consent.
• Pregnant women.
• < 17 years of age.
• External/Internal Electrical Devices – Left ventricular Assist Device, pacemaker dependence, implantable cardioverter defibrillator, transcutaneous electrical nerve stimulation (TENS) unit, or spinal cord stimulator.  (Rational – interference with interpretation).

Eligibility last updated 10/29/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18, Age ≤ 100.
• Patients having undergone total knee arthroplasty with highly congruent or posterior stabilized designs(DJO 3D Empowr vs Zimmer MP vs PS Stryker primary TKA).

• No vulnerable populations.

Eligibility last updated 10/28/21. Questions regarding updates should be directed to the study team contact.

• Patients 18 years or older with obesity (for adults BMI ≥ 30kg/m^2 or BMI ≥ 27kg/m^2 and at least one obesity-related chronic disease (such as type 2 diabetes mellitus, hypertension, obstructive sleep apnea, amongst others)).
• Individuals undergoing an evaluation for weight loss interventions (e.g., diet, medication, bariatric endoscopic procedure, or surgery)

• Principal investigator discretion.
• Individuals who are unable to sign consent (e.g., those declared legally incompetent).
• Patients without a tracking device (smart phone or wearable device).

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.

Inclusion Critieria:

• Suspicion for VEXAS syndrome based on the following being present.
• Current or historical elevated inflammatory markers (ESR > 20 mm/hr and/or CRP > 10 mg/L).
• PLUS at least one of the following inflammatory features present currently or historically:
  • Inflammatory arthritis;
  • Nasal or auricular chondritis;
  • Ocular inflammation (scleritis, episcleritis, uveitis);
  • Orbital / peri-orbital swelling/edema;
  • Cutaneous inflammation (inflammatory skin nodules, neutrophilic dermatosis, urticarial lesions, leukocytoclastic vasculitis);
  • Venous thromboembolism OR superficial thrombophlebitis;
  • Biopsy or radiographic confirmed evidence of vasculitis;
  • Inflammatory lung findings (multifocal ground glass opacity);
  • Recurrent fever, night sweats, unintentional weight loss.
• PLUS at least one of the following hematologic parameters:
  • MCV > 95 fl;
  • Anemia (hemoglobin < 13.2 g/dl for male or < 11.6 g/dl for female);
  • Thrombocytopenia (platelets < 135 x 10^9/L for male or < 157 x 10^9/L for female);
  • Leukopenia (white blood cell count < 3.4 x 10^9/L);
  • Neutropenia (neutrophil count < 1.56 x 10^9/L).

• Patients who are not able to provide informed consent.
• Patients < 18 years of age.
• Pregnancy.
• Patients who do not meet the above listed inclusion criteria.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

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

• Subjects who have received at least one dose of cilta-cel in a Janssen-sponsored clinical study.
• Subjects who have provided informed consent for Study MMY4002.

• No exclusion criteria are applicable in this study.

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

• Subjects ≥ 18 years old.
• Subjects who have had no personal or family (first degree relatives; i.e., subjects’ parents, siblings, and children) history of major psychiatric disorder.  Specifically, major depressive disorder, schizophrenia, or substance use disorder (SUD). Specifically, in order to ensure subjects without a history of SUD and/or psychiatric disorders, we will question the subjects about these diseases in themselves and their first-degree relatives.
• Ability to provide informed consent.
• This initial pilot study will be limited to European-American subjects because of striking differences among different ethnic groups in their allele frequencies or type, and all of the iPSCs that we have generated to this point were derived from European-American subjects.  However, our eventual goal is to generate panels of iPSCs from all major ethnic groups.  Unfortunately, that is not practically possible at this time because of cost in terms of reagents and the extended time required to generate each iPSC line.

• Subjects with a known bleeding issue. 
• Subjects who are under 18 years old.
• Subjects with a personal or first-degree relative history of major psychiatric disorder.  Specifically, major depressive disorder, schizophrenia or substance use disorder.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.

• Patients with a diagnosis of interstitial cystitis.
• One group of patients with interstitial cystitis who report a history or current use of pentosan polysulfate sodium.
• An age-matched control group of patients with interstitial cystitis who deny a history or current use of pentosan polysulfate sodium.

• Patients without a diagnosis of interstitial cystitis.

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

Residents of the 9-county area surrounding Rochester, MN with a diagnosis of interstitial cystitis identified via the Rochester Epidemiology Project (REP). All patients with a diagnosis of interstitial cystitis will be called via telephone to determine if they have ever taken or are currently taking PPS. Patients who have a history of PPS use or current PPS use will be recruited for a dilated funduscopic examination along with ultra-widefield fundus photography (Optos California icg, Dunfermline, Scotland, UK), ultra-widefield fundus autofluorescence (Optos California icg), spectral-domain macula optical coherence tomography (OCT) (Spectralis, Heidelberg Engineering), and near infrared reflectance (NIR) (Spectralis, Heidelberg Engineering) to screen for evidence of pentosan polysulfate maculopathy. Patients with a diagnosis of interstitial cystitis who denied a history of PPS use will also be recruited to an age-matched control cohort and undergo a dilated funduscopic examination along with ultra-widefield fundus autofluorescence, spectral-domain macula OCT, and NIR to screen for pattern dystrophy-like changes.

• Understand and voluntarily sign an informed consent form.
• Patients must be at least 22 years of age.
• Patients must be able to undergo routine non-contrast CT scans of the chest.
• Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
• The patients must have at least an expected 6 month survival.
• Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
• Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design.
• Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS.

• Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
• Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES) or 6 weeks following bare metal coronary stent).
• Unstable cardiac disease.
• Allergy to silicone.
• Stenting to manage vascular compression syndromes.
• Multi-drug resistant bacterial or fungal chronic infections.
• Emergent/urgent clinically indicated stent.
• Chronic/permanent mechanical ventilation.
• Pure Excessive Dynamic Airway Collapse (EDAC) patients.
• Pure Pulmonary Resistance (Rp) patients.

Eligibility last updated 11/4/21. Questions regarding updates should be directed to the study team contact.

• Ability to provide informed consent.
• 40 patients:
  • 20 preoperative THA, 20 postoperative THA;
  • Sex: 20 men, 20 women;
  • Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.

• Patients with lumbosacral hardware, contralateral THA.

Eligibility last updated 11/5/21. Questions regarding updates should be directed to the study team contact.

Inclusion Criteria;

• Age ≥ 18 years old.
• Scheduled to undergo UDS for clinical care of one of the included diagnoses.

• Obesity (BMI > 35kg/m^2).
• Known neurologic disease impacting bladder function (e.g., spinal cord injury, multiple sclerosis, Parkinson’s, prior cerebrovascular accident).
• Previous pelvic radiation therapy.
• Previous radical pelvic surgery (such as for uterine or colorectal cancer).
• Prior bladder surgery (including prostate resection).
• Pregnant or breast-feeding women.

Eligibility last updated 11/8/22. Questions regarding updates should be directed to the study team contact.

• Parent or LAR has signed information consent.
• Subject weighs between 2.5-10 kg (or 5.5-22 lbs).
• Subject is receiving medical care in an intensive care unit.
• Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
• Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT.

• Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator.
• Subject has irreversible brain damage, in the opinion of the investigator.
• Subject is intolerant to anticoagulation, as documented in the medical record.
• Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days.
• Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) < 30 ml/min/1.73m^2.
• Subject has received at least 12 hours of CRRT with another machine (not including ECMO) during the current hospitalization.
• Subject is currently or has chronically been treated with a circulatory support device (i.e., left ventricular assist device (LVAD)) other than ECMO.
• Subject has had prior CRRT treatments using the Carpediem™ system.
• Subject is enrolled in clinical trials or being treated with other investigational therapeutic devices or products for acute kidney injury or fluid overload.
• Subject has any other medical condition that may confound the study objectives, in the opinion of the investigator.

Eligibility last updated 12/9/21. Questions regarding updates should be directed to the study team contact.