• 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.

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. 

• Subjects 18 years of age or older.
• A 3-day voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 hours.
• Have a diagnosis of UUI for at least 6 months.
• No OAB pharmacotherapy for 2 weeks prior to completion of the baseline voiding diary and Overactive Bladder Quality of Life (OAB-q) questionnaire.
• Failed, or are not a candidate for, conservative non-pharmacologic treatment (e.g., pelvic floor training, biofeedback, behavioral modification)
• In the opinion of the Investigator, subject has failed and/or is intolerant to at least 1 overactive bladder medication or Investigator has determined that medication use is not appropriate based on the subject’s profile and medical history.
• Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol.
• Willing and able to provide signed and dated informed consent.

• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• Severe uncontrolled diabetes.
• History of urinary retention within the previous 6 months.
• Current symptomatic urinary tract infection.
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component [see enrollment/baseline requirements for use of the Medical, Epidemiological, and Social Aspects of Aging urinary incontinence questionnaire (MESA) questionnaire].
• Diagnosis of bladder pain syndrome, pelvic pain, or interstitial cystitis.
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• History of a prior implantable tibial neuromodulation system.
• Knowledge of planned diathermy procedures.
• Have had treatment of urinary symptoms with sacral neuromodulation in the past 6 months, botulinum toxin therapy in the past 9 months or percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) in the past 3 months.
• Skin lesions or compromised skin integrity (e.g., skin atrophy, thinning, fragility, etc.) which may affect incision healing at the implant site.  Current or a recent history (within the past 6 months) of a medical condition such as venous insufficiency and/or venous stasis ulcers, clinically significant malnutrition, immunocompromised state, or other relevant chronic disease which may indicate a higher risk for delayed or poor wound healing.
• Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device (including any metal implant that is within 20 cm of the intended neurostimulator location).
• Previous pelvic floor surgery in the last 6 months.
• Women who are pregnant or planning to become pregnant during the course of the study.
• Any subject who is considered to be part of a vulnerable patient population.**
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
• Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.***

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

Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.

• Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy.
• Subject plans to undergo a one-level Open or Mini-Open TLIF procedure (stabilized with pedicle screws) independent of this research protocol.
• Subject is to be treated with on-label use of an FDA-cleared TLIF cage and pedicle screw system independent of this research protocol.
• The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (< 25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
  • Herniated nucleus pulposus;
  • Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
  • Facet joint degeneration/osteophyte formation;
  • Spondylosis (defined by the presence of osteophytes);
  • Disc degeneration and/or annular degeneration; and/or
  • Lumbar stenosis defined by spinal cord or nerve root compression.
• Exhausted conservative treatment (e.g., bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency.
• Preoperative Oswestry Disability Index score > 40/100 at baseline.
• Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
• Signed informed consent.

• More than one vertebral level requiring treatment.
• revious instrumented surgery (i.e., anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level.
• Degenerative or lytic spondylolisthesis greater than Grade 1 (< 25% translation).
• Rotatory scoliosis at the level to be treated.
• Congenital bony and/or spinal cord abnormalities at the level to be treated.
• Subcaudal defect, disrupting the integrity of the pedicle.
• Clinically compromised vertebral bodies at the involved level due to current or past trauma; e.g., by the radiographic appearance of the fracture callus, malunion or nonunion.
• Disrupted anterior longitudinal ligament at the index level.
• Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated.
• Back pain of unknown etiology without leg pain.
• Severe spondylosis at the level to be treated as characterized by any of the following:
  • Autofusion (solid arthrodesis) determined radiographically (CT);
  • Totally collapsed disc; or
  • Vertebral body that cannot be mobilized.
• Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E.
• Unable to undergo a CT scan or other radiograph assessments.
• Osteopenia: All patients will completeThe SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening.
• Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta).
• Insulin-dependent diabetes mellitus.
• Lactating, pregnant or interested in becoming pregnant in the next 3 years.
• Active infection – systemic or local.
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
• Body Mass Index > 40.
• Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease.
• Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation.
• Spinal tumor.
• Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
• Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease.
• Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
• In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
• Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code.
• Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered ‘current’).
• Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation.
• Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results.
• Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

Eligibility last updated 7/21/22. 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.

• ≥ 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 21 years or older with obesity (for adults BMI ≥ 30kg/m^2.).
• 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 11/8/21. 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.

• Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
• Newly diagnosed non-metastatic PC judged by tumor board to be feasible for (m)FOLFIRINOX and SBRT.
• Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy.
• Female or male subjects ≥ 18 years of age.
• ECOG performance status of 0-2.
• Adequate end-organ function.

• Subjects with documented metastatic disease.
• First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total period of longer than 4 months prior to start of SBRT.
• Prior abdominal RT with substantial overlap in radiation fields.
• Subjects not recovered/controlled from treatment-related toxicities.
• Uncontrolled malignancy other than PC 6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing.
• Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy.

Eligibility last updated 11/2/21. 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.

• 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.

• 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.

• Age ≥ 18 years old.
• Patients with clinically indicated MRI-PDFF (Proton Density Fat Fraction) for liver imaging.

Exclusion Criteria

• Individuals < 18 years old.
• Vulnerable subjects such as:
  • Prisoners;
  • Adults lacking capacity to consent.
• Patients with liver iron overload, which may confound PDFF measurements.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years.
• BMI ≤ 30.
• No current cardiac medications.
• Systolic BP ≤ 140 mmHg.
• Diastolic BP ≤ 90 mmHg.
• Capacity to consent.

• Age < 18 years.
• To be assessed via EMR screening.
• Patient confirmation during screening visit.
• Screening tests as applicable.
• History of cardiovascular disease.
• eGFR < 30.
• Current orthopedic limitations.

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

• Evaluation for total knee arthroplasty (TKA) at Mayo Clinic (Rochester, MN) or OrthoCarolina (Charlotte, NC).
• Evaluated and scheduled for TKA at Mayo Clinic by Drs. Cody Wyles, Robert Trousdale, Kevin Perry, or Nic Bedard or at OrthoCarolina by Drs. Thomas Fehring, Bo Mason, Keith Fehring, or Jesse Otero. 
• Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery.
• ≥ 18 years of age at enrollment.

• Previous surgery with hardware on the joint of interest.
• Varus or valgus defor 1mity > 15° or any other preoperative deformity at the discretion of the surgeon portending a risk of needing a constrained or hinged device.
• Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease).
• BMI ≥ 40.
• Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol.
• Contralateral side previously enrolled in this study (i.e., simultaneous bilateral or staged bilateral patients cannot have both sides enrolled).
• Current tobacco use.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 3/16/23. Questions regarding updates should be directed to the study team contact.

• Age 15-30 years inclusive.
• Male gender.
• Active participation in collegiate level baseball as a batter.
•  Unrestrictive baseball participation.
• No current musculoskeletal complaints for which the subject is being treated.
• Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
• Willingness to participate in the study

• Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
• Known neurological, visual, or vestibular disease affecting balance or coordination.
• Congenital deformity of the neck, upper extremity, or lower extremity.
• Congenital or acquired scoliosis or significant thoracic kyphosis (>30 degrees).
• History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

Eligibility last updated 2/27/23. Questions regarding updates should be directed to the study team contact.

• Age ≥ 18 years of age.
• Hiccups in the 4 weeks prior to phone contact (patient must confirm).
• Able to speak and read English.
• Has an e-mail address.

• Individuals < 18 years of age.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

• Participants from birth to age 90 years must meet all the following criteria for inclusion during screening:
  • Have a documented activating variant of the CASR gene for ADH1 or documented activating variant of the GNA11 gene for ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment
    • Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
  • Be willing and able to provide informed consent or assent after the nature of the study has been explained, and prior to any research-related procedures.
  • Be willing to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available.
  • Be willing and able to comply with the study visit schedule and study procedures.

• Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures.
• Enrollment in an ADH1/2 interventional clinical study at the time of DMS Screening visit or at any point during the DMS.

Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.

• Subjects who are ≥ 18 years of age.
• Subjects who are known to be positive for syphilis antibodies using routine, standard of care serologic assays.

• Subjects who are < 18 years of age.
• Subjects who are unable to give informed consent.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 2/7/23. Questions regarding updates should be directed to the study team contact.

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

• Active disease as defined by SES-CD (PMID: 15472670) > 6 (> 4 if ileal only), AND active symptoms of CD (CDAI score > 220) or full Mayo score for UC ≥ 2 with an endoscopy score of ≥2 (PMID: 31272578) within the past 4-6 weeks. 9,10,11,12,13
• Remission as defined by SES-CD 0-2 and CDAI score ≤150, or full Mayo score for UC 0-2 with endoscopy score < 2.9,10,11,12,13.
• Ability to give informed consent.

Healthy Adults

• ≥ 18 years age.
• No underlying medical illnesses that could serve as confounders with the objectives of the study.  

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

• Less than 18 years of age.
• Prior history gastrointestinal surgeries including IPAA, ileostomy and colostomy.
• Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test.
• Use of osmotic laxatives and unable to unwilling to stop taking one week prior to permeability test.
• Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous two weeks and for the duration of the study.
• Multiple dietary restrictions or unable or unwilling to alter dietary protein or dietary fiber for the permeability testing.
• Unwilling or unable to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
• Bowel preparation for colonoscopy must be completed more than 48 hours prior to completion of permeability test. If intestinal biopsies were performed, 7 days must pass prior to permeability testing.
• Pregnancy or plan to become pregnant during the study time frame.
• Vulnerable adult.

Healthy Adults 

• Less than 18 years of age.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

Either:

• TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment; or
• TEGSEDI Unexposed Cohort: Patients diagnosed with hATTR-PN who have not taken any dose of TEGSEDI within 25 weeks prior to enrollment and are eligible for TEGSEDI treatment per applicable product label.
• Clinically managed in Canada, Europe, or the US.
• Have provided appropriate written informed consent.

• None.

Eligibility last updated 12/2/21. Questions regarding updates should be directed to the study team contact.

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

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.