AI-CARE Trial: A Pilot study to assess Safety, Efficacy, Feasibility, and Diagnostic Performance Evaluation of Artificial Intelligence-Augmented ECG Interpretation Vs. Standard of Care 12-Lead ECG Computerized ECG Interpretation Software Using a 12-Lead ECG Smartheart Device. (AI-CARE)
Study of Artifiicial Intelligence-augmented ECG vs. 12-Lead Computerized ECG
- ≥ 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.
Outcomes of Highly Congruent Polyethylene and Posterior Stabilized Designs in Total Knee Arthroplasty
Highly Congruent Polyethylene and Posterior Stabilized Designs in Total Knee Arthroplasty
- 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.
An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept (Orencia) in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (LIMIT JIA)
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)
1. Age ≥ 2 years old and ≤16.5 years old
2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months
3. Arthritis affecting ≤4 joints between disease onset and randomization
4. Enrollment in the CARRA Registry
5. Participants of childbearing potential must agree to remain abstinent or agree to use
an effective and medically acceptable form of birth control from the time of written
or verbal assent to at least 66 days after taking the last dose of study drug.
6. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent
to participate in the Limit-JIA study.
The presence of any of the following will exclude a study participant from inclusion in the
study:
1. 1. Systemic JIA as defined by 2004 ILAR criteria1
2. Sacroiliitis (clinical or radiographic)
3. Inflammatory bowel disease (IBD)
4. History of psoriasis or currently active psoriasis
5. History of uveitis or currently active uveitis
6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the
following: DMARD or biologic medication)
7. Current or previous (within 30 days of enrollment) treatment with systemic
glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)
8. History of active or chronic liver disease
9. Chronic or acute renal disorder
10. AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5
mg/dL or any other laboratory abnormality considered by the examining physician to be
clinically significant within 2 months of the randomization visit
11. Presence of any medical or psychological condition or laboratory result which would
make the participant, in the opinion of the investigator, unsuitable for the study
12. Participation in another concurrent clinical interventional study within 30 days of
randomization
13. Known positive human immunodeficiency virus (HIV)
14. Received a live virus vaccine within 1 month of the baseline visit
15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold
TB
16. Pregnant, breast feeding, or planned breast feeding during the study duration
17. Planned transfer to non-participating pediatric rheumatology center or adult
rheumatologist in the next 12 months
18. Active malignancy of any type or history of malignancy
19. Chronic or active infection or any major episode of infection requiring
hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral
antibiotics within 14 days prior to screening
20. Primary language other than English or Spanish
21. Positive for Hepatitis B surface antigen or core antibody
22. <10 Kg in weight
23. If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19
exposure at screening, it is recommended that the site follow CDC guidance regarding
testing and quarantine requirements. The subject can be re-screened when there is no
longer concern for active infection. A subject with a positive COVID -19 test may be
re-screened.
Multi-omics and Virtual Phenotyping in patients with Obesity: Multi-center Biobank and Outcomes Registry
Multi-center Biobank and Outcomes Registry for Obesity
- 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.
VEXAS Syndrome Biorepository (VEXAS)
VEXAS Biobank
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.
GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer (GRECO-2)
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
1. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable
if histology cannot be obtained.
2. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
3. Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a
gemcitabine-based doublet regimen prior to start of SBRT
4. Remain non-metastatic as confirmed by a CT scan at screening.
5. Female or male subjects ≥ 18 years of age
6. ECOG performance status of 0-2
7. Adequate end-organ function
1. Subjects with documented metastatic disease
2. First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based
doublet regimen
3. Prior abdominal RT with substantial overlap in radiation fields
4. Subjects not recovered/controlled from treatment-related toxicities
5. Uncontrolled malignancy other than PC
6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
7. Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
Eligibility last updated 5/9/23. Questions regarding updates should be directed to the study team contact.
Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel
Long-Term Study of Participants Previously with Ciltacabtagene Autoleucel
- 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.
Control Subjects for the Generation of Induced Pluripotent Stem Cells for use in Neuropsychiatric Research (iPSC)
Control Subjects for the Generation of Induced Pluripotent Stem Cells for use in Neuropsychiatric Research
- 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.
Prospective Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent
- 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.
A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis (Quanta 02-001)
Quanta Home Run Trial
1. Provision of a written informed consent form signed by the participant
2. Age between 18 and 80 years at time of enrollment
3. A care partner must be available for training on SC+ and to be present in the home
during all home hemodialysis sessions
4. Participants should be either receiving regular, facility-based hemodialysis therapy
for at least 90 days, or in the case of peritoneal patients transitioning to
hemodialysis, at least 90 days, or performing home dialysis (with any frequency) for
at least 90 days and willing to return to facility for purpose of study, and should be
clinically stable and deemed suitable for home dialysis in the opinion of the
principal investigator
5. Willing to accept a dialysis prescription of 3 sessions per week, 4 hours each session
or facility standard during in-clinic visits; 4 sessions, 3.5 hours each session
during in-home sessions
6. In the opinion of the Investigator, participant has well-functioning and stable
vascular access (tunneled, central venous catheter, arteriovenous fistula, or graft)
that allows a blood flow of at least 300 ml/min
7. Home environment is adequate to ensure that appropriate electrical connections and
water supply necessary for the use and storage of the device as assessed by Quanta
prior to subject C1 visit. Also ensure that cellular signal and/or WIFI capacity is
adequate.
8. Participant or care partner are capable of understanding the nature of procedures and
requirements of the study protocol and of home-based hemodialysis, and are willing and
capable of complying with protocol and returning to treatment center as stated in
protocol
9. Participant or care partner are capable of being trained to use the machine and
troubleshoot should an alarm situation occur
10. In the opinion of the treating physician, the subject is able to participate in the
trial in terms of social factors and personal functioning
11. Acceptable physical ability of the participant and/or care partner to perform the
hemodialysis treatment at home
12. Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or
other arrangement acceptable to participant
1. Pregnant or trying to become pregnant (women of childbearing potential must use
medically accepted contraceptive measures)
2. Predicted life expectancy of less than 12 months from first study procedure
3. Major cardiovascular adverse event in the 3 months prior to screening
4. Fluid overload due to intractable ascites secondary to liver cirrhosis
5. Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg)
6. Unstable coronary artery disease
7. New York Class III or IV heart failure, or ejection fraction less than 30%
8. Participation in other clinical studies that may interfere with the current protocol
9. Known problems with coagulation
10. Active, life-threatening, rheumatologic disease.
11. Hematocrit less than 28% at enrollment
12. Hemoglobin less than 9 g/dL at enrollment
13. Suffering from active severe infection
14. Seroreactive for hepatitis B surface antigen
15. Suffering from active malignancy with expected deteriorating course within 6-12 months
16. History of severe reactions to dialyzer membrane material
17. Expected to receive an organ transplant during the course of the study
18. Have dementia or inability to understand procedures
19. Lack an ability for self-care
20. Are non-adherent to their current dialysis treatments
21. Experience intra-dialytic hypotension defined as a decrease in systolic blood pressure
of greater than or equal to 20 mmHg or a decrease in mean arterial pressure of greater
than or equal to 10 mmHg provided that the decrease is associated with clinical events
(symptoms) and the need for an intervention (ultrafiltration turned off, bolus of
fluid) in 3 of 5 previous treatments
22. Is intolerant to heparin
23. Considered in the investigator's opinion to be clinically unstable for any other
reason
24. Undergoing outpatient dialysis for the treatment of acute kidney injury (AKI)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.
Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty
- 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.
Noninvasive Ultrasound Assessment of Detrusor Dysfunction (QUBV)
Ultrasound Bladder Vibrometry
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.
Carpediem(TM) Post Market Surveillance Study (056-F154)
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
- 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.
Hepatic Steatosis Quantification with Ultrasound
A Study Evaluating the Effectiveness of Ultrasound Imaging for Liver Steatosis Staging
- 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.
Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
Registry for Mayo Clinic Adult Congenital Heart Disease Control Population
- 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.
Patient Satisfaction with a Medial Constrained Versus Posterior Stabilized Total Knee Arthroplasty from a Single Design: A Multicenter Randomized Clinical Trial
A Study of Patient Satisfaction Comparing Medial Constrained Versus Posterior Stabilized Total Knee Arthroplasty from a Single Design
- 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.
Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE)
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
1. Is greater than 50 years of age
2. Has at least a 10-year life expectancy
3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
4. Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL
5. Has Gleason score 3+4 or 4+3
6. Has no evidence of extraprostatic extension by mpMRI
7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by
biopsy
8. Physician is able to visualize prostate gland adequately on transrectal ultrasound
imaging during enrollment evaluation
9. Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core
systematic biopsies to include adequate sampling of the peripheral zone correlating
with an intermediate risk lesion in the area of the MR-visible lesion
10. A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE)
treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will
not be considered an exclusion criterion provided the non-MRI visible lesion is
singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and
comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core
on standard biopsy)
11. Has signed a written informed consent and in the judgment of the physician, the study
is in the best interest of the subject
12. Understands and accepts the obligation and is logistically able to present for all
scheduled follow-up visits
1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis
3. Has an active urinary tract infection (UTI)
4. Has a history of bladder neck contracture
5. Is interested in future fertility
6. Has a history (within 3 years) of inflammatory bowel disease
7. Has a concurrent major debilitating illness
8. Had active treatment for a malignancy within 3 years, including malignant melanoma,
except for prostate cancer or other types of skin cancer
9. Has any active implanted electronic device (e.g., pacemaker)
10. Is unable to catheterize due to a urethral stricture disease
11. Has had prior or current prostate cancer therapies:
1. Biologic therapy for prostate cancer
2. Chemotherapy for prostate cancer
3. Hormonal therapy for prostate cancer within three months of procedure
4. Radiotherapy for prostate cancer
5. Surgery for prostate cancer
12. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or
prostatic implants
13. Has had prior major rectal surgery (except hemorrhoids)
14. Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac
pacemaker, metallic implants that are likely to contribute significant image
artifacts, allergy or contraindication to gadolinium (to enhance MRI))
15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a
bleeding disorder
16. Is a member of a vulnerable population such as prisoners, handicapped or mentally
disabled persons, or economically or educationally disadvantaged persons
17. In the opinion of the treating physician, has a contraindication listed in the current
NanoKnife System User Manual (section 2.3)
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.
Understanding the Baseball Swing Through Motion Capture (MoCap)
A Study of the Baseball Swing Through Motion Capture
- 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.
A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups
A Study of Educational Materials for Hiccups
- 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.
Autosomal Dominant Hypocalcemia Types 1 and 2 (ADH1/2) Disease Monitoring Study (DMS) (CLARIFY)
CLARIFY: ADH1 and ADH2 Disease Monitoring Study (DMS)
- Patients age 1 year through adult.
- 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 3/30/23. Questions regarding updates should be directed to the study team contact.
Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum (DBS)
Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum
- 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.
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) (VGN-TED-301)
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis
associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale)
for the most severely affected eye (primary study eye) at Screening and Baseline
- Confirmed active TED (not sight-threatening but has an appreciable impact on daily
life, with onset (as determined by patient records) within 12 months prior to the
Baseline visit and usually associated with one or more of the following: lid
retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm
above normal for race and gender, and/or inconstant or constant diplopia.
- Subjects must be euthyroid with the participant's baseline disease under control or
have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free
triiodothyronine levels [FT3] < 50% above or below the normal limits) at Screening.
- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other
ophthalmological intervention at the time of Screening and is not planning for any
such treatment during the course of the study.
- Decreased best corrected visual acuity due to optic neuropathy as defined by a
decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color
defect secondary to optic nerve involvement within the last 6 months.
- Corneal decompensation unresponsive to medical management.
- Previous orbital irradiation or orbital surgery.
- Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalent to
>= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of
Screening.
- Prior IGF-1R inhibitor therapy for any condition.
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.
CAAA617C12301, PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PSMAddition)
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC
Participants eligible for inclusion in this study must meet all of the following criteria:
1. Signed informed consent must be obtained prior to participation in the study
2. Patients must be adults ≥18 years of age
3. Patients must have an ECOG performance status of 0 to 2
4. Patients must have a life expectancy >9 months as determined by the study investigator
5. Patients must have metastatic prostate cancer with histologically or cytologically
confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic
site)
6. Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT
scan, and eligible as determined by the sponsor's central reader
7. Patients must have at least one documented metastatic bone and/or soft tissue/visceral
lesion documented in the following manners within 28 days prior randomization:
1. Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone
scintigraphy on either pre-ADT scans or baseline scans AND/OR
2. Lymph node metastases of any size or distribution. If lymph nodes are the only
site of metastasis, then at least one must be at least 1.5 cm in short axis AND
outside of the pelvis AND/OR
3. Visceral metastases of any size or distribution. If a participant has a history
of visceral metastases at any time prior to randomization, he should be coded as
having visceral metastases at baseline (i.e., patients with visceral metastases
prior to ADT that disappear at baseline will be counted as having visceral
metastases and would therefore have high volume disease for stratification
purposes).
8. Patients must have adequate organ function:
- Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥9 g/dL
- Hepatic Total bilirubin ≤2 x the institutional upper limit of normal (ULN). For
patients with known Gilbert's Syndrome ≤3 x ULN is permitted Alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x
ULN for patients with liver metastases
- Renal eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease
(MDRD) equation
9. Albumin ≥2.5 g/dL
10. Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low
risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in
this trial
11. Patients must be:
Treatment naïve OR minimally treated with:
- Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or
bilateral orchiectomy with or without first generation anti-androgen (e.g.
bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF
signature. If given, first generation anti-androgen must be discontinued prior to
start of study therapy or after 45 days whatever happens first.
- If received, prior LHRH agonist/antagonist with or without first generation
anti-androgen use in the adjuvant/neo-adjuvant setting must have been discontinued >
12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND
must not have shown disease progression within 12 months of completing
adjuvant/neo-adjuvant therapy.
- Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is
allowed prior to ICF signature. No CYP17 inhibitor or ARDT exposure for earlier stages
of prostate cancer is allowed.
Participants meeting any of the following criteria are not eligible for inclusion in this
study.
1. Participants with rapidly progressing tumor that requires urgent exposure to
taxane-based chemotherapy
2. Any prior systemic anti-prostate cancer therapy (with the exception of the drugs
listed on inclusion criteria 11), including chemotherapy, Poly (adenosine
diphosphate-ribose) polymerase (PARP) inhibitors, immunotherapy or biological therapy
(including monoclonal antibodies).
3. Concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, PARP
inhibitor, biological therapy or investigational therapy
4. Previous treatment with any of the following within 6 months of randomization:
Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body
irradiation. Previous PSMA-targeted radioligand therapy is not allowed
5. Ongoing participation in any other clinical trial
6. Use of other investigational drugs within 30 days prior to day of randomization
7. Known hypersensitivity to any of the study treatments or its excipients or to drugs of
similar chemical classes
8. Transfusion for the sole purpose of making a participant eligible for study inclusion
9. Participants with CNS metastases that are neurologically unstable, symptomatic, or
receiving corticosteroids for the purpose of maintaining neurologic integrity.
Participants with epidural disease, canal disease and prior cord involvement are
allowed if those areas have been treated, are stable, and not neurologically impaired.
Participants with parenchymal CNS metastasis (or a history of CNS metastasis), that
have received prior therapy and are neurologically stable, asymptomatic and not
receiving steroids for CNS metastases, are allowed, baseline and subsequent
radiological imaging must include evaluation of the brain (magnetic resonance imaging
(MRI) preferred or CT with contrast).
10. Diagnosed with other malignancies that are expected to alter life expectancy or may
interfere with disease assessment. However, participants with a prior history of
malignancy that has been adequately treated and who have been disease free, treatment
free for more than 3 years prior to randomization, or participants with adequately
treated non-melanoma skin cancer, superficial bladder cancer are eligible.
11. Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, uncontrolled infection, known active hepatitis B or C,
or other significant co-morbid conditions that in the opinion of the investigator
would impair study participation or cooperation. Participants with an active
documented COVID-19 infection (any grade of disease severity) at time of informed
consent may be included only when completely recovered (in accordance with local
guidance).
12. Active clinically significant cardiac disease defined as any of the following:
- NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature
unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45%
with improvement in symptoms to class < 3.
- History or current diagnosis of ECG abnormalities indicating significant risk of
safety for participants in the study such as: Concomitant clinically significant
cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle
branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block,
Mobitz type II and third degree AV block)
- History of familial long QT syndrome or known family history of Torsades de
Pointes
- Cardiac or cardiac repolarization abnormality, including any of the following:
History of myocardial infarction (MI), angina pectoris, or coronary artery bypass
graft (CABG) within 6 months prior to ICF signature
13. History of somatic or psychiatric disease/condition that may interfere with the
objectives and assessments of the study
14. Symptomatic cord compression, or clinical or radiologic findings indicative of
impending cord compression
15. Any condition that precludes raised arms position
16. Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note:
participants with bladder outflow obstruction or urinary incontinence, which is
manageable and controlled with best available standard of care (incl. pads, drainage)
are allowed.
17. Sexually active males unwilling to use a condom during intercourse while taking study
treatment and for 14 weeks after stopping study treatment. A condom is required for
all sexually active male participants to prevent them from fathering a child AND to
prevent delivery of study treatment via seminal fluid to their partner. In addition,
male participants must not donate sperm for the time period specified above. If local
regulations deviate from the contraception methods listed above to prevent pregnancy,
local regulations apply and will be described in the ICF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/28/23. Questions regarding updates should be directed to the study team contact.
Intestinal Permeability in Patients with Active Inflammatory Bowel Disease: Towards Development of a Non-invasive, Inexpensive Test to Detect Intestinal Inflammation
Developing a Non-invasive Test to Detect Intestinal Inflammation in Active Inflammatory Bowel Disease
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.
Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN)
A Non-interventional Cohort Safety Study of Patients With hATTR-PN
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.
Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR) (AMSCAR)
Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients
- Able to understand and provide informed consent.
- Have received a renal transplant (first or repeat), and the most recent protocol
biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.
Clinical
- Stable renal function:
- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the
serum creatine prior to the biopsy (must be within 3 months of the biopsy);
- Estimated eGFR > 30 ml/min by MDRD.
Histologic Criteria for Eligibility:
- ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular
capillaritis (ptc) (g:1 or 2; ptc:1 or 2).
- Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2);
intimal arteritis (v) (v: 1 or 2).
- Mixed ABMR and cellular rejection.
- Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year
preceding screening.
- History of post-transplant intervention for obstructive uropathy
- One or more of the following laboratory values:
o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT)
≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0,
Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase
their platelet count will not be excluded).
- One or more of the following parameters:
o Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤
90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or >
140/min
- Patients with the following grades/classes of vascular diseases:
- NYHA Class 3-4 CHF
- Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular
response, supraventricular tachycardia, Wolff-Parkinson-White syndrome,
ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled
chronic atrial fibrillation will be allowed to participate.
- Cerebrovascular accident (CVA) within 90 days of screening
- Peripheral Arterial Disease (PAD), patients who have had prior vascular
interventions for PAD in the index lower extremity.
- Acute illness within 30 days of screening.
- History of allergy or intolerance to iodinated contrast agents
- Women of childbearing potential or male subjects with female partners of childbearing
potential unwilling to use an effective method of contraception during and for 12
months post-treatment.
- History of or current evidence of alcohol abuse, illicit drug use or dependence
- Active COVID 19 or positive test for the SARS-CoV-2 virus
- History of malignancy within 5 years of enrollment. History of adequately treated
in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous
cell) will be permitted
- Serologic evidence of human immunodeficiency virus 1 or 2 infection
- Epstein Barr Virus (EBV) sero-negativity (EBV naïve)
- Cytomegalovirus (CMV) sero-negativity
- Active post-transplant opportunistic infections at the time of screening (CMV, BK
virus, polyoma virus, EBV)
- Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core
antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV
IgG positive), or those with HBV surface antibody positive but HBV core antibody
negative subjects will not be excluded from the study.
- Have received a kidney transplant from a Hepatitis C positive donor and plan to
receive anti-viral treatment after transplant
- Any chronic condition for which anti-coagulation cannot be safely interrupted for
kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall
into either the high or the moderate thrombotic risk, they will be deemed to be not
safe to interrupt anticoagulation:
- High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any
caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months)
stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6,
CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic
attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within
3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or
antithrombin; antiphospholipid antibodies; multiple abnormalities)
- Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve
prosthesis and 1 or more of the of following risk factors: atrial fibrillation,
prior stroke or transient ischemic attack, hypertension, diabetes, congestive
heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6;
Venous thromboembolism: VTE within the past 3 to 12 months, non-severe
thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation),
recurrent VTE
- For all other subjects, anticoagulation can be safely interrupted for 3 days
prior to infusion and resumed a day after the infusion.
- Positive pregnancy test
- Participation in any other studies that involved investigational drugs or regimens in
the preceding year
- Any other condition, in the investigator's judgment, that increases the risk of A-MSC
infusion or prevents safe trial participation
- Unwilling or unable to adhere to study requirements and procedures
- Per Banff criteria category 6: the presence of other changes not considered to be
caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant
Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury,
Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or
Drug-Induced Interstitial Nephritis
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Tradipitant for Functional Dyspepsia
- Able to provide written consent
- Body Mass Index (BMI) of 18-35 kg/m2
- Absence of other diseases which could interfere with interpretation of study results
- Current H. pylori infection
- Pregnancy or nursing
- Recent history of Alcohol Use Disorder or Substance Use Disorder
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/21/23. Questions regarding updates should be directed to the study team contact.
Developing a Cancer Distress Management Program for Liver and Biliary Cancer within a Specialized Program of Research Excellence (SPORE) (SPORE)
Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
- Patients who have received care for hepatobiliary cancer at Mayo Clinic in the past 5 years.
- Caregiver of above patient.
- Clinician providing care for hepatobiliary cancer patients at Mayo Clinic.
- Member of SPORE Patient Advocacy Board.
- Inability to complete an English language electronic survey for any reason. Non-English speaking patients will be offered translation services when available.
Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.
IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients by Using a 20 Hz Filter to Better Assess Electrocardiogram Abnormalities (IQ-ECG)
IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients
- Adults ≥ age of 18 years.
- Must have a left ventricular assist device (LVAD).
- Must be able to consent.
- No LVAD.
- Unable to consent.
- Under the age of 18 years.
Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.
Investigating the Effect of Human Umbilical Cord MSCs Derived Exosome / Extracellular Vesicle on Endogenous Neural Cells Proliferation in Rats with Spinal Cord Injury
Umbilical Cord MSC's
- Healthy, full-term women (18-35 years old) who underwent elective cesarean section.
- Free of Human Immunodeficiency Virus (HIV) types 1 & 2, Hepatitis A, B, and C, Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhea, and HTLV 1 & 2.
- Able to give written informed consent prior to collection of the cord.
- On chronic, immunosuppressive transplant therapy or having a chronic, immuno-suppressive state, including use of systemic steroids/corticosteroids.
- Takin anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, Hepatitis, and syphilis.
- History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.