Collecting Urine Samples in Patients with Autosomal Dominant Polycystic Kidney Disease to Develop a Biomarker Assay (Regulus Biomarker)
Regulus Biomarker
- Male or female patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- Age ≥ 18 to 65 years old.
- Must have Class 1C, 1D or 1E Mayo Imaging Classification of ADPKD (based upon an MRI obtained in the year prior to randomization).
- Must have estimated GFR between 30 to 90 mL/min/1.73 m^2 from screening serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI).
Exclusion Criteria:
- Administration of tolvaptan in the 30 days prior to sample collection.
- Mayo Class 1A 1B ADPKD.
- Unable to travel to Mayo Clinic.
- Unable to provide consent.
Research of Neurovascular Specimens
Research of Neurovascular Specimens
- Adult (≥ 18 years).
- Undergoing neurovascular surgery clinically or who are identified during autopsy as having biospecimens of interest.
- Technical inability to safely obtain specimen.
Evaluation of Cochlear Implantation at Mayo Clinic (ECI)
Evaluation of Cochlear Implantation
- All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
- If patients declined MN research authorization, they may be contacted for consent for approval.
- Patients that did not undergo cochlear implantation at the Mayo Clinic.
Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.
UMCC 2018.132, Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma (UMCC 2018.132)
A Study to Evaluate Trabectedin with Olaparib in Advanced Unresectable or Metastatic Sarcoma
- Age ≥ 16 years.
- Advanced unresectable or metastatic sarcoma.
Cohort 1
- Leiomyosarcoma (LMS)/Liposarcoma (LPS).
Cohort 2
- Other sarcoma histologies (excluding gastrointestinal stromal tumors).
- Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
- Measurable disease by RECIST 1.1.
- Adequate hematologic, renal, hepatic function.
- Adequate creatine phosphokinase.
- ECOG performance status ≤ 1.
- Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal (LLN).
- Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment.
- Men must agree to use barrier contraception or abstinence and not donate sperm during treatment and for 5 months after the last dose of study treatment. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.
- Left ventricular ejection fraction ≥ institutional LLN.
- Ability to understand and the willingness to sign a written informed consent.
- Must have a life expectancy ≥ 16 weeks.
- Prior therapy with PARP inhibitor, including olaparib.
- Prior therapy with trabectedin.
- Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years.
- Pregnant or breastfeeding women.
- Known hypersensitivity to trabectedin or olaparib.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome (MDS) /acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Immunocompromised patients; e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with known active hepatitis (i.e., Hepatitis B or C).
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
- Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
- Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St. John’s Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Participation in another clinical study with an investigational product administered in the last 30 days prior to anticipated study treatment.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Has received a live vaccination with 2 weeks of enrollment.
- Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation.
- Involvement in the planning and/or conduct of the study.
- Previous enrollment in the present study.
Evaluating Patient Reported Outcome Measures in Children with Eye Conditions (PedEyeQ)
A Study to Evaluate Patient Reported Outcome Measures in Children with Eye Conditions
- Children ages 0 to 17 years and one parent/legal guardian.
- Current or previous diagnosis of an eye condition.
- Any treatment status: pre-treatment, post-treatment, current treatment, no treatment.
- Neurodevelopmental delay and/or systemic health disorders allowed.
- Individuals ≥ 18 years of age.
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
A Study to Develop a Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
- All patients ≥ 16 years old.
- Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN), and Mayo Clinic Orthopedics and Sports Medicine (Minneapolis, MN).
- Patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
- Substantial alcohol or drug abuse.
- History of narcotics within 6 months of surgery.
- Pregnancy.
- Renal impairment.
- Peptic ulcer disease.
- GI bleeding.
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
A Study to Develop a Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
- All patients ≥ 16 years old.
- Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN), and Mayo Clinic Orthopedics and Sports Medicine (Minneapolis, MN).
- Patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin.
- Substantial alcohol or drug abuse.
- History of narcotics within 6 months of surgery.
- Pregnancy.
- Renal impairment.
- Peptic ulcer disease.
- GI bleeding.
Rare Kidney Stone Consortium Registry for Hereditary Kidney Stone Diseases (RKSC)
Rare Kidney Stone Consortium Patient Registry
- Inclusion of Legacy PH patients from two previous Mayo Clinic Hyperoxaluria Center registry protocol databases will be rolled into the 6401 PH Registry.
- Patients < 18 years with a history of kidney stones, and/or nephrocalcinosis; OR
- Patients > 18 yrs with a history of kidney stones, and/or nephrocalcinosis and at least one of the following:
- Family history of stones or nephrocalcinosis or unexplained kidney failure;
- Growth retardation due to metabolic bone disease and/or renal failure;
- Crystals of unusual type;
- Mild to moderate proteinuria;
- Elevated serum creatinine and/or reduced GFR;
- Hypomagnesemia;
- Increased urinary calcium excretion;
- Increased urinary oxalate excretion; or
- Renal cysts.
- Family member of a patient who meets any of the above inclusion criteria
- Any patient unwilling to sign a consent.
Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System
Focal Prostate Ablation Utilizing TULSA Profound System
- Male patients.
- Age 45-80 years, with > 10 years life expectancy.
- Biopsy-confirmed, NCCN (favorable GG2 and unfavorable GG3) intermediate-risk prostate cancer.
- Stage ≤ T2c, N0, M0.
- ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy (minimum 3 cores from each PI-RADS v2 category ≥ 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline.
- PSA ≤ 20 ng/mL reported within 3 months of baseline.
- Treatment naïve.
- Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline.
- Inability to undergo MRI or general anaesthesia.
- Suspected tumour > 30 mm from the prostatic urethra.
- Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumour on low-dose pelvic CT:
- Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcifications. Imaging for calcification screening must be dated within 1 year of baseline visit.
- Unresolved urinary tract infection or prostatitis.
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder.
- Artificial urinary sphincter, penile implant or intraprostatic implant.
- Less than 10 years life expectancy.
- Patients who are otherwise not deemed candidates for RP.
- Inability or unwillingness to provide informed consent.
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices.
Eligibility last updated 2/7/22. Questions regarding updates should be directed to the study team contact.
Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant (HSCT)
• >10% decrease in FEV1 from baseline or decrease of 25% of FEF 25-75 from baseline
• active GVHD in another organ system + pulmonary symptoms (Tachypnea without wheezing, new oxygen requirement, cough)
• Increased R5 by 50% by clinical IOS
• Air trapping on CT, small airway thickening, or bronchiectasis AND
•All age groups, including adults: Adequate renal function defined as estimated Creatinine Clearance (CrCl) ≥ 30 mL/min as calculated by the cystatin c GFR or nuclear GFR Adequate hepatic function as defined by:
• ALT and AST ≤ 5 x ULN, unless the ALT / AST increase is due to cGVHD
• Total bilirubin of ≤ 5 x ULN (unless of non-hepatic origin or due to Gilbert's Syndrome) or Total bilirubin of < 10 x ULN if due to GVHD Adequate hematological function defined as:
• Absolute neutrophil count ≥1.0 x 10^9/L
• Platelets ≥30 x 10^9/L PT/INR <2 x ULN and PTT (aPTT) < 2 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
• Known hypersensitivity to any constituent of the study medication.
• Active uncontrolled pulmonary infection (preceding infectious evaluation including bronchoscopy as clinically indicated)
• Subjects who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 90 days for both females and males after the last dose of study drug.
• Subjects previously treated with investigational agent for GVHD within the 30 days prior to first dose of study treatment. Other non-GVHD additional investigational agents may be allowed on a case by case basis with review/approval by the study Lead PI.
Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)
Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
• Age: <18 years and >3 months
• Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy
• Preoperative opiate use within the last 30 days
• Bilateral surgery
• No English speaking caregiver
• Parental/patient refusal
• Severe preoperative respiratory compromise
• Allergy to ropivacaine
• Coagulopathy: Defined by INR>1.5 or Platelet count <100k
• Current Infection at site of injection
• VP Shunt on side of surgical procedure
• Pregnant patients: determined by patient history and available laboratory data. Patients will not be required to have pregnancy testing done if not otherwise indicated.
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)
• Patients with SMA, genetically confirmed on or after 24 May 2018.
• Appropriate consent/assent has been obtained for participation in the registry
•Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA. Note: Patients that are participating in a Compassionate Use Program (CUP) for AVXS-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of genetic confirmation of SMA.
Microbiome of Infectious Pleural Diseases
Microbiome of Infectious Pleural Diseases
- Individuals of 18 year of age and older undergoing thoracentesis or pleural catheter insertion (inpatient and outpatient)
- Samples obtained from a chest tube not implanted at the time of sample collection
- Not enough fluid for analysis
- Lack of research authorization on file
Comparison of CSF Flow Metrics Across MRI Platforms
Comparison of CSF Flow Metrics
- Male or female, ≥ 18
•40 years of age. - A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.
- Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.
OtoVU Design and Human Factors Validation
Human Factors Validation of OtuVU
Study participants taking the role as circulating clinical personnel and scrub personnel must have the following:
- A high school diploma, or equivalent, minimum level of education.
- Professional working proficiency, or higher, in English.
- Experience working in the OR and trained in aseptic technique.
- The role of circulating clinical personnel can be undertaken by the following people: doctor, surgeon, surgical trainee, surgical technician, or other adequately trained personnel.
- The role of scrub personnel can be undertaken by the following people: surgical technician, surgeon, surgical trainee, or other adequately trained personnel.
Study participants taking the role of the surgeon must have the following:
- A good working knowledge of ENT anatomy.
- Have worked with cadaveric tissue or live patients in the past.
- < 18 years of age.
- The role of surgeon can be undertaken by the following people: surgeon or surgical trainee. Individuals may take on multiple roles throughout the study, but not during the same test session.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.
Prospective Biobanking Study in Immunodeficiency Patients
Biobanking Study in Immunodeficiency Patients
- Capable and willing to provide informed consent.
- Confirmed or suspected physician diagnosis of Primary Immunodeficiency.
- Not willing to provide consent.
- Not diagnosed with Primary Immunodeficiency.
Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.
Mayo Clinic Digital Menopause Management Study
Testing of a Menopause Management Digital Health Application
- Adult postmenopausal women, aged 45-60 years.
- Menopause symptoms (hot flashes/night sweats) rated moderate or greater or total MRS score ≥ 14.
- Current use of hormone therapy.
Eligibility last updated 3/10/22. Questions regarding updates should be directed to the study team contact.
Home Alone: An Intervention for People With Cognitive Impairment Who Live Alone
• 55 years of age or older
• Lives alone in a non-residential setting
• Either 1) provider diagnosis of MCI, 2) Montreal Cognitive Assessment by telephone (T-MoCA) score between 13 and 18, and/or 3) subjective endorsement of memory impairment on screening
• Resides in the US
• Demonstrates capacity to consent
• Live in assisted living, a group care home, or similar residential setting that provides care and services
• Are not English speaking
• Are currently participating in any other type of service that provides one-to-one psychosocial consultation or independent living coaching
• Have a new or worsening mental health condition and are not receiving ongoing treatment
• Have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics, or anti-psychotics, for the prior three months
• Are not willing/interested in participating or cannot actively participate in the intervention, per researcher discretion
EZH-302: A Phase 1b/3 Double-blind, Randomized, Active-controlled, 3-stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination With Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
A Study to Evaluate Tazemetostat Combined with Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
- Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
- Males or females are ≥ 18 years of age (≥ 20 years for Taiwan) at the time of providing voluntary written informed consent.
- Life expectancy ≥ 3 months before enrollment.
- Subjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion and are hepatitis B surface antigen negative and/or have undetectable hepatitis C virus (HCV) RNA.
- Have histologically confirmed FL, Grades 1 to 3A.
- Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
- Systemic therapy includes treatments such as:
- Rituximab monotherapy;
- Chemotherapy given with or without rituximab;
- Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.
- Systemic therapy does not include, for example:
- Local involved field radiotherapy for limited-stage disease;
- Helicobacter pylori eradication.
- Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criteria.
- Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed;
- Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.
- Systemic therapy includes treatments such as:
- Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression < 6 months after last dose).
- Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- For subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy):
- At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0; OR
- Are clinically stable and no longer clinically significant.
- Have provided sufficient tumor tissue for EZH2 mutation testing and to allow for stratification:
- If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tissue will be required for confirmatory testing of EZH2 status at studyspecific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections are also acceptable.
- NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor’s or Designee Medical Monitor.
- Time between prior anticancer therapy and first dose of tazemetostat as follows:
- Cytotoxic chemotherapy – At least 21 days;
- Noncytotoxic chemotherapy (eg, small molecule inhibitor) – At least 14 days;
- Nitrosoureas – At least 6 week;
- Monoclonal and/or bispecific antibodies or CAR T – At least 28 days;
- Radiotherapy – At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.
- Adequate renal function defined as calculated creatinine clearance ≥ 40 mL/minute per the Cockcroft and Gault formula.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1000/mm^3 (≥ 1.0 × 10^9 /L) if no lymphoma infiltration of bone marrow OR ANC ≥ 750/mm^3 (≥ 0.75 × 10^9 /L) with bone marrow infiltration;
- Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days;
- Platelets ≥ 75,000/mm^3 (≥ 75 × 10^9 /L)
- Evaluated at least 7 days after last platelet transfusion;
- Hemoglobin ≥ 9.0 g/dL;
- May receive transfusion.
- Adequate liver function:
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome;
- Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases).
- International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless on warfarin, then INR ≤ 3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.
- Females of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).
- Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:
- Examples of highly effective methods:
•Intrauterine device (IUD), Hormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrelreleasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel])
•Bilateral tubal ligation
•Partner’s vasectomy (if medically confirmed [azoospermia] and sole sexual partner). - Examples of additional effective methods:
•Male latex or synthetic condom
•Diaphragm
•Cervical Cap.- NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
- All study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used. a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.
- Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
- NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
- Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
- Prior exposure to lenalidomide.
- Grade 3b, mixed histology, or FL that has histologically transformed to DLBCL (subjects transformed from DLBCL to FL may be enrolled).
- Has thrombocytopenia, neutropenia, or anemia of Grade ≥ 3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
- Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL).
- Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
- Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John’s wort).
- Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from their diet.
- Major surgery within 4 weeks before the first dose of study drug.
- Note: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
- Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
- Prolongation of corrected QT interval using Fridericia’s formula (QTcF) to ≥ 480 msec at screening or history of long QT syndrome.
- Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat whereas subjects greater than 3 months since deep vein thrombosis/pulmonary embolism are eligible but recommended to receive prophylaxis.
- Have an active infection requiring systemic therapy.
- Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.
- Inability to be treated with a Pneumocystis prophylaxis medication.
- Active viral infection with or seropositive for hepatitis B virus (HBV): HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA. NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible. Consult Sponsor’s or Designee Medical Monitor with questions regarding testing or results prior to enrollment.
- Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA), human immunodeficiency virus (HIV), AND/OR human T-cell lymphotropic virus 1 (as measured by positive HTLV-1 antibody).
- NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible. Consult Sponsor’s or Designee Medical Monitor with questions regarding testing or results prior to enrollment.
- Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study OR interfere with their ability to receive study treatment or complete the study.
- Female subjects who are pregnant or lactating/breastfeeding.
- Subjects who have undergone a solid organ transplant.
- Subjects with malignancies other than FL.
- Exception: Subjects with another malignancy who have been disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Can Ultrasound Detect Medial Meniscal Extrusion More Frequently Than MRI?
A Study to Evaluate Whether Ultrasound Can Detect Medial Meniscal Extrusion More Frequently Than MRI?
- Adult male or female between 18 and 65 years of age.
- Adult male or female who is scheduled to receive a knee MRI at our facility.
- Prior history of knee surgery.
- Inability to WB
- MRI incompatibility (e.g., presence of ferromagnetic implants, claustrophobia, etc.).
Significance of Glandular Atypia in Barrett’s Esophagus Determined by Volumetric Laser Endomicroscopy
A Study to Evaluate Glandular Atypia in Barrett?s Esophagus Determined by Volumetric Laser Endomicroscopy
- Patients with Barrett's Esophagus (BE) undergoing endoscopic surveillance.
- Patients with contraindications to endoscopic resection and/or volumetric laser endomicroscopy (VLE) imaging.
Comparison of Episcleral Venous Pressure Measured in Multiple Body Positions with Two Devices (EVP)
A Study to Compare Episcleral Venous Pressure Measured in Multiple Body Positions with Two Devices
- ≥ 18 years of age.
- Either gender.
- Any self-declared ethno-racial category.
- Subjects with two healthy eyes with the crystalline lens, without glaucoma or any other clinically significant eye diseases.
- Open angles in both eyes.
- Intraocular pressure less than 22 mmHg in either eye.
- Be able and willing to provide signed informed consent and follow study instructions.
- Ability to cooperate for the examinations required for study and be able to attend all study visits.
- Contact lenses removed before the study visit.
- Best-corrected visual acuity (BCVA) in each eye of 20/50 or better.
- Under 18 years of age.
- Narrow angle of < Shaffer grade 2, peripheral synechiae, or peripheral iridotomy in either eye.
- Subjects with a central corneal thickness less than 480 µm or greater than 620 µm in either eye.
- Chronic or recurrent inflammatory eye diseases.
- Ocular infection or ocular inflammation in the past 3 months.
- Ocular trauma other than corneal abrasion within the past 6 months.
- Clinically significant retinal disease (eg, diabetic retinopathy, exudative or severe non-exudative macular degeneration).
- Cornea pathologic changes preventing reliable measurement (eg, scarring, opacity) in either eye.
- Previous intraocular surgery or laser procedure in either eye.
- Myopia greater than -6.00D, or hyperopia greater than +2.00D.
- Moderate to severe dry eye in either eye.
- Serious hypersensitivity to topical anesthetic eye drops.
- Use of any topical ophthalmic medications other than lubricants and artificial tears within the past 30 days.
- Use of any products of cannabis (THC or CBD compounds) within the past 30 days.
- Lack of suitable episcleral vein for EVP measurement.
Low Dose Chest CT
A Study to Evaluate Low Dose Chest CT vs. Standard CT in Cystic Fibrosis Patients
- Children, 1-17 years of age.
- Presence of Cystic Fibrosis (CF):
- Sweat tests > 60mEq/L or presence of 2 CF causing mutations;
- Non-CF bronchiectasis or other clinical indications for chest CT;
- Patients who did not sign Minnesota research authorization will be contacted by study PI and phone consent will be obtained.
- Over 17 years of age.
- Acute respiratory distress.
- Unstable cardiovascular status.
- hypoxia (SaO2 less than 93% in room air).
- Pneumothorax.
- Pulmonary edema.
- Pulmonary emboli.
- Fractured ribs or other chest trauma.
- Recent bronchoscopy.
Outcomes of Descemet Membrane Endothelial Keratoplasty
Outcomes of Descemet Membrane Endothelial Keratoplasty
Inclusion Criteria
- Patient age 21 years or older; either sex.
- Corneal endothelial disease: Presence of corneal endothelial dysfunction requiring keratoplasty, including pseudophakic corneal edema and Fuchs endothelial dystrophy.
- Lenticular status: Pseudophakic with posterior chamber intraocular lens or phakic with or without cataract requiring extraction.
Exclusion Criteria
- Uncontrolled glaucoma or prior filtering surgery (tube shunt or trabeculectomy).
- Uncontrolled uveitis.
- High graft failure risk including herpetic keratouveitis or any condition with two or more quadrants of stromal neovascularization.
- Presence of anterior chamber intraocular lens.
- Pregnancy
- Those unlikely to complete the study due to plans to move, preference to follow-up with local provider, international patients, etc.
Characterization of microvasculature in kidney transplant by super-resolution ultrasound imaging
Ultrasound Microvessel Imaging of Transplant Kidney
- Male and female patients.
- Age ≥ 18 years old.
- Having transplant kidney and undergoing clinically indicated allograft biopsy.
- Able and willing to consent.
- Patients lacking capacity to consent.
- Vulnerable subjects such as prisoners, pregnant women, nursing mothers.
- Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
Prospective Validation of GFRNMR at Mayo Clinic (proGFRMayo)
Validation of GFRNMR at Mayo Clinic
Inclusion Criteria:
- Patient is scheduled for renal iothalamate renal clearance measurement.
- Age ≥ 18 years.
- Patient information received, read, understood, and signed.
- Individuals < 18 years.
- Patients under haemodialysis within 7 days before renal iothalamate clearance measurement.
- Patients under peritoneal dialysis within 7 days before renal iothalamate clearance measurement.
Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.
Molecular Breast Imaging (MBI) Patient Survey
Patient Survey of Molecular Breast Imaging
- Female.
- MBI exam performed at Mayo Clinic in Rochester, MN.
- Email address provided in the medical record.
- Protected research populations (pregnant women, prisoners, children, and adults lacking capacity to consent) will not be included in the study.
Eligibility last updated 6/7/22. Questions regarding updates should be directed to the study team contact.
Genomic Analysis of Glioma Tissue Samples
Genomic Analysis of Glioma Tissue Samples
- Stereotactic imaging available corresponding to tissue location.
- Age > 18 years.
- MRI suggestive of glioma.
- Planned craniotomy or biopsy.
- Negative urine pregnancy test.
- Informed written consent.
- Signature for release of information.
- Not meeting criteria above.
Childhood Onset Sjogren Disease Registry (cSD)
A Registry of Childhood Sjogren Disease
- Subject diagnosed with Sjogren Disease prior to 21 years of age. This will include patients either:
- Fulfilling AECG or ACR/EULAR criteria; or
- Are diagnosed by an expert.
- Patients with a history of recurrent or persistent salivary or lacrimal gland inflammation or swelling without an underlying etiology. This can include patients with a label of recurrent juvenile parotitis.
- Elevated SSA/Ro or SSB/La without a diagnosis of SD at study entry.
- Subject suspected of having SD in evolution based on expert opinion.
- Symptom onset after 21 years of age.
- Not receiving care at a study related institution.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/2/23. Questions regarding updates should be directed to the study team contact.