COVID-19 and Acute Kidney Injury (AKI) (COVAKI)
COVID-19 and Acute Renal Failure
- Adult patients, ≥ 18 years of age.
- Patients testing positive for SARS-CoV-2 and requiring hospitalization at the Mayo Clinic Arizona, Rochester, or Florida campuses.
- Patients < 18 years of age.
- Patients with pre-existing end-stage renal disease; i.e., need for renal replacement therapy (RRT) prior to index hospitalization.
COVID in the Community - Epidemiology of COVID-19 in Olmsted County
COVID in the Community (Enrolling by Invitation Only)
- Member of identified high risk population; i.e., employees of long-term care facilities, first responders, health care workers, and day care providers.
- Known clinically-diagnosed COVID-19 infection.
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Tool
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Tool
Inclusion Criteria
•Patients:
- Adult patients (18 years of age or older) who present for evaluation of a thyroid nodule and may have a discussion regarding the need for thyroid biopsy.
Inclusion Critieria
•Clinicians:
- Clinicians who counsel patients with thyroid nodules from the Division of Endocrinology.
Exclusion Criteria
•Patients:
- Patients who do not speak English.
- Patients who lack the capacity to consent.
- Patients with hyperthyroidism, pregnant patients, and those in which the nodule of interest has already been biopsied or who have received consultation with a thyroid nodule specialist.
Exclusion Criteria
•Clinicians:
- N/A.
Generation of Algorithms that Enable Early Detection of Symptomatic SARS-CoV-2/COVID-19 Infection in High Risk Employees
A Study to Analyze Algorithms for Evaluating Early Detection of SARS-CoV/COVID-19 Infection in Critical Service Employees
- Age 18 years or older.
- Employed at > 0.75 FTE as a healthcare worker, emergency services worker, or critical services employee that has direct contact with patients/customers and cannot abide by social distancing guidelines.
- Physicians, nurses, allied health, etc.;
- Police officers, State Patrol, etc.;
- Cashiers, other positions that can clearly describe how the above criteria place them at high-risk due to regular interactions.
- Patient is comfortable and willing to interact with a tablet-based interface on a daily basis.
- Under the age of 18 years old.
- Has previously tested positive or has a pending test for SARS-CoV-2/COVID-19.
- Is currently undergoing self-quarantine for suspected COVID-19.
- Works less than 0.75 FTE or cannot clearly articulate the nature of patient/interpersonal interactions that place them at high-risk.
- Is unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
- Is unwilling or unable to provide baseline data required for entry into the study.
- Recent history of unexpected hospitalizations due to a chronic medical condition (e.g., chronic, unstable heart failure).
- Travel to and from a high-risk area within the past 14 days (e.g., U.S. or international “hot spot”).
MC200703: Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
A Study to Evaluate Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
- Age ≥ 18 years.
- Histological confirmation of melanoma. Patients may have completed biopsy outside of Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to confirming eligibility.
- Measurable or non-measurable disease. Patient must meet one of these criteria.
- ECOG Performance Status (PS) ≤ 3.
- sPD-L1 levels >1.7 ng/ml.
- Negative pregnancy test done ≤ 7 days prior to radiation therapy, for women of childbearing potential only.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Willing to provide blood samples for correlative research purposes.
- Persons taking a biotin supplement.
- sPD-L1 level < 1.7 ng/ml by ELISA.
- Pregnant or nursing women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.
1901: Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, as a Single Agent or Combined With Ruxolitinib, in Patients With Myelofibrosis
A Study to Evaluate 9-ING-41 As a Single Agent or in Combination with Ruxolitinib in Myelofibrosis Patients
- Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures.
- Is aged ≥ 18 years.
- Has documented diagnosis of symptomatic primary MF, PPV-MF or PET-MF as defined by the World Health Organization classification.
- Is ineligible or unwilling to undergo stem cell transplantation at time of study entry.
- Is refusing, ineligible for, intolerant of, or not adequately responding to approved therapies for myelofibrosis.
- Has laboratory function within specified parameters per local laboratory (may be repeated):
- Absolute neutrophil count (ANC) ≥ 100/μL;
- Platelets ≥ 20,000/mL;
- Hemoglobin ≥ 8.0 g/dL;
- Transaminases (AST/ALT) and alkaline phosphatase ≤ 3 x ULN;
- Bilirubin ≤ 1.5 x ULN (unless patient has Gilbert’s Syndrome);
- Serum amylase and lipase ≤ 1.5 x ULN.
- Has adequate performance status (PS):
- Eastern Co-operative Oncology Group (ECOG) PS 0-3.
- Has received the final dose of any of the following treatments/procedures with the specified minimum intervals before first dose of 9-ING-41 (unless in the opinion of the investigator and the study medical coordinator the treatments/procedures will not compromise patient safety or interfere with study conduct:
- Chemotherapy, immunotherapy, or systemic radiation therapy
•14 days maximum, or ≥ 5 half-lives (whichever is shorter); - Surgery with general anesthesia – 7 days.
- Chemotherapy, immunotherapy, or systemic radiation therapy
- Patients who are to receive 9-ING-41 plus Ruxolitinib must have attempted ≥18 weeks of Ruxolitinib therapy and required dose reductions/interruptions and/or had an inadequate response.
- Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 100 days after discontinuation of study treatment.
- Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 100 days after discontinuation of study treatment and use appropriate barrier contraception or true abstinence.
- Must not be receiving any other investigational product.
- Is pregnant or lactating.
- Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation.
- Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41.
- Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation.
- Is considered to be a member of a vulnerable population (for example, prisoners).
- Herbal preparations / medications are prohibited throughout the study. These herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), Gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and Ginseng. Patients should stop using cannabinoids or herbal preparations/medications at least 7 days prior to first dose of study treatment.
Generation of Algorithms for Early Prediction of Aggressive Progression and Hospitalization in Patients Diagnosed with SARS-CoV-2/COVID-19 Infection
A Study to Generate Algorithms for Early Prediction of Aggressive Progression and Hospitalization in Patients Diagnosed with SARS-CoV-2/COVID-19 Infection
- Over the age of 18 years old.
- Received a positive test for COVID-19 within the past 48 hours and can provide documentation of the test.
- Self reports that the patient is comfortable and willing to interact with a tablet-based interface on a daily basis.
- Under the age of 18 years old.
- Tested positive more than 48 hours prior to contacting study staff or has a pending test for SARS-CoV-2/COVID-19.
- Cannot confirm a positive test for COVID-19.
- Unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
- Unwilling or unable to provide baseline data required for entry into the study.
- Currently enrolled in a remote monitoring program via the Center for Connected Care.
- Any of the following conditions that are contraindicated for use with this device:
- pacemaker implantation;
- implantable defibrillator;
- use of a neuro-stimulator.
ROR2002: Generation of Algorithms that Enable Early Detection of SARS-CoV-2/COVID-19 Infection and Unrelated Mechanisms of Clinical Decline in High Risk Radiation Oncology Patient Populations (ROR2002)
A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients
- Over the age of 18 years old.
- Is currently undergoing clinically-indicated care in the Radiation Oncology Practice or scheduled to start treatment in the Radiation Oncology Practice at Mayo Clinic Rochester.
- Self reports that the patient is comfortable and willing to interact with a tablet-based interface on a daily basis.
- Remaining treatment duration of at least 2 weeks.
- Under the age of 18 years old.
- Has previously tested positive or has a pending test for SARS-CoV-2/COVID-19.
- Is currently undergoing self-quarantine for suspected COVID-19.
- Is unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
- Is unwilling or unable to provide baseline data required for entry into the study.
- Recent history of unexpected hospitalizations due to a chronic medical condition (e.g., chronic, unstable heart failure).
- Currently enrolled in the Remote monitoring program via Center for Connected Care.
A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS) (RAVENS)
A Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)
- Male patient must be ≥ 18 years of age.
-
- Patient must have at least one and up to three asypmtomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are ≤ 5.0 cm or < 250 cm^3 as seen on either CT/MRI scan and/or bone scan. Up to five lesions are allowed on advanced funcitonal imaging such as fluciclovine (Axumin), choline or 18F-DCFPyL (“PyL”) PET-CT scan. (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and/or bone scan).
- Patient must have had their primary tumor treated with surgery and/or radiation.
- Histologic confirmation of malignancy (primary or metastatic tumor).
- PSADT < 15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
- Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
- PSA > 0.5 but < 50.
- Testosterone > 125 ng/dL.
- Patient must have a life expectancy ≥ 12 months.
- Patient must have an ECOG performance status ≤ 2.
- Patient must have normal organ and marrow function as defined as:
- Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 10^9/L;
- The platelet count ≥ 100 x 10^9; and
- Hemoglobin ≥ 10 g/dL.
- Patient must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Patient is under 18 years of age.
- No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
- PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan.
- Castration-resistant prostate cancer (CRPC).
- Spinal cord compression or impending spinal cord compression.
- Suspected pulmonary and/or liver metastases (> 10 mm in largest axis).
- Patient receiving any other investigational agents.
- Patient receiving abiraterone and prednisone.
- Patient is participating in a concurrent treatment protocol.
- Serum creatinine > 3 times the upper limit of normal.
- Total bilirubin > 3 times the upper limit of normal.
- Liver Transaminases > 5-times the upper limit of normal.
- Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
- Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
- Refusal to sign informed consent.
ACCRU-GI-1701 A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients With Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
Pemigatinib to Treat Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
- Histologically or cytologically confirmed diagnosis of metastatic or unresectable colorectal cancer (mCRC), based on documentation from local or outside review of pathology according to each site’s established institutional procedure.
- Documentation of an activating genomic alteration(s) in FGF/FGFR1-3 (gain of function mutations, translocations, and amplifications allowed) in tumor tissue or blood tested at a Clinical Laboratory Improvement Amendments (CLIA) – certified laboratory.
- Provide informed written consent.
- Age ≥ 18 years. Age = ________.
- Patient must have received and progressed on, or be intolerant to, each of the following treatments for mCRC (or have contraindication to these treatments):
- Fluoropyrimidine;
- Oxaliplatin;
- Irinotecan;
- Pembrolizumab;
- Nivolumab;
- Anti-VEGF (vascular endothelial growth factor) monoclonal antibody, if eligible for this therapy;
- Anti-EGFR (epidermal growth factor receptor) monoclonal antibody, if eligible for this therapy.
- Measurable disease as defined:
- A non-nodal lesion is considered measurable if its longest diameter can be accurately measured as ≥ 2.0 cm with chest x-ray, or as ≥ 1.0 cm with CT scan, or MRI;
- A superficial non-nodal lesion is measurable if its longest diameter is ≥ 1.0 cm in diameter as assessed using calipers (e.g., skin nodules) or imaging. In the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended;
- A malignant lymph node is considered measurable if its short axis is > 1.5 cm when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm).
- NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease.
- ECOG Performance Status (PS) of 0, 1, or 2. Form is available on the ACCRU web site.
- ECOG Performance Status = ________.
- The following laboratory values obtained ≤ 28 days prior to registration:
- Earliest laboratory test date __ __/__ __/__ __ __ __; latest laboratory test date __ __/__ __/__ __ __ __.
- NOTE: These dates pertain to the following labs only:
- Absolute neutrophil count (ANC) ≥ 1500/mm^3. ANC = _______;
- Platelet count ≥ 100,000/mm^3. Platelet count = ________;
- Hemoglobin ≥ 9.0 g/dL. Hemoglobin = ________;
- Total bilirubin < 1.5 x upper limit of normal (ULN), or < 2.5 x ULN if patient has Gilbert syndrome or disease involving the liver.
- NOTE: These dates pertain to the following labs only:
- Does subject have Gilbert syndrome or disease involving the liver? (this question may be answered 1=Yes or 2=No).
- ____ Yes. Total bilirubin (≤ 2.5 x ULN) = _______; ULN = _______.
- ____ No. Total bilirubin (≤ 1.5 x ULN) = _______; ULN = _______.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN (or <5 x ULN in presence of suspected liver metastases).
- Does subject have suspected liver metastases? (this question may be answered 1=Yes or 2=No).
- ____ Yes. AST (≤ 5 x ULN) = _______; ULN = _______.
- ALT (≤ 5 x ULN) = _______; ULN = _______.
- ____ No. AST (≤ 2.5 x ULN) = _______; ULN = _______.
- ALT (≤ 2.5 x ULN) = _______; ULN = _______.
- Serum phosphate < institutional ULN. Serum phosphate = _______; ULN = _______.
- Serum calcium within institutional normal range, or serum albumin-corrected calcium within institutional normal range (if serum albumin is outside of the institutional normal range).
Which test was done to satisfy eligibility?
____ Serum calcium. Serum calcium = _______; LLN = _______; ULN = _______.
____ Serum albumin-corrected calcium = _______; LLN = _______; ULN = _______. - Potassium levels > institutional lower limit of normal (supplementation can be used to correct potassium level during screening). Potassium = _______; LLN = _______.
- Serum creatinine < 1.5 x ULN, or calculated creatinine clearance >30 mL/min using the Cockcroft-Gault formula or 24-hours urine collection analysis.
Which test was done to satisfy eligibility?
____ Serum creatinine. Serum creatinine = _______; ULN = _______.
____ Calculated creatinine clearance = _______. - Corrected QT interval (QTc) by Fridericia’s method (QTcF) assessed by electrocardiogram (ECG) completed ≤ 28 days prior to registration, and resulted as:
- QTcF < 450 msec in men;or
- QTcF < 470 msec in women.
- Negative serum pregnancy test completed ≤ 7 days prior to registration, for women of childbearing potential only.
See Appendix I for definition of WOCBP.
If not a woman of childbearing potential or male (check NA)
If a woman of childbearing potential – Negative serum pregnancy test date __ __/__ __/__ __ __ __. - Willing to provide tissue and blood samples for correlative research purposes.
- Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research.
All responses in above section must be “Yes” unless specified as “NA.”
- Prior treatment with Pemigatinib.
- Prior treatment with a selective FGFR inhibitor <180 days (6 months ) prior to registration.
- Known hypersensitivity or severe reaction to an FGFR inhibitor, or to the excipients of Pemigatinib (i.e. microcrystalline cellulose, sodium starch glycolate, and magnesium stearate).
- Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
- Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications <14 days prior to registration.
- Major surgery < 28 days prior to registration.
- External beam radiation therapy < 28 days prior to registration, or palliative radiation for non-CNS disease <14 days prior to registration.
- External beam radiation therapy < 28 days prior to registration.
If no prior external beam radiation therapy (check NA).
If prior external beam radiation therapy
•Last day of external beam radiation therapy.
__ __/__ __/__ __ __ __ - Palliative radiation for non-CNS disease <14 days prior to registration.
If no prior palliative radiation for non-CNS disease (check NA).
If prior palliative radiation for non-CNS disease
•Last day of palliative radiation for non-CNS disease.
__ __/__ __/__ __ __ __ - Brain metastases, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- NOTE: Patients who are asymptomatic or previously treated and stable, without evidence of progression for > 28 days prior to registration are eligible.
- NOTE: Patients taking concomitant corticosteroids and/or anticonvulsants are allowed if patient is on a stable or decreasing dose of such treatment for > 28 days prior to registration.
- History or presence of significant cardiovascular disease or condition including:
- Uncontrolled angina pectoris (Canadian Cardiovascular Society Grade II-IV despite medical therapy);
- Congestive heart failure (New York Heart Association Class III or IV);
- Uncontrolled arrhythmia requiring therapy.
- NOTE: Patients with a pacemaker and well-controlled rhythm for > 28 days prior to registration are not excluded;
- Any of the following occurring < 6 months prior to registration: Myocardial infarction, angioplasty, cardiac stenting, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack.
- Failure to adequately recover (i.e., to < Grade 1 (according to CTCAE v.5) or to pre-treatment baseline) from adverse events (AEs) deemed by the investigator as clinically significant and attributed to prior therapy. Exception: alopecia.
- Current use of prohibited medication:
- Concomitant administration of potent CYP3A4 inhibitors and inducers and moderate CYP3A4 inducers. Based on the low overall bioavailability of topical ketoconazole, there are no restrictions on topical ketoconazole;
- Any concomitant use of a selective FGFR inhibitor (other than Pemigatinib);
- Investigational study drug for any indication;
- Use of any anticancer medications (other than Pemigatinib).
- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers < 14 days or 5 half-lives (whichever is shorter) prior to registration.
- NOTE: Topical ketoconazole will be allowed.
- History of hypovitaminosis D requiring supraphysiologic doses to replenish the deficiency.
- NOTE: Patients receiving Vitamin D food supplements are allowed.
- History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung; with the exception of calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
- Unable or unwilling to swallow Pemigatinib and keep a medication diary, or significant gastrointestinal disorder(s) that could interfere with absorption, metabolism or excretion of Pemigatinib per the discretion of the investigator.
- Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women;
- Nursing women;
- Women of childbearing potential or men able to father children who have a female partner of childbearing potential, who are unwilling to employ acceptable contraception.
- Known history of human immunodeficiency (HIV) infection or positivity on immunoassay confirmed per local standards.
- NOTE: HIV test is not required for screening, but patients with a known history of HIV infection will be excluded.
- Evidence of active hepatitis B (HBV) or hepatitis C (HCV) infection.
- Other known active malignancy < 5 years prior to registration.
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma in situ of the cervix, provided there is no known active disease and no additional therapy for the condition is ongoing or required during the trial period.
- NOTE: Anti-estrogen/androgen therapy or bisphosphonates allowed.
- Co-morbid systemic illness, other severe concurrent disease, or psychiatric illness/social situation which, in the judgment of the investigator, would make the patient inappropriate for entry into this study, limit compliance with study requirements, or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen.
All responses in above section must be “No” unless specified as “NA”.
Mayo Clinic Experience of Tele-Medicine in an Advanced Prostate Cancer Clinic During the COVID-19 Pandemic (TM-APC-S)
Tele-Medicine in an Advanced Prostate Cancer Clinic
- Any patient with advanced prostate cancer presented to us through Tele-consult during COVID-19 for a consult.
- Patients consented to be enrolled in the study
- Patients that refuse to be enrolled in the study
Phase 1/2 Study of APR-246 in Combination with Pembrolizumab in Subjects with Solid Tumor Malignancies (A20-11195)
A Study of APR-246 and Pembrolizumab in Patients with Solid Tumor Malignancies
- Signed informed consent form (ICF) and ability to comply with protocol requirements.
- Known tumor TP53 mutation status from recent or archival sample.
- Histologically and/or cytologically confirmed solid tumor malignancy:
- Safety lead-in portion:
- Patients with histologically and/or cytologically confirmed diagnosis of advanced non-central nervous system (CNS) primary tumors that have progressed after first line treatment, who are intolerant to first line treatment, or who are unable to receive first line treatment, and for whom pembrolizumab, or pembrolizumab-based therapy, is considered appropriate in the opinion of the investigator. Primary CNS tumors are excluded. Patients with clinically stable, known metastatic tumors to the CNS are eligible. CNS radiography is not required in the absence of suspicion for clinical involvement.
- Phase 2 Expansion portion:
- Patients with histologically and/or cytologically confirmed diagnosis of advanced gastric or gastroesophageal junction (GEJ) tumors that have progressed after first line treatment, who are intolerant to first line treatment, or who are unable to receive first line treatment. Patients with clinically stable, known metastatic tumors to the CNS are eligible with Medical Monitor approval. CNS radiography is not required in the absence of suspicion for clinical involvement. Prior treatment with anti-PD1/anti-PD-L1 therapy is prohibited;
- Patients with histologically and/or cytologically confirmed diagnosis of advanced bladder/urothelial tumors that have progressed after first line treatment, or who are intolerant to first line treatment, or who are unable to receive first line treatment with cisplatin-based chemotherapy. Patients with clinically stable, known metastatic tumors to the CNS are eligible with Medical Monitor approval. CNS radiography is not required in the absence of suspicion for clinical involvement. Prior treatment with anti-PD-1/anti-PD-L1 therapy is prohibited;
- Patients with histologically and/or cytologically confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 therapy. Patients with clinically stable, known metastatic tumors to the CNS are eligible with Medical Monitor approval. CNS radiography is not required in the absence of suspicion for clinical involvement.
- Safety lead-in portion:
- Adequate organ function as defined by the following laboratory values:
- Creatinine clearance > 30 mL/min (by Cockcroft-Gault method;
- Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless due to Gilbert’s syndrome, tumor involvement, hemolysis or considered an effect of regular blood transfusions;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 × ULN, unless due to involvement by the underlying malignancy.
- Age ≥ 18 years at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Projected life expectancy of ≥ 12 weeks.
- In the expansion portion, measurable disease meeting the following criteria:
- At least 1 lesion of ≥ 10 mm in the longest diameter (LD) for a non-lymph node or ≥ 15 mm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1;
- Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation must show subsequent evidence of substantial size increase (ex., 20% increase in LD) to be deemed a target lesion.
- Negative serum or urine pregnancy test prior to study treatment initiation in female subjects of childbearing potential.
- Women of childbearing potential and men with female partners of childbearing potential must be willing to use an effective form of contraception such as latex condom, hormonal birth control, intrauterine device or double barrier method during chemotherapy treatment and for at least six months thereafter.
- Known history of untreated human immunodeficiency virus (HIV)/HIV with a detectable viral load or active hepatitis B or active hepatitis C infection.
- Any of the following cardiac abnormalities:
- Myocardial infarction within six months prior to registration;
- New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction (LVEF) < 40%;
- A history of familial long QT syndrome;
- Symptomatic atrial or ventricular arrhythmias not controlled by medications;
- QTcF ≥ 470 msec, unless due to underlying bundle branch block and/or pacemaker and with approval of the Medical Monitor.
- Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. Subjects with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g, cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer are permitted.
- Pregnancy or lactation.
- Active uncontrolled systemic infection.
- An autoimmune condition requiring ≥ 10 mg (or equivalent corticosteroid) prednisone daily, or any other systemic immunosuppressive treatment within 28 days of first dose of study therapy.
- Known history of active tuberculosis.
- Current (non-infectious) pneumonitis, or a history of pneumonitis that required steroids.
- A live vaccine administered within 30 days of the first dose of study treatment.
- Receipt of any investigational product within 14 days or 5 half-lives prior to study treatment initiation, whichever is shortest.
- Prior intolerance to pembrolizumab or other anti-PD-1/PD-L1 agents.
The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)
The International Diabetes Closed Loop Trial DCLP4
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
- Using an insulin pump for at least 3 months (which may include use of automated features).
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥ 18 years old.
- For females, not currently known to be pregnant.
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study.
- Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial.
- Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol.
- Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial.
- Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months.
- Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months.
- Hemophilia or any other bleeding disorder.
- A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk.
- History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Telemedicine in Occupational Medicine: Patient Satisfaction and Outcomes in a Telehealth Pilot (TMOM)
Telemedicine in Occupational Medicine
- Employed by Mayo Clinic.
- ≥ 18 years old.
- Medical condition that affects work ability.
- Less than 18 years old.
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) and Acquired Angioedema (AAE) Due to C1-INH Deficiency
A Study to Evaluate the Effectiveness and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema in Adolescents and Adults
- Males and females, 12 years of age and older for subjects with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF).
- Documented clinical history of recurrent attacks of angioedema in the absence of wheals/urticaria.
- Investigator-confirmed diagnosis of non-histaminergic bradykinin-mediated angioedema with normal C1-INH as documented by a history of angioedema attack(s) at screening and occurrence of attacks during the observation period:
- History of recurrent angioedema with at least an average of 1 angioedema attack per 4 weeks prior to screening and this attack rate must be confirmed during the observation period while treated with chronic high-dose antihistamine (cetirizine 40 mg/day or equivalent high-dose second-generation antihistamine medication);
- Diagnostic testing results obtained during screening from a sponsor-approved central laboratory that confirm C1-INH function ≥ 50% of normal and C4 level not below the normal range. With prior sponsor approval, subjects may be retested during the observation period if results are incongruent with clinical history;
- Clinical history of not responding to high-dose antihistamine treatment (cetirizine 40 mg/day or equivalent high-dose second-generation antihistamine medication), which must be confirmed during the observation period with at least 1 angioedema attack per 4 weeks with chronic high-dose antihistamine treatment and no significant difference (as assessed by the investigator and in consultation with the sponsor’s medical monitor, as necessary) from the historic attack rate without high-dose antihistamine treatment.
- Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.
- Subjects ≥ 18 years of age must be willing to use icatibant as the rescue medication during the observation and treatment period. During the observation period, subjects need to be treated with icatibant for at least 2 angioedema attacks or at least 1 moderate or severe attack. In the opinion of the investigator, subjects with no response to icatibant for acute angioedema attacks in the past medical history/screening, or no improvement or worsened attack severity 2 hours after icatibant treatment during the observation period (based on totality of assessments), will not be included.
- Note: For subjects 12 to < 18 years of age, standard of care therapy per local protocols should be provided.
- Males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent* or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
- Females of non-childbearing potential are defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months.
- The subject (or the subject’s parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC). If the subject is an adult, be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. OR If the subject is a minor (i.e., <18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (ie, permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor subjects.
* Abstinence will be accepted as a highly effective method only if sexual abstinence is the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, symptothermal or post-ovulation), declaration of abstinence for the duration of exposure to IMP, or withdrawal (coitus interruptus) are not acceptable methods of contraception
- Concomitant diagnosis of Type I or Type II HAE, or recurrent angioedema associated with urticaria.
- Dosing with any investigational drug or exposure to an investigational device within 4 weeks prior to screening.
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or rituximab within 6 months prior to screening.
- Use of any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
- Response to omalizumab (prophylactic) or corticosteroid (acute/prophylactic) or epinephrine (acute) or anti-leukotrienes (prophylactic) treatments in the past.
- Use of long-term prophylactic therapy for HAE; e.g., C1-INH, attenuated androgens (eg, danazol, methyltestosterone, testosterone), or anti-fibrinolytics within 2 weeks prior to entering the observation period as long as the investigator determines that doing so would not place the subject at any undue safety risk, and that the subject is at least 18 years of age.
- Any exposure to prophylactic plasma kallikrein inhibitors prior to screening.
- Use of short-term prophylaxis for HAE within 7 days prior to entering the observation period. Short-term prophylaxis is defined as C1-INH, attenuated androgens, or anti-fibrinolytics used to avoid angioedema complications from medically indicated procedures.
- Have any active infectious illness or fever defined as an oral temperature > 38°C (100.4°F), tympanic > 38.5°C (101.3°F), axillary > 38°C (100.4°F), or rectal/core > 38.5°C (101.3°F) within 24 hours prior to the first dose of study drug in the treatment period.
- Any of the following liver function test abnormalities: ALT > 3 x upper limit of normal, or AST > 3 x upper limit of normal, or total bilirubin > 2 x upper limit of normal (unless the bilirubin elevation is a result of Gilbert’s syndrome).
- Pregnancy or breast feeding.
- Subject has a known hypersensitivity to the investigational product or its components.
- Have any uncontrolled underlying medical condition which would require treatment adjustment during the study treatment period that, in the opinion of the investigator or sponsor, may confound the results of the safety assessments or may place the subject at risk. Subjects with stable treatment for at least 3 months prior to screening and NOT expecting any change to their treatment regimen for 6 months during the study treatment period, will not be excluded.
- Have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (e.g., significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results).
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers (DECAMP)
A Study to Predict Lung Cancer Using Noninvasive Biomarkers
Arm 1
•Screening
- Age 55-77 years old.
- Current and former smokers with 30 pack-years or more(and quit less than 15 years ago)
Arm 2
•Incidental
- Age > 45 years old.
- Current and former smokers with 10 pack-years or more (and quit less than 15 years ago).
- History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer).
- Any receipt of cytotoxic agents within the past 6 months.
- Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis).
- Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above).
COVID-19 Cytokine Assay Validation (COVID-19)
COVID-19 Cytokine Assay
Inclusion Critera:
- Individuals ≥ 18 and ≤ 60 years of age
- Has recently been clinically tested for COVID-19 qPCR with either known positive and symptomatic.
- Patients must be within a radius of Rochester, MN, that allows for reasonable transportation time of the phlebotomist.
- Patients without prior COVID-19 qPCR results, patients with ambiguous COVID-19 qPCR results.
- Children under 18 years old or patients over 59 years old.
- Pregnant women.
- Patients over 60 years old.
- Patients residing beyond a 1 hour drive for the phlebotomist.
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Contribution of GLP-1 Receptor
- Weight stable, healthy subjects.
- 18-65 years of age.
- Willing and able to provide written consent.
- Unable/willing to provide written consent.
- History of active disease or diabetes.
- < 18 or > 65 years of age.
BGB-3111-LTE1 - An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies (BGB-3111-LTE1)
A Study to Evaluate Zanubrutinib to Treat Patients with B-cell Malignancies
- Currently enrolled in an eligible BeiGene study or recently treated with zanubrutinib in an eligible BeiGene study.
- Intent to continue or start zanubrutinib treatment after occurrence of any of the following in the eligible BeiGene study:
- At time of final analysis or study closure;
- At time of disease progression if:
- Patient was receiving a non-BTK inhibitor comparator drug on the eligible BeiGene study at the time of progression and both investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (sponsor agreement required before enrollment);
- Patient was receiving zanubrutinib on the eligible BeiGene study at the time of progression and both investigator and the patient agree it is in the patient's best interest to continue zanubrutinib (sponsor agreement required before enrollment);
- Sponsor decision to transfer patient from eligible BeiGene study at an alternative time and confirm eligibility for this current long-term extension study.
- In the opinion of the investigator, patient will continue to benefit from zanubrutinib treatment.
- Must meet the following criteria within 15 days before first dose of zanubrutinib:
- Platelets ≥ 50,000/mm^3;
- Absolute neutrophil count ≥ 750/mm^3;
- Aspartate aminotransferase and alanine aminotransferase ≤ 2 x upper limit of normal;
- Serum total bilirubin < 2.5 x upper limit of normal;
- QTcF ≤ 480 msec;
- No known New York Heart Association Class III or IV congestive heart failure;
- Creatinine clearance ≥ 30 mL/min as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease) based on ideal body mass.
- Female patients of childbearing potential must agree to practice highly effective methods of birth control initiated before the first dose of zanubrutinib, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib.
- Male patients are eligible if abstinent, vasectomized or if they agree to the use of barrier contraception in combination with protocol-approved highly effective methods during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib.
- Written informed consent obtained before enrolling in this current long-term extension study and receiving study drug.
Inclusion Criteria for Survival Follow-up Patients Only:
- Currently enrolled in an eligible BeiGene study, or recently treated with zanubrutinib in an eligible BeiGene study.
- Written informed consent obtained prior to enrolling in this current long-term extension study.
- Permanently discontinued from zanubrutinib treatment in the eligible BeiGene study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent.
- Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy.
- Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk.
- Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy.
- Pregnant or lactating women.
- Inability to comply with study procedures.
- Concurrent participation in another therapeutic clinical study.
Exclusion Criteria for Survival Follow-up Patients Only:
- Permanently discontinued from the eligible BeiGene study.
- Inability to comply with requests for survival follow-up.
Transcutaneous Electric Nerve Stimulation For Pain control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopic Injection for Overactive Bladder: A Phase III Randomized Controlled Trial (TENS-BOTOX)
A Study to Evaluate TENS for Pain Control During Office Cystoscopic Botox Injections
- Women ≥ 18 years of age.
- Scheduled to receive Intradetrusor Onabotulinumtoxin A injection.
- English speaking.
- Unable or decline to give Informed Consent.
- Allergy to adhesives.
- Participant self-report of previous use of TENS Unit or any immediate family member (1st degree relative) who has used a TENS Unit within 1 year prior to study enrollment.
- Fitted with pacemaker or automatic implanted cardiac defibrillator.
- History of Epilepsy.
- Pregnancy and postpartum period (within 12 weeks postpartum).
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough
A Study to Evaluate S-600918 in Adults With Refractory Chronic Cough
- Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
- If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
- Capable of giving signed informed consent.
- Currently smokes or uses potentially irritating inhalational agents (e.g., e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
- Has chronic obstructive pulmonary disease or uncontrolled asthma.
- Has a clinically unstable medical condition.
- History of or ongoing significant psychiatric disorder.
- History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
- History of malignancy in the last 5 years.
- History of severe drug allergy.
- History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
- Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
- Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
- Received S-600918 previously.
- Received an investigational drug in the last 3 months.
- Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
- Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
- If female, pregnant or trying to become pregnant or breastfeeding.
Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes (ACT Study)
A Study to Evaluate Patient Outcomes in Care Transition of Acute Kidney Injury (AKI) Survivors
- KDIGO Stage 3 AKI, PCP @ Mayo Rochester.
- Patient with need for dialysis at discharge from hospital or hospice.
- Enrolled in the Primary Care Transition Program.
- Non-English speaking.
- Cognitive impairment.
- Dementia.
JCAR017-EAP-001 Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel that is Nonconforming for Commercial Release
A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients
- Patient must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Patient is ≥ 18 years of age at the time of signing the ICF.
- Patient had a patient-specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria. The Sponsor Internal Review Process has determined that the nonconforming lisocabtagene maraleucel may be released for use under the EAP.
- Remanufacturing (e.g., repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the patient.
- Patient meets any other relevant medical criteria for LD chemotherapy and infusion of a cellular therapy product as per Investigator’s clinical judgement.
- Females of childbearing potential (FCBP*) must:
- Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting (LD) chemotherapy following institutional testing methodology practices. This applies even if the patient practices true abstinenceb from heterosexual contact;
- Either commit to true abstinence* from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration;
- Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
- There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
- Male patients must:
- Practice true abstinence** or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the patient has undergone a successful vasectomy;
- There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician.
- Patient must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration. There are insufficient exposure data to provide any recommendation concerning the duration of refraining from tissue donation following treatment with lisocabtagene maraleucel; therefore, patients treated with lisocabtagene maraleucel should not donate blood, organs, tissues, and cells for transplantation.
* A female patient of childbearing potential (FCBP) is a female who:
- has achieved menarche at some poin;
- has not undergone a hysterectomy or bilateral oophorectomy; or
- has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
** True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. In contrast, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Patient has a hypersensitivity to the active substance or to any of the excipients.
- Patient has a contraindication to lymphodepleting chemotherapy.
- Patient should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of AEs associated with LD chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
- Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the EAP or complying with protocol requirements in the Investigator’s judgement.
- Patient has any condition and/or laboratory abnormality that places the patient at unacceptable risk if he/she were to participate in the EAP based on the Investigator’s judgement.
Colon and Rectal Surgery Patient Fitness and Prehabilitation Program Survey during COVID 19 Pandemic (POWER survey)
Evaluation of patients perceived health and fitness prior to surgery during the COIVD 19 pandemic
Inclusion Criteria: Adults patients (> 18 years old) being seen in colon and rectal surgery clinic for a surgical condition requiring an inpatient operation.
Exclusion Criteria:
Children (age < 18 years old)
Patients with surgical conditions requiring an outpatient operation
Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes (PSBPSMP3)
Psychological Support Via MP3 Recordings
- Critically ill adults (age ≥ 18 years old).
- Patients in acute respiratory failure (ARF) and/or requiring vasopressors admitted to the ICU and expected to stay > 48 hours.
- History of dementia.
- Mental retardation.
- Attempted suicide.
- Psychotic disorders such as schizophrenia.
- Acute alcohol/substance intoxication or withdrawal.
- Severe metabolic encephalopathy.
- Patients on comfort care.
- Patients not expected to survive the hospital stay.
- Patients with hearing impairment.
- Non-English speaking patients.
A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia (HGEN003-06)
A Study to Evaluate Effectiveness and Safety of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia (Enrolling by Invitation Only)
- Adults 18 years of age and older who are capable of providing informed consent or have a proxy capable of giving consent for them. See Section 10.1 for details on the consenting process for subjects with COVID-19.
- Virologic confirmation of SARS-CoV-2 infection via any diagnostic test for SARS-CoV- 2 authorized by US FDA or other national regulatory agency or ministry of health (e.g., qualitative SARS-CoV-2 real time polymerase chain reaction (RT-PCR), nucleic acid amplification (molecular) test, etc.) assessed locally per institution standard of care, prior to randomization.
- Pneumonia diagnosed by chest x-ray or computed tomography (CT) revealing infiltrates consistent with pneumonia. Note that a CT scan may be used if available, but is not required.
- Subject must have an SpO2 ≤ 94% on room air and/or require supplemental oxygen (including high-flow oxygen support or NPPV) to be eligible.
- Subject is hospitalized and has not required invasive mechanical ventilation during this hospitalization.
- Subject has not participated in other clinical trials for COVID-19 using an immunomodulating monoclonal antibody or kinase inhibitor. Subjects on corticosteroids, convalescent plasma, remdesivir or other anti-virals and/or hydroxychloroquine with or without azithromycin are not excluded from the study. Agents that have received emergency use authorization or approval from the FDA or are considered by the study site to be standard of care treatment at the institution for COVID-19 are permitted provided the agent is not an immunomodulating monoclonal antibody or kinase inhibitor. Participation in clinical trials with remdesivir or convalescent plasma is permitted provided the subject meets all other eligibility criteria.
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 5 months following their last dose of study drug. A negative urine pregnancy test or serum beta human chorionic gonadotropin (β-hCG) is required for all women of childbearing potential within 1 week prior to receiving first dose of study drug.
- Subject requires invasive mechanical ventilation or extracorporeal membrane oxygenation (i.e., category 2 on the ordinal scale).
- Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
- Known active tuberculosis (TB), history of incompletely treated TB or suspected or known extrapulmonary TB.
- Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIV infection.
- History of pulmonary alveolar proteinosis (PAP).
- Women of childbearing potential who are pregnant or breastfeeding.
- Known hypersensitivity to lenzilumab or any of its components.
- Use of any FDA approved anti-IL-6 (e.g., tocilizumab, sarilumab, sitlukimab), anti-IL-1 (e.g., anakinra, canakinumab) or kinase inhibitor (e.g., baracitinib, ibrutinib, acalabrutinib) therapy to treat COVID-19 within 8 weeks prior to randomization. Use of any neutralizing monoclonal antibodies such as bamlanivimab (LY-CoV555) or REGNCOV2 within 8 weeks prior to randomization. Subjects receiving other FDA-approved immunomodulators to treat underlying autoimmune disorders such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, asthma, COPD, atopic dermatitis, multiple sclerosis, etc., would not be excluded unless there is a potential drug interaction with lenzilumab. Note: Subjects receiving convalescent plasma or corticosteroids are not excluded from the study. Note: Subjects receiving remdesivir or other anti-virals and/or hydroxychloroquine with or without azithromycin are not excluded from the study.
- Use of GM-CSF agents (e.g., sargramostim) within 2 months prior to randomization.
- Expected survival < 48h in the opinion of the investigator or subjects with Do Not Resuscitate or Do Not Intubate orders at baseline.
- Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the subject at unacceptably high risk from the study.
Patient Experiences of Neuromodulation for Epilepsy
Patient Experiences of Neuromodulation for Epilepsy
- Is 18 years or older, or is 13 years or older with a parent or guardian to participate in the study as a dyad or triad.
- Has a diagnosis of drug-resistant epilepsy and is going to be seen or has already been seen in the Mayo Clinic Neuromodulation Clinic.
- Pre-implantation or longitudinal cohort: Is considering a neuromodulation device but has not been implanted.
- Post-implantation: underwent device implantation between 1 year and 18 months post-interview.
- Has had resective surgery on their brain to treat their epilepsy.
- Does not fall into the diagnostic or age categories listed in the inclusion criteria.
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.
Brain Magnetic Resonance Elastography at 7T MRI
Brain MRE at 7T
- Healthy adult volunteers aged 18 or older.
- Absent confounding medical conditions with no known brain diseases that are considered safe for 7T MRI exams.
- Individuals with a known neurologic disease.
- Individuals who has implants or who may have implants that are not MR safe such as pacemakers, deep brain stimulators or vagus nerve stimulators.
- Individuals with metal from prior surgery or injury (such as metallic fragments in the eyes).
- Children younger than 18 years old.
- Pregnant women.
Treatment burden, stress, and coping in the context of social distancing: A qualitative study of patients with diabetes mellitus
Treatment burden, stress, and coping in the context of social distancing: A qualitative study of patients with diabetes mellitus
- Adult (≥ 18 years old)
- Diagnosis of diabetes mellitus using insulin pump and/or CGM technology
- No evidence of cognitive impairment
- English proficiency
- Has a contact telephone number listed in patient chart
- Pediatric patients (<18 years old)
- Not diagnosed with diabetes mellitus
- Evidence of cognitive impairment, or inability to give consent
- Limited English proficiency
- No telephone number listed in patient chart