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604 Study Matches

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Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer

A Study to Determine Baseline Levels for Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment

Eugene Kwon
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122919-H01-RST
19-011292
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Inclusion Criteria (Prostate Cancer Patients):

  • ≥ 18 years of age.
  • Able to give informed consent.
  • Patients with prostate cancer.
  • Patients treated with primary prostatectomy.

Inclusion Criteria (Female Control Patients)

  • ≥ 18 years of age. 
  • Able to give informed consent.                                                        

Exclusion Criteria (Prostate Cancer Patients): 

  • Unable or unwilling to provide informed consent.
  • Metastatic prostate cancer – defined radiographic evidence of metastatic disease on pre-procedural testing.

Exclusion Criteria (Female Control Patients)

  • Unable or unwilling to provide informed consent.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease (TOPAZ)

A Study to Evaluate Zoledronic Acid for Fracture Prevention in Parkinson's Disease Patients

Matthew Drake
All
65 years and over
Phase 4
This study is NOT accepting healthy volunteers
0000-122921-P01-RST
19-011299
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Inclusion Criteria:

  • Men and women age 65 years or older.
  • Current PD diagnosis with symptoms severity at Hoehn & Yahr (H&Y) stage 1-4 based on an expert assessment (movement disorders neurologist report or telemedicine evaluation).
  • Willing and able to continue in follow-up for at least 2 years.
  • Willing and able to provide informed consent.


Exclusion Criteria:

  • History of hip fracture.
  • Any use of a bisphosphonate drug within the last 12 months.
  • Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last 6 months.
  • Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months.
  • Non-ambulatory; i.e., unable to walk without assistance of another person.
  • Undergoing kidney dialysis.
  • A diagnosis of multiple myeloma or Paget's disease.
  • Unable to speak or read English sufficiently to complete informed consent.
  • Any other criteria, which would make the patient unsuitable to participate in this study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol addiction).
Drug, Other
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A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis

A Study to Evaluate MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with Amyotrophic Lateral Sclerosis (ALS)

Nathan Staff
All
18 years to 80 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122926-P01-RST
19-011368
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Inclusion Criteria:
 

  • Written or verbal informed consent is obtained.
  • Male or female subjects age 18 to 80 years, inclusive.
  • Diagnosis of familial or sporadic AL as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory supported].
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • ALS onset of ≤ 18 months from first clinical signs of weakness prior to screening.
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • If currently using edaravone, subject should have completed the first 14 days of their initial treatment cycle prior to initiating study drug.
  • Documented ALS history of location of disease onset (i.e., bulbar onset, limb onset).
  • A total ALSFRS-R score of at least 35 overall at screening and:
    • No more than one of the 12 ALSFRS-R individual component items have a score of 1 or less at screening;
    • For limb onset subjects, ALSFRS-R score of ≥ 3 on item #1 (speech), #2 (salivation) and #3 (swallowing).
  • ALSFRS-R progression rate from onset of the first symptom of weakness to the ALSFRS-R score at Screening of ≥ 0.3 points and ≤ 1 point per month calculated as:
    • ALSFRS-R score at onset of first symptom of weakness (assume 48) minus ALSFRS-R score at Screening divided by number of months since onset of first symptom of weakness.
  • Documented pulmonary function test (PFT) result within the last 6 months (i.e., slow vital capacity or forced vital capacity) must be ≥ 70% of predicted. If subject does not have a documented PFT result within the last 6 months, they will be administered a PFT.
  • Female subjects of childbearing potential must use one or more effective methods of contraception throughout the entire study period and for 30 days after study drug discontinuation.
  • Male subjects agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire study period and for 30 days after study drug discontinuation.
  • Able to swallow study medication capsules.
  • Willing and able to comply with the protocol assessments and visits, in the opinion of the Investigator.
  • No known allergies to the study drug or its excipients.
  • At clinical sites where the pneumococcal vaccine is available and administered as standard of care, has received pneumococcal vaccine within 6 years prior to starting clinical trial.

Exclusion Criteria;

  • Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT > 3 times the upper limit of normal).
  • Currently has a clinically significant psychiatric disorder or dementia which would preclude evaluation of symptoms.
  • Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic including clinically significant chronic hepatitis, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, central nervous system infection or other active infection including a history of HIV (human immunodeficiency virus) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
  • Female subject is lactating, pregnant or planning pregnancy at Screening or Baseline.
  • History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or repeated demonstration of a QTc interval of > 450 ms in males and > 470 ms in females.
  • Past or current use of ibudilast.
  • Current use or treated with parenteral (intravenous or intramuscular) high-dose (> 25 mg/week) vitamin B12 (i.e., methylcobalamin, hydroxylcobalamin, cyanocobalamin, adenosyl cobalamin) within 30 days prior to study drug administration.
  • History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
  • History of alcohol or substance abuse (DSM-5 criteria) ≤ 3 months prior to screening or alcohol or substance dependence (DSM-5 criteria) ≤ 12 months prior to screening.
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
  • Currently participating, or has participated in, a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent.
  • Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator.
  • Use of tracheostomy or > 22/24h ventilatory support.

Eligibility last updated 10/13/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Maternal-fetal Immune Responses to Fetal Surgery

A Study to Evaluate Maternal-fetal Immune Responses to Fetal Surgery

Mauro Schenone
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-122928-H01-RST
19-011382
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Inclusion Criteria:

Surgery Cohort

  • Maternal age ≥ 18 years old.
  • Pregnant with a congenital anomaly diagnosis.
  • Undergoing endoscopic in utero fetal intervention.
  • Singleton pregnancy
  • Delivery planned at Mayo Clinic.

Control Cohort

  • Maternal age ≥ 18 years old.
  • Pregnant with normal ultrasound findings.
  • Singleton pregnancy
  • Delivery planned at Mayo Clinic.


Exclusion Criteria:
 

  • Delivery planned elsewhere.
  • Abnormal fetal karyotype.
  • Multiples (i.e. twins/triplets, etc)
  • Undergoing open in utero fetal intervention
Disorder of embryonic structure, Fetal surgery, Fetoscopy
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Pathogenesis and Mechanisms of Mitral Annular Calcification

A Study to Assess the Biological Progression and Mechanisms of Mitral Annular Calcification

Amir Lerman
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122932-H01-RST
19-011417
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Inclusion Criteria:

  • Patients with diagnosis of mitral annular calcification (MAC) (case group) and patients coming to the Valve Clinic without MAC diagnosis (control group).
  • Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC (case group) or without diagnosis of MAC (control group).


Exclusion Criteria:
 

  • Subjects unwilling to participate or to provide consent.

 

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Isolation, Activation and Expansion of Mutation Reactive T-cells

A Study to Analyze Isolation, Activation and Expansion of Mutation Reactive T-cells

Dennis Wigle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122959-H01-RST
19-011642
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Inclusion Criteria:

  • Adults, ≥ 18 years old.
  • Adults with lung disease undergoing lung resection surgery.


Exclusion Criteria:
 

  • < 18 years old.
Cancer, Lung cancer
Cell-free DNA test, Disorder of lung, Medical Oncology, Respiratory system, Somatic mutation, Wedge resection of lung
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CELLTOP Part II: A Phase II Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury

A Study to Evaluate Autologous Adipose Derived Mesenchymal Stem Cells to Treat Spinal Cord Injury Patients

Mohamad Bydon
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122969-H01-RST
19-011706
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Inclusion Criteria:

  • Male or female aged 18 years and older.
  • Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle.  Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
  • Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer.  Monitoring will include perinatal and neonatal outcome.  Any SAEs associated with pregnancy will be recorded. 
  • AIS grade A or B of SCI at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional improvement
  • SCI must be traumatic, blunt/non-penetrating in nature and not degenerative.
  • Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments.
  • Full understanding of the requirements of home exercise program prescribed by physical and occupational therapists.
  • Once the nature of the study is fully explained and prior to any study-related procedure is initiated the subject is willing to provide written, informed consent and complete HIPAA documentation.


Exclusion Criteria:

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • AIS grade of SCI other than A or B at the time of injury.
  • Non-traumatic SCI.
  • History of receiving mesenchymal stem cell, gene or exosome therapy for any indications.
  • History of intra-spinal infection
  • History of superficial infection in the index spinal level within 6 months of study.
  • Evidence of current superficial infection affecting the index spinal level at the time of enrollment.
  • On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
  • Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
  • Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline.
  • Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater.
  • Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes, osteoporosis).
  • History of malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
  • History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
  • Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
  • Known allergy to local anesthetics of other components of the study drug.
  • Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
  • History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry.
  • Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment.
Drug, Regenerative injection therapy, Spinal cord injury rehabilitation
Spinal cord injury
Cellular therapy, Nervous system, Physical therapy, Regenerative medicine therapy, Spinal cord injury, Spinal injury, Stem cell injection, Stem cell therapy
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Validation of Dried Blood Spot Testing for HIV Screening and Syphilis Serology

A Study to Screen HIV and Syphilis Screening Using Dried Blood Spot Testing

Mary Kasten
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122978-H01-RST
19-011796
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Inclusion Criteria:

  • Patients who are > 18 years of age.
  • Patients who are either known to be HIV seropositive or have a positive syphilis serology or who require HIV or syphilis serologic testing as part of their routine care.


Exclusion Criteria:

  • Unable due to cognitive or physical limitations to understand dried blood spot collection instructions or to safely perform finger-stick for DBS self-collection.
  • Patients who are unable to give informed consent.
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MC1973: A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk

Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk

Ivy Petersen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122983-H01-RST
19-011871
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Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either:
    • Deemed a candidate for complete macroscopic resection of the primary sarcoma; OR
    • Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy.
  • No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
  • Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3.
  • Life expectancy greater than 6 months.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Ability to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).


Exclusion Criteria:

  • Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma.  In other words, treatment on this trial would require re-irradiation of tissues.
  • Patients with nodal or distant metastases.
  • Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
  • Any of the following:
      •  
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
Behavioral, Radiation, Other
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Pilot Studies on Non-invasive Measures of Cardiac Hemodynamics during Submaximal Exercise

A Study to Measure Cardiovascular Blood Flow During Submaximal Exercise

Bruce Johnson
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122984-H01-RST
19-011882
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Inclusion Criteria:

  • Healthy participants above the age 18 years old.
  • Participants capable of performing submaximal exercise.


Exclusion Criteria:
 

  • Participants less than the age of 18 years and older than 65.
  • Participants with compromised cardiovascular or pulmonary function.
  • Unable to pedal an exercise ergometer.

 

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ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA) (ARREST)

ARrest RESpiraTory Failure From PNEUMONIA

Ognjen Gajic
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122986-P01-RST
19-011892
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Inclusion Criteria:
 

  • Severe Pneumonia defined as hospitalization for acute (< 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L), OR known current immunosuppression preventing inflammatory response.
  • Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.


Exclusion Criteria:
 

  • A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments).
  • Contraindication or known allergy to inhaled corticosteroids or beta-agonists.
  • Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation).
  • Intubation (or impending intubation) prior to enrollment.
  • This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment.
  • Do Not Intubate order but does not include a "Do Not Resuscitate" order.
  • Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome.
  • Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization.
  • Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours, or K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved.
  • Younger than 18 years of age.
  • Pregnancy.
Drug, Corticosteroid and corticosteroid derivative therapy, Drug therapy, Corticosteroid and/or corticosteroid derivative therapy
Acute respiratory failure, Hypoxemia, Pneumonia, Respiratory failure
Acute respiratory failure, Hypoxemia, Patient requires hospitalization, Pneumonia, Respiratory system
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ROR1905: Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

Allison Garda
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-122989-H01-RST
19-011924
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Able to provide written consent.
  • Patient has given permission to give tumor/blood sample for research testing.
  • Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
  • Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV.
  • Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits.
  • Consent to allow blood specimens to be shared with potential external collaborators.
  • Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC):
    • FIGO 2019 Stage IB2-IIIC or not a surgical candidate;
    • Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy.


Exclusion Criteria:
 

  • Other active malignancy ≤ 2 years prior to registration. 
    • EXCEPTIONS:  Non-melanotic skin cancer.
    • NOTE:  If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer.
  • Pregnancy or lactation.
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

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Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System With Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine (TLIF)

Transforaminal Lumbar Interbody Fusion (TLIF)

Brett Freedman
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122998-P01-RST
19-012027
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Inclusion Criteria:

A subject must meet all of the following inclusion criteria to participate in this study:

  • Has radiographic evidence (i.e., CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:
    • History of radiating leg or buttock pain, paresthesia, numbness or weakness; or
    • History of neurogenic claudication.
    • *If a subject hasn’t had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained.
  • Has a history of low back pain.
  • Has radiographic evidence (i.e., CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine including at least one of the following:
    • Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm; or
    • Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability; or
    • Recurrent disc herniation.
    • *If a subject hasn’t had a CT or MRI in the last 12 months, a CT/MRI will need to be obtained.
  • Has preoperative Oswestry Disability Index score ≥ 35.
  • Has preoperative back pain and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.
  • Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
  • Is at least 18 years of age and skeletally mature at the time of surgery.
  • Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.
  • Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.


Exclusion Criteria:

A subject will be excluded from participating in this study for any of the following reasons:

  • Prior surgical procedure at the involved or adjacent spinal levels (e.g., bony decompression, fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
  • Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
  • Planned use of an internal or external bone growth stimulator.
  • Lumbar scoliosis > 30 degrees.
  • Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. If subject has a prevalent fragility fracture and a T-score hasn’t been assessed in the last 12 months, a DEXA will need to be obtained.19/
  • Morbidly obese, as defined by a Body Mass Index (BMI) > 40.
  • Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
  • Overt or active bacterial infection, either local to surgical space or systemic.
  • Has undergone administration of any type of corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.
    • This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment;
    • Use of steroidal inhalers, short-term NSAID use, and short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks;
    • Use of NSAIDs and/or steroids for longer than two weeks post-operatively through the 24 Month Follow-Up Visit is prohibited.
  • Co-morbidities, which in the investigator’s opinion, precludes the subject from being a surgical candidate.
  • Autoimmune disease, which in the investigator’s opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves’ disease, Hashimoto’s thyroiditis).
  • Any endocrine or metabolic disorder, which in the investigator’s opinion, is known to affect osteogenesis (e.g., Paget’s disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
  • Known exposure to any recombinant proteins used for bone formation (e.g., Infuse™ Bone Graft, OP1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
  • Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
  • History of any allergy resulting in anaphylaxis.
  • Is a prisoner.
  • Is mentally incompetent. If questionable, obtain psychiatric consult.
  • Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
  • Pregnant or nursing.
  • Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.
  • A documented diagnosis of substance use disorder as defined by the DSM-5. (Nicotine use is allowed.)
  • Pursuing worker’s compensation or active litigation for spinal fusion procedure.
  • Any condition, which in the investigator’s opinion, would interfere with the subject’s ability to comply with study instructions, which might confound data interpretation.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

Device
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The Use of Virtual Reality Modules to Reduce Pre-Operative Anxiety in a Cardiac Surgery Inpatient Population

Healium Virtual Reality Protocol

Jordan Miller
All
21 years to 80 years old
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
0000-123015-H01-RST
19-012262
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Inclusion Criteria:

  • Able to understand the goals of the study and provide informed consent.
  • Any hospitalized patient scheduled for a first-time sternotomy or thoracotomy under the care of Mayo Clinic cardiovascular inpatient service or thoracic inpatient service admitted after 1 February 2020, who is not excluded due to criteria listed below.
  • Between the ages of 21 and 80 years old.
  • English speaking.


Exclusion Criteria:

  • Unable to consent to study due to cognitive difficulty.
  • Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of virtual reality (VR) hardware and software.
  • Sensitivity to flashing light or motion.
  • Patients who received anxiolytic drugs or sedatives within the preceding 24 hours.
  • Recent stroke.
  • Post-transplant patient, or pre-transplant patient with severe illness.
  • At the time of in-room virtual reality (VR) administration, patient on ventilator, is receiving BiPAP or CPAP, or other breathing assistance equipment.
  • Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face).
  • Non-English speaking.

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

Behavioral, Device
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Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (EPAS)

A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

Brian Lundstrom
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123016-P01-RST
19-012307
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Inclusion Criteria:


- Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE)
2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure
(secondary generalization). The final determination shall be made by the Investigator
based on a clinical description of the seizures and previous diagnostic testing that
includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one
ictal event

- Anticipated average of 6 or more focal (partial) onset seizures per month during CMM
phase, with no more than 30 consecutive seizure-free days during the CMM phase

- Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness

- Age 18 or older at the time of enrollment

- Willing and able to complete the diary, with or without the assistance of a caregiver,
in a reliable way as assessed by the clinical staff

- Able to use the Patient Programmer with or without the assistance of a caregiver

- Ability of the subject or legal representative to understand and provide signed
consent for participating in the study

- Willing and available to attend visits as scheduled and to comply with the study
protocol


Exclusion Criteria:


- Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE)
2017 classification)

- Seizure frequency is too frequent that subject is unable to provide daily count in
order to maintain a reliable seizure diary

- Any episode of convulsive status epilepticus within the 12 months prior to the
Enrollment Visit

- Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to
the Enrollment Visit

- Surgical candidate for and willing to undergo resective surgery

- Evidence of a neurological condition that is likely to progress (e.g., brain tumor,
arteriovenous malformations or cavernous angiomas)

- Diagnosed with a progressive or degenerative neurological disorder affecting the brain

- Significant medical condition that may impact study participation in the opinion of
the investigator

- Presence of any of the following within 1 year prior to the Enrollment Visit:
psychiatric illness hospitalization, suicide attempt or symptoms of psychosis
(hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a
medication

- Malignancy or history of malignancy within 1 year prior to the Enrollment Visit
(excluding resected basal cell carcinomas)

- Presence of implanted electrical stimulation medical device anywhere in the body
(e.g., cardiac pacemakers, spinal cord stimulator, RNS) or any metallic implants in
the head (e.g., aneurysm clip, cochlear implant). In the case of an implanted vagus
nerve stimulator (VNS), CMM study assessment collection may occur with the device
implanted but may not begin until the VNS has been off for at least 30 days. The VNS
generator must be explanted prior to or at the time of the DBS neurostimulator implant
and the leads removed or trimmed and capped. In the case of a subject who had been
previously implanted with a responsive neurostimulator (RNS) but had a full system
explant, a subject cannot begin CMM study assessment collection until the RNS has been
off for at least 30 days.

- Risk factors that would put the participant at risk for intraoperative or
postoperative bleeding. This includes administration of any antiplatelet or
anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use,
chronic aspirin use of greater than 325 mg/day, and any participant with a history of
hemorrhagic stroke

- History of drug or alcohol abuse within the past year

- Condition or disease that is known to require repeat magnetic resonance imaging (MRIs)

- Currently participating, or plans to participate, in another investigational study
unless written approval is provided by the Medtronic study team

Implant Criteria

- Experienced an average of 6 or more focal (partial) onset seizures per month during
CMM phase, with no more than 30 consecutive seizure-free days (all seizure types)

- Completed a qualifying baseline diary. A qualifying baseline diary meets at least one
the following criteria: 1) a study diary with at least 28 completed days; 2) a
pre-existing diary with at least 70 completed days.

- Completed 3-month CMM visit

- No suicide attempt or other self-harm behaviors within past year (assessed by Columbia
Suicide Severity Rating Scale (C-SSRS) at 3-month CMM Visit)

- For female subjects of child-bearing potential, has negative pregnancy test and if
sexually active continues using reliable form of birth control.

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

Eligibility last updated10/11/22. Questions regarding updates should be directed to the study team contact.

Device, Deep brain stimulation
Epilepsy, Seizure
Deep brain stimulation, Localization-related epilepsy, Nervous system, Tonic-clonic epilepsy
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Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery - ENCASE II (ENCASE II)

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE II)

Jamie VanGompel
All
22 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123018-P01-RST
19-012327
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Inclusion Criteria:


pre-operative

1. Subjects who are able to provide written informed consent prior to participating in
the clinical investigation.

2. Subjects who are ≥ 18 years old.

3. Subjects who are able to comply with the follow-up or other study requirements.

4. Subjects wo are planned for elective surgery including a trepanation to reach the
subdural infratentorial space (with lower limit of incision defined as the lower edge
of C2) in whom a dural incision will be closed.

5. Female subjects of child bearing potential must agree to use a form of contraception
from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

1. Subjects with surgical wound classification Class I/Clean.

2. Subjects with minimally 5 mm of dural space surrounding dural opening.


Exclusion Criteria:


pre-operative

1. Female subjects who are pregnant or breastfeeding.

2. Subjects with an assumed impaired coagulation due to medication or otherwise.

3. Subjects suspected of an infection requiring antibiotics.

4. Subjects with any type of dural diseases in planned dural closure area.

5. Subjects requiring re-opening of planned surgical area within 90 days after surgery.

6. Subjects with a known allergy to any of the components (Lactide-Caprolactone
co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl
Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.

7. Subjects who previously received a LIQOSEAL®.

8. Subjects who previously participated in this study or any investigational drug or
device study within 30 days of screening.

9. Subjects with a presence of hydrocephalus.

10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe
claustrophobia, injured by a metallic object that was not removed, cochlear (ear)
implants, metallic implants [e.g. knee replacement].

intra-operative

1. Subjects in whom elevation of PEEP has a potential detrimental effect.

2. Subjects who will require a CSF drain, electrodes or other devices passing the dural
layer or extra to intracranial bypass surgery.

3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or
autologous material other than galea.

4. Subjects in whom no intra-operative CSF leakage is present after primary closure of
the dura mater with elevation of PEEP.

5. Subjects who after primary closure (including galea, if applicable) of the dura mater
have a gap > 3 mm.

6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).

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

Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.

Device
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Prospective Assessment of Changes in Plasma Biomarkers in Patients with Gliomas Receiving Standard Therapy

A Study to Assess Metabolic Changes in the Blood with Standard Treatment in Patients with Gliomas

Sani Kizilbash
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123035-H01-RST
19-012496
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Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Patients with histopathologic or molecular confirmation of either IDH-mutant diffuse astrocytoma or IDH-mutant anaplastic astrocytoma.
  • Patients who will be proceeding to receive routine standard of care treatment (radiation with concurrent oral temozolomide) at Mayo Clinic, Rochester.


Exclusion Criteria:
 

  • Patients who have previously received any adjuvant therapy (radiation, chemotherapy, investigational) directed towards the glioma.
  • Patients who have been previously treated with Gliadel wafers.
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Transplant Caregiver (CG) Research Registry

Caregiver Registry

Cassie Kennedy
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123038-H01-RST
19-012536
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Inclusion Criteria:

  • Solid organ transplant candidates (18 years or older) on deferred, active, or inactive transplant waiting lists.
  • Nominated adult caregivers (18 years or older) of solid organ transplant patients listed for deceased donor solid organ transplantation.
  • CG identified in the electronic medical record.


Exclusion Criteria:

  • Individuals unwilling to provide consent.
  • Patients or CG unable to complete questionnaires or consents due to limited English proficiency.
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Development and Validation of Innovative Hybrid Molecular Imaging, 68Ga-PSMA-dual Contrast PET/MRI and 68Ga-PSMA PET/CT, to Transform the Care of Patients with Hepatocellular Carcinoma

A Study to Develop and Validate Hybrid Molecular Imaging to Transform the Care of Hepatocellular Carcinoma Patients

Ajit Goenka
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-123040-P01-RST
19-012563
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Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC.
  • Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy.
  • No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm).
  • For the systemic therapy arm, patients who have had unequivocal progression after prior LRT and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.


Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC.
  • Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to PET/MRI).
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
  • Subjects with higher than the weight/size limitations of PET/MRI or PET/CT scanner.
  • Subjects with contraindication to MRI (relevant to PET/MRI):
    • Subjects who have a heart pacemaker;
    • Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain;
    • Subjects who have implanted devices with magnets;
    • Subjects who have other implanted electronic devices;
    • Subjects who have deep brain stimulator;
    • Subjects who have vagal nerve stimulator;
    • Subjects with cochlear (ear) or auditory implants.
Administration of antineoplastic agent, Biopsy of liver lesion, Liver excision, Nuclear medicine procedure, PET CT of whole body, Radiation, Excision of liver, Diagnostic Test, Procedure/Surgery
Cancer, Hepatocellular carcinoma, Liver cancer
Cancer treatment, Chemoembolization for liver cancer, Digestive system, Gadobutrol, Gadoxetic acid [INN], Gallium Ga-68, Gallium Ga-68 gozetotide, Liver cell carcinoma, Liver transplant, Liver tumor ablation, Medical Oncology, Radioembolization for liver cancer, gadobutrol, gadoxetate, gallium, Liver resection, Gallium Ga 68 gozetotide [USAN]
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A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients with Celiac Disease

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients

Joseph Murray
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-123041-P01-RST
19-012571
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Inclusion Criteria:

  • Adults aged 18 to 80 years, inclusive.
  • Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
  • Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
  • Has followed a GFD for > 12 months immediately prior to study entry.
  • Negative for tTG and negative or weak positive for DGP-IgA/IgG during screening.
  • Male or female, and using at least 2 acceptable birth control methods or who are sterile or postmenopausal.
  • Capable of understanding and complying with protocol requirements.
  • Patient understands and has signed the informed consent form.


Exclusion Criteria:

  • Refractory celiac disease.
  • Selective IgA deficiency.
  • Positive for HLA-DQ8 (DQA1*03, DQB1*0302).
  • Previous treatment with tolerance-inducing therapies for celiac disease.
  • Known wheat allergy.
  • Part B only: History of hyperacute or prolonged symptoms following gluten exposure.
  • Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation.
  • History of dermatitis herpetiformis.
  • Pregnant or breastfeeding.
Drug, Drug therapy
Celiac disease
Celiac disease, Digestive system
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Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Molly Jeffery
All
15 years and over
This study is NOT accepting healthy volunteers
0000-123046-P01-RST
19-012615
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Inclusion Criteria:

  • Age 15 and over (15+ will only occur in dental setting).
  • English- or Spanish-speaking.
  • Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed.
  • Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone.
    • We do not anticipate many opioid-naïve people receiving an opioid analgesic for acute pain will receive the following drugs, however, we will not exclude otherwise eligible patients who receive one of the following drugs: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol.
    • All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
  • Opioid naive (no use of prescribed opioids or illicit opioids, including medical or non-medical use, in the past 6 months) by self-report.
  • Willing and able to give consent and participate in study.
  • Able to access a mobile device (smartphone or tablet) with web access every day to complete study surveys.
  • Willing to connect Fitbit to a device that can regularly link to Hugo for data transfer.
  • Willing to use the health data sharing platform.
  • Released/discharged to home after their visit.


Exclusion Criteria:
 

  • Pain thought to be caused by a systemic disease very likely to progress to chronic pain (e.g., sickle cell disease, fibromyalgia, lupus, multiple sclerosis, etc.).
  • Cancer or end-of-life pain.
  • Unable to give consent and be enrolled within 3 days of their visit.

 

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Assessment of Traumatic Brain Injury with Multiparametric Magnetic Resonance Elastography

Assessment of Traumatic Brain Injury with Multiparametric Magnetic Resonance Elastography

Ziying Yin
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-123048-H01-RST
19-012651
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We propose recruiting a total of 150 subjects with ages ranging from 18 to 99 including 3 groups: (1) mTBI+/RHI+: 50 patients with diagnosed mild traumatic brain injury (mTBI) and with the history of organized contact-sports; (2) mTBI-/RHI+: 50 age (by decades) /sex-matched participants that has a history of organized contact-sports but without diagnosed mTBI; (3) mTBI-/RHI-: 50 age (by decades)/sex-matched control participants with no history of organized contact-sports and no diagnosis of mTBI. It is not anticipated that these subjects will have mild cognitive impairment (MCI) from the TBI. MCI is a syndrome defined as a cognitive decline greater than expected for an individual’s age and education level but that does not interfere with activities of daily living.

Group 1 recruitment mTBI+/RHI+:

Residents of Olmsted County, Minnesota who were diagnosed with mTBI will be identified by using the medical-records linkage system of the Rochester Epidemiology Project (REP) between 2017 and 2020. The REP indexes all medical information of individuals residing and receiving care in Olmsted County, Minnesota. Individuals will be identified if they had a diagnostic code in the medical records suggestive of a potential head injury (Table 1),then the medical records will be reviewed for the dates of the specific codes and determined whether a mTBI occurred based on the Mayo Classification System for TBI severity (Definite, Probable, and Possible). By this definition, a “Definite” TBI had to have at least one of the following: loss of conscious of ≥30 minutes, post-traumatic anterograde amnesia of ≥24 hours, intracerebral hematoma, subdural hematoma, epidural hematoma, cerebral contusion, hemorrhagic contusion, penetrating TBI (dura penetrated) or subarachnoid hemorrhage; a “Probable” TBI had to have at least one of the following: loss of consciousness of momentary to <30 minutes, post-traumatic anterograde amnesia of momentary to <24 hours, or depressed, basilar, or linear skull fracture; a “Possible” TBI had to have at least two of the following: blurred vision, confusion (mental state changes), dazed, dizziness, focal neurologic symptoms, headache, or nausea.

If the “Probably” or “Possible” TBI criteria apply to the trauma event, the event will be considered as a mTBI.

The participation of organized contact-sport will be self-reported. Potential participants will be approached with the phone script and/or the letter. If the patient expresses willingness to participate, we will send him/her the follow-up letter or email with a tentative study visit date according to his/her preference. The consent form will be enclosed with the letter/email for his/her review. The questionnaire about the history of contact-sports play will also be enclosed.

Table 1- Codes for traumatic brain injury-related emergency department visits and hospitalizations as recommended by Center for Disease Control and Prevention

Description

ICD-9-CM Codes

Concussion

850

Cerebral laceration and contusion

851

Intracranial injury of other and unspecified nature

854

Injury to optic nerve and pathways

950.1-950.3

Head injury, unspecified

959.01

Inclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Possible” or “Probably” TBI as defined above.
  2. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

 

Exclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Definite” TBI as defined above.
  2. A history of chronic neurological disease;
  3. Pregnancy or breastfeeding;
  4. Inability to provide consent.

 

Group 2 and Group 3 recruitment:

Recruitment of these paid, groups 2 and 3 participants will be conducted (1) through established Mayo Clinic Rochester research study advertisements, and (2) through Mayo Clinic Study of Aging (MCSA) that provides a list of Olmsted County, MN residents who enrolled in MCSA, from whom matched control will be drawn. The participation of organized contact-sport will be self-reported.

Inclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

Inclusion Criteria for Group 3 (mTBI-/RHI-):

  1. No history of participating in any organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 3 (mTBI-/RHI-):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

 

The 3 groups will be age- (by decades) and sex-matched. We will start by recruiting the 3 groups together for the efficiency of data collection. During the recruitment process, if we notice a certain age range or sex is lacking, we will focus on targeting this particular age group or sex group to ensure the maximum matching. For example, if we particularly looking for 18-25-year-old male volunteers with no history of contact-sports participation in group 3, we will have a 2nd advertisement focusing on this particular age group and/or sex group.

 

Remuneration of $75 will be provided for each participant. If the participant were asked to return for additional imaging, remuneration of $75 will be provided for each visit.

 

All subjects will be carefully screened by MRI personnel to be certain that they do not have any contraindication to an MRI exam such as foreign bodies in the brain or eye or an incompatible device such as a cardiac pacemaker. This safety screening is part of the routine clinical practice and is performed before any subject is permitted to enter the scanning room. The patients and parents will be given the option of withdrawing from the study at any point in the project without jeopardizing their medical care at Mayo Clinic. Patients requiring sedation to complete the MRI will be excluded from the study.

 

Pregnant or nursing women are not eligible to participate in this study.  If the participant wishes to participate with the study she will be asked about her pregnancy status.  If she thinks she may be pregnant or if she is unsure of her pregnancy status, she will be offered a no-charge urine pregnancy test before proceeding with any study visit imaging.

 

We will attempt to recruit an equal number of men and women, but the final proportions will be dependent upon the available subjects in the disease group. Although we will make every effort to include minority subjects, most of the subjects enrolled in Rochester will be of Caucasian background which is a reflection of the regional demographics.

 

If there is a question on whether or not the subject has the capacity to provide informed consent, the investigator or a member of the study team will assess the patient by reviewing questions regarding the study such as:

  1. Can you tell me the purpose of this study?
  2. Do you have to be in this study?
  3. Can you tell me what will happen if you agree to take part in this study?
  4. What will happen to you if you choose not to be in the study?

 

If it is determined that the subject does not have the capacity to provide informed consent, the subject will then be excluded from the study.

 

The investigator or coordinator will meet with the potential participants in a private consult room to review and discuss the details of the study using the informed consent document as a guide. The discussion will include all of the elements of informed consent. Potential participants will be given an opportunity to ask questions and we be provided a copy of the informed consent document.

Concussion, Head injury, Sports injury, Traumatic brain injury, Traumatic injury, Head and brain injury
Concussion injury of brain, Injury while engaged in sports activity, MRI, Magnetic resonance elastography, Musculoskeletal system, Nervous system
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PIANO: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease (PIANO)

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Sunanda Kane
Female
0 years to 45 years old
This study is NOT accepting healthy volunteers
0000-123049-P01-RST
19-012655
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy.


Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age.
  • Confirmed multiple gestation.

Eligibility last updated 10/18/21. Questions regarding updates should be directed to the study team contact.

 

Inflammatory bowel disease
Complication occurring during pregnancy, Digestive system, Inflammatory bowel disease, Reproductive system
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Evaluation of 7T Magnetic Resonance Imaging in Multiple Sclerosis

A Study to Evaluate 7T Magnetic Resonance Imaging in Multiple Sclerosis

Padraig Morris
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123051-H01-RST
19-012681
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Capable of giving consent.
  • Established diagnosis of Multiple Sclerosis according to McDonald Criteria (2018). Patients may be diagnosed with any of the conventional phases of MS, primary progressive, relapsing remitting, secondary progressive etc.
  • Willing to participate in a 7T MRI examination within a few days of their clinical 3T or 1.5T examination.


Exclusion Criteria:

  • Age < 18 years old.
  • Any metallic implant, device implant, ventriculoperitoneal shunt, cardiac valve, pacemaker which would constitute a contraindication to 7T imaging.
  • Previous craniotomy.
  • Permanent facial makeup (for brain scanning).
  • Suffer from claustrophobia.
  • Pregnancy.
  • Fever / elevated temperature.

 

 

 

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Assessing the psychosocial and financial impact of CAR-T on survivors and caregivers (APFCART)

Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

Urshila Durani
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123053-H01-RST
19-012702
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Inclusion Criteria:

  • Age ≥ 18.
  • Blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma).
  • Receiving a CAR-T product.
  • Able to complete a written questionnaire in English either at home or with assistance at an appointment.
  • Able to perform a verbal interview either in person or via phone teleconference.


Exclusion Criteria:

  • Severe cognitive deficit of neuropsychiatric condition that would prevent person from being able to provide informed consent or complete survey or interview questions.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.

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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients (Spire)

A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

Roberto Benzo
All
40 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-123059-H01-RST
19-012772
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Inclusion Criteria:

  • Adults, age ≥ 40 years old.
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • At least 10 pack years of smoking.


Exclusion Criteria:
 

  • Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
  • Unable to follow commands (cognitive impairment).
  • Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
  • Live in an area that does not have cellular service (Verizon).

Eligibility last updated 8/27/21. Questions regarding updates should be directed to the study team contact.

Behavioral
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ROR1903: Spatially Fractionated Radiation (GRID) Therapy for Tumors of the Head and Neck, Thorax, Abdomen, and Extremities (GRID)

A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors

Dawn Owen
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123063-H01-RST
19-012801
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Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
  • Histological confirmation of oncologic diagnosis.
  • Completed oncologic imaging (per discretion of treating physician).
  • ECOG Performance Status 0-3.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Provide informed written consent.


Exclusion Criteria:
 

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.  NOTE:  Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Radiation, Radiotherapy to abdomen, Radiotherapy to head, Radiotherapy to neck, Radiotherapy to pelvis, Radiotherapy to thorax
Cancer, Head and neck cancer, Lung cancer, Stomach cancer
Cancer treatment, Digestive system, Fractionated radiation therapy, Medical Oncology, Neoplasm of abdomen, Neoplasm of extremity, Neoplasm of head and neck, Neoplasm of pelvis, Neoplasm of thorax, Radiation therapy, Reproductive system, Respiratory system
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Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Jad Sfeir
All
55 years and over
This study is NOT accepting healthy volunteers
2020-101784-P01-RST
19-007740
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Inclusion Criteria:

  • Adults self-referred or referred by their physicians starting a senotherapeutic intervention.
  • Any individual with senescence-associated medical conditions as defined above, refractory to current standards or care, or without known treatments.
  • Any individual taking senotherapeutic agents or performing dietary restriction for any reason.


Exclusion Criteria:

  • Absolute contraindications to indicated senotherapeutic agents due to drug-drug or other interactions.
  • Pregnancy or breast-feeding.
  • Clinically significant dehydration, infection, renal or hepatic insufficiency.
  • Excessive acute or chronic alcohol use.
  • Acutely ill individuals requiring hospitalization, emergency, or urgent care.
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MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR (TIF vs LNF)

A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia

Barham Abu Dayyeh
All
22 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-300765-P01-RST
19-005226
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Inclusion Criteria:

  • 22
    •80 years of age.
  • Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
  • Pathologic reflux while off PPI based on Lyon criteria by either of the following:
    • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
    • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
  • Commitment to long-term study.
  • Ability to give consent individually or by a legally authorized representative.


Exclusion Criteria:

  • Hiatal hernia > 5 cm.
  • Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
  • Pregnancy (in females) at time of procedure.
  • Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
  • Subjects requiring mesh treatment at time of procedure.
  • Provider discretion.
  • BMI > 35.
Procedure/Surgery
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LS1981: Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL) or Histiocytic/Dendritic Cell Neoplasms

Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms

Jonas Paludo
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2020-300780-P01-RST
19-009349
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Inclusion Criteria:


- Biopsy-proven relapsed and/or refractory non-Hodgkin lymphoma or histiocytic/dendritic
cell neoplasms. Relapsed is defined as a relapse that occurred after having a response
to the last therapy that lasted > 26 weeks. Refractory is no response (stable disease
or progressive disease while on therapy) or relapse within 6 months. Refractoriness to
autologous stem cell transplant will be defined as disease progression within 52 weeks
following transplant.

- Most recent tumor biopsy must be < 26 weeks prior to registration

- Measurable or assessable disease: Measurable disease is defined as measurable by
computed tomography (CT) (dedicated CT or the CT portion of a positron emission
tomography [PET]/CT) or magnetic resonance imaging [MRI]: To be considered measurable,
there must be at least one lesion that has a single diameter of >= 1.5 cm. NOTE: Skin
lesions can be used if the area is >= 1.5cm in at least one diameter and photographed
with a ruler. Patients with assessable disease by PET/CT are also eligible as long as
the assessable disease is biopsy proven lymphoma

- Patients must have previously been treated with at least 2 lines of therapy

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

- Absolute neutrophil count (ANC) >= 1,000/mm^3 (obtained =< 14 days prior to
registration)

- Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)

- Hemoglobin >= 8.5 g/dL (may be transfused to reach criteria) (obtained =< 14 days
prior to registration)

- Total bilirubin < 2 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN
with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's
syndrome) (obtained =< 14 days prior to registration)

- Aspartate transaminase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x
ULN (obtained =< 14 days prior to registration)

- Calculated creatinine clearance must be >= 35 ml/min using the Cockcroft Gault formula
(obtained =< 14 days prior to registration)

- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Female of childbearing potential (FCBP*) must commit to take highly effective
contraceptive precautions** without interruption during the study and continue for at
least 12 weeks after the last dose of selinexor and CS. FCBP must refrain from
breastfeeding and donating oocytes during the course of the study. Males must use an
effective barrier method of contraception without interruption during the study and
continue for at least 12 weeks after the last dose of selinexor and CS. They must
refrain from donating sperm during the study participation.

- *FCBP defined as sexually mature women who have not undergone bilateral tubal
ligation, bilateral oophorectomy, or hysterectomy; or who have not been
postmenopausal (i.e., who have not menstruated at all) for at least 1 year

- Highly effective forms of birth control are methods that achieve a failure
rate of less than 1% per year when used consistently and correctly. Highly
effective forms of birth control include: hormonal contraceptives (oral,
injectable, patch, and intrauterine devices), male partner sterilization, or
total abstinence from heterosexual intercourse, when this is the preferred
and usual lifestyle of the patient NOTE: The double-barrier method (e.g.,
synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream,
or gel), periodic abstinence (such as calendar, symptothermal,
post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea
method, and spermicide-only are not acceptable as highly effective methods
of contraception

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study)

- Willingness to provide mandatory blood specimens per protocol for Pharmacokinetics
(PKs) and banking, and mandatory tissue samples for correlative research. NOTE: If an
institution is not able to provide the tissue, it does not cause the patient to be
ineligible; however, the collection of these tissues is strongly recommended


Exclusion Criteria:


- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:

- Pregnant women

- Nursing women

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Patients known to have active hepatitis B, or C infection, or known to be positive for
hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg)
(hepatitis B virus [HBV] surface antigen). Patients known to be human immunodeficiency
virus (HIV) positive, except those with CD4+ T-cell (CD4+) counts >= 350 cells/uL and
on an established antiretroviral therapy (ART) for at least twelve weeks and have an
HIV viral load less than 400 copies/mL prior to enrollment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Life expectancy of < 6 months

- Active gastrointestinal (GI) dysfunction interfering with the ability to swallow
tablets, or any GI dysfunction that could interfere with absorption of study treatment

- Known intolerance to or contraindications for choline salicylate therapy. Patients
with known allergy to acetylsalicylic acid (ASA) are not eligible

- Prior exposure to a selective inhibitors of nuclear export (SINE) compound, including
selinexor

- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm

- Active second malignancy requiring treatment that would interfere with the assessment
of the response of the lymphoma to this protocol therapy. Patients with treated
malignancies on hormonal therapy (for example breast or prostate cancer) are eligible

- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks
prior to registration. NOTE: Exception: patients on any BTK inhibitor (ibrutinib,
zanabrutinib, acalabrutinib, etc), or venetoclax, or corticosteroids (any dose) may
continue therapy up until the new regimen has started at investigator discretion.
After the start of protocol therapy, corticosteroids can be used at investigator's
discretion and tapered to lowest possible dose

- Active graft versus (vs.) host disease (after allogeneic stem cell transplantation) at
registration

- Major surgery (including bowel resection) =< 3 weeks prior to registration

- Must not be currently eligible or have declined high-dose therapy with autologous stem
cell transplantation rescue or chimeric antigen receptor (CAR)-T cell therapy

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Known active central nervous system (CNS) lymphoma. Patients with previous CNS
involvement can enroll if the CNS component is inactive

- Patients who are on active anticoagulant therapy with direct oral anticoagulants
(DOACs), aspirin or warfarin are not eligible due to potential bleeding. EXCEPTIONS:
Patients who are on aspirin (81 mg) for primary prevention of cardiovascular disease
can enroll, but the ASA needs to be held while on this protocol therapy

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact

Drug
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