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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

596 Study Matches

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Senescence in Human Atherosclerosis

A Study to Evaluate the Process of Aging in Human Atherosclerosis

Fahad Shuja
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122839-H01-RST
19-010502
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Inclusion Criteria:

  • Subject must be > 18 years of age.
  • Subjects will be undergoing routine endarterectomy to remove culprit atheromas in either the carotid, aortoiliac, or femoral arterial beds.
  • All eligible subjects regardless of race or gender or ethnicity will be eligible and included in the study.


Exclusion Criteria:

  • None.

 

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Mayo Clinic — Rochester, MN

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the LIPOSORBER® LA-15 System (LDL Apheresis)

Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 System

Hatem Amer
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
0000-122850-P01-RST
19-010588
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Inclusion Criteria:
 

  • A patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when:
    • Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient’s glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2 .
    • The patient is post renal transplantation.  


Exclusion Criteria:
 

  • Patient is greater than 75 years of age at the start of the treatment period or less than 22.
  • The patient is unwilling or unable to sign and date the informed consent.
  • Pregnant, lactating, or planning to become pregnant prior to completing the study.
    • Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied.  There may be unknown risks to an embryo/fetus. Sexually active women of childbearing  potential should avoid pregnancy during the use of the LIPOSORBER device and  throughout the study duration. 
  • Unable or unwilling to comply with the follow-up schedule.
  • Simultaneously participating in another investigational drug or device study.
  • Body weight < 15 kg (33.1 lbs)

Medical


Exclusion Criteria:
 

  • Currently being administered ACE inhibitors that cannot be withheld for at least 24  hours prior to each apheresis treatment.
    • Note: The time period to withhold ACE  inhibitors should be prolonged, if determined by the treating physician, considering  each individual's renal function and the biological half-life of the ACE-inhibitor  currently in use. 
  • Currently being administered antihypertensive drugs other than ACE inhibitors (e.g.,  ARBs) that cannot be withheld on the day of apheresis until after the procedure.
  • Medical condition or disorder that would limit life expectancy to less than the  primary clinical study endpoint or that may cause noncompliance with the study plan or  confound the data analysis.
  • Hypersensitivity to dextran sulfate, heparin, or ethylene oxide.
  • Adequate anticoagulation cannot be achieved due to severe hemophilia, severe  hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K  antagonist medications.
  • Extracorporeal circulation therapy with LIPOSORBER® LA-15 System cannot be tolerated  due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac  arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe  uncontrollable hypotension.
    • Note: Severe uncontrollable hypotension/hypertension  indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for  age, gender, and height.
  • Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated  congestive heart failure, or valvular disease.
  • Thyroid disease or liver abnormalities.
  • Unresolved systemic or local infection that could affect the clinical study outcomes.
Device
Focal segmental glomerulosclerosis, Nephrotic syndrome
Focal segmental glomerulosclerosis, Nephrotic syndrome associated with another disorder, Urinary system
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Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction

A Study to Evaluate Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction

Bradley Kemp
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122851-P01-RST
19-010591
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Inclusion Criteria:

  • 18 years of age or older.
  • Subjects who are able and willing to sign the informed consent.
  • Subjects who are able to follow verbal commands.
  • A negative urine pregnancy test within 48 hours prior to PET imaging procedures in females of childbearing potential.
  • Subjects who are scheduled for a PET/CT study under Mayo Clinic Rochester IRB research protocol 08-005553 (Aim 1 cohort only).
  • A positive 18F-FDG oncology PET/CT exam in the last six months (Aim 2 cohort only).


Exclusion Criteria:

  • Patients who are unable to lay still for an additional 15 minutes (for Aim 1 cohort).
  • Patients who are unable to lay still for 90 min for 18F-FDG scans or 100 min for 18F-AV1451 scans (for Aim 2 cohort).
  • Patients who cannot follow the prep instructions.
Device, Drug, Other, Positron emission tomography of brain
Positron emission tomography scan
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Validation Study of Self-collected Rectal and Pharyngeal Swabs for Chlamydia and Gonorrhea Testing

A Study to Evaluate Self-collected Rectal and Pharyngeal Swabs for Chlamydia and Gonorrhea Testing

Mary Kasten
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122853-H01-RST
19-010609
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Inclusion Criteria:

  • Patients who are > 18 years old.
  • Patients who require a pharyngeal and/or rectal swab for CT/NG NAAT as part of their routine care.


Exclusion Criteria:
 

  • Patients who can not physically obtain a self-collected swab due to either mental or physical disability.
  • Patients who cannot give informed consent.
  • Planned Parenthood site Mayo Clinic Employees or participant in other Mayo Studies

 

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Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2

A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2

Stephen Kopecky
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122854-H01-RST
19-010612
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • May be on oral therapy (including metformin) or insulin.
  • Most recent HgbA1c level measuring between 6.5 -10 within the last 3 months.
  • May be on stable (> 4 weeks) statin dose or no statin therapy.
  • Willing to sign informed consent and stay on current medical regimen.
  • Does not use regular dietary fiber supplements; has not had any psyllium containing products in the previous 30 days; is willing to refrain from taking any other fiber containing supplement products during the study.
  • Has not used systemic steroid agents in the last 30 days.
  • Able to participate fully in all aspects of the study.
  • Have access and ability to utilize text messaging or email.


Exclusion Criteria:

  • Unwilling/unable to participate.
  • Comorbid inflammatory bowel disease, celiac sprue, nephrotic syndrome, severe cholestasis (e.g., primary biliary cirrhosis), or history of bariatric surgery/bowel resection.
  • Alcohol use in excess of 14 drinks/week.
  • Allergic reactions to psyllium or wheat dextrin.
  • Has participated in a clinical drug study or used an investigational new drug during the previous 30 days.
  • Self-Report of known or suspected pregnancy or immediate plans (within 3 months) of becoming pregnant.
  • Currently breastfeeding.
  • Has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
  • Anticipated or recent major changes in diet or exercise routine.
  • Anticipated colonoscopy prep during 3 months of study period.
Dietary Supplement
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Collecting Surgical Tumor Samples for Generating Prostate Cancer Patient-derived Xenograft

A Study to Collect Surgical Tumor Samples for Prostate Cancer-derived Tissue Graft

Liewei Wang
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122863-H01-RST
19-010734
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Inclusion Criteria:

  • Males, 18 years of age or older.
  • Metastatic Prostate Cancer (lymph node-positive metastatic prostate cancer).


Exclusion Criteria:
 

  • Life expectancy of less than 3 months.
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Humanizing the Intensive Care Unit: Perspectives of Patients and Their Families on the Get to Know Me Board and the Process of Humanization of Critical Illness

A Study to Assess the Perspectives of Patients and Their Families and the Process of Humanization of Critical Illness

Sumera Ahmad
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122864-H01-RST
19-010753
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Inclusion Critieria:

  • Adults ( ≥ 18 years).
  • Critically ill patients admitted to medical, surgical, cardiac, neuro or mixed ICU at Mayo Clinic.
  • Has a family member available.
  • > 24.00 hours in ICU length of stay.
  • Get to Know Me board was used in the ICU.


Exclusion Criteria:

  • If patient unable to communicate and has no family members or friends available.
  • Patients without research authorization.

 

Under care of intensive care specialist
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An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation

A Study to Evaluate the Long-Term Effectives on ALS Disease Progression of BIIB067

Eric Sorenson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122865-P01-RST
19-010784
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Inclusion Criteria:

  • Must have diagnosis of SOD1-ALS, and must have completed the End of Study Visit for either Parts A, B, or C of Study 233AS101 (NCT02623699) (i.e., were not withdrawn).
  • If taking riluzole, must be receiving a stable dose for ≥ 30 days prior to Day 1. 
  • For participants of childbearing potential must agree to practice effective contraception during the study and be willing and able to continue contraception for 5 months after their last dose of study treatment. 
  • Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry, as determined by the Investigator. 
  • Participants from Study 233AS101 Parts A and B must have a washout ≥ 16 weeks between the last dose of study treatment received in Study 233AS101 and the first dose of BIIB067 received in the current Study 233AS102.
  • If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1.
    • Edaravone may not be administered on dosing days during this study.


Exclusion Criteria:
 

  • History of allergies to a broad range of anesthetics. 
  • Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally and could place a participant at an increased risk for bleeding during or after a Lumbar Puncture (LP) procedure. These risks could include, but are not limited to, anatomical factors at or near the LP site (e.g., vascular abnormalities, neoplasms, or other abnormalities) and underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease).
  • Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter. 
  • Prior or current treatment with small interfering ribonucleic acid (RNA), stem cell therapy, or gene therapy. 
  • Treatment with another investigational drug, biological agent (excluding BIIB067), or device within 1 month or 5 half-lives of study agent, whichever is longer.
  • Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period. 
  • Female participants who are pregnant or currently breastfeeding. 
  • Current enrollment in any other interventional study. 
  • Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis(N4-methylthiosemicarbazone)) or pyrimethamine. 
  • Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive hepatitis B surface antibody immunoglobulin G, and positive HBcAb) or vaccination (defined as positive anti-HBs) are eligible to participate in the study. 
  • Presence of an implanted intravenous port/catheter.
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug
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Mayo Clinic — Rochester, MN

Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

A Study to Evaluate Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Dana Erickson
All
18 years to 95 years old
This study is NOT accepting healthy volunteers
0000-122866-H01-RST
19-010785
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Inclusion Criteria:

  • Patients 18-95 years old.
  • Diagnosed with sellar and suprasellar masses.
  • Undergo neurosurgical procedure at Mayo Clinic Rochester.


Exclusion Criteria:

  • Patients under 18 or over 95 years old.
  • Patients with preexisting central diabetes insipidus (CDI).
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Cohort Study of Pancreatic Cancer Risk

A Study of Pancreatic Cancer Risk

Gloria Petersen
All
50 years and over
This study is NOT accepting healthy volunteers
0000-122867-H01-RST
19-010791
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Inclusion Criteria:

  • An individual who has previously consented to the Biospecimen Resource for Pancreas Research (Substudy #1 – Pancreatic Disease Cases) – IRB 354-06 who does not have pancreas disease but does have a family history of pancreas disease or (Substudy #2 Family Studies) – IRB 355-06.
  • Individual who does not have a personal history of pancreatic cancer and meets one of the following:
    • Has relatives in family that contains pancreatic cancer, and carries a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53; OR
    • Is a first- or second-degree blood relative of an individual with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and this PDAC patient has a germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53; OR
    • Is a first- or second-degree blood relative of an individual with a germline mutation in one of these genes and where the mutation carrier is also a first-degree relative to a PDAC case; OR     
    • Is a blood relative to a PDAC patient in a family that contains three blood relatives (all maternal side or all paternal side) with PDAC;
    • Age 50 or older; OR
    • Or within 10 years of the age of diagnosis of the youngest PDAC blood relative.
  • Individual with a valid United States mailing address.


Exclusion Criteria:

  • Individual who has a personal history of PDAC.
  • Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e., leukemia or lymphoma).
  • Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness.
  • Individual who is non-English speaking
  • Individual who is a prison inmate.

Eligibility last updated 10/6/21. Questions regarding updates should be directed to the study team contact.

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Analysis of Waste Specimens from the Eye After Surgery

A Study to Analyze Waste Specimens from the Eye After Surgery

Sophie Bakri
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122868-P01-RST
19-010795
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Inclusion Criteria:

  • All patients undergoing surgery by Dr. Bakri.
  • Any waste tissue will be saved.


Exclusion Criteria:
 

  • None.

 

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Trial Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD) (TRC-PAD)

TRC-PAD Program: In-Clinic Trial-Ready Cohort

Jonathan Graff-Radford
All
50 years to 85 years old
This study is NOT accepting healthy volunteers
0000-122900-P01-RST
19-011094
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Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated availability and willingness to comply with all study procedures until referred to a clinical trial.
  • Age 50-85 (inclusive).
  • Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia.
  • Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function.
  • In good general health as evidenced by medical history.
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Fluent in English or Spanish.
  • For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan.
  • Completed six grades of education or has a good work history.
  • Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center.


Exclusion Criteria:

  • Treatment with another anti-amyloid investigational drug or other intervention within 12 months.
  • Enrolled in another interventional clinical trial within the last 12 weeks.
  • Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  • Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
  • History of schizophrenia (DSM V criteria).
  • History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria).
  • Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
  • History within the last 3 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
  • Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
  • Clinically significant abnormalities in screening laboratories or ECG.
  • For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin).
  • Participants whom the Site PI deems to be otherwise ineligible.
    • Site PIs should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC would be appropriate.

Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director and Coordinating Center.

Alzheimer's disease, Dementia
Alzheimer's disease, Dementia, Nervous system, Positron emission tomography scan
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Long Term Follow-Up of Participants Treated with GSK Adoptive Cell Therapies

Long Term Follow-Up of Subjects Exposed to GSK3377794

Steven Robinson
All
12 years and over
This study is NOT accepting healthy volunteers
0000-122904-P01-RST
19-011100
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Inclusion Criteria:

  • Subjects who have received at least one dose of GSK3377794 in the interventional study.
  • Subjects who have either completed the interventional study or have withdrawn from it.
  • Male or female subjects.
  • Capable of giving signed informed consent prior to the study participation.


Exclusion Criteria:

  • None.
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Minimal Residual Disease in Chronic Lymphocytic Leukemia

A Study to Evaluate Minimal Residual Disease in Chronic Lymphocytic Leukemia

Sameer Parikh
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122912-H01-RST
19-011191
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Inclusion Criteria:

  • Age 18+ Years Old.
  • Diagnosis of Chronic Lymphocytic Leukemia (B-CLL).


Exclusion Criteria:

  • Pregnant.
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Epidural Spinal Stimulation User Experience Survey for Individuals with Paralysis Due to Spinal Cord Injury

A Study to Survey Epidural User Experience for Individuals with Spinal Cord Injury Paralysis

Kristin Zhao
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122914-H01-RST
19-011212
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Inclusion Criteria:

  • Individuals with spinal cord injury who have received an epidural spinal stimulation implant for return of functional return.
  • Individuals who have received an epidural spinal stimulation implant but have since had it removed.
  • English speaking individuals.


Exclusion Criteria:
 

  • Individuals with spinal cord injury who have received an epidural spinal stimulation implant for pain.
  • Non-English speaking individuals.
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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:

  • Age 18+ years of age.
  • Able to give informed consent.

Prostate Cancer Patients

  • Patients with intermediate-risk, high-risk or very-high risk prostate cancer (≥ Grade Group 2).
  • Patients scheduled to undergo open radical prostatectomy (ORP).
  • Patients scheduled to undergo conventional laparoscopic radical prostatectomy (LRP).
  • Patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RALP).
  • Patients scheduled to undergo external beam radiation therapy (EBRT).

Nephrolithiasis Patients

  • Patients treated for nephrolithiasis (Extracorporeal Shock Wave Lithotripsy/Surgery).    


Exclusion Criteria:
                                 

Prostate Cancer patients

  • Unable or unwilling to provide informed consent.
  • On hormone therapy (Casodex, GnRH agonist/antagonist).
  • Patients with Benign Prostatic Hyperplasia (BPH).
  • Active (non-skin) malignancy within the past 5 years excluding prostate cancer.

Nephrolithiasis Patients

  • Unable or unwilling to provide informed consent.
  • History of Benign Prostatic Hypertrophy (BPH).
  • Active (non-skin) malignancy within the past 5 years including prostate cancer.

Eligibility last updated 3/2/22. Questions regarding updates should be directed to the study team contact.

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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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The Ability of the Spectral Topogram at Photon Counting Detector Computed Tomography (PCD-CT) to Predict Osteoporosis and Osteopenia: a Pilot Study

A Study to Evaluate the Spectral Topogram to Predict Osteoporosis and Osteopenia

Joel Fletcher
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122939-H01-RST
19-011485
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Inclusion Criteria:

  • Male and female patients aged 18 years or more.
  • Patients with IBD, Celiac disease, and a history of receiving a liver transplant, or potential conditions or on drugs that may predispose them to osteoporosis.
  • Ability to undergo a research DEXA scan on Gonda 2.
  • Patients able and willing to sign informed consent.


Exclusion Criteria:

  • Patients not meeting inclusion criteria will be excluded.
  • Patients unable or unwilling to provide informed consent.
  • Patients with metal artifacts affecting the regions of interest.
  • Pregnancy.
  • Body mass index of more than 30.

 

  •  

 

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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

Christine Hunt
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

Safia Ahmed
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
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

A Study to Evaluate Human Papilloma Virus Circulating Tumor DNA 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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Transform the Practice – Pilot Study: Radio Signal Characterization of Seizures

A Study to Evaluate Radio Signal Characterization of Seizures

Melissa Lipford
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123001-H01-RST
19-012065
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Inclusion Criteria:

  • Consented adult (18+) male and female subjects who are admitted to the Mayo Clinic Hospital (Saint Marys Campus) Inpatient Epilepsy Monitoring Unit.
  • Have a confirmed diagnosis of epilepsy (by a Mayo Clinic Neurologist).


Exclusion Criteria:

  • Subjects who are pregnant or may be pregnant.
  • Pediatric patients (< 18 years of age).
  • Subjects who are unable to provide consent.
  • Those admitted primarily for classification of indeterminate (possibly non-seizure) events.
  • Subjects who plan to have more than one additional person in the room with them during nocturnal hours (10 pm – 6 am) (excluding clinical providers).
  • Subjects who have an implanted vagal nerve stimulator or other neurostimulation device.
  • Patients with implantable drug delivery systems or implanted cardiac devices (including pacemakers and defibrillators).
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