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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.

2881 Study Matches

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FAITH! Trial Ancillary Study (FAITH! Heart Health+): Social determinants of health, stress, structural racism and cardiovascular health among African-Americans

FAITH! Heart Health+

LaPrincess Brewer
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306290-H01-MPMC
21-011103
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Inclusion Criteria:

  • Enrolled FAITH! Trial participant.
  • Men and women, 18 years of age and older.
  • African-American race/ethnicity.
  • Active email address.

 


Exclusion Criteria:
 

  • Not enrolled in the FAITH! Trial.

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

 

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Mayo Clinic Square — Minneapolis, MN

Transcranial Magnetic Stimulation Evoked Potentials as a Quantitative Diagnostic Tool (TMS/QDT)

Using Transcranial Magnetic Stimulation Evoked Potentials to Diagnose

Matej Markota
All
18 years to 64 years old
This study is NOT accepting healthy volunteers
2021-306305-H01-RST
21-011143
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Inclusion Criteria:

  • Demographic characteristics: ≥ 18 and ≤ 65 years of age.
  • Required laboratory results: negative pregnancy test for those with female sex assigned at birth (contraception will not be required to participate in the study).
  • Health status: Schizophrenia spectrum disorder (as defined by the DSM-5; Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia, Schizoaffective Disorder, Catatonia, Other Specified Schizophrenia Spectrum Disorder, Unspecified Schizophrenia and Other Psychotic Disorder; but NOT Substance/Medication-Induced Psychotic Disorder or Psychotic Disorder Due to Another Medical Condition) for case group; control group can have any non-schizophrenia spectrum psychiatric illness with exceptions listed below  
  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Has an established mental health provider (e.g. ,integrated behavioral health, Mayo W11 psychiatric longitudinal clinic) or a follow up appointment with a new mental health provider within 2 weeks of study appointment.


Exclusion Criteria:

  • Demographic characteristics: < 18 or  ≥ 65 years of age.
  • Any legal history of violence, or self-reported personal history of violence in the past 10 years (history of violence is routinely checked in everyday clinical work at the time of admission, and should be apparent in medical records).
  • Any active movement disorder that would interfere with quality TMS-EEG.
  • Any confirmed or suspected history of a seizure.
  • Any major neurocognitive disorder.
  • Current diagnosis of Bipolar Disorder with psychotic features or Major Depressive Disorder with psychotic features.
  • Current diagnosis of Autism Spectrum Disorder.
  • No follow up appointments with a primary care physician or mental health provider.
  • Positive pregnancy test
  • Positive or presumptive positive urine drug screen test for alcohol or any illicit substance (with the exception of cannabis) at time of recruitment.
  • Those with female sex assigned at birth with negative pregnancy test actively trying to become pregnant. Women who are lactating will be included, as long as the infant/toddler can be away from mother for the duration of the study (per mother’s judgement).
  • Use of benzodiazepines; any antiepileptic drugs (including gabapentin, valproate, topiramate, carbamazepine, lamotrigine, etc.), opioids, and opioid antagonists.
  • TMS or electroconvulsive treatment within the past 12 months, and any past significant adverse events with TMS exposure.
  • Any past neuroanatomic findings of gross structural abnormalities; or such findings detected on the MRI. Gross structural abnormalities of the brain include aneurysms, tumors, encephalomalacia and other anatomic sequalae of trauma, infarcts, etc. Of note, in routine clinical practice significant anatomic abnormalities are rarely discovered in patients undergoing workup for psychosis.
  • Any active substance use disorder, apart from cannabis and nicotine use disorder.
  • Claustrophobia and inability to tolerate MRI (including MRI non-compatible implants, and movement disorders that would interfere with obtaining a quality MRI image).
  • Inability or unwillingness of individual to give written informed consent.
  • Individual has a legal guardian (any legal guardian) or is in the process of awaiting court hearing for potential guardianship.
  • Current involuntary hospitalization as evidenced by active 72h hold; any type of ongoing commitment process (including provisional discharge, stay of commitment, awaiting commitment hearing, etc.).
  • Insufficient knowledge of English.
  • Any metal, electronic, or other implant that is incompatible with TMS or MRI technology.

Eligibility last updated 5/31/22. Questions regarding updates should be directed to the study team contact

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A Prospective Data Collection Study of Patients Treated with a Single-level Lumbar Interbody Fusion Stabilized with Pedicle Screws (3Spine)

3Spine TLIF Real World Evidence Study

Ahmad Nassr
All
21 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306317-P01-RST
21-011175
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Inclusion Criteria:

  • Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy.
  • Subject plans to undergo a one-level Open or Mini-Open TLIF procedure (stabilized with pedicle screws) independent of this research protocol.
  • Subject is to be treated with on-label use of an FDA-cleared TLIF cage and pedicle screw system independent of this research protocol.
  • The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (< 25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:
    • Herniated nucleus pulposus;
    • Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
    • Facet joint degeneration/osteophyte formation;
    • Spondylosis (defined by the presence of osteophytes);
    • Disc degeneration and/or annular degeneration; and/or
    • Lumbar stenosis defined by spinal cord or nerve root compression.
  • Exhausted conservative treatment (e.g., bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency.
  • Preoperative Oswestry Disability Index score > 40/100 at baseline.
  • Surgical candidate for a posterior approach to the lumbar spine.
  • Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
  • Signed informed consent.


Exclusion Criteria:

  • More than one vertebral level requiring treatment.
  • revious instrumented surgery (i.e., anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level.
  • Degenerative or lytic spondylolisthesis greater than Grade 1 (< 25% translation).
  • Rotatory scoliosis at the level to be treated.
  • Congenital bony and/or spinal cord abnormalities at the level to be treated.
  • Subcaudal defect, disrupting the integrity of the pedicle.
  • Clinically compromised vertebral bodies at the involved level due to current or past trauma; e.g., by the radiographic appearance of the fracture callus, malunion or nonunion.
  • Disrupted anterior longitudinal ligament at the index level.
  • Overlying thoracolumbar kyphosis within one level (includes target and adjacent level) of the level to be treated.
  • Back pain of unknown etiology without leg pain.
  • Severe spondylosis at the level to be treated as characterized by any of the following:
    • Autofusion (solid arthrodesis) determined radiographically (CT);
    • Totally collapsed disc; or
    • Vertebral body that cannot be mobilized.
  • Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E.
  • Unable to undergo a CT scan or other radiograph assessments.
  • Osteopenia: All patients will complete SCORE/MORES to screen if a DEXA scan is indicated. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening.
  • Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta).
  • Insulin-dependent diabetes mellitus.
  • Lactating, pregnant or interested in becoming pregnant in the next 3 years.
  • Active infection – systemic or local.
  • Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
  • Body Mass Index > 40.
  • Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease.
  • Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation.
  • Spinal tumor.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
  • Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease.
  • Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  • In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
  • Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code.
  • Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping).
  • Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation.
  • Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results.
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
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Control-IQ Technology in Individuals with Type 2 Diabetes (2IQ) (2IQ)

Control-IQ Technology in Individuals with Type 2 Diabetes

Yogish Kudva
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-306321-P01-RST
21-011266
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Inclusion Criteria:

  • Age ≥ 18 years old and residing in the US.
  • Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
  • Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ).
  • Total daily insulin dose ≤ 200 units/day.
  • Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin.
  • For females, not currently known to be pregnant If female of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study as documented in the study records. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • HbA1c ≥ 7.5% and ≤ 12% at screening.
  • Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one).
  • Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study.
  • Has the ability to read and understand written English.
  • Investigator believes that the participant has capacity such that they can provide informed consent and can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.


Exclusion Criteria:

  • Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology.
  • Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months.
  • History of inpatient psychiatric treatment in the past 6 months.
  • History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
  • History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe.
  • History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system.
  • Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in section 8.3 of the protocol or determined by investigator to interfere with the study.
  • Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication or starting a new glucose lowering agent during the trial.
  • Unstable dose of any medication used for weight loss or starting a new medication for weight loss during the trial. 
  • Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (> 450 ms).
  • History of hemodialysis.
  • History of adrenal insufficiency.
  • Uncontrolled hypo- or hyperthyroidism.
  • Significant diabetes related complications, based on investigator assessment.
  • Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

 

 

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Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding (CHAMP)

Clopidogrel Monotherapy After PCI in Patients with High Bleeding Risk

Mandeep Singh
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306326-H01-RST
21-011053
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Inclusion Criteria:


- Informed consent in adults

- Successful percutaneous coronary intervention (PCI) [no non-fatal MI/stroke/repeat
target revascularization/bleeding/acute kidney injury].

- Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.


Exclusion Criteria:


- Chronic use of warfarin or direct oral anticoagulant (DOAC).

- Unsuccessful PCI (see above).

- Lesions with angiographic thrombus.

- Prior PCI within 6 months.

- Planned PCI or surgical intervention to treat any cardiac or noncardiac condition
within 6 months.

- High risk lesion/stent characteristics (> 50% unprotected left main disease,
bifurcation disease requiring 2 stents technique, rotational atherectomy.

- Vein graft.

- Unprotected left main intervention or history of definite stent thrombosis.

- Women of child-bearing age unless negative pregnancy test is done.

- Life expectancy < 1 year.

- Known drug/alcohol dependence.

- Assessment that the patient will not be compliant with the study protocol.

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Muscle Oxygen Transport Measured with Near-infrared Spectroscopy (NIRS): A Comparison of NIRS Technologies for Experimental and Clinical Applications

NIRS - Minimal Risk

Michael Joyner
All
18 years to 45 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306336-H01-RST
21-011252
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Inclusion Criteria:

  • Healthy adults between the ages of 18 and 45.


Exclusion Criteria:

  • Individuals < 18 or > 45 years of age.
  • Pregnant women (testing will be done by research team if requested).
  • History of pulmonary, neurologic, cardiovascular, or musculoskeletal diseases.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

 

 

 

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AI-CARE Trial: A Pilot study to assess Safety, Efficacy, Feasibility, and Diagnostic Performance Evaluation of Artificial Intelligence-Augmented ECG Interpretation Vs. Standard of Care 12-Lead ECG Computerized ECG Interpretation Software Using a 12-Lead ECG Smartheart Device. (AI-CARE)

Study of Artifiicial Intelligence-augmented ECG vs. 12-Lead Computerized ECG

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306348-H01-RST
21-011419
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Capacity to consent.
  • Patients undergoing a clinically indicated.


Exclusion Criteria:

  • Unable or not willing to consent.
  • Pregnant women.
  • < 17 years of age.
  • External/Internal Electrical Devices – Left ventricular Assist Device, pacemaker dependence, implantable cardioverter defibrillator, transcutaneous electrical nerve stimulation (TENS) unit, or spinal cord stimulator.  (Rational – interference with interpretation).

Eligibility last updated 10/29/21. Questions regarding updates should be directed to the study team contact.

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Outcomes of Highly Congruent Polyethylene and Posterior Stabilized Designs in Total Knee Arthroplasty

Highly Congruent Polyethylene and Posterior Stabilized Designs in Total Knee Arthroplasty

Cory Couch
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2021-306349-H01-RST
21-011355
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Inclusion Criteria:

  • Age ≥ 18, Age ≤ 100.
  • Patients having undergone total knee arthroplasty with highly congruent or posterior stabilized designs(DJO 3D Empowr vs Zimmer MP vs PS Stryker primary TKA).


Exclusion Criteria:

  • No vulnerable populations.

Eligibility last updated 10/28/21. Questions regarding updates should be directed to the study team contact.

 

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VEXAS Syndrome Biorepository (VEXAS)

VEXAS Biobank

Matthew Koster
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306362-H01-RST
21-011449
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Inclusion Critieria:

  • Suspicion for VEXAS syndrome based on the following being present.
  • Current or historical elevated inflammatory markers (ESR > 20 mm/hr and/or CRP > 10 mg/L).
  • PLUS at least one of the following inflammatory features present currently or historically:
    • Inflammatory arthritis;
    • Nasal or auricular chondritis;
    • Ocular inflammation (scleritis, episcleritis, uveitis);
    • Orbital / peri-orbital swelling/edema;
    • Cutaneous inflammation (inflammatory skin nodules, neutrophilic dermatosis, urticarial lesions, leukocytoclastic vasculitis);
    • Venous thromboembolism OR superficial thrombophlebitis;
    • Biopsy or radiographic confirmed evidence of vasculitis;
    • Inflammatory lung findings (multifocal ground glass opacity);
    • Recurrent fever, night sweats, unintentional weight loss.
  • PLUS at least one of the following hematologic parameters:
    • MCV > 95 fl;
    • Anemia (hemoglobin < 13.2 g/dl for male or < 11.6 g/dl for female);
    • Thrombocytopenia (platelets < 135 x 10^9/L for male or < 157 x 10^9/L for female);
    • Leukopenia (white blood cell count < 3.4 x 10^9/L);
    • Neutropenia (neutrophil count < 1.56 x 10^9/L).


Exclusion Criteria:
 

  • Patients who are not able to provide informed consent.
  • Patients < 18 years of age.
  • Pregnancy.
  • Patients who do not meet the above listed inclusion criteria.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

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GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer (GRECO-2)

Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Kenneth Merrell
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306377-P01-RST
21-011529
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Inclusion Criteria:

  • Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
  • Newly diagnosed non-metastatic PC judged by tumor board to be feasible for (m)FOLFIRINOX and SBRT.
  • Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy.
  • Female or male subjects ≥ 18 years of age.
  • ECOG performance status of 0-2.
  • Adequate end-organ function.


Exclusion Criteria:

  • Subjects with documented metastatic disease.
  • First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total period of longer than 4 months prior to start of SBRT.
  • Prior abdominal RT with substantial overlap in radiation fields.
  • Subjects not recovered/controlled from treatment-related toxicities.
  • Uncontrolled malignancy other than PC 6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing.
  • Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

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Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

Long-Term Study of Participants Previously with Ciltacabtagene Autoleucel

Yi Lin
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306381-P01-RST
21-011543
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Inclusion Criteria:

  • Subjects who have received at least one dose of cilta-cel in a Janssen-sponsored clinical study.
  • Subjects who have provided informed consent for Study MMY4002.


Exclusion Criteria:

  • No exclusion criteria are applicable in this study.

Eligibility last updated 11/2/21. Questions regarding updates should be directed to the study team contact.

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Control Subjects for the Generation of Induced Pluripotent Stem Cells for use in Neuropsychiatric Research (iPSC)

Control Subjects for the Generation of Induced Pluripotent Stem Cells for use in Neuropsychiatric Research

Richard Weinshilboum
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306387-H01-RST
21-011561
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Inclusion Criteria:

  • Subjects ≥ 18 years old.
  • Subjects who have had no personal or family (first degree relatives; i.e., subjects’ parents, siblings, and children) history of major psychiatric disorder.  Specifically, major depressive disorder, schizophrenia, or substance use disorder (SUD). Specifically, in order to ensure subjects without a history of SUD and/or psychiatric disorders, we will question the subjects about these diseases in themselves and their first-degree relatives.
  • Ability to provide informed consent.
  • This initial pilot study will be limited to European-American subjects because of striking differences among different ethnic groups in their allele frequencies or type, and all of the iPSCs that we have generated to this point were derived from European-American subjects.  However, our eventual goal is to generate panels of iPSCs from all major ethnic groups.  Unfortunately, that is not practically possible at this time because of cost in terms of reagents and the extended time required to generate each iPSC line.


Exclusion Criteria:

  • Subjects with a known bleeding issue. 
  • Subjects who are under 18 years old.
  • Subjects with a personal or first-degree relative history of major psychiatric disorder.  Specifically, major depressive disorder, schizophrenia or substance use disorder.

Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.

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Increasing Digital Equity and Access Among Rural Patients (IDEA) Study (IDEA)

IDEA

Christi Patten
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306395-H01-RST
21-011617
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Inclusion Criteria:

  • Mayo Clinic Midwest patient (Rochester or Mayo Clinic Health System [MCHS]) (has a Mayo Clinic number)
  • Aged 18 years or older
  • Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic’s portal services are not offered in languages other than English.
  • Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit.
  • Rural resident based on RUCA codes derived from ZIP code of current or last known address.
  • Has access to a phone (of any type). Access to a phone is needed to complete the coaching support intervention and to follow-up with participants if there are issues with accessing the patient portal for the smoking cessation intervention.
  • Current smoker defined as one or more cigarettes (even a puff) smoked in the past 30 days. This definition allows for enrollment of non-daily and/or “light smokers” enhancing the generalizability. In addition, to enhance the generalizability of our findings, we will enroll participants using other tobacco/nicotine products if cigarette smoking is the primary product used.
  • For past 3 months not enrolled in a program or using pharmacotherapy to stop smoking.
  • Willing to make a quit attempt.
  • Has digital access barriers defined by one or more of the following:
    • based on participant ZIP code from current or last known address geocoded census block group indicates area of poor BB internet coverage;
    • no existing Mayo Clinic patient portal account; or
    • has a Mayo Clinic patient portal account but has not used it in the past 5 years;
    • self-reports having no access to broadband (high speed) internet connection for personal use; and/or
    • self-reports low digital literacy defined with the screening question “How comfortable are you using technology to manage your health care remotely? For example, using patient online services (i.e., patient portal) to schedule appointments, check for test results, or send a message to your provider?” (included: not at all or a little comfortable).


Exclusion Criteria:

  • Anyone not meeting all inclusion criteria will be excluded. 
  • Has participated in a behavioral smoking cessation program in the past 3 months.

Eligibility last updated 11/5/21.  Questions regarding updates should be directed to the study team contact.

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Prospective Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Ryan Kern
All
22 years and over
This study is NOT accepting healthy volunteers
2021-306398-P01-RST
21-011636
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Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Patients must be at least 22 years of age.
  • Patients must be able to undergo routine non-contrast CT scans of the chest.
  • Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
  • The patients must have at least an expected 6 month survival.
  • Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
  • Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design.
  • Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS.


Exclusion Criteria:

  • Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
  • Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES) or 6 weeks following bare metal coronary stent).
  • Unstable cardiac disease.
  • Allergy to silicone.
  • Stenting to manage vascular compression syndromes.
  • Multi-drug resistant bacterial or fungal chronic infections.
  • Emergent/urgent clinically indicated stent.
  • Chronic/permanent mechanical ventilation.
  • Pure Excessive Dynamic Airway Collapse (EDAC) patients.
  • Pure Pulmonary Resistance (Rp) patients.

Eligibility last updated 11/4/21. Questions regarding updates should be directed to the study team contact.

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Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

Matthew Abdel
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306404-H01-RST
21-011655
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Inclusion Criteria:

  • Ability to provide informed consent.
  • 40 patients:
    • 20 preoperative THA, 20 postoperative THA;
    • Sex: 20 men, 20 women;
    • Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years.


Exclusion Criteria:

  • Patients with lumbosacral hardware, contralateral THA.

Eligibility last updated 11/5/21. Questions regarding updates should be directed to the study team contact.

Other
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Carpediem(TM) Post Market Surveillance Study (056-F154)

Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.

Cheryl Tran
All
up to 5 years old
This study is NOT accepting healthy volunteers
2021-306434-P01-RST
21-012849
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Inclusion Criteria:

  • Parent or LAR has signed information consent.
  • Subject weighs between 2.5-10 kg (or 5.5-22 lbs).
  • Subject is receiving medical care in an intensive care unit.
  • Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
  • Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT.


Exclusion Criteria:

  • Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator.
  • Subject has irreversible brain damage, in the opinion of the investigator.
  • Subject is intolerant to anticoagulation, as documented in the medical record.
  • Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days.
  • Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) < 30 ml/min/1.73m^2.
  • Subject has received at least 12 hours of CRRT with another machine (not including ECMO) during the current hospitalization.
  • Subject is currently or has chronically been treated with a circulatory support device (i.e., left ventricular assist device (LVAD)) other than ECMO.
  • Subject has had prior CRRT treatments using the Carpediem™ system.
  • Subject is enrolled in clinical trials or being treated with other investigational therapeutic devices or products for acute kidney injury or fluid overload.
  • Subject has any other medical condition that may confound the study objectives, in the opinion of the investigator.

Eligibility last updated 12/9/21. Questions regarding updates should be directed to the study team contact.

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Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry

Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

Alexander Egbe
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
2021-306467-H01-RST
21-011938
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Inclusion Criteria:

  • Age ≥ 18 years.
  • BMI ≤ 30.
  • No current cardiac medications.
  • Systolic BP ≤ 140 mmHg.
  • Diastolic BP ≤ 90 mmHg.
  • Capacity to consent.


Exclusion Criteria:

  • Age < 18 years.
  • To be assessed via EMR screening.
  • Patient confirmation during screening visit.
  • Screening tests as applicable.
  • History of cardiovascular disease.
  • eGFR < 30.
  • Current orthopedic limitations.

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

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Patient Satisfaction with a Medial Constrained Versus Posterior Stabilized Total Knee Arthroplasty from a Single Design: A Multicenter Randomized Clinical Trial

A Study of Patient Satisfaction Comparing Medial Constrained Versus Posterior Stabilized Total Knee Arthroplasty from a Single Design

Robert Trousdale
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306470-H01-RST
21-012001
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Inclusion Criteria:

  • Evaluation for total knee arthroplasty (TKA) at Mayo Clinic (Rochester, MN) or OrthoCarolina (Charlotte, NC).
  • Evaluated and scheduled for TKA at Mayo Clinic by Drs. Cody Wyles, Robert Trousdale, Kevin Perry, or Nic Bedard or at OrthoCarolina by Drs. Thomas Fehring, Bo Mason, Keith Fehring, or Jesse Otero. 
  • Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery.
  • ≥ 18 years of age at enrollment.


Exclusion Criteria:

  • Previous surgery with hardware on the joint of interest.
  • Varus or valgus defor 1mity > 15° or any other preoperative deformity at the discretion of the surgeon portending a risk of needing a constrained or hinged device.
  • Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease).
  • BMI ≥ 40.
  • Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol.
  • Contralateral side previously enrolled in this study (i.e., simultaneous bilateral or staged bilateral patients cannot have both sides enrolled).
  • Current tobacco use.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery, Other
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Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE)

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Derek Lomas
Male
50 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-306482-P01-RST
21-012020
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Inclusion Criteria:

  • Is greater than 50 years of age.
  • Has at least a 10-year life expectancy.
  • Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c.
  • Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL.
  • Has Gleason score 3+4 or 4+3.
  • Has no evidence of extraprostatic extension by mpMRI.
  • Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy.
  • Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation.
  • Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion.
  • A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy).
  • Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject.
  • Understands and accepts the obligation and is logistically able to present for all
  • scheduled follow-up visits.


Exclusion Criteria:

  • Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium.
  • Is unfit for anesthesia or has a contraindication for agents listed for paralysis.
  • Has an active urinary tract infection (UTI).
  • Has a history of bladder neck contracture.
  • Is interested in future fertility.
  • Has a history (within 3 years) of inflammatory bowel disease.
  • Has a concurrent major debilitating illness.
  • Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer.
  • Has any active implanted electronic device (e.g., pacemaker).
  • Is unable to catheterize due to a urethral stricture disease.
  • Has had prior or current prostate cancer therapies:
    • Biologic therapy for prostate cancer;
    • Chemotherapy for prostate cancer;
    • Hormonal therapy for prostate cancer within three months of procedure;
    • Radiotherapy for prostate cancer;
    • Surgery for prostate cancer.
  • Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants.
  • Has had prior major rectal surgery (except hemorrhoids).
  • Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)).
  • Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder.
  • Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons.
  • In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual.

Eligibility last updated 4/6/22. Questions regarding updates should be directed to the study team contact.

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A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups

A Study of Educational Materials for Hiccups

Aminah Jatoi
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306492-H01-RST
21-012057
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Inclusion Criteria:

  • Age ≥ 18 years of age.
  • Hiccups in the 4 weeks prior to phone contact (patient must confirm).
  • Able to speak and read English.
  • Has an e-mail address.


Exclusion Criteria:
 

  • Individuals < 18 years of age.

Eligibility last updated 11/17/21. Questions regarding updates should be directed to the study team contact.

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Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum (DBS)

Validation of Dried Blood Spots for Detection of Antibodies to Treponema Pallidum

Elitza Theel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306510-H01-RST
21-012151
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Inclusion Criteria:

  • Subjects who are ≥ 18 years of age.
  • Subjects who are known to be positive for syphilis antibodies using routine, standard of care serologic assays.


Exclusion Criteria:
 

  • Subjects who are < 18 years of age.
  • Subjects who are unable to give informed consent.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

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IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients by Using a 20 Hz Filter to Better Assess Electrocardiogram Abnormalities (IQ-ECG)

IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306589-H01-RST
21-013016
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Inclusion Criteria:

  • Adults ≥ age of 18 years.
  • Must have a left ventricular assist device (LVAD).
  • Must be able to consent.


Exclusion Criteria:

  • No LVAD.
  • Unable to consent.
  • Under the age of 18 years.

Eligibility last updated 12/15/21. Questions regarding updates should be directed to the study team contact.

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S2104 Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors

Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Timothy Hobday
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306702-P01-RST
21-013251
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Inclusion Criteria:

  • Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam.
  • Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report.
  • Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be ≥ 3% and ≤ 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria.
  • Participants with localized resected pNETS must have a Zaidi score of ≥ 3 derived by the following factors and points:
    • 1 point; symptomatic tumor defined as one of the following:
      • Gastrointestinal bleed;
      • Jaundice;
      • Gastrointestinal obstruction;
      • Pain from primary tumor prior to surgical resection;
      • Pancreatitis.
    • 2 points; primary pancreas tumor size > 2 cm.
    • 1 point; Ki-67 3% to 20% -1 point; lymph node positivity = 1.
    • 6 points; Ki-67 21% to 55%.
  • Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection.
  • Participants must not have unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must have recovered from effects of surgery as determined by the treating investigator.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must be ≥ 18 years old
  • Participants must have Zubrod performance status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to registration.
  • Patients must have adequate organ and marrow function as defined below within 28 days prior to registration:
    • Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration);
    • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration);
    • Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration);
    • Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration);
    • Serum creatinine ≤ 1.5 x institutional ULN (within 28 days prior to registration);
    • Calculated creatinine clearance ≥ 50 ml/min (within 28 days prior to registration).
    • Calculated Creatinine Clearance = (140
      •age) X (weight in kg) † 72 x serum creatinine:
    • * Multiply this number by 0.85 if the participant is female.
    • † The kilogram weight is the participant weight with an upper limit of 140% of the IBW.
    • * Actual lab serum creatinine value with a minimum of 0.8 mg/dL.
  • Participants must be able to swallow pills.
  • Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential."In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
  • No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.


Exclusion Criteria:

  • Participants must not have unresected or unablated metastatic disease.
  • Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted.
  • Participants must not have received somatostatin analogs after surgery.
  • Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed.
  • Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine.
  • Participants must not have known absorption issues that would limit the ability to absorb study agents.
  • Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration.
  • Participants must not have active or uncontrolled infection.
  • Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator.
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Eligibility last updated 12/27/21. Questions regarding updates should be directed to the study team contact.

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Evaluating Paternal Antigen Exposure and Maternal Immune Tolerance

Evaluating Paternal Antigen Exposure

Elizabeth Ann Enninga
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306706-H01-RST
21-013107
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Inclusion Criteria:

  • Pregnant women ≥ 18 years old, having their second pregnancy.
  • Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems.
  • Ability to provide informed written consent.
  • No known pregnancy complications at the first obstetrics visit (uncomplicated pregnancy).
  • Known paternity for pregnancy.
  • Singleton pregnancies.


Exclusion Criteria:
 

  • History of preeclampsia or other hypertensive disease.
  • History of preterm delivery.
  • History of miscarriage.
  • History of stillbirth.
  • History of prior fetal growth restriction.
  • Current pregnancy with congenital anomaly.
  • Mothers < 18 years of age.
  • Multiple fetuses.
  • Conception following assisted reproductive technologies.

Eligibility last updated 12/17/21. Questions regarding updates should be directed to the study team contact.

Other
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Mayo Clinic Phage Program Biobank (Phagebank)

Mayo Clinic Phage Program Biobank

Gina Suh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306707-H01-RST
21-013112
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Able to provide informed consent.
  • Individual must have a future treatment plan to receive or has historically received phage therapy.


Exclusion Criteria:

  • Individuals , 18 years of age.
  • Unwilling/unable to provide informed consent.

Eligibility last updated 1/10/22. Questions regarding updates should be directed to the study team contact.

 

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A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Open Nipple Sparing Mastectomy (NSM)

James Jakub
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-306747-P01-RST
21-006696
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Inclusion Criteria:

  •  All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval.


Exclusion Criteria:
  

  • Patients who have not undergone open prophylactic NSM surgery.

Eligibility last updated 12/29/21. Questions regarding updates should be directed to the study team contact.

 

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Cardiovascular and Cognitive Implications of CNS hypersomnias and Their Treatments (CVCOGNARCIH)

Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition

Virend Somers
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306758-H01-RST
21-013321
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Inclusion Criteria:

  • Diagnosed with a CNS hypersomnia according to ICSD-3 classifications.
  • Age 18
    •75 years.
  • BMI between 18 and 40 kg/m^2.
  • Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol) by a clinical sleep specialist as part of routine medical care and covered by subject’s health insurance plan.
  • If subject has not yet started the prescribed medication, then subject must be willing to postpone starting medication until after completion of baseline assessment(s).
  • If subject has been taking a prescribed medication at a stable dose for at least 3 months and has been prescribed a new medication, then then subject may complete baseline assessment(s) while taking initial medication before starting new medication.


Exclusion Criteria:
 

  • Any change to medication(s) within the last 45 days.
  • History of chronic alcohol or drug abuse within the prior 12 months.
  • Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study.
  • Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit.
  • Participation in another study of an investigational drug within the 28 days prior to screening visit or currently.
  • Pregnancy and/or breast-feeding.
  • Subjects who, in the opinion of the Investigator, may not be suitable for the study.                     

Eligibility last updated 4/28/22. Questions regarding updates should be directed to the study team contact.

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Tonation Breathing Technique, a Non-pharmacogenic Method to Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms - A Pilot Study (TBT)

Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms

Prema Peethambaram
Female
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306764-P01-RST
21-012300
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Inclusion Criteria:

  • Eligible patients are females with stage I-III breast cancer taking adjuvant AI (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled. Treating physicians determine if pain is secondary to an AI.  
  • ≥ 18 years old.
  • Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment.
  • Patients should have an ECOG performance score of 0-2. 


Exclusion Criteria:

  •  Age less than 18 years.
  • Significant underlying pulmonary disease.

Eligibility last updated 1/14/22.  Questions regarding updates should be directed to the study team contact.

 

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Prospective Collection of Blood and Urine of Healthy Individuals for Liquid Biopsy Research (HDEV)

Liquid Biopsy Controls

Fabrice Lucien-Matteoni
All
50 years and over
This study is NOT accepting healthy volunteers
2021-306772-P01-RST
21-013474
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Inclusion Criteria:

  • Able to give informed consent.
  • Adults  > 50 years old.
  • No prior cancer diagnosis.


Exclusion Criteria:
 

  • Individuals < 50 years old.
  • Unable or unwilling to provide informed consent.

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

 

 

 

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EA2174, A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Shanda Blackmon
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-306824-P01-RST
22-000135
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Inclusion Criteria:

STEP 1:

  • Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II).
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy.
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Hemoglobin (Hgb) ≥ 9 g/dL (within less than or equal to 14 days prior to randomization).
  • Leukocytes ≥ 3,000/mm^3 (within less than or equal to 14 days prior to randomization).
  • Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy.
  • Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy.
  • Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy.
  • Patients must have no contraindication to receiving radiation therapy.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
    • Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years.
  • Date of last evidence of disease.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs.
  • For patients with evidence of CHF, myocardial infarction (MI), cardiomyopathy, or myositis, cardiac evaluation including lab tests and cardiology consultations including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram.
  • Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility.
  • Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as 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 will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from carboplatin, paclitaxel, or nivolumab. All females of childbearing potential must have a blood test or urine study done within 2 weeks prior to registration to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
  • If patient says 'Yes' to "I choose to take part in the imaging study and will have the diffusion weighted magnetic resonance imaging (MRI) scans": patients must be able to tolerate MRI scans:
    • No history of untreatable claustrophobia;
    • No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies;
    • Weight compatible with limits imposed by the MRI scanner table.

STEP 2:

  • Patient registration must not exceed 12 weeks from time of esophagectomy.
  • Patients must have a post-operative ECOG performance status of 0-2
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • AST (SGOT)/ ALT (SGPT) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical computed tomography (CT) scan. Patients must also have a negative surgical margin (R0 resection).
  • Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as 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 will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from nivolumab or ipilimumab. All females of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to registration to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy.
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine, Radiation
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Location Contacts
Mayo Clinic — Rochester, MN