Health Studies MN

Within 


Search Results

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.

3159 Study Matches

Sorting by: Relevance Distance

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
Show full eligibility criteria
Hide eligibility criteria

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
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

NOX66-004, A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2

A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma

Scott Okuno
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306447-P01-RST
21-011924
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Adult patients with a histologically confirmed diagnosis of metastatic or recurrent
soft tissue sarcoma

- Patients for whom treatment with doxorubicin is considered to be appropriate

- Left ventricular ejection fraction ≥ 50%

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Disease that is considered measurable according to RECIST v1.1.


Exclusion Criteria:


- Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal
tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma,
and desmoid tumor

- Untreated metastases to the central nervous system

- Received previous treatment with anthracyclines and anthracenediones

- Previous radiation therapy to the mediastinal or pericardial area

- A known allergy to any of the treatment components

- Patient not willing to use suppositories

- Patients with a colostomy

- Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis

- Patients for whom administration of the suppositories are likely to cause pain (e.g.,
inflamed hemorrhoids, fissures, or lesions of the anus or rectum)

- Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or
alternating irritable bowel disease

- Patients with inflammatory bowel disease

- Previous treatment with an investigational agent or the non-approved use of a drug or
device within 4 weeks before study entry

- Uncontrolled diabetes mellitus

- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4,
CYP2D6 or P- glycoprotein (P- gp)

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Hepatic Steatosis Quantification with Ultrasound

A Study Evaluating the Effectiveness of Ultrasound Imaging for Liver Steatosis Staging

Shigao Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306462-H01-RST
21-011918
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Patients with clinically indicated MRI-PDFF (Proton Density Fat Fraction) for liver imaging.

Exclusion Criteria

  • Individuals < 18 years old.
  • Vulnerable subjects such as:
    • Prisoners;
    • Adults lacking capacity to consent.
  • Patients with liver iron overload, which may confound PDFF measurements.

Eligibility last updated 11/12/21. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
2021-306482-P01-RST
21-012020
Show full eligibility criteria
Hide eligibility criteria

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.

Device
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Autosomal Dominant Hypocalcemia Types 1 and 2 (ADH1/2) Disease Monitoring Study (DMS) (CLARIFY)

CLARIFY: ADH1 and ADH2 Disease Monitoring Study (DMS)

Peter Tebben
All
up to 90 years old
This study is NOT accepting healthy volunteers
2021-306497-P01-RST
21-012116
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Participants from birth to age 90 years must meet all the following criteria for inclusion during screening:
    • Have a documented activating variant of the CASR gene for ADH1 or documented activating variant of the GNA11 gene for ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment
      • Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.
    • Be willing and able to provide informed consent or assent after the nature of the study has been explained, and prior to any research-related procedures.
    • Be willing to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available.
    • Be willing and able to comply with the study visit schedule and study procedures.


Exclusion Criteria:

  • Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures.
  • Enrollment in an ADH1/2 interventional clinical study at the time of DMS Screening visit or at any point during the DMS.

Eligibility last updated 8/4/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Intestinal Permeability in Patients with Active Inflammatory Bowel Disease: Towards Development of a Non-invasive, Inexpensive Test to Detect Intestinal Inflammation

Developing a Non-invasive Test to Detect Intestinal Inflammation in Active Inflammatory Bowel Disease

Michael Camilleri
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306555-H01-RST
21-012369
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

  • Active disease as defined by SES-CD (PMID: 15472670) > 6 (> 4 if ileal only), AND active symptoms of CD (CDAI score > 220) or full Mayo score for UC ≥ 2 with an endoscopy score of ≥2 (PMID: 31272578) within the past 4-6 weeks. 9,10,11,12,13
  • Remission as defined by SES-CD 0-2 and CDAI score ≤150, or full Mayo score for UC 0-2 with endoscopy score < 2.9,10,11,12,13.
  • Ability to give informed consent.

Healthy Adults

  • ≥ 18 years age.
  • No underlying medical illnesses that could serve as confounders with the objectives of the study.  


Exclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

  • Less than 18 years of age.
  • Prior history gastrointestinal surgeries including IPAA, ileostomy and colostomy.
  • Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test.
  • Use of osmotic laxatives and unable to unwilling to stop taking one week prior to permeability test.
  • Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous two weeks and for the duration of the study.
  • Multiple dietary restrictions or unable or unwilling to alter dietary protein or dietary fiber for the permeability testing.
  • Unwilling or unable to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
  • Bowel preparation for colonoscopy must be completed more than 48 hours prior to completion of permeability test. If intestinal biopsies were performed, 7 days must pass prior to permeability testing.
  • Pregnancy or plan to become pregnant during the study time frame.
  • Vulnerable adult.

Healthy Adults 

  • Less than 18 years of age.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR) (AMSCAR)

Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients

Timucin Taner
All
18 years to 70 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-306557-H01-RST
21-012522
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Able to understand and provide informed consent.
  • Between 18 and 70 years of age at the time of consent.
  • Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.
  • Both sexes and all genders will be eligible for the study.

Clinical

Inclusion Criteria:

  • Stable renal function:
    • Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the serum creatine prior to the biopsy (must be within 3 months of the biopsy);
    • Estimated eGFR > 30 ml/min by MDRD.

Histologic Criteria for Eligibility:

  • ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular capillaritis (ptc) (g:1 or 2; ptc:1 or 2).
  • Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2); intimal arteritis (v) (v: 1 or 2).
  • Mixed ABMR and cellular rejection.


Exclusion Criteria:

  • Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening.
  • History of post-transplant intervention for obstructive uropathy.
  • One or more of the following laboratory values:
    • Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT)  ≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0, Platelet count < 50 x 10^9/L (patients who receive a platelet transfusion to increase their platelet count will not be excluded).
  • One or more of the following parameters:
    • Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤ 90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or > 140/min.
  • Patients with the following grades/classes of vascular diseases:
    • NYHA Class 3-4 CHF;
    • Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular response, supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular fibrillation, or sick sinus syndrome;
      • Subjects with rate-controlled chronic atrial fibrillation will be allowed to participate. 
    • Cerebrovascular accident (CVA) within 90 days of screening;
    • Peripheral Arterial Disease (PAD), patients who have had prior vascular interventions for PAD in the index lower extremity.
  • Acute illness within 30 days of screening.
  • History of allergy or intolerance to iodinated contrast agents.
  • Women of childbearing potential or male subjects with female partners of childbearing potential unwilling to use an effective method of contraception during and for 12 months post-treatment.
  • History of or current evidence of alcohol abuse, illicit drug use or dependence.
  • Active COVID 19 or positive test for the SARS-CoV-2 virus.
  • History of malignancy within 5 years of enrollment. History of adequately treated in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous cell) will be permitted.
  • Serologic evidence of human immunodeficiency virus 1 or 2 infection.
  • Epstein Barr Virus (EBV) sero-negativity (EBV naïve).
  • Cytomegalovirus (CMV) sero-negativity.
  • Active post-transplant opportunistic infections at the time of screening (CMV, BK virus, polyoma virus, EBV).
  • Active Hepatitis B or Hepatitis C infection (e.g., NAT positive), and/or HBV core antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV IgG positive), or those with HBV surface antibody positive but HBV core antibody negative subjects will not be excluded from the study.
  • Have received a kidney transplant from a Hepatitis C positive donor and plan to receive anti-viral treatment after transplant.
  • Any chronic condition for which anti-coagulation cannot be safely interrupted for kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall into either the high or the moderate thrombotic risk, they will be deemed to be not safe to interrupt anticoagulation:
    • High thrombotic risk:
      • Mechanical heart valve: Any mitral valve prosthesis, any caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months) stroke or transient ischemic attack;
      • Atrial Fibrillation: CHADS2 score 5-6, CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic attack, rheumatic valvular heart disease;
      • Venous thromboembolism: Recent (within 3 months) VTE, severe thrombophilia (e.g., deficiency of protein C, protein S, or antithrombin; antiphospholipid antibodies; multiple abnormalities).
    • Moderate thrombotic risk:
      • Mechanical heart valve: Bileaflet aortic valve prosthesis and 1 or more of the of following risk factors: atrial fibrillation, prior stroke or transient ischemic attack, hypertension, diabetes, congestive heart failure;
      • Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6;
      • Venous thromboembolism: VTE within the past 3 to 12 months, non-severe thrombophilia (e.g., heterozygous factor V Leiden or prothrombin gene mutation), recurrent VTE.
    • For all other subjects, anticoagulation can be safely interrupted for 3 days prior to infusion and resumed a day after the infusion.
  • Positive pregnancy test.
  • Participation in any other studies that involved investigational drugs or regimens in the preceding year.
  • Any other condition, in the investigator’s judgment, that increases the risk of A-MSC infusion or prevents safe trial participation.
  • Unwilling or unable to adhere to study requirements and procedures.
  • Per Banff criteria category 6: the presence of other changes not considered to be caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury, Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or Drug-Induced Interstitial Nephritis.

Eligibility last updated 5/10/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Developing a Cancer Distress Management Program for Liver and Biliary Cancer within a Specialized Program of Research Excellence (SPORE) (SPORE)

Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE

Shawna Ehlers
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306566-H01-RST
21-012404
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients who have received care for hepatobiliary cancer at Mayo Clinic in the past 5 years.
  • Caregiver of above patient.
  • Clinician providing care for hepatobiliary cancer patients at Mayo Clinic.
  • Member of SPORE Patient Advocacy Board.


Exclusion Criteria:
 

  • Inability to complete an English language electronic survey for any reason. Non-English speaking patients will be offered translation services when available.

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

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS Registry)

Prospective Evaluation Analysis and Kinetics Registry (PEAKS)

Abhishek Deshmukh
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306583-P01-RST
21-012967
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adults age 18 years and older.
  • Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician.
  • IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy.
  • Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures .


Exclusion Criteria:

  • Study materials not available in the subject’s preferred language.
  • Patients undergoing treatment for active concomitant ventricular arrhythmias.
  • Standard exclusions for elective sotalol use (at the time of initiation):
    • Heart rate < 40 bpm or 2nd/3rd degree AV block without pacemaker;
    • QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block);
    • Severe left ventricular hypertrophy (thickness > 1.5 cm).
  • Patients who were previously intolerant to antiarrhythmic class III therapy.
  • Patients missing key data elements in their electronic health record (for retrospective subjects only).

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Investigating the Effect of Human Umbilical Cord MSCs Derived Exosome / Extracellular Vesicle on Endogenous Neural Cells Proliferation in Rats with Spinal Cord Injury

Umbilical Cord MSC's

Mohamad Bydon
Female
18 years to 35 years old
This study is NOT accepting healthy volunteers
2021-306602-H01-RST
21-012746
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pregnant women, age 18 or older. Cord blood will not be collected from a minor.
  • Able to give verbal informed consent prior to collection of the cord.
  • Able to give written informed consent prior to collection of the cord.


Exclusion Criteria:
 

  • N/A.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

A Study to Evaluate the Effectiveness and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

Ratnasari Padang
All
35 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2021-306606-P01-RST
21-012772
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Male or female adult ≥ 35 years of age at time of screening.
  • Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by Doppler echocardiography results:
    • Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on TTE within 2 weeks prior to randomization; and
    • Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization.
  • Subject provides written informed consent prior to initiation of any study procedures.
  • Subject understands and agrees to comply with planned study procedures.


Exclusion Criteria:

  • Subject has concomitant moderate or more aortic valve regurgitation.
  • Subject has concomitant moderate or severe mitral or tricuspid valve disease.
  • Subjects has left ventricular ejection fraction < 50%.
  • Subject previous history of aortic valve surgery.
  • Subject has NYHA class III or IV heart failure.
  • Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range.
  • Subjects who cannot undergo Cardiac CT.
  • Subjects whose life expectancy is < 2 years.
  • Subjects with ESRD (End-stage Renal Disease) defined as eGFR (calculated using MDRD equation) ≤ 30 mL/min/1.73m^2 or in need of dialysis.
  • Subject has diabetes mellitus
  • Subject has history of pancreatitis.
  • Subjects who are currently taking or anticipated to take any of the following medications for the duration of the study:
    • Insulin, DPP4 inhibitor, oral hypoglycemic agent;
    • Vitamin K;
    • Bisphosphonate;
    • Any medications that impact hepatic metabolism, by way of inducing CYP3A4 system, giving rise to drug-drug interaction (with the exception of focal treatment);
    •  CYP3A4 inducer: barbiturates (phenobarbital), rifampicin/rifabutin, carbamazepine, phenytoin, primidone, St. John’s Wort, Efavirenz, griseofulvin, and chronic (> 1 month) supraphysiologic glucocorticoid use (> 7.5 mg/day prednisone or equivalent glucocorticoid dosing).
  • Subjects with history of severe allergic reaction to DPP4 inhibitors including anaphylaxis and angioedema.
  • Subjects with galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption.
  • Subjects with history of severe cerebrovascular diseases (such as cerebral infarction or transient ischemic attack), severe cardiovascular diseases (such as unstable angina, myocardial infarction and life-threatening arrhythmia) within 6 months of screening.
  • Subjects with history of malignant tumor within the past 3 years prior to Screening Visit (Visit 1) unless cure is expected.
  • Subjects with history of drug or alcohol abuse. History of cannabis/Marijuana use including recreational use in the last 6 months and an unwillingness to abstain during the course of the study.
    • Note: Alcohol abuse is a pattern of drinking that result in harm to one’s health, interpersonal relationships, or ability to work. Manifestations of alcohol abuse include the following: Failure to fulfill major responsibilities at work, school, or home, drinking in dangerous situations, such as drinking while driving or operating machinery, legal problems related to alcohol, such as being arrested for drinking while driving or for physically hurting someone while drunk and continued drinking despite ongoing relationship problems that are caused or worsened by drinking.
  • Subjects with history of medication non-compliance.
  • Pregnant or lactating women
  • Subjects who used investigational drugs or devices within 4 weeks prior to screening or investigational biologics within the last 6 months prior to screening.
  • Inability to provide informed consent or to comply with test requirements.
  • Subjects with physical (severe hepatic, cardiac, renal, pulmonary, hematological, endocrine, gastrointestinal, etc. conditions) or mental (cognitive, psychiatric, etc. conditions) conditions that may impact their ability to take part in the study.
  • Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment
  • Women of child-bearing age who are sexually active but decline to take proper contraceptive measures during the study period.
    • Note: To be eligible for the study, Women of childbearing potential (WOCBP) and Women not of childbearing potential are eligible to participate. Both women of childbearing potential and women of no childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of investigational product).
    • Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners must agree to consistently and correctly use a condom for the duration of the study and for 30 days after taking the study drug. In addition, subjects may not ova or donate sperm for the duration of the study and for 30 days after taking the last dose investigational product.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (FibroGen095)

Zephyrus II: Effectiveness and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Teng Moua
All
40 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306608-P01-RST
21-012801
Show full eligibility criteria
Hide eligibility criteria

Key

Inclusion Criteria:


1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.

2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.

3. FVCpp value >45% and <95% at Screening and Day 1.

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and
≤90%.

5. Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib)
but discontinued at least 1 week prior to screening, unless neither treatment is
available in the host country.

Key
Exclusion Criteria:


1. Previous exposure to pamrevlumab.

2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.

3. Female participants who are pregnant or nursing.

4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
study.

5. Interstitial lung disease other than IPF.

6. Sustained improvement in the severity of IPF.

7. Other types of respiratory diseases that, in the opinion of the Investigator, would
impact the primary protocol endpoint or otherwise preclude participation in the study,
including diseases of the airways, lung parenchyma, pleural space, mediastinum,
diaphragm, or chest wall.

8. Certain medical conditions, that, in the opinion of the Investigator, would impact the
primary protocol endpoint or otherwise preclude participation in the study (such as,
myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or
cancers).

9. Acute IPF exacerbation during Screening or Randomization including hospitalization due
to acute IPF exacerbation within 4 weeks prior to or during screening.

10. Recent use of any investigational drugs or unapproved therapies, or participation in
any clinical trial.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient.

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

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

Biologic/Vaccine, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults. A Double Blind Randomized Clinical Trial

Effects of Energy Drinks on Sleep and Cardiovascular Health

Anna Svatikova
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306640-H01-RST
21-012902
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adults 18 years of age and older.
  • Healthy subjects without known cardiovascular disease and thyroid disease.
  • Subjects who are on no medications (except oral contraceptive pill).
  • Nonsmokers.
  • No prior history of caffeine sensitivity or allergy.


Exclusion Criteria:
           

  • Subjects with known cardiovascular or thyroid disease.
  • Subjects currently taking medications other than oral contraceptive pill.
  • Smokers.
  • Prior history of caffeine sensitivity or allergy.
  • Pregnancy.
      •  
  • Subjects who regularly consume energy drinks.
  • Subjects who typically go to sleep after midnight.
  • Subjects who traveled across 2 time zones in the last 7 days.
  • Shift workers.
  • Subjects who have or are suspected to have sleep apnea.
  • Subjects who have a body mass index > 35kg/m^2.

Eligibility last updated 3/7/22. Questions regarding updates should be directed to the study team contact.

 

Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Double-Blind, Randomized, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF-COMFORT)

Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Vivek Iyer
All
40 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306667-P01-RST
22-002204
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Diagnosis of IPF established according to the 2018 joint ATS/ERS/JRS/ALAT Clinical
Practice Guideline

- FEV1/FVC ratio ≥0.65 at the screening visit

- Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25%
within 12 months of the screening visit

- Arterial oxygen saturation on room air or oxygen ≥90% at Screening

- Life expectancy of at least 12 months

- Cough that is attributed to IPF, which has not responded to anti-tussive treatment,
and which has been present for at least 8 weeks prior to Screening

- Mean daily IPF Coughing Severity Scale score ≥5.0 during the second week of the
baseline assessment period


Exclusion Criteria:


- Recent respiratory tract infection (<8 weeks prior to Screening)

- Recent acute exacerbation of IPF (<8 weeks prior to Screening)

- Current smokers or ex-smokers with <6 months' abstinence prior to Screening

- Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is
greater than the extent of fibrosis according to the reported results of the most
recent scan

- Mean early morning cough scale score ≥5.0 and rest of the day cough scale score <5
during the second week of the baseline assessment period (assessed at Visit 2)

- Cough that is predominantly productive in nature and attributable to lung pathology
such as chronic bronchitis or bronchiectasis

Drug, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People with Severe Von Willebrand Disease (VWD) (ATHN 9)

ATHN 9: Severe Von Willebrand Disease Natural History Study

Rajiv Pruthi
All
Not specified
This study is NOT accepting healthy volunteers
2021-306671-P01-RST
21-013017
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Males and females.
  • Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPIbM or VWF:Ag ≤ 30% of pooled normal control plasma on more than one occasion.
  • Participants with clinically severe VWD as defined by VWF:RCo or VWF:Ag ≤ 40% of normal with severe bleeding phenotype defined as requiring use of recurrent factor concentrates.
  • Co-enrollment in the ATHN dataset.

Exclusion Criteria

  • Diagnosis of platelet-type VWD;
  • Diagnosis of acquired VWD (clinical diagnosis made by the hemophilia health care provider, typically based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).

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

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pregnant patients seen for prenatal care in Rochester and deliver within the Mayo Clinic Health Systems
  • Ability to provide informed written consent
  • Known paternity for pregnancy
  • Singleton pregnancies


Exclusion Criteria:
 

  • Mothers < 18 years of age
  • Multiple fetuses

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.

Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open Label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Eva Carmona Porquera
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306733-P01-RST
21-013316
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Male or female age ≥ 18 years.
  • Is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form.
  • Have a ≥ 6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
  • Have high-resolution computed tomography (HRCT) and PET scan consistent with active pulmonary sarcoidosis of the lung parenchyma confirmed by central read.
  • Have FVCp ≥ 50% to ≤ 90% and DLCO ≥ 50%.
  • If receiving prednisone (or equivalent), dose must have been ≤25 mg, and dose must have been stable for at least 4 weeks prior to randomization.
  • Symptomatic as indicated by mMRC Dyspnea scale >1 (i.e., Grade 2 or more) in the prior year.
  • If receiving methotrexate and/or other immunosuppressive therapy (IST) dose must have been stable for ≥ 3 months prior to randomization.
  • Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) throughout the study, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:
    • Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization;
    • Postmenopausal defined as 12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age > 40 years) a documented serum FSH level must be ≥ 30 mIU/mL;
    • Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to the start of dosing, throughout the study, and for 4 months following the last dose of study drug.
  • Males who are sexually active must agree to use one of the allowed BC methods. Male subjects must also agree to sufficiently minimize the risk of pregnancy throughout study participation (and for 4 months following the last dose of study drug).
  • Body Mass Index (BMI) 18 to 40 kg/m^2 at screening.
  • Subjects must agree to steroid taper, and cessation of their IST therapy at randomization.
  • Completion of vaccination for COVID-19 at least 2 weeks prior to randomization.

Exlusion Criteria:

  • Hospitalized for any respiratory illness ≤ 30 days prior to screening.
  • Prednisone dose > 25 mg/day at any time in the previous 4 weeks.
  • ≥ 20% fibrosis as indicated on CT-scan that has been confirmed by central read prior to randomization.
  • eGFR ≤30 mL/min/1.73 m^2 (MDRD equation) or requiring hemofiltration or dialysis.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3 × upper limit of normal range (ULN).
  • Platelet count <100,000 per mm^3.
  • Hemoglobin ≤ 9.5 g/dL.
  • Absolute neutrophil count < 1,000 per mm^3.
  • History of known anti-GM-CSF autoAb or tests positive at screening, or history of pulmonary alveolar proteinosis (PAP).
  • Use of biologic — approved or investigational agents (e.g., anti-TNFα, anti-IL-1, anti-IL-6, anti-IL-17, anti-IL-12/23 or specific anti-IL-23 inhibitors, anti CD20, anti-IL-18) within the 6 months prior to screening.
  • Prior use of immunoglobulin within 6 months prior to screening.
  • Prior use of any investigational immunomodulator (e.g., NRP2 modulator) within 6 months of screening.
  • Prior use of any JAK inhibitor within 3 months of screening.
  • Participation in another interventional clinical trial within 6 months prior to screening.
  • Known left ventricular ejection fraction (LVEF) ≤30% or NYHA class III or IV heart failure.
  • ECG abnormalities that warrant further investigation, in the opinion of the Investigator.
  • Pulmonary hypertension requiring therapy.
  • Systolic blood pressure (SBP)  < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg.
  • Known COVID-19 infection within 3 months prior to screening.
  • Have received any live virus or bacterial vaccinations < 3 months of screening. Age-appropriate non-live vaccinations may be administered during screening so long as the last vaccine dose is administered at least 2 weeks prior to planned randomization.
  • Any infection requiring antibiotics or pulse of OCS where completion of treatment has been < 30 days prior to screening.
  • History of 3 or more lower respiratory tract infections requiring anti-microbial therapy in the past year.
  • Any history of mycetoma or fungal respiratory infection.
  • Requirement for supplemental oxygen at rest.
  • Prior history of, or likely to have any organ transplantation during study including OLE.
  • History of smoking (or vaping) in the prior year or current use. Occasional use (defined as less frequently than once per month) is allowable, though subjects should be counseled to remain abstinent during the study including OLE.
  • Other significant pulmonary disease likely to interfere with the primary endpoint, in the opinion of the Investigator.
  • Other autoimmune disease likely to require therapy during the study.
  • Symptoms and features of extra-PS that may warrant treatment in addition to that required for lung involvement.
  • Significant ischemic heart disease (i.e., myocardial infarction within 6 months, unstable angina or PCTA/stent within 1 month or planned intervention during study).
  • Known or suspected active and untreated/inadequately treated tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B or C infection. Subjects with latent TB may be enrolled if anti-TB therapy is commenced prior to randomization.
  • For women: pregnant or planning to become pregnant during the study or currently breastfeeding.
  • Prior history of any malignancy or lymphoproliferative disorder (not including fully resected basal cell carcinoma of the skin, fully resected intra-epithelial neoplasia or carcinoma in situ) within the past 5 years.

Eligibility last updated 12/23/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Remote Monitoring for Lifestyle Changes in Patients with Lung Cancer Related Fatigue

Roberto Benzo
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306737-P01-RST
21-013228
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosed with advanced NSCLC being treated with any line of non-curative intent, systemic treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
  • The ability to read and respond to questions in English or Spanish.
  • Receiving primary cancer care at Mayo Clinic, Rochester or MCHS.
  • Life expectancy at least 6 months.


Exclusion Criteria:

  • Individuals < 18 years.
  • Patients wioth cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

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

Behavioral
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

Diagnostic Test
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Screening for High Frequency Malignant Disease (SHIELD) (SHIELD)

Screening for High Frequency Malignant Disease

David Midthun
All
50 years to 80 years old
This study is NOT accepting healthy volunteers
2021-306760-P01-RST
22-000772
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Subject aged 50-80 years at time of consent.
  • Increased risk of lung cancer defined by having at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
  • Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening.
  • Willing to consent to the investigational blood draw during index low dose CT scan screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
  • Willing to consent to a 1-year, 2-year and additional follow-up per protocol.


Exclusion Criteria:

  • Subject has not smoked for 15 or more years.
  • Subject has less than 20 pack-year smoking history.
  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
  • Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer.
  • Preexisting or history of lung cancer.
  • Previously diagnosed high-risk lung lesion.
  • History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
  • Currently receiving treatment for pneumonia.
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  • Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
  • Additional cohorts: inclusion and exclusion criteria will be specified for each cohort as appendixes.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

Behavioral
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN