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.

3292 Study Matches

Sorting by: Relevance Distance

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

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

Location Contacts
Mayo Clinic — Rochester, MN

An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept (Orencia) in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (LIMIT JIA)

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

Matthew Basiaga
All
2 years to 16.5 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306351-P01-RST
21-011389
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


1. Age ≥ 2 years old and ≤16.5 years old

2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months

3. Arthritis affecting ≤4 joints between disease onset and randomization

4. Enrollment in the CARRA Registry

5. Participants of childbearing potential must agree to remain abstinent or agree to use
an effective and medically acceptable form of birth control from the time of written
or verbal assent to at least 66 days after taking the last dose of study drug.

6. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent
to participate in the Limit-JIA study.


Exclusion Criteria:


The presence of any of the following will exclude a study participant from inclusion in the
study:

1. 1. Systemic JIA as defined by 2004 ILAR criteria1

2. Sacroiliitis (clinical or radiographic)

3. Inflammatory bowel disease (IBD)

4. History of psoriasis or currently active psoriasis

5. History of uveitis or currently active uveitis

6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the
following: DMARD or biologic medication)

7. Current or previous (within 30 days of enrollment) treatment with systemic
glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)

8. History of active or chronic liver disease

9. Chronic or acute renal disorder

10. AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5
mg/dL or any other laboratory abnormality considered by the examining physician to be
clinically significant within 2 months of the randomization visit

11. Presence of any medical or psychological condition or laboratory result which would
make the participant, in the opinion of the investigator, unsuitable for the study

12. Participation in another concurrent clinical interventional study within 30 days of
randomization

13. Known positive human immunodeficiency virus (HIV)

14. Received a live virus vaccine within 1 month of the baseline visit

15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold
TB

16. Pregnant, breast feeding, or planned breast feeding during the study duration

17. Planned transfer to non-participating pediatric rheumatology center or adult
rheumatologist in the next 12 months

18. Active malignancy of any type or history of malignancy

19. Chronic or active infection or any major episode of infection requiring
hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral
antibiotics within 14 days prior to screening

20. Primary language other than English or Spanish

21. Positive for Hepatitis B surface antigen or core antibody

22. <10 Kg in weight

23. If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19
exposure at screening, it is recommended that the site follow CDC guidance regarding
testing and quarantine requirements. The subject can be re-screened when there is no
longer concern for active infection. A subject with a positive COVID -19 test may be
re-screened.

Drug, Other
Arthritis, Juvenile arthritis, Juvenile idiopathic arthritis
Juvenile idiopathic arthritis, extended oligoarthritis, Juvenile idiopathic arthritis, oligoarthritis, Musculoskeletal system
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Multi-omics and Virtual Phenotyping in patients with Obesity: Multi-center Biobank and Outcomes Registry

Obesity Phenotype Biobank

Maria Hurtado Andrade
All
21 years and over
This study is NOT accepting healthy volunteers
2021-306361-H01-RST
21-011737
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients 21 years or older with obesity (for adults BMI ≥ 30kg/m^2.).
  • Individuals undergoing an evaluation for weight loss interventions (e.g., diet, medication, bariatric endoscopic procedure, or surgery).


Exclusion Criteria:

  • Principal investigator discretion.
  • Individuals who are unable to sign consent (e.g., those declared legally incompetent).
  • Patients without a tracking device (smart phone or wearable device).

Eligibility last updated 11/8/21. 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

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Phase 4
This study is NOT accepting healthy volunteers
2021-306381-P01-RST
21-011543
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Understanding the Baseball Swing Through Motion Capture (MoCap)

A Study of the Baseball Swing Through Motion Capture

Christopher Camp
Male
14 years to 30 years old
This study is NOT accepting healthy volunteers
2021-306490-H01-RST
21-012145
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Age 15-30 years, inclusive.
  • Male gender.
  • Active participation in collegiate level baseball as a batter. 
  • No current musculoskeletal complaints for which the subject is being treated.
  • Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
  • Willingness to participate in the study
  • The testing will be completed at the Mayo Clinic Motion Analysis Laboratory utilizing currently available equipment and standardized techniques for motion capture.


Exclusion Criteria:
 

  • Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
  • History of fracture, dislocation, subluxation, or separation affecting the cervical spine, thoracic spine, rib cage, elbow, or either shoulder girdle.
  • History of rotator cuff injury, elbow injury, or shoulder instability for which the subject has been evaluated and/or treated in the past 12 months.
  • History of dominant side shoulder or elbow surgery.
  • Known neurological, visual, or vestibular disease affecting balance or coordination
  • Congenital deformity of the neck, upper extremity, or lower extremity.
  • Congenital or acquired scoliosis or significant thoracic kyphosis (> 30 degrees).
  • History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

Eligibility last updated 11/18/21. 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

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.

Autosomal dominant hypocalcemia
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

CAAA617C12301, PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PSMAddition)

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

Brian Costello
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306540-P01-RST
22-000515
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Patients must be adults ≥ 18 years of age.
  • Patients must have an ECOG performance status of 0 to 2.
  • Patients must have a life expectancy > 9 months as determined by the study investigator.
  • Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site).
  • Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader.
  • Patients must have documented metastatic disease to bone and/or soft tissue/visceral sites documented in one of the following manners within 28 days prior randomization:
    • Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans; OR
    • Lymph node metastases of any size or distribution. If lymph nodes are the only site of metastasis, then at least one must be at least 1.5 cm in short axis AND outside of the pelvis; OR
    • Visceral metastases of any size or distribution. If a subject has a history of visceral metastases at any time prior to registration, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes).
  • Patients must have adequate organ function:
    • Bone marrow reserve ANC ≥ 1.5 x 10^9/L;
    • Platelets ≥100 x 10^9/L;
    • Hemoglobin ≥ 9 g/dL;
    • Hepatic Total bilirubin ≤ 2 x the institutional upper limit of normal (ULN);
    • For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases;
    • Renal eGFR ≥ 50 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation.
  • Albumin ≥ 2.5 g/dL.
  • Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial.
  • Patients must be:
    • Treatment naïve OR minimally treated with:
    • Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of therapy.
    • If received, prior LHRH agonist/antagonist use in the adjuvant/neo-adjuvant setting must have been discontinued > 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy;
    • Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No exposure for earlier stages of prostate cancer is allowed.


Exclusion Criteria:

  • Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy.
  • Any systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria 11), including chemotherapy, PARP inhibitors, immunotherapy or biological therapy (including monoclonal antibodies).
  • Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  • Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  • Ongoing participation in any other clinical trial.
  • Use of other investigational drugs within 30 days prior to day of randomization.
  • Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
  • Transfusion for the sole purpose of making a subject eligible for study inclusion.
  • Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (magnetic resonance imaging (MRI) preferred or CT with contrast).
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.
    • Note: Patients with a history of CNS metastases that have received prior therapy and are neurologically stable, asymptomatic and not receiving corticosteroids are allowed.
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance) and had no symptoms for at least 28 days before the first dose of study medication.
  • No active clinically significant cardiac disease defined as any of the following:
    • NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45% with improvement in symptoms to class < 3;
    • History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as:
    • Concomitant clinically significant cardiac arrhythmias; e.g., sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block);
    • History of familial long QT syndrome or known family history of Torsades de Pointes;
    • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature .
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Any condition that precludes raised arms position.
  • Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 6 months after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

Eligibility last updated 1/17/22. 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

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.

- 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.

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:

o 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 109/L (patients who receive a platelet transfusion to increase
their platelet count will not be excluded).

- One or more of the following parameters:

o 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

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

Eligibility last updated 12/13/22. 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:

  • Healthy, full-term women (18-35 years old) who underwent elective cesarean section.
  • Free of Human Immunodeficiency Virus (HIV) types 1 & 2, Hepatitis A, B, and C, Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhea, and HTLV 1 & 2.
  • Able to give written informed consent prior to collection of the cord.


Exclusion Criteria:
 

  • On chronic, immunosuppressive transplant therapy or having a chronic, immuno-suppressive state, including use of systemic steroids/corticosteroids.
  • Takin anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, Hepatitis, and syphilis.
  • History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.

Eligibility last updated 12/16/22. 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

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 Delaying Progression of Mild or Moderate Calcific Aortic Stenosis (EVOID-AS trial)

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