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3292 Study Matches

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A051902: A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Nabila Bennani
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306080-P01-RST
21-010262
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Inclusion Criteria:

  • Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma.
  • Patients will be stratified by presence or absence of TFH phenotype (i.e., diagnosis of AITL, TFH-PTCL, follicular T-cell lymphoma) based on local review of pathology. Determination of TFH phenotype can be defined by expression of two or more of the following markers CD10, BCL6, CXCL13, ICOS, and PD1 by immunohistochemistry.
  • Measurable disease as defined by the Lugano criteria.
  • No prior systemic therapy for lymphoma (excluding corticosteroids).
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Platelet count ≥ 75,000/mm^3 (≥ 50,000/mm^3 if secondary to bone marrow involvement from lymphoma per investigator assessment; the first 12 patients on each arm of the study must have platelets ≥ 75,000/mm^3 regardless of bone marrow involvement).
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN) * Except in subjects with documented liver involvement by lymphoma.
  • Calculated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula.
  • Total bilirubin ≤ 2.0 x ULN * Except in cases of Gilbert's Syndrome or documented liver or pancreatic involvement by lymphoma.
  • Archival tissue must be available for submission.
  • No active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Those who are seropositive (e.g., hepatitis B core antibody [Ab] positive) are permitted if they are negative by polymerase chain reaction (PCR). Those who are seropositive for hepatitis B and are negative for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) by PCR must receive concomitant hepatitis B directed antiviral therapy. Those who have hepatitis C Ab positivity who have completed curative therapy for hepatitis C with negative hepatitis C PCR are eligible.
  • Patients with history of HIV are eligible if they have an undetectable viral load for at least 6 months.
  • No active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment).
  • Patients with Epstein-Barr virus (EBV) viremia related to their lymphoma are permitted.
  • Patients must have documented left ventricular ejection fraction of ≥ 45%.
  • No significant active cardiac disease within the previous 6 months including: 
    • New York Heart Association (NYHA) class III or IV congestive heart failure;
    • Unstable angina or angina requiring surgical or medical intervention; and/or
    • Myocardial infarction.


Exclusion Criteria:

  • Patients with expression of CD30 in ≥ 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted.
  • Patients with a diagnosis of other PTCL subtype histologies other than those specified in the inclusion criteria are excluded including large cell transformation of mycosis fungoides.
  • Patients known to have HTLV 1/2.
  • Patients with known central nervous system involvement.
  • No concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted.
  • No contraindication to any drug in the chemotherapy regimen, including neuropathy ≥ grade 2.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

Eligibility last updated 9/30/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Analysis of Patients with Polyuria as a Manifestation of Paroxysmal Atrial Tachyarrhythmias (ATACHPOLY)

Analysis of Fast Atrial Rhythm Manifesting with Increased Urination

Allan Jaffe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306085-H01-RST
21-010267
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Inclusion Criteria:

  • Age 18 or older.
  • Patients with paroxysmal atrial tachyarrhythmias with and without polyuria as a manifestation of their tachyarrhythmia episode.
  • Documentation of their paroxysmal atrial tachyarrhythmia episode.


Exclusion Criteria:

  • Patients who are unable to manage the logistics of participating in the study (coming to Saint Mary’s Hospital ot have their blood drawn and urine sample collected during their atrial tachyarrhythmia episode).
  • Chronic kidney disease stage 4 or higher.
  • Clinical history of heart failure.

Eligibility last updated 10/1/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

James Pipe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306089-H01-RST
21-010301
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Inclusion Criteria:

  • Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.


Exclusion Criteria:

  • None.

Eligibility last updated 9/30/21. Questions regarding updates should be directed to the study team contact.

 

 

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A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

Wei Ding
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306097-P01-RST
21-013100
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Key Eligibility Criteria:

  • Provision of signed and dated written informed consent prior to any study specific procedures, sampling, or analyses.
  • Age 18 years or older.
  • Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:

Note: For R/R cohorts, patients who have only received 1 line of therapy must be otherwise ineligible for, or intolerant to, available standard-of-care options.

NHL Cohorts:

a. MZL

i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy;
ii. Active disease requiring treatment.

b. FL i. R/R follicular lymphoma (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy ii. Active disease requiring treatment.
c. DLBCL

i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy);
ii. Active disease requiring treatment.

d. Transformed indolent B-cell NHL

i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter’s transformation) are not eligible for Part 1;
ii. Active disease requiring treatment MCL Cohorts:

e. WHO-defined MCL

i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy;
ii. Requiring treatment in the opinion of the investigator.

CLL/SLL Cohorts:

f. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria (Hallek et al 2008):

i. Meeting the following sets of prior treatment criteria:

(1) For R/R cohorts (Cohorts 1B, 1C, 2C, 2D, 2E, 3A, and 4A), disease that relapsed after, or was refractory to, at least 1 prior therapy.
For the venetoclax-treated cohort (Cohort 2E): prior therapy history must include progression after a therapy containing ≥ 2 months of venetoclax treatment (monotherapy or combination).
(2) For the treatment-naïve cohorts (Cohorts 3C and 4B), patients should have no prior treatment for CLL/SLL (other than 1 aborted regimen < 2 weeks in duration and > 4 weeks before enrollment).

Note: TN CLL/SLL patients will only be enrolled at investigational sites where this is allowed by regulatory authorities/local ethics.

ii. Requiring treatment WM Cohorts:

g. WHO-defined WM (clinical and definitive histologic diagnosis)

i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy

ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström’s Macroglobulinemia (Dimopoulos et al 2014)

4. Measurable disease by computed tomography/magnetic resonance imaging, defined as:

a. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes on flow cytometry.
b. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered measurable for this study. For MCL, clonal lymphocytes measured by flow cytometry is considered measurable.
c. WM: serum IgM level > 0.5 g/dL.

Key


Exclusion Criteria:

  • Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
  • Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
  • Known central nervous system involvement by lymphoma/leukemia.
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter’s syndrome.
  • Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric antigen receptor T-cell (CAR-T) therapy unless ≥ 3 months after cell infusion.
  • Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.
  • History of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.

Eligibility last updated 9/12/22. Questions regarding updates should be directed to the study team contact.

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Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS) (FITCATS)

Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS)

Peter Amadio
All
45 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306106-H01-RST
21-010406
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Inclusion Criteria:

  • Adult men and post-menopausal women between age 45 and 80.
  • Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long, or radial border of ring finger.
  • Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
  • A clinical diagnosis of carpal tunnel syndrome.
  • Able to complete English-language questionnaires and clinical evaluations.


Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Previous carpal tunnel release on the study hand.
  • History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
  • Currently take a steroid medication either regularly or on as needed basis.
  • Currently taking warfarin (medication can be safely held during the following times:
    • Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
    • Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30).
  • Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases).
  • Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period then they will be removed from the study primarily due to risk of drug-drug interaction.
  • Any of the following clinical diagnoses or conditions:
    • Cervical radiculopathy; 
    • Renal failure (see below);
    • Liver disease (see below);
    • Taking warfarin;
    • Peripheral nerve disease;
    • Uncontrolled diabetes (see below); or
    • Other metabolic disorder (as per clinical judgement).
  • The following laboratory tests as indicated or as per clinical judgement:
    • fasting plasma glucose > 200 as a marker of poor diabetic control;
    • CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease;
    • AST > 100 as a marker of liver disease;
    • Bilirubin > 2.0 as a marker of liver disease;
    • Cystatin c > 3 as a marker of advanced kidney disease;
    • A1c > 8 as a marker of poor diabetic control;
    • CRP > 10 as a marker of systemic inflammation;
    • ESR > 25 as a marker of systemic inflammation.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Women of child-bearing potential.

Eligibility last updated 2/25/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase 3, Multicenter, Prospective, Randomized, Double-blind, Efficacy and Safety Study of Rezafungin for Injection Versus the Standard Antimicrobial Regimen for the Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)

Paschalis Vergidis
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306121-P01-RST
21-012795
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Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Males or females, ≥ 18 years of age.
  • Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  • Diagnosed with 1 of the following underlying diseases:
    • Refractory anemia;
    • Refractory anemia with ringed sideroblasts;
    • Refractory cytopenia with multilineage dysplasia;
    • Refractory cytopenia with multilineage dysplasia and ringed sideroblasts;
    • Refractory anemia with excess blasts
      •1 (5-10% blasts);
    • Refractory anemia with excess blasts
      •2 (10-20% blasts);
    • Myelodysplastic syndrome, unclassified;
    • Myelodysplastic syndrome associated with isolated del (5q);
    • Chronic myelomonocytic leukemia;
    • Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant;
    • Aplastic anemia;
    • Primary or secondary myelofibrosis.
  • Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
  • Acute lymphoblastic leukemia, in first or second complete remission.
  • Acute undifferentiated leukemia in first or second remission.
  • Acute biphenotypic leukemia in first or second complete remission.
  • Chronic myelogenous leukemia in either chronic or accelerated phase.
  • One of the following myelodysplastic syndrome(s) defined by the following:
    • Receiving myeloablative or reduced-intensity conditioning regimens.
  • Adequate renal and hepatic function, within 6 weeks of initiation of conditioning, as measured by:
    • Hepatic (within 72 hours of Day 0): alanine aminotransferase;
    • Renal (within 72 hours of Day 0): Serum creatinine within normal range for age or if serum creatinine above ULN range for age, a creatinine clearance [CrCl]) ≥60 mL/min.;
    • Baseline blood samples drawn for serum Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 14 days before randomization, with results available prior to randomization;
    • Baseline Toxoplasma serologies available within 6 weeks prior to randomization;
    • Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency testing with no evidence of G6PD deficiency performed within 6 weeks prior to randomization.
  • Female subjects of child-bearing potential < 2 years post-menopausal must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.


Exclusion Criteria:

  • Diagnosis of AML not in morphological remission.
  • Diagnosis of chemotherapy-resistant lymphoma.
  • Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening.
  • Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤ 40%, LVEF > 40% but fails to improve with exercise, or shortening fraction ≤ 26%.
  • Personal or family history of Long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected (QTc) interval (> 470 msec in males and > 480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, or quinidine.
  • Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin), forced expiratory volume 1, forced vital capacity ≤ 45% of predicted value, or O2 saturation ≤ 85% on room air.
  • Suspected or documented PCP within 2 years of screening.
  • Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (≥ 80 pg/mL).
  • Receipt of previous allogeneic BMT.
  • Planned receipt of cord blood for transplantation.
  • Planned peripheral blood or marrow autograft.
  • Underlying diagnosis of multiple myeloma.
  • Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per NCI CTCAE version 5.0.
  • History of severe ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease).
  • Planned or ongoing therapy at screening with a known neurotoxic medication for a complete list of prohibited neurotoxic medications).
  • Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
  • Known hypersensitivity or inability to receive TMP/SMX or any of its excipients.
  • Recent use of an investigational medicinal product within 28 days of the first dose of prophylactic study drug or presence of an investigational device at the time of screening.
  • Known infection with HIV.
  • Pregnant or lactating females.
  • The Principal Investigator (PI) determines that the subject should not participate in the study.
  • Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).

Eligibility last updated 10/5/21. Questions regarding updates should be directed to the study team contact.

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A PhAse 1a/b, Dose finding, open-label study to eValuate sAfety and toxicity, of iNtravesiCal instillation of TARA-002 in adults with high-gradE non-muscle invasive blaDder cancer (ADVANCED-1)

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade, Non-muscle Invasive Bladder Cancer

Paras Shah
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306123-P01-RST
22-000182
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Inclusion Criteria:


- Male or female subjects 18 years of age or older at the time of signing the informed
consent

- Subjects who have voluntarily given written informed consent after the nature of the
study has been explained according to applicable requirements prior to study entry

- Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with
concomitant Ta) urothelial cell carcinoma of the bladder on central review

- Subjects who are treatment naïve, are unable to obtain intravesical BCG for the
treatment of NMIBC, have received at least one dose of intravesical BCG, or at least
one dose of intravesical chemotherapy


Exclusion Criteria:


- Penicillin allergy (subjects with a questionable history of allergy to penicillin or
no history of penicillin use will undergo penicillin blood allergy testing prior to
inclusion in the study)

- Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or
histological variants including plasmacytoid, sarcomatoid, or squamous components
according to central review

- Concomitant prostatic or upper tract urothelial involvement, per Investigator's
assessment

- Nodal involvement or metastatic disease that existed at any time (past or present
disease)

- Bladder cancer stage ≥ T1 within the last 36 months according to central histology
review

- Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.

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
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A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer (PRIME)

Prostate Imaging Using MRI +/- Contrast Enhancement

Lance Mynderse
Male
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306129-P01-RST
21-011273
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Inclusion Criteria:

  • Men at least 18 years of age referred with clinical suspicion of prostate cancer.
  • Serum PSA ≤ 20ng/ml.
  • Fit to undergo all procedures listed in protocol.
  • Able to provide written informed consent.


Exclusion Criteria:

  • Prior prostate biopsy.
  • Prior treatment for prostate cancer.
  • Prior prostate MRI on a previous encounter.
  • Contraindication to MRI.
  • Contraindication to prostate biopsy.
  • Unfit to undergo any procedures listed in protocol.

Eligibility last updated 10/5/21. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans (FOODPRINT)

Studying the Hedonic and Homeostatic Regulation of Food Intake using Functional MRI

Andres Acosta
All
21 years to 50 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306140-P01-RST
21-010514
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Inclusion Criteria:

  • BMI 18-25 kg/m^2.
  • Age > 21 and < 50 years.
  • Weight stable for 3 months prior to study entry.
  • For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
  • Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures.
  • Ability to perform light to moderate physical activity.


Exclusion Criteria:

  • Any contraindication for MRI scanning.
  • Any history of childhood (> 95th percentile) or adult obesity (BMI >30 kg/m^2).
  • Claustrophobia.
  • High intensity training or physical activity.
  • Any contraindication for intragastric balloon insertion.
  • Any allergies to the study meals.
  • Any history of eating disorder.
  • Any substance abuse disorder (including alcohol and tobacco).
  • Any history of psychiatric disorders.
  • Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
  • Pregnancy or nursing.
  • Any history of bariatric surgery or endoscopic bariatric procedure.
  • Use of any medication or supplement that alters appetite.
  • Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

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

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A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) (AVTX-803)

A Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)

Eva Morava-Kozicz
All
6 months to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306143-P01-RST
21-010539
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Inclusion Criteria:


- Subject must be between 6 months and 75 years old

- Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

- Subject has a documented history of Lewis antigen deficiency

- Subject has a history of recurrent infections, opportunistic infections or infections
that did not respond well to standard of care treatment

- Subject or parent (for subjects under legal age for consent) has provided written
informed consent for this study. Additionally, written informed assent has been
provided, as appropriate, for minors of older age, per local institutional review
board (IRB)/ethics committee (EC) policy and requirements

- Subject is willing and able to comply with the protocol

- Women of childbearing potential (WOCBP) meeting the criteria below:

1. Non-lactating and has a negative pregnancy test at screening -AND-

2. Uses an acceptable double-barrier method of contraception as determined by the
investigator or sub-investigator for the duration of the study and 30 days
following the last dose of study drug.

- Male subjects must agree to use an acceptable double-barrier method of contraception
with their partner as determined by the investigator or sub-investigator for the
duration of the study and 30 days following the last dose of study drug.


Exclusion Criteria:


- Subject has severe anemia defined as hemoglobin <8.0 g/dL (<4.9 mmol/L)

- Subject has impaired renal function as defined by an eGFR <90 mL/min

- Subject has a total absence of fucosylation on red blood cells and the presence of
anti-H antigen

- Subject has known or suspected intolerance or hypersensitivity to fucose or any
ingredients of the investigational product

- In the investigator's opinion, subject has a history of failure to respond to fucose
at adequate dosing

- In the investigator's opinion, subject is not able or not willing to comply with the
study requirements.

- Subject is pregnant

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

Drug
Leukocyte adhesion deficiency - type 2, fucose
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ASCEND-ARDS in Children and ECMO Initiation Strategies Impact on Neuro-Development

ARDS in Children and ECMO Impact on Neuro-Development (ASCEND)

Jeffrey Weatherhead
All
14 days to 17 years old
This study is NOT accepting healthy volunteers
2021-306154-P01-RST
21-010577
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Inclusion Criteria:

  • Children aged 14 days
    •17 years.
  • At least moderate PARDS, bilateral lung disease, intubated within four days of severe PARDS and no exclusion criteria.


Exclusion Criteria:

  • Children will be excluded if they have any of the following at the start of mechanical ventilation: perinatal related lung disease, congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis, respiratory failure explained by cardiac failure or fluid overload, cyanotic heart disease, cardiomyopathy, unilateral lung disease, primary pulmonary hypertension, status asthmaticus (patient with a severe asthma exacerbation. A previous history of asthma or the use of bronchodilators is NOT an exclusion if the primary disease process is not considered to be obstructive airway disease), obstructive airway disease (e.g., severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 < 0.30 and/or evidence of increased resistance visible on the flow – time scalar and/or presence of intrinsic PEEP),  bronchiolitis obliterans, post Hematopoietic Stem Cell Transplant, post lung transplant, home ventilator (including noninvasive) dependent, neuromuscular respiratory failure, critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass), facial surgery or trauma in previous 15 days, head trauma, intracranial bleeding, unstable spine, femur or pelvic fractures, acute abdominal process/open abdomen, supported on ECMO, previously enrolled in current study, family/medical team deciding not to provide full support, enrolled in any other critical care interventional clinical trial concurrently and known pregnancy.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

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Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis (APPLe)

Advancing Prevention of Pulmonary Fibrosis

Teng Moua
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306157-P01-RST
21-010596
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Inclusion Criteria:

  • Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP).
  • Age at least 40 years old and younger than 75 years old.


Exclusion Criteria:

  • Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent.
  • Other genetic diseases associated with interstitial lung disease.
  • Pregnant women.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

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Investigation of Accuracy and Reliability of Tablet/iPhone-based Visual Acuity Test

Vision Testing Using iPad/iPhone

Cheryl Khanna
All
18 years and over
Phase 3, Feasibility
This study is NOT accepting healthy volunteers
2021-306164-P01-RST
21-010653
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Inclusion Criteria:

  • 100 subjects > 18 (200 eyes) with visual acuity at any level.

Exclusion Criteria:

  • Patients with no ability to sign the consent forms with no LAR.
  • Subjects with limited comprehension of English.

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

 

 

 

Diagnostic Test, Device
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A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI) (iTBS rTMS in MCI)

iTBS rTMS in Mild Cognitive Impairment

Maria Lapid
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2021-306168-H01-RST
21-010661
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Inclusion Criteria:


- Must speak English fluently

- Diagnosis of MCI as defined by:

- Clinical diagnosis by a neurologist

- Neuropsychological testing support of MCI

- Meet criteria for MCI

- Subjective cognitive decline reported by participant and/or an informant

- Objective memory impairment in one or more cognitive domains for age

- Essentially preserved general cognitive function

- Largely intact functional activities

- Does not meet criteria for dementia as judged by a clinician

- Eligible for transcranial magnetic stimulation (TMS) based on safety criteria

- Clinical Dementia Rating=0.5

- Geriatric Depression Scale score less than 6

- Medically stable and in good general health

- Not pregnant, lactating, or of childbearing potential

- Stable medication regimen for at least 4 weeks prior to baseline visit

- Adequate visual and auditory abilities to complete neuropsychological testing

- Ability to provide informed consent

- Have a care partner who is available to accompany the participant to study visits for
the duration of the protocol.


Exclusion Criteria:


- Inability to communicate in the English language

- Meet criteria for dementia

- Contraindications to TMS or MRI, including patients who have

- conductive, ferromagnetic or other magnetic-sensitive metals implanted in their
head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted
electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or
jewelry)

- active or inactive implants, including deep brain stimulators, cochlear implants,
vagus nerve stimulators or implanted device leads

- Any true positive findings on the TMS safety screening form

- Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within
the past 12 months

- History of epilepsy or seizures

- Medical conditions or use of medications that increase risk of seizures

- History of traumatic brain injury

- History of intracranial mass or lesion

- History of stroke, including hemorrhagic stroke and ischemic stroke

- Medications associated with seizures (Examples: Analgesics
•Opioids (e.g.,
meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab;
Antimicrobials
•Carbapenems (e.g., imipenem), Cephalosporins (fourth
generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins;
Hypoglycemic agents; Immunosuppressants
•Azathioprine, Cyclosporine,
Mycophenolate, Tacrolimus; Psychiatric medications
•Antipsychotics, Atomoxetine,
Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs -
Aminophylline, Theophylline; Stimulants
•Amphetamines, Methylphenidate;
Sympathomimetics and decongestants
•Anorexiants (e.g., diethylpropion,
phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)

- Psychiatric disorders

- Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform
disorder), any history

- Primary mood disorder (major depressive disorder, bipolar disorder) within the
past 12 months

- Substance use disorder (except caffeine and nicotine) within the past 12 months

- Active symptoms of depression, anxiety, mania, psychosis, or substance use (except
caffeine and nicotine) within the past year

- Active symptoms of depression will be identified based on geriatric depression
scale ≥ 6

- Other active symptoms of psychiatric conditions to be determined by study
investigators

- Sleep disorders that are considered clinically significant and not sufficiently
treated by the investigative team, including untreated obstructive sleep apnea
(apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior
disorder, untreated/suboptimally treated restless legs syndrome

- Pregnancy or suspected pregnancy

- Participation in another concurrent interventional clinical trial

- Any unstable medical condition

- Inability to provide informed consent

- Inability to adhere to the protocol

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial Shunt System (ALt FLOW US) (ALt FLOW US)

Early Feasibility Study - Transcatheter Atrial Shunt System

Trevor Simard
All
18 years and over
Not Applicable, Early Feasibility
This study is NOT accepting healthy volunteers
2021-306204-P01-RST
21-010797
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Inclusion Criteria:


1. Signed and dated IRB approved study consent form prior to study related procedures

2. ≥ 18 years old

3. Chronic symptomatic Heart Failure (HF) documented by the following:

1. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory
NYHA class IV AND

2. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or
treatment with intravenous (IV) or intensification of oral diuresis for HF in a
healthcare facility (emergency department/acute care facility) within the 12
months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus
rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal
sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.

4. In the judgment of the investigator, subject is on stable Guideline Directed Medical
Therapy (GDMT) for heart failure and management of potential comorbidities according
to current ACCF/AHA Guidelines and that is expected to be maintained without change
for 3 months

5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine
ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP)
exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine
ergometer exercise stress test as measured at end-expiration

6. Willing to attend study follow-up assessments for up to 5 years

Inclusion Criteria for RV Overload group only:

I1B. Pulmonary Hypertension (PH) that maybe reversible, documented by the following:

1. Pulmonary Vascular Resistance (PVR) > 4 Wood Units at rest AND

2. Mean Pulmonary Artery Pressure (mPAP) ≥ 25 mmHg at rest AND

3. Successful reversibility of PH under a resting Sodium Nitroprusside challenge where
success is defined as a lowering of the PVR by ≥ 20% to a level < 4 Wood Units while
maintaining a Systolic Blood Pressure ≥ 90 mmHg


Exclusion Criteria:


1. Severe heart failure defined as one or more of the below:

1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF

2. If BMI < 30, Cardiac index < 2.0 L/min/m2

3. If BMI ≥ 30, cardiac index < 1.8 L/min/m2

4. Inotropic infusion (continuous or intermittent) within the past 6 months

5. Patient is on the cardiac transplant waiting list

6. LVEF < 20%

2. Presence of significant valve disease defined by the site cardiologist as:

1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS

2. Tricuspid valve regurgitation defined as grade > 2+ TR

3. Aortic valve disease defined as > 2+ AR or > moderate AS

3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current
indication for coronary revascularization

4. Valve replacement or surgical annuloplasty within the past 12 months

5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA)
within the past 6 months

6. Hemodynamic instability within 30 days of scheduled implant procedure

7. Patient requiring surgery under general anesthesia for any reason within 30 days of
scheduled implant procedure

8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive
pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)

9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or
estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis

10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases,
total bilirubin, or alkaline phosphatase

11. Performance of the 6 minute walk test with a distance <50m OR >600m

12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin
(analogue); or has a documented coagulopathy

13. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be
adequately medicated

14. Known hypersensitivity to Nickel and/or Tantalum

15. In the judgment of the investigator, life expectancy <12 months for noncardiovascular
reasons

16. In the opinion of the investigator, the subject is not an appropriate candidate for
the study

17. Anatomy (including implantable devices) that is not compatible with the Edwards
Transcatheter Atrial Shunt System

18. Active endocarditis or infection within 3 months of scheduled implant procedure

19. Currently participating (e.g., undergoing trial specific exams/treatment/procedures)
in an investigational drug or device study. Note: trials requiring extended follow-up
for products that were investigational but have since become commercially available
are not considered investigational trials.

20. Patient is a current intravenous drug user

21. Positive serum pregnancy test in female subjects of child-bearing potential or nursing
mothers or planning on becoming pregnant during the duration of the trial

22. Patient is under guardianship

23. Known pre-existing shunting, determined to be clinically significant by the
investigator

24. (Not applicable to RV Overload group) Right ventricular dysfunction, defined by the
site cardiologist as:

1. More than mild RV dysfunction as estimated by TTE; OR

2. TAPSE <1.4 cm; OR

3. RV size ≥ LV size as estimated by TTE; OR

4. Echocardiographic or clinical evidence of congestive hepatopathy

25. Evidence of pulmonary hypertension with PVR >4 Wood units

Exclusion Criteria for RV Overload group only:

E1B. Propensity for increased Right ventricular dysfunction, defined by the site
cardiologist as:

1. More than moderate RV dysfunction as estimated by TTE; OR

2. TAPSE <1.2 cm; OR

3. RV size ≥ LV size as estimated by TTE; OR

4. Right Atrial Pressure (RAP) > 18 mm Hg; OR

5. Echocardiographic or clinical evidence of congestive hepatopathy;

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

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Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

Care Anywhere with Community Paramedics Program to Reduce Hospitalization

Rozalina McCoy
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306210-H01-RST
21-010816
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Inclusion Criteria
•Aim 1:

  • Clinicians (physicians, Nurse Practitioners, Physician Assistants), nurses, community paramedics, administrators, care coordinators, and other stakeholders likely to be engaged in the CACP program.

Inclusion Criteria
•Aim 2:

  • Adults (age ≥ 18 years) who are:
    • Currently admitted to the ED, hospital; or are
    • In a pre-hospital setting but being considered for referral to the ED or hospital at Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting if such services were available to them.
  • Eligible participants have to reside within an approximately 40-mile radius of Rochester, MN or within the service radius of Barron, WI. 
  • Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home. For the purposes of the trial, “residence” and “home” refer to the place where the participant will be physically located after clinic, ED, or hospital discharge, and can include a hotel or another housing arrangement (i.e., not only their permanent residence).

Inclusion Criteria
•Aim 3:

  • All community paramedics (up to 18), clinicians who referred participants enrolled in the CACP intervention arm (up to 100), administrators involved with the CACP program (up to 30), and Mayo Clinic Ambulance leaders (up to 20) will be surveyed. 
  • All community paramedics (up to 18), purposive sample of participants enrolled in the CACP intervention arm (up to 35), and a purposive sample of clinicians, administrators, administrators, and Ambulance leaders (up to 35) will be interviewed.
  • Patient participants will be purposively sampled to ensure diversity of geography, age, sex, race and ethnicity, and clinical diagnosis for CACP program referral. Clinician and administrator participants will be purposively sampled to ensure representation of different ED and hospital service lines and frequency of referrals to the CACP program.

Exclusion Criteria
•Aim 1:​​

  •  
  • ​​​No exclusion criteria.

Exclusion Criteria
•Aim 2:​​

  • Referring clinician believes the patient requires referral to the ED (for patients in the pre-hospital setting) or hospital admission (for patients in the ED or hospital)
  • Not meeting criteria outlined in the Community Paramedic Referral Guide
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service
  • Living conditions unsafe for CPs to enter (e.g., patient refuses to secure weapons or animals prior to CP’s arrival)
  • Enrolled in the trial during an earlier hospitalization or ED visit.

Exclusion Criteria
•Aim 3:​​

  • There will be no exclusion criteria for Aim 3 clinicians or other clinical or administrative stakeholders.
  • Patient participants will be excluded if they:
    • Have a communication barrier due to medical illness or cognitive impairment; or
    • Are seriously ill or hospitalized at the time of interview recruitment.

Eligibility last updated 3/16/22. Questions regarding updates should be directed to the study team contact.

 

Other, Behavioral
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Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy

IRB#21-009968: Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy

Allison Garda
Female
18 years and over
This study is NOT accepting healthy volunteers
2021-306217-P01-RST
21-009968
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Inclusion Criteria:

  • English speaking.
  • Ability to complete a questionnaire.
  • ≥ 18 years of age.
  • Patients treated for endometrial cancer from 2013-2018 (about 590 patients treated between 2013-2018 per Rad Onc Outcomes):
  • Status post-surgery +:
    • Pelvic +/- para-aortic external beam radiotherapy;
    • External beam radiotherapy +/- vaginal cuff brachytherapy;
    • Brachytherapy alone.
  • Patients treated for cervical cancer from 2013-2018 (62 definitive or adjuvant treated between 2015-2018 per Rad Onc outcomes):
    • Status post-surgery and external beam radiotherapy +/- chemotherapy;
    • Definitive radiotherapy +/- chemotherapy.
  • Patients treated for vulvar cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (40 treated between 2013-2018 per Rad Onc outcomes).
  • Patients treated for vaginal cancer from 2013-2018 receiving radiotherapy +/- surgery +/- chemotherapy (34 treated between 2013-2018 per Rad Onc outcomes).
  • Patients treated for anal cancer from 2013-2018 receiving radiotherapy +/- chemotherapy +/- surgery (243 treated between 2013-2018 per Rad Onc outcomes).


Exclusion Criteria:

  • Females < 18 years of age.
  • Any exception to above Inclusion Criteria.

Eligibility last updated 11/18/21. Questions regarding updates should be directed to the study team contact.

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AKI in Care Transitions (ACT) Trial (AKI ACT)

Acute Kidney Injury in Care Transitions (ACT) Trial

Erin Barreto
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306236-H01-RST
21-011055
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Inclusion Criteria
•Clinician:

  • All clinicians responsible for caring for eligible patients will be considered for inclusion in the qualitative research. 

Exclusion Criteria
•Clinician:

  • If the clinician declines to participate, the patient is still eligible for the study, but qualitative evaluations will be omitted.

Inclusion Criteria
•Patient:

  • Participants will be recruited from those identified by a developed electronic health record list of patients with AKI. 
  • Included individuals that populate the list are those with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.

Exclusion Criteria
•Patient: 

  • Dementia.
  • Non-English speaking.
  • Expected to be dismissed to a skilled nursing facility or hospice at discharge.
  • Expected to need dialysis at discharge.
  • Primary Care Transitions Program enrollment.
  • Transplant recipients within 100 days of transplant.
  • Can only have one time enrollment.  

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

 

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A 2-Stage (Open-Label Run-in followed by Randomized Withdrawal), Double-Blind, Placebo-Controlled, Phase 2 Study of Setmelanotide in Patients with Specific Gene Defects in the Melanocortin-4 Receptor Pathway (DAYBREAK)

DAYBREAK: Phase 2 Study in Patients With Specific Gene Defects in the MC4R Pathway

Andres Acosta
All
6 years to 65 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306255-P01-RST
21-008061
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 Inclustion Criteria:

  • Patients must have a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity.

For a gene variant to be eligible for inclusion in the study, the variant must be categorized by a CLIA/CAP/ISO15189 -certified laboratory using ACMG criteria as (1) Pathogenic, (2) Likely Pathogenic or (3) a VUS. In the case where an investigator has genetic results on a patient who may be eligible for the study, but the genetics have not yet been categorized by a CLIA/CAP/ISO15189 -certified laboratory, then the Sponsor may provide testing and/or categorization through a third-party laboratory.

  • Patients between the ages of 6 and 65 at the time of signing Informed Consent or Assent are eligible for the study.
  • Patients must be obese, defined as BMI ≥40 kg/m2 for patients ≥18 years of age or BMI ≥97th percentile for age and gender for patients 6 up to 17 years of age based on based on the US Centers for Disease Control and Prevention criteria.
  • Study participant and/or parent or guardian is able to communicate well with the Investigator, to understand and comply with the requirements of the study (including QD injection regimen and all other study procedures) and is able to understand and sign the written informed consent/assent. Patients who are unable to comply with all study procedures due to cognitive limitations or any other reason should not be enrolled into the study.
  • If male or a childbearing female, including pre-pubertal females if relevant, the patient must agree to use a highly reliable form of contraception throughout the study and for 90 days following the study.
  • Highly reliable acceptable forms of contraception include hormonal (i.e., oral, implantable, or injectable) AND single-barrier method (i.e., condom), or an intrauterine device (IUD) AND single-barrier method (i.e., condom) or vasectomy/vasectomized partner. True abstinence is acceptable only if it is the preferred and usual lifestyle of the patient. Female participants of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), post-menopausal for at least 12 months (and confirmed with a screening follicle-stimulating hormone [FSH] level in the post-menopausal lab range), and failure to have achieved menarche, do not require contraception during the study. Female patients must not become pregnant and male patients must not donate sperm during and for 90 days following their participation in the study.


Exclusion Criteria:

  • Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that has resulted in > 3% weight loss.
  • Use of any medication that is approved to treat obesity within 3 months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).
  • Note: Glucagon-like peptide-1 (GLP-1) receptor agonists may be used up to the dose approved for the treatment of diabetes mellitus (e.g., liraglutide up to a daily dose of 1.8 mg) as long as (1) it is not being prescribed for the treatment of obesity, (2) the dose has been stable for at least 3 months prior to enrollment, (3) the patient has not experienced weight loss during the previous 3 months, AND (4) the patient intends to keep the dose stable throughout the course of the study.
  • Bariatric surgery within the previous 6 months. Note: Patients with a history of gastric bypass surgery should have documented evidence of stable weight, defined as weight loss in the last 3 months of < 3% of body weight.
  • Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s) that the Investigator believes will interfere significantly with study compliance.
  • Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) during Screening, any suicide attempt in the past 20 years or any suicidal behavior in the last month.
  • Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results. Any patient with a potentially clinically significant disease should be reviewed with the Sponsor to determine eligibility.
  • Has significant features of (or meets the diagnostic criteria for) a genetic syndrome that is associated with obesity, such as Tatton-Brown-Rahman syndrome (DNMT3A), Rett Syndrome (MECP2), Chung-Jansen syndrome (PHIP), Schaaf-Yang syndrome (MAGEL2), ulnar mammary syndrome (TBX3), or Rubinstein-Taybi syndrome (CREBBP).
    • Note: Although some of the genetic variants that are eligible to be enrolled into this study are associated with specific syndromes, the intent of this study is not to enroll children with significant cognitive impairment or other significant co-morbidities. Patients with the correct genetic variants, but who otherwise do not exhibit the syndrome, are eligible for enrollment.
  • HbA1C > 10.0% at Screening.
  • History of significant liver disease other than non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
  • Glomerular filtration rate (GFR) < 60 mL/min at Screening.
  • History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism.
    • Note: If the type of skin cancer is not known, then the patient should not be enrolled into the study.
  • Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion), determined as part of a comprehensive skin evaluation performed by the Investigator during Screening. Any concerning lesions identified during Screening will be biopsied and results known to be benign prior to enrollment. If the pretreatment biopsy results are of concern, the patient may need to be excluded from the study.
  • Patient is, in the opinion of the Study Investigator, not suitable to participate in the study.
  • Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
  • Patients previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
  • Significant hypersensitivity to any excipient in the study drug.
  • Females who are breastfeeding or nursing.

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

Drug, Other
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A Multicenter, Phase 2B, Randomized, Double-blind, Stratified, Vehicle-controlled Study Evaluating the Safefty and Efficacy of Sirolimus 3.9% Topical Gel in Prevention of BCCS in Patients with Gorlin Syndrome (CODY)

CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome

Addison Demer
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306267-P01-RST
21-011039
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Screening

Inclusion Criteria:

  • The participant must be at least 18 years of age at the time of informed consent.
  • The participant must provide written informed consent prior to any study procedures.
  • The participant must meet diagnostic criteria for Gorlin Syndrome (GS) including major criterion #3a plus 1 additional major criterion or plus 2 additional minor criteria listed below. While not required for study entry, if participant has genetic testing results available at study entry or any time during the study, the testing result will be collected.

Major Criteria

  • > 2 histologically confirmed BCCs or 1 for participant under age 20.
  • Odontogenic keratocysts of the jaw confirmed histologically.
  • ≥ 3 palmar and/or plantar pits seen at the Screening Visit.
  • Bilamellar calcification of the falx cerebri present at less than 20 years of age. Fused, bifid, or markedly splayed ribs.
  • First degree relative with GS.
  • Patched protein 1 (PTCH1) mutation predicted to be of functional significance in normal tissue.

Minor Criteria

  • Macrocephaly.
  • Congenital malformations including frontal bossing, cleft lip or palate, "coarse face", moderate to severe hypertelorism.
  • Skeletal abnormalities detectable clinically: Sprengel deformity, marked pectus deformity, or marked finger syndactyly.
  • Skeletal abnormalities detectable radiographically: bridging of the sella turcica; vertebral abnormalities such as hemivertebrae, fusion or elongation of the vertebral bodies; modeling defects of the hands and feet; flame shaped lucencies of the hands or feet.
  • Ovarian fibroma.
  • Medulloblastoma.
  • The participant is willing to have blood collected for safety and PK testing.
  • The participant is willing to abstain from application of a non-study topical medication (prescription or over the counter) to face for the duration of the trial. Moisturizers and emollients are allowed. Participant will be encouraged to use their preferred sunscreen with a sun protector factor (SPF) of at least 30 daily on all exposed skin on the face.
  • Participants of childbearing potential must agree to use a medically acceptable, highly effective form of contraception for the entire duration of the study including through the follow-up period.
  • The participant is willing to forego treatment of BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might
    compromise the health of the participant. During the trial, the only allowed form of BCC treatment is surgical.

Screening


Exclusion Criteria:

  • The participant has previously participated in a clinical trial evaluating sirolimus topical gel within the last 5 years.
  • Participants with known hypersensitivity to any of the ingredients in the study medication formulation.
  • Participants with current, recent (within five half-lives of the experimental drug or if half-life not known, within the past 6 months prior to Day 0), or planned participation in an experimental drug study while enrolled in this study.
  • Participants who are pregnant, breastfeeding or planning to become pregnant during the study including through the follow-up period.
  • Participants of childbearing potential who are unwilling or unable to comply with contraception measures.
  • The participant has any condition or situation which, in the Investigator's opinion, may put the participant at significant risk, could confound the study results, including disease activity, or could interfere significantly with participation in the study.
  • Participants deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including photographs of their face, if needed, adherence to the study drug administration regimen, and other protocol-required activities.

Baseline

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply at Day 0, Baseline:

  • The participant must have had at least a history of 10 BCCs present on the face, scalp, ears and/or neck (clinically diagnosed and/or biopsy confirmed) within 24 months prior to Randomization/Day 0.
  • Female participants of childbearing potential must have a negative urine pregnancy test to participate in the study.

Baseline


Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply at Day 0, Baseline:

  • The participant has > 20 clinically suspicious lesions on the face at time of randomization.
  • The participant has used topical or systemic treatment that might interfere with the evaluation of the study IP.  Among these are use of the following:
    • 5-fluorouracil, imiquimod, diclofenac, ingenol mebutate (topical); itraconazole, SUBA-itraconazole (systemic) within the 3 months prior to Day 0;
    • Hedgehog inhibitors (glasdegib, vismodegib, sonidegib, patidegib) systemically within the 6 months prior to Day 0. Topical Hedgehog inhibitors within the 3 months prior to Day 0;
    • Systemic chemotherapy of any kind within 1 year prior to Day 0;
    • Known inhibitors of the mTOR signaling pathway or systemically within 2 months prior to Day 0;
    • Photodynamic therapy (PDT) to target lesions within 3 months prior to Day 0;
    • Nicotinamide orally (500mg/2 time daily) within 3 months prior to Day 0.
  • The participant has previously participated in a clinical trial evaluating an investigational product for treatment of BCCs or GS within 3 months prior to Day 0.
  • Participants with an ECOG > 2 at Day 0.
  • Participants previously treated for invasive cancer within the past 5 years excluding nonmelanoma skin cancer, Stage I cervical cancer, in situ ductal cell carcinoma of the breast, or chronic lymphocytic leukemia (CLL) Stage 0, at Day 0.

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

 

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20210098 - A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102) (FORTITUDE-102)

Bemarituzumab plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone

Harry Yoon
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306277-P01-RST
21-011107
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Inclusion Criteria Part 1:

- Adult with unresectable, locally advanced or metastatic (not amenable to curative
therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Measurable disease or non-measurable, but evaluable disease, according to Response
Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)

- Participant has no contraindications to mFOLFOX6 chemotherapy or nivolumab

- Adequate organ function as follows:

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior
to the first dose of study treatment

- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper
limit of normal (ULN) (or < 5 x ULN if liver involvement)

- Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's
disease)

- Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated
using the formula of Cockcroft and Gault

- International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except
for participants receiving anticoagulation, who must be on a stable dose of
anticoagulant therapy for 6 weeks prior to enrollment

Additional Inclusion Criteria Part 2:

- No prior treatment for metastatic or unresectable disease except for a maximum of 1
dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and
peri-operative therapy is allowed, provided it has been completed more than 6 months
prior to the first dose of study treatment

- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by
centrally performed immunohistochemistry (IHC) testing


Exclusion Criteria:


- Prior treatment with any selective inhibitor of the fibroblast growth factor
(FGF)-FGFR pathway

- Known positive human epidermal growth factor receptor 2 (HER2) status

- Untreated or symptomatic central nervous system disease metastases and leptomeningeal
disease

- Peripheral sensory neuropathy grade 2 or higher

- Clinically significant cardiac disease

- Other malignancy within the last 2 years (exceptions for definitively treated disease)

- Chronic or systemic ophthalmologic disorders

- Major surgery or other investigational study within 28 days prior to randomization

- Palliative radiotherapy within 14 days prior to randomization

- Abnormalities of the cornea that may pose an increased risk of developing a corneal
ulcer

- Active autoimmune disease that has required systemic treatment (except replacement
therapy) within the past 2 years or any other diseases requiring immunosuppressive
therapy while on study

Eligibility last updated 6/21/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other
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A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions (ROBOCOP)

Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

Ryan Kern
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-306281-H01-RST
21-008716
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Inclusion Criteria:

  • Male and female patient’s age ≥ 18 at the time of informed consent.
  • Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

  • Pulmonary nodules of 8-50mm in largest dimension.


Exclusion Criteria:

  • Patients with known bleeding diathesis; Platelet count < 50,000.
  • Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
  • Inability or unwillingness to give informed consent.
  • Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
  • Pulmonary hypertension, defined as a right ventricular systolic pressure > 50 mmHg.
  • Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
  • International Normalized Ratio (INR) < 1.5.
  • Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Eligibility last updated 10/20/21. Questions regarding updates should be directed to the study team contact.

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MC210811, REsponse Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma (REACH) (REACH)

Response Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma

Shaji Kumar
All
18 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306286-P01-RST
22-002687
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Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80 years.
  • High risk myeloma, which is untreated, defined as any of:
    • ISS stage 3 and gain of chr1q or del17p);
    • bi-allelic deletion of TP53;
    • t(4;14) or t(14;16) and gain of chr1q;
    • t(4;14) or t(14;16) and presence of del17p; or
    • presence of a high-risk gene expression signature on Sky92 assays (Skyline Diagnostics).
  • The following laboratory values obtained ≤ 14 days prior to registration.
    • Calculated creatinine clearance (using Cockcroft-Gault equation below)* ≥ 30 mL/min;
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3 (without the use of growth factors);
    • Platelet count ≥ 75000/mm^3;
    • Hemoglobin ≥ 8.0 g/dL;
    • Total bilirubin ≤ 1.5 x ULN;
    • ALT and AST ≤ 3 x ULN;
    • *Cockcroft-Gault Equation:
    • Creatinine clearance for males =
    • (140
      •age)(actual body weight in kg)/ (72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =
    • (140
      •age)(actual body weight in kg)(0.85)/(72)(serum creatinine in mg/dL).
  • LVEF ≥ 40%.
  • ECOG performance status (PS) 0 or 1.
  • Provide informed written consent. 
  • Negative pregnancy test done ≤ 14 days prior to registration, for women of childbearing potential only.
    • Note: All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
    • Note: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Willing to follow strict birth control measures as outlined in the protocol.
  • Female subjects: If they are of childbearing potential, agree to one of the following:
    • Practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of trial drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
  • Male subjects: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
    • Agree to practice effective barrier contraception during the entire trial treatment period and through 90 days after the last dose of trial drug, OR
    • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable; OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 
  • Willing to return to enrolling institution for follow-up during the Active Treatment Phase of the trial.
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation. 
    • Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.
  • Male subjects must agree not to donate sperm for at least 90 days after the last dose of study treatment.
  • Willing to provide blood and bone marrow samples for planned research.
  • Life expectancy > 6 months.
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation.  Note: Subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.


Exclusion Criteria:

  • MGUS, smoldering myeloma, light chain amyloidosis with organ involvement
  • Diagnosed or treated for another malignancy ≤ 1 year prior to registration or previously diagnosed with another malignancy and have any evidence of residual disease.  Note: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol).
  • Other co-morbidity which would interfere with subject's ability to participate in trial; e.g., uncontrolled infection, uncompensated heart or lung disease.
  • Other concurrent chemotherapy, or any ancillary therapy considered investigational. 
    • NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
  • Peripheral neuropathy ≥ Grade 3 on clinical examination or grade 2 with pain ≤ 30 days prior to registration.
  • Major surgery ≤ 14 days prior to registration.
  • Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.  Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
  • Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
  • NYHA II, III, IV heart failure
  • Known human immunodeficiency virus (HIV) positive.
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).  Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels.  Those who are PCR positive will be excluded. 
    • EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Known or suspected active hepatitis C infection.
  • Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
  • Prior radiation therapy for bony lesions or plasmacytomasKnown allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure) or known sensitivity to mammalian-derived products.  Known allergies, hypersensitivity, or intolerance to trial drugs.
  • Inability to comply with protocol/procedures.

Eligibility last updated 3/9/22. Questions regarding updates should be directed to the study team contact.

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REST/NRSF, miRNAs and Tissue Remodeling in Adenomyosis Pathophysiology (REST.NSRF)

Tissue Remodeling in Adenomyosis Pathophysiology

Elizabeth Stewart
All
21 years to 50 years old
This study is NOT accepting healthy volunteers
2021-306288-P01-RST
21-011098
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Inclusion Criteria;

  • Pre-menopausal (21
    •50 years of age).
  • Study group will consist of women seeking hysterectomy for possible adenomyosis adenomyomectomy.
  • Controls will consist of women seeking hysterectomy for uterine prolapse or pelvic pain or transgender men prior to androgen treatment and whose pathology shows a uterus < 100 grams with no evidence of adenomyosis, endometriosis, or leiomyomas.


Exclusion Criteria:

  • No ua\se of GnRH analogues, aromatase inhimitors, selective E2 or P4 receptor modulators, oral contraceptives, or immunotherapy within 3 months prior to surgery in any patient.
  • No history /confirmation or suspicion of autoimmune disease, fibromyalgia, endometriosis, or leiomyomas in any patient.
  • No current or previous history of STDs, pelvic inflammatory disease, endometrial/cervical cancer in any patient.
  • Women who do not exhibit menstrual cycles.

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


 

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

Using Transcranial Magnetic Stimulation Evoked Potentials to Diagnose

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

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


Exclusion Criteria:

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

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

Schizoaffective disorder, Schizophrenia
Brief reactive psychosis, Catatonia, Delusional disorder, EEG, Schizoaffective disorder, Schizophrenia, Schizophreniform disorder, Transcranial magnetic stimulation
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A STUDY TO IDENTIFY THE LOCATION OF ATROPHY AND GENETICALLY DEFINE SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION (TELESCOPE)

Telescope

Brittni Scruggs
All
55 years and over
This study is NOT accepting healthy volunteers
2021-306306-P01-RST
21-011136
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Inclusion Criteria:

  • Aged ≥ 55 years.
  • Able and willing to give consent to study participation.
  • Presence of unilateral or bilateral GA, secondary to AMD.


Exclusion Criteria:

  • History or evidence of choroidal neovascularisation (for example, wet AMD) in both eyes.  Subjects with CNV in only one eye may be included after approval from Gyroscope.
  • Currently receiving active treatment for CNV in either eye.
  • Presence of severe non-proliferative diabetic retinopathy or worse in either eye.
  • Have received any investigational product for the treatment of GA within the past 6 months, or 5 half-lives (whichever is longer) other than nutritional supplements such as the age-related eye disease study formula.
  • Received gene/cell therapy at any time previously.
  • Have any other significant ocular or non-ocular medical or psychiatric condition which,in the opinion of the Investigator, may either put the Subject at risk or may influence the results of the study.

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

Nonexudative age-related macular degeneration
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Evaluation of Implantable Tibial Neuromodulation (TITAN 2) Pivotal Study (TITAN 2)

Study to Evaluate Implantable Tibial Neuromodulation

Brian Linder
All
18 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-306307-P01-RST
21-011172
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Inclusion Criteria:

  • Subjects 18 years of age or older.
  • A 3-day voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 hours.
  • Have a diagnosis of UUI for at least 6 months.
  • No OAB pharmacotherapy for 2 weeks prior to completion of the baseline voiding diary and Overactive Bladder Quality of Life (OAB-q) questionnaire.
  • Failed, or are not a candidate for, conservative non-pharmacologic treatment (e.g., pelvic floor training, biofeedback, behavioral modification)
  • In the opinion of the Investigator, subject has failed and/or is intolerant to at least 1 overactive bladder medication or Investigator has determined that medication use is not appropriate based on the subject’s profile and medical history.
  • Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol.
  • Willing and able to provide signed and dated informed consent.


Exclusion Criteria:

  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • Severe uncontrolled diabetes.
  • History of urinary retention within the previous 6 months.
  • Current symptomatic urinary tract infection.
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component [see enrollment/baseline requirements for use of the Medical, Epidemiological, and Social Aspects of Aging urinary incontinence questionnaire (MESA) questionnaire].
  • Diagnosis of bladder pain syndrome, pelvic pain, or interstitial cystitis.
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • History of a prior implantable tibial neuromodulation system.
  • Knowledge of planned diathermy procedures.
  • Have had treatment of urinary symptoms with sacral neuromodulation in the past 6 months, botulinum toxin therapy in the past 9 months or percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) in the past 3 months.
  • Skin lesions or compromised skin integrity (e.g., skin atrophy, thinning, fragility, etc.) which may affect incision healing at the implant site.  Current or a recent history (within the past 6 months) of a medical condition such as venous insufficiency and/or venous stasis ulcers, clinically significant malnutrition, immunocompromised state, or other relevant chronic disease which may indicate a higher risk for delayed or poor wound healing.
  • Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device (including any metal implant that is within 20 cm of the intended neurostimulator location).
  • Previous pelvic floor surgery in the last 6 months.
  • Women who are pregnant or planning to become pregnant during the course of the study.
  • Any subject who is considered to be part of a vulnerable patient population.**
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.***
Device, Percutaneous electrical nerve stimulation of tibial nerve for urinary incontinence
Urinary incontinence
Urinary system
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study (PEER2)

Recording Pelvic Health Signals After Stimulation of a Sacral Nerve

Brian Linder
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-306315-P01-RST
21-011168
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Inclusion Criteria
•Overactive Bladder:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent.
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation.
  • For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion).
  • For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria
•Non-Obstructive Urinary Retention:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent..
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation.
  • Have a diagnosis of non-obstructive urinary retention as demonstrated by a urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-day period; and chronic non-obstructive urinary. retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Inclusion Criteria - Fecal Incontinence:

  • 18 years of age or older.
  • Candidate for or undergoing Medtronic InterStim lead implant labeled indication* requiring an advanced evaluation.
  • Willing and able to provide signed and dated informed consent.
  • Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol.
  • Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation.
  • Have a diagnosis of fecal incontinence as demonstrated by a bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate, or severe soiling) per week.
  • *Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject’s condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria
•Overactive Bladder:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • History of diabetes unless the diabetes is well‐controlled through diet and/or medications.
  • Have symptomatic urinary tract infection (UTI).
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component.
  • Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study.
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
  • Women who are pregnant or planning to become pregnant.
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria - Non-Obstructive Urinary Retention:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • History of diabetes unless the diabetes is well‐controlled through diet and/or medications
  • Have symptomatic urinary tract infection (UTI)
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  • Women who are pregnant or planning to become pregnant
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

Exclusion Criteria
•Fecal Incontinence:

  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co‐enrollment in an interventional study is only allowed when documented pre‐approval is obtained from the Medtronic study manager or designee).
  • Implanted with a neurostimulator, pacemaker or defibrillator.
  • Pelvic floor muscle dysfunction due to surgical intervention or injury.
  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • Have uncorrected high grade internal rectal prolapse.
  • Treatment of symptoms with tibial neuromodulation therapy in the last 3 months.
  • Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study.
  • Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy.
  • Women who are pregnant or planning to become pregnant.
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.

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

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

3Spine TLIF Real World Evidence Study

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

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


Exclusion Criteria:

  • More than one vertebral level requiring treatment.
  • revious instrumented surgery (i.e., anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level.
  • Degenerative or lytic spondylolisthesis greater than Grade 1 (< 25% translation).
  • Rotatory scoliosis at the level to be treated.
  • Congenital bony and/or spinal cord abnormalities at the level to be treated.
  • Subcaudal defect, disrupting the integrity of the pedicle.
  • Clinically compromised vertebral bodies at the involved level due to current or past trauma; e.g., by the radiographic appearance of the fracture callus, malunion or nonunion.
  • Disrupted anterior longitudinal ligament at the index level.
  • Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated.
  • Back pain of unknown etiology without leg pain.
  • Severe spondylosis at the level to be treated as characterized by any of the following:
    • Autofusion (solid arthrodesis) determined radiographically (CT);
    • Totally collapsed disc; or
    • Vertebral body that cannot be mobilized.
  • Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E.
  • Unable to undergo a CT scan or other radiograph assessments.
  • Osteopenia: All patients will completeThe SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening.
  • Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta).
  • Insulin-dependent diabetes mellitus.
  • Lactating, pregnant or interested in becoming pregnant in the next 3 years.
  • Active infection – systemic or local.
  • Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
  • Body Mass Index > 40.
  • Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease.
  • Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation.
  • Spinal tumor.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
  • Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease.
  • Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  • In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
  • Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code.
  • Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered ‘current’).
  • Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation.
  • Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results.
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

Eligibility last updated 7/21/22. Questions regarding updates should be directed to the study team contact.

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

Control-IQ Technology in Individuals with Type 2 Diabetes

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

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


Exclusion Criteria:

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

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

 

 

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