Health Studies MN

Within 


Search Results

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

3289 Study Matches

Sorting by: Relevance Distance

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.


 

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Using Transcranial Magnetic Stimulation Evoked Potentials to Diagnose

Matej Markota
All
18 years to 64 years old
This study is NOT accepting healthy volunteers
2021-306305-H01-RST
21-011143
Show full eligibility criteria
Hide eligibility criteria

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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

Location Contacts
Mayo Clinic — Rochester, MN

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
Show full eligibility criteria
Hide eligibility criteria

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.

 

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306348-H01-RST
21-011419
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Highly Congruent Polyethylene and Posterior Stabilized Designs in Total Knee Arthroplasty

Cory Couch
All
18 years to 100 years old
This study is NOT accepting healthy volunteers
2021-306349-H01-RST
21-011355
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

  • No vulnerable populations.

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

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

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

Inclusion Criteria:


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

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

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

4. Enrollment in the CARRA Registry

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

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


Exclusion Criteria:


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

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

2. Sacroiliitis (clinical or radiographic)

3. Inflammatory bowel disease (IBD)

4. History of psoriasis or currently active psoriasis

5. History of uveitis or currently active uveitis

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

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

8. History of active or chronic liver disease

9. Chronic or acute renal disorder

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

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

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

13. Known positive human immunodeficiency virus (HIV)

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

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

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

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

18. Active malignancy of any type or history of malignancy

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

20. Primary language other than English or Spanish

21. Positive for Hepatitis B surface antigen or core antibody

22. <10 Kg in weight

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Obesity Phenotype Biobank

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

Inclusion Criteria:

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


Exclusion Criteria:

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

Eligibility last updated 11/8/21. Questions regarding updates should be directed to the study team contact.

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

Location Contacts
Mayo Clinic — Rochester, MN

VEXAS Syndrome Biorepository (VEXAS)

VEXAS Biobank

Matthew Koster
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306362-H01-RST
21-011449
Show full eligibility criteria
Hide eligibility criteria

Inclusion Critieria:

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


Exclusion Criteria:
 

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

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

 

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Kenneth Merrell
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306377-P01-RST
21-011529
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Long-Term Study of Participants Previously with Ciltacabtagene Autoleucel

Yi Lin
All
18 years and over
Phase 4
This study is NOT accepting healthy volunteers
2021-306381-P01-RST
21-011543
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

  • No exclusion criteria are applicable in this study.

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Richard Weinshilboum
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306387-H01-RST
21-011561
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Ryan Kern
All
22 years and over
This study is NOT accepting healthy volunteers
2021-306398-P01-RST
21-011636
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Matthew Abdel
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306404-H01-RST
21-011655
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

  • Patients with lumbosacral hardware, contralateral THA.

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Cheryl Tran
All
up to 5 years old
This study is NOT accepting healthy volunteers
2021-306434-P01-RST
21-012849
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

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

Inclusion Criteria:


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

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

- Left ventricular ejection fraction ≥ 50%

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

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


Exclusion Criteria:


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

- Untreated metastases to the central nervous system

- Received previous treatment with anthracyclines and anthracenediones

- Previous radiation therapy to the mediastinal or pericardial area

- A known allergy to any of the treatment components

- Patient not willing to use suppositories

- Patients with a colostomy

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

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

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

- Patients with inflammatory bowel disease

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

- Uncontrolled diabetes mellitus

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

Hepatic Steatosis Quantification with Ultrasound

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

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

Inclusion Criteria:

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

Exclusion Criteria

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry

Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

Alexander Egbe
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
2021-306467-H01-RST
21-011938
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Robert Trousdale
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306470-H01-RST
21-012001
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN

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

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

Derek Lomas
Male
50 years and over
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
2021-306482-P01-RST
21-012020
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

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


Exclusion Criteria:

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

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

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

Location Contacts
Mayo Clinic — Rochester, MN