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

3290 Study Matches

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Impact of General Anesthesia vs. Moderate Sedation on Cognitive Function After LAOO: An Observational Study

Impact Of General Anesthesia Vs Moderate Sedation On Cognitive Function After LAAO

Mohamad Adnan Alkhouli
All
50 years and over
This study is NOT accepting healthy volunteers
2022-307407-H01-RST
22-002761
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Inclusion Criteria:

  • Men and women ≥ 50 years of age.
  • The patient has met eligibility criteria and is planned to undergo LAAO with the WATCHMAN FLX device as part of clinical care.
  • The patient is able and willing to undergo non-invasive cognitive testing using the Viewmind headset by a trained personal.
  • The patient is able to give informed consent for the procedure.


Exclusion Criteria:

  • The patient unwilling or unable to complete cognitive testing using the specialized virtual reality googles.
  • Primary language is not English.

Eligibility last updated 3/11/22. Questions regarding updates should be directed to the study team contact.

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Artificial Intelligence Enhanced Assessment of Speech Disorders: Prospective Data (NAIP-Speech)

Artificial Intelligence Enhanced Assessment of Speech Disorders

Hugo Botha
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307409-H01-RST
22-002430
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Inclusion Criteria:

  • Adult (18 years or older).
  • Able to provide informed consent 
  • Able to provide samples in English.
  • U.S. based patient.


Exclusion Criteria:

  • Age < 18 years of age.
  • Unable to provide samples in English (i.e., need for interpreter flag in Epic).
  • Nonverbal / No speech.
  • HPP (High Profile Patient) status.
  • International patient.

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

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A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations

A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

Zhaohui Jin
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307410-P01-RST
22-002140
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Inclusion Criteria:


- Provide written informed consent prior to initiation of any study-specific procedures

- Advanced stage solid tumor

- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of
tumor tissue or ctDNA

- Measurable or evaluable disease according to RECIST v1.1

- ECOG performance status 0 or 1

- Adequate organ function, as measured by laboratory values (criteria listed in
protocol)

- Able to swallow, retain, and absorb oral medications


Exclusion Criteria:


- Known clinically-active or clinically-progressive brain metastases from non-brain
tumors

- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic
mineralization or calcification, or corneal or retinal disorder/keratopathy

- GI tract disease causing an inability to take oral medication, malabsorption syndrome,
requirement for intravenous alimentation, or uncontrolled inflammatory GI disease

- Active, uncontrolled bacterial, fungal, or viral infection

- Women who are lactating or breastfeeding, or pregnant

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

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

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A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated and Decompensated Cirrhotic Patients (PharmaIN)

A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated Cirrhotic Patients

Douglas Simonetto
All
18 years to 70 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-307414-P01-RST
22-002190
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Inclusion Criteria:


1. Body mass index within the range 18 to 40 kg/m2 (inclusive) at screening.

2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using
highly efficient contraception for the full duration of the study.

3. Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or
reliable Fibroscan >15 kPa at screening.


Exclusion Criteria:


1. Significant abnormalities in medical history or on physical examination, including:
respiratory disease requiring therapy or history of respiratory failure,
cardiovascular disease or hypertension, electrocardiogram abnormalities or history of
significant EKG abnormalities.

2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone
secretion, or any other disorder associated with fluid or sodium imbalance.

3. Significant kidney disease

4. Estimated glomerular filtration rate (eGFR by CKD-Epi) <60 ml/min/1.73 m2 or Cr >2.0
mg/dL.

5. Hepatic encephalopathy ≥ grade 1.

6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).

7. Known positive HIV serology confirmed by HIV viral load.

8. Patients with acute hepatitis B; patients with known chronic hepatitis B are eligible
if treatment regimen is not changed in the 4 weeks prior to study inclusion

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

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

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A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) (HER2CLIMB-05)

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Ciara O'Sullivan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307417-P01-RST
22-002198
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Inclusion Criteria:

  • Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines.
  • Have unresectable locally advanced or metastatic disease.
  • If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease.
  • Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression.
  • Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-]).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -CNS Inclusion.
  •  Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following:
    • No evidence of brain metastases;
    • Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane;
    • Previously treated brain metastases which are asymptomatic;
    • Brain metastases previously treated with local therapy must not have progressed since treatment.


Exclusion Criteria:

  • Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug).
  • Unable to undergo contrast MRI of the brain -

CNS Exclusion:

  • Based on screening brain MRI and clinical assessment.
  • Symptomatic brain metastasis.
  • Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane.
  • Ongoing use of systemic corticosteroids at a total daily dose of > 2 mg of dexamethasone (or equivalent).
  • Any untreated brain lesion in an anatomic site which may pose risk to participant.
  • Known or suspected leptomeningeal disease (LMD).
  • Poorly controlled (> 1/week) seizures, or other persistent neurologic symptoms.

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other
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A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma (CLN-PRO-V005)

Humacyte’s Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients with Life or Limb-threatening Vascular Trauma

Todd Rasmussen
All
14 years to 85 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-307421-P01-RST
22-001156
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Inclusion Criteria:

  • Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction.
  • Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
  • Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g., because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization.
  • Aged 18 to 85 years old, inclusive.
  • Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures.
  • Patient or relative is able, willing and competent to give informed consent.
  • Life expectancy of at least 1 year.


Exclusion Criteria:

  • Mangled Extremity Severity Score (MESS) of ≥ 7.
  • Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury).
  • Catastrophic injuries that make survival unlikely (e.g., Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) > 60).
  • HAV may not be used for coronary artery repair.
  • Known pregnant women.
  • Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries.
  • Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV.
  • Previous exposure to HAV.
  • Known participation in any investigational study within the last 30 days.
  • Employees of the sponsor or patients who are employees or relatives of the investigator.

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

Drug, Procedure/Surgery
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A Phase 0/Ia Study of BI 907828 Concentrations in Brain Tissue and a Non-randomized Open-label, Dose- escalation Study of BI 907828 in Combination with Radiotherapy in Patients with Newly-diagnosed Glioblastoma (BI 1403-0007)

A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma

Jann Sarkaria
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307429-P01-RST
22-002233
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Inclusion Criteria
•Main Phase 0:

  • Histologically (if prior biopsy) or radiologically diagnosed glioblastoma.
  • Eligible for neurosurgical tumor resection.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Inclusion Criteria
•Main Phase Ia:

  • Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated MGMT promoters (Glioblastoma definition according to 2021 WHO Classification of CNS tumors; i.e., IDH-wild type only).
  • Patient has undergone neurosurgical tumor resection and is eligible for standard radiotherapy.
  • Formalin-fixed paraffin-embedded tumor blocks or representative H/E (haematoxylin/eosin) slides (preferably both) must be available for retrospective histopathological central review.
  • Locally performed histopathological diagnosis will be accepted for entry into this trial.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Exclusion Criteria
•Main Phase 0:

  • Known TP53 mutant glioblastoma.
    • Note: testing is not mandatory for inclusion.
  • Known IDH mutant grade IV astrocytoma.
    • Note: testing is not mandatory for inclusion.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

Exclusion Criteria
•Main Phase Ia
:

  • Patients who have received previous systemic therapy (with the exception of patients who participated in Phase 0) or radiotherapy for glioblastoma.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

Eligibility last updated 3/1/22. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
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A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors (CGT9486-21-301)

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Thanh Ho
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307438-P01-RST
22-002700
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Inclusion Criteria:


1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST

2. Documented disease progression on or intolerance to imatinib

3. Have at least 1 measurable lesion according to mRECIST v1.1

4. ECOG
•0 to 2

5. Have clinically acceptable local laboratory screening results (clinical chemistry and
hematology) within certain limits


Exclusion Criteria:


1. Prior treatment with < 2 Tyrosine Kinase Inhibitors (TKIs) (Part 1b only)

2. Prior treatment with any TKI other than imatinib (Part 2 only)

3. Known PDGFR alpha D842V mutation or known succinate dehydrogenase deficiency

4. Clinically significant cardiac disease

5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study
drug

6. Gastrointestinal abnormalities including, but not limited to, significant nausea and
vomiting, malabsorption, external biliary shunt, or significant bowel resection that
would preclude adequate absorption

7. Any active bleeding excluding hemorrhoidal or gum bleeding

8. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis
C virus (HCV) antibody.

9. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening

10. Received strong CYP3A4 inhibitors or inducers

11. Received sunitinib within 3 weeks (Part 1a, Part 1b)

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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II) (COSIRA-II)

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

Amir Lerman
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307440-P01-RST
22-001671
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Inclusion Criteria:

  • Subject is older than 18 years of age.
  • Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy.
  • Must have attempted treatment with the maximally tolerated dose of at least three of the four (and preferably all four) approved classes of anti-anginal agents:
    • long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for greater than 2 months prior to enrollment, with no intent to change the medical regimen for at least 12 months after randomization.
  • Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization.
  • Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR, iFR, or other non-hyperemic FDA approved tests in the distribution of the left coronary artery (LCA). Note: if the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution.
  • Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 8 minutes:
    • Subject has ETT variability less than 20% between last two ETTs performed.
  • Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to procedure (must be reassessed after any intervening myocardial infarction); the most recent LVEF assessment is used as the qualifying test.
  • Subject is willing and able to sign informed consent.
  • Subject is willing to comply with the specified follow-up evaluations.


Exclusion Criteria:

  • Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI).
  • Recent successful revascularization by CABG or PCI within six months prior to enrollment.
  • Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30 days prior to enrollment.
  • The predominant manifestation of angina is dyspnea .
  • Has extra-coronary contributory causes of angina; e.g., untreated hyperthyroidism, anemia (hgb < 10 g/dL), uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently >100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), etc.
  • NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment.
  • Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker.
  • Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids.
  • Severe valvular heart disease (any valve).
  • Moderate or severe RV dysfunction by echocardiography.
  • Pacemaker electrode/lead is present in the coronary sinus.
  • A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines.
  • Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment.
  • Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or subjects on chronic dialysis.
  • Known allergy to stainless steel or nickel.
  • Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of randomization, etc.).
  • Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures.
  • Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the randomization procedure).
  • Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
  • Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant.
  • Comorbidities limiting life expectancy to less than one year.

Eligibility last updated 4/15/22. Questions regarding updates should be directed to the study team contact.

Device, Procedure/Surgery
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Mayo Clinic Digital Menopause Management Study

Testing of a Menopause Management Digital Health Application

Ekta Kapoor
Female
45 years to 60 years old
This study is NOT accepting healthy volunteers
2022-307444-H01-RST
22-001795
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Inclusion Criteria:

  • Adult postmenopausal women, aged 45-60 years.
  • Menopause symptoms (hot flashes/night sweats) rated moderate or greater or total MRS score ≥ 14.


Exclusion Criteria:

  • Current use of hormone therapy.

Eligibility last updated 3/10/22. Questions regarding updates should be directed to the study team contact.

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Tiered Inpatient Telemetry - Validation

Tiered Inpatient Telemetry

Peter Noseworthy
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307454-H01-RST
22-003171
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Inclusion Criteria:

  • Age 18+.
  • Capable of consenting.
  • Actively being monitored on Philips inpatient telemetry.


Exclusion Criteria:

  • Under the age of 18.
  • Unable to consent.
  • Pregnant patients.

Eligibility last updated 4/21/22. Questions regarding updates should be directed to the study team contact.

 

 

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A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

GB5121 in Adult Subjects With Relapsed/Refractory CNS Lymphoma

Arushi Khurana
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-307457-P01-RST
22-002304
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Inclusion Criteria:


1. Patients must have histologically/cytologically confirmed primary central nervous
system lymphoma (PCNSL), primary vitreoretinal lymphoma (PVRL), or CNS-only
involvement of a systemic B-cell lymphoma.

2. All patients must have relapsed/refractory disease and must have received all possible
standard-of-care CNS-directed therapy treatment regimens or patients for which further
standard-of-care treatment options are contraindicated or declined.

3. Patients must be able to tolerate gadolinium-enhanced magnetic resonance imaging (MRI)
scans, or contrast-enhanced computed tomography (CT).

4. Patients with parenchymal lesions must have baseline imaging (gadolinium-enhanced MRI
or if contraindicated, contrast-enhanced CT, of the brain) within 28 days prior to
first study drug dose. For patients with leptomeningeal disease only, cerebrospinal
fluid (CSF) cytology must document lymphoma cells and/or imaging findings consistent
with leptomeningeal disease after informed consent and prior to first study dose (at
the discretion of the Investigator).

5. Patients with parenchymal lesions must have measurable disease (disease that has at
least one lesion on imaging ≥ 10 mm in the longest diameter) on imaging
(gadolinium-enhanced MRI or if contraindicated, contrast-enhanced CT, of the brain)
prior to first study dose.

6. Patients must be able to tolerate and consent for a lumbar puncture and/or have
pre-existing placement of an Ommaya reservoir, unless clinically contraindicated.

7. Patients must have a performance status of 0, 1, or 2 on the Eastern Cooperative
Oncology Group (ECOG) Performance Scale.

8. Demonstrate adequate bone marrow and organ function.


Exclusion Criteria:


1. Patients are concurrently using other approved or investigational antineoplastic
agents.

2. Patients have an active concurrent malignancy requiring active therapy.

3. Patients are allergic to components of the study drug.

4. Patients have a known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.

5. Patients who require therapeutic anticoagulation, including dual antiplatelet agents.
Patients who have received therapeutic anticoagulation, including dual antiplatelet
agents, within 5 half-lives of the anticoagulant or 14 days, whichever is longer,
prior to starting the study drug. Patients who require the use of antiplatelet agents
should be discussed with the Sponsor's Medical Monitor.

6. Patients have significant abnormalities on screening electrocardiogram (ECG) and
active and significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, uncontrolled hypertension, valvular disease,
pericarditis, or myocardial infarction within 6 months of screening.

7. Patients with any of the following will be excluded:

1. A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of
a QTc interval > 480 ms [CTCAE grade 2]) using Frederica's QT correction formula.

2. A history of additional risk factors for Torsades de Pointes (eg, heart failure,
hypokalemia, family history of long QT syndrome).

3. The use of concomitant medications that prolong the QT/QTc interval.

8. Patients are known to have a history of active or chronic infection with hepatitis C
virus (HCV), hepatitis B virus (HBV), as determined by serologic tests.

9. Known history of infection with human immunodeficiency virus (HIV).

10. Patients are known to have an uncontrolled active infection.

11. Patients have a history of stroke or intracranial hemorrhage within 6 months prior to
enrollment.

12. Patients have a life-threatening illness, medical condition, or organ system
dysfunction that, in the opinion of the Investigator, could compromise the subject's
safety or put the study outcomes at undue risk.

13. Women who are pregnant or nursing (lactating).

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

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

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REstrictive versus LIberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury ( RELIEVE-AKI)

REstrictive versus LIberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (RELIEVE-AKI)

Kianoush Banaei Kashani
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307471-H01-RST
22-002673
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Stage 3 acute kidney injury according to the KDIGO criteria.
  • Started or intending to start CKRT for volume management.
  • Attending intensivist or nephrologist intending to remove fluid using CKRT for at least 48 hours.


Exclusion Criteria:

  • Respiratory distress due to pulmonary edema or fluid overload.
  • Massive volume infusion (i.e., > 200 mL/h for > 6 hours of continuous infusion).
  • No intention to remove fluid as determined by attending intensivist or nephrologist.
  • Attending intensivist or nephrologist believes that the protocol will not be followed.
  • Continuous fluid removal for > 24 hours prior to study enrollment.
  • Actual or estimated premorbid body weight > 120 kilograms.
  • Patients treated with intermittent hemodialysis during the current admission.
  • Patients on chronic outpatient hemodialysis. 
  • Patients with history of, or current admission for kidney transplantation.
  • Do not resuscitate, intubate, or comfort measures only orders (i.e., DNR/DNI/CMO).
  • Moribund not expected to survive > 24 hours.
  • Confirmed pregnancy.
  • Patients treated with extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or intra-aortic balloon pump (IABP).
  • Organ donors with neurological determination of death (i.e., brain dead donors).
  • Drug overdose requiring CKRT.
  • Enrollment in a concurrent interventional clinical trial with direct impact on fluid balance (e.g., > 500 mL study drug administration).

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

Continuous renal replacement therapy, Procedure/Surgery
Acute kidney injury
Acute renal failure syndrome, Continuous renal replacement therapy
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

William Hogan
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307504-P01-RST
22-002478
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Inclusion Criteria:


1. Is willing and able to provide written informed consent/assent and to comply with all
protocol procedures and assessments required for the study.

2. Is age ≥ 12 years and > 40kg at informed consent/assent.

3. Has had an initial allogeneic HSCT for any indication using any graft source, donor
source, conditioning regimen intensity or prophylaxis.

4. Has evidence of myeloid engraftment

5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based
on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.

6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of
study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day


Exclusion Criteria:


1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy,
with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the
breast.

2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after
HSCT.

3. Evidence of persistent molecular disease requiring treatment that was not specified
prior to HSCT.

4. Evidence of cGVHD or overlap syndrome

5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.

6. Use of any systemic corticosteroids of > 0.5 mg/kg/day methylprednisolone or equivalent
for any indication other than aGVHD within 7 days before the onset of aGVHD.

Eligibility last updated 7/19/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug
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A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

A Trial to Investigate Long Term Effectiveness and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Irina Bancos
All
23 years to 81 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-307528-P01-RST
22-009082
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Inclusion Criteria:


- Signing of the trial specific informed consent.

- Completion of the treatment period and Visit 7 assessments of trial TCH-306, including
collection and upload of Visit 7 DXA scan.

- Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial
hypertension or diabetic retinopathy stage 2 / moderate or above.


Exclusion Criteria:


- Diabetes mellitus if any of the following are met:

1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to
central laboratory at Visit 6 in trial TCH-306;

2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4
(DPP-4) inhibitors.

- Active malignant disease or history of malignancy. Exceptions are:

1. Resection of in situ carcinoma of the cervix uteri;

2. Complete eradication of squamous cell or basal cell carcinoma of the skin.

- Known history of hypersensitivity and/or idiosyncrasy to the investigational product
(somatropin or excipients).

- Female who is pregnant, plans to become pregnant, or is breastfeeding.

- Female participant of childbearing potential (i.e., fertile, following menarche and
until becoming post-menopausal unless permanently sterile) not willing throughout the
trial to use contraceptives as required by local law or practice.

- Male participant not willing throughout the trial to use contraceptives as required by
local law or practice. 

- Any disease or condition that, in the judgement of the investigator, may make the
participant unlikely to comply with the requirements of the protocol or any condition
that presents undue risk from the investigational product or trial procedures.

Eligibility last updated 3/31/22. Questions regarding updates should be directed to the study team contact.

Drug
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Methodology for Examining Elements in the Physical Environment Impacts on Fatigue and Resilient Performance

Examining Elements in the Physical Environment Impacts on Fatigue and Resilient Performance

Renaldo Blocker
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307534-H01-RST
22-002563
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Inclusion Criteria:

  • Practicing physicians, nurses and allied health staff that participate in surgery process.   


Exclusion Criteria:

  • Physicians, Nurses and allied health staff that do not have time to participate in the study.

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

 

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The MCSA Sleep Study: Investigating Associations Between Sleep Characteristics, Cognitive Function, Alzheimer’s Disease and Vascular Pathology Biomarkers in Participants in the Mayo Clinic Study of Aging (MCSA)

Sleep Characteristics, Cognitive Function, Alzheimer’s Disease and Vascular Pathology Biomarkers in Cognitively Unimpaired Older Adults

Diego Zaquera Carvalho
All
60 years and over
This study is NOT accepting healthy volunteers
2022-307554-H01-RST
22-002639
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Inclusion Criteria:

  • Age ≥ 60 years old at time of consent.
  • Concurrent enrollment in the Mayo Clinic Study of Aging (MCSA, IRB 14-004401):
    • Note: Participants may be but are not required to be concurrently enrolled in Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment and Dementia (PiB, IRB 08-005553).  
  •  Normal or mildly impaired cognition with CDR ≤ 1.0.


Exclusion Criteria:
 

  • History of dementia or major neurological condition (i.e., non-lacunar stroke, TBI, epilepsy, tumor, CNS infection, demyelinating disease, neurodegenerative disease), severe autonomic failure (pure autonomic failure or autonomic neuropathy), major psychiatric disease (i.e., alcohol/drug abuse and schizophrenia), 
  • Current treatment of OSA. Diagnosed but untreated OSA is acceptable.
  • Use of short-acting nitrates within 3 hours of the sleep study.
  • Use of selective α1-adrenergic receptor antagonists, for example, tamsulosin (Flomax®), doxazosin (Cardura®), prazosin (Minipress®), and terazosin (Hytrin®) and nonselective α1 and α2 blockers (pentholamine and phenoxybenzamine).
  • Finger deformity that precludes adequate sensor application.
  • Placement of a permanent pacemaker.
  • Persistent atrial fibrillation or other sustained non-sinus cardiac arrhythmias.
  • Severe peripheral vascular disease (e.g., status post stent or by-pass surgery in one of the limbs, faint/absent pulses).
  • Status post bilateral cervical or thoracic sympathectomy.
  • Acute lung or heart disease (e.g., decompensated COPD or heart failure).

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.

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SGNTUC-029 - An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)

Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Joleen Hubbard
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307572-P01-RST
22-002828
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Inclusion Criteria:


- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum
which is metastatic and/or unresectable

- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE)
tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment
initiation to a central laboratory

- If archival tissue is not available, a newly-obtained baseline biopsy of an
accessible tumor lesion is required within 35 days prior to start of study
treatment

- HER2+ disease as determined by a tissue based assay performed at a central laboratory.

- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as
determined by local or central testing

- Radiographically measurable disease per RECIST v1.1 with:

- At least one site of disease that is measurable and that has not been previously
irradiated, or

- If the participant has had previous radiation to the target lesion(s), there must
be evidence of progression since the radiation

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- CNS Inclusion
•based on contrast brain magnetic resonance imaging, participants may
have any of the following:

- No evidence of brain metastases

- Previously treated brain metastases which are asymptomatic


Exclusion Criteria:


- Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic
setting

- May have received chemotherapy for CRC in the adjuvant setting if it was
completed >6 months prior to enrollment

- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting
of stereotactic radiosurgery)

- Previous treatment with anti-HER2 therapy

- Ongoing Grade 3 or higher neuropathy

- GI perforation within 12 months of enrollment

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The Burden of Respiratory Syncytial Virus Disease in Adults with High-Risk Conditions in North American Communities: A Community-Based Prospective Case-Cohort Study

Respiratory Syncytial Virus Disease in Adults with High-Risk Conditions in North American Communities

Young Juhn
All
18 years to 64 years old
This study is NOT accepting healthy volunteers
2022-307626-H01-RST
22-003660
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Inclusion Criteria:

  • Southeast Minnesota (SEMN, covering MCR and MCHS vicinities), Southwest Wisconsin (SWWI, covering MCR and MCHS vicinities), Florida (covering Jacksonville FL region) and Arizona (covering Scottsdale AZ region) residents (residency established at least one year prior to consent).
  • Aged 18- 64 years at the time of consenting.
  • Those who have primary care physician at Mayo Clinic and had at least one visit to one of Mayo Clinic sites within 3 years prior to the study index date.
  • Those who authorize use of their medical record for research (MN only).
  • Those who provide written consent to participate in the study.


Exclusion Criteria:

  • Subjects without authorization for use of medical records for research.
  • Those who do not reside in catchment areas served by MCR/MCHS, MCF, and MCA.
  • Those who receive primary care at a non-Mayo medical facility.
  • Those who develop ARI after October 1st, 2022, if consent is done between October 1st, 2022, and November 30th, 2022.
  • Those who refuse swab test.
  • Those who cannot ambulate or those who are bedridden.
  • Those with known cognitive impairment.
  • Those who reside out of their resident counties > 2 weeks during winter season (Oct-April) and/or >4 weeks during summer season (May-Sep).
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Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU

Power of Technology to Transform Delirium Severity Measurement in the ICU

Heidi Lindroth
All
50 years and over
This study is NOT accepting healthy volunteers
2022-307655-H01-RST
22-003098
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Inclusion Criteria:

Aim 1-3 Patient Participants

  • Age ≥ 50 years old;
  • Estimated length of stay ≥ 24 hours in ICU; and
  • Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.

Aim 3 Nurse Clinician Participants

  • Age ≥ 18 years old;
  • Employed by Mayo Clinic;
  • Assigned to care for study patient for > 4 hours.

Aim 3 Care Partner Participants

  • Age ≥ 18 years old;
  • Proxy decision maker for patient participant;
  • Willing to complete survey (verbal consent).


Exclusion Criteria:

 

Aim 1-3 Patient Participants

  • Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal;
  • Admitted for acute neuronal injury;
  • Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf); or
  • Language (does not speak English).

Aim 3 Nurse Clinician Participants

  • Not assigned to study patient.

Aim 3 Care Partner Participants

  • Did not visit patient in ICU during study period;
  • Already listed above in previous protocol version, was not copied/mentioned here.

Eligibility last updated 12/1/22. Questions regarding updates should be directed to the study team contact.

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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (EPICS-III)

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

John Eaton
All
18 years to 75 years old
Phase 2/3
This study is NOT accepting healthy volunteers
2022-307656-P01-RST
22-003097
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Inclusion Criteria:


1. Males or females, between 18 and 75 years of age, both inclusive at screening.

2. Subjects on Ursodeoxycholic acid (UDCA) for at least 12 months at a therapeutic dose
(at least 13 mg/kg per day) and a stable dose for 6 months prior to Screening Visit
and having ALP ≥ 1.67 x ULN.

OR Subjects who are unable to tolerate UDCA and did not receive UDCA for at least 3
months prior to the date of screening and having ALP ≥ 1.67 x ULN.

3. History of confirmed PBC diagnosis, based on American Association for the Study of
Liver Disease [AASLD] and European Association for Study of the Liver [EASL] Practice
Guidelines, as demonstrated by the presence of at least ≥ 2 of the following 3
diagnostic factors:

1. History of elevated ALP levels for at least 6 months prior to screening

2. The subjects should have positive anti-mitochondrial antibodies (AMA) titer OR if
AMA is negative or in low titer (< 1:80), then the subjects should have PBC
specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the
major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])

3. Liver biopsy consistent with PBC

4. ALP ≥ 1.67 x ULN at both Visits 1 and 2 and with < 30% variance between the levels
from Visit 1 to Visit 2

5. Total bilirubin < 2 x ULN at screening (Visit 1)

6. Must provide written informed consent and agree to comply with the trial protocol


Exclusion Criteria:


1. Consumption of 2 standard alcohol drinks per day if male and 1 standard alcohol drink
per day if female for at least 3 consecutive months (12 consecutive weeks) within 5
year before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce
of spirits/hard liquor).

2. History or presence of other concomitant liver diseases at screening:

1. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: However, If the
subject has been treated for the HCV infection and has been cured for a duration
of more than 2 years from screening, such subjects can be enrolled in the study)

2. Primary sclerosing cholangitis (PSC).

3. Alcoholic liver disease.

4. Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome.

Note: The Paris criteria are commonly used to define the presence of PBC with
features of AIH and have been endorsed by EASL and AASLD. According to these
criteria, a diagnosis can be made in a patient with PBC as follows:

At least two of the following:

I. ALP > 2 x ULN or GGT > 5 x ULN. II. AMA > 1:40. III. Florid bile duct lesion
on histology. AND

At least two of the following three features:

I. ALT > 5 x ULN. II. Immunoglobulin G serum levels > 2 x ULN or smooth muscle
autoantibody positive.

III. Moderate to severe interface hepatitis on histology.

5. Hemochromatosis.

6. Non-alcoholic steatohepatitis (NASH) on historical biopsy.

3. Cirrhosis with complications, including history or presence of: spontaneous bacterial
peritonitis, hepatocellular carcinoma, encephalopathy, known large esophageal varices
or history of variceal bleeding and active or history of hepatorenal syndrome at
screening.

4. Clinically silent compensated cirrhosis (at screening), defined as (a) nodular liver
contour by abdominal imaging with at least one sign of liver dysfunction (> ULN INR or
< LLN serum albumin); or (b) prolonged INR (> ULN) and diminished albumin (< LLN); or
(c) platelet count <140x109/L with INR > ULN or serum albumin < LLN.

5. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
or which may diminish life expectancy to < 2 years, including known cancers.

6. Use of thiazolidinediones or fibrates (within 12 weeks prior to screening).

7. Use of obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate,
mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (Note:
Prednisone dose should not be more than 10 mg per day); potentially hepatotoxic drugs
(including ?-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within
12 weeks prior to screening).

8. Use of drugs that are known CYP2C8 inhibitors/substrate within 4 weeks prior to
screening (refer to Appendix 7 for List of Known CYP2C8 Inhibitors/Substrate).

9. History of bowel surgery (gastrointestinal [bariatric] surgery in the preceding 1 year
or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity,
extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for
OLT.

10. Type 1 diabetes mellitus.

11. Unstable cardiovascular disease, including:

1. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in
the 12 weeks before screening and throughout the Screening Period), acute
coronary syndrome in the 24 weeks before screening and throughout the Screening
Period, acute myocardial infarction in the 12 weeks before screening and
throughout the Screening Period or heart failure of New York Heart Association
class (III
•IV) or worsening congestive heart failure, or coronary artery
intervention, in the 24 weeks before screening and throughout the Screening
Period.

2. History/current unstable cardiac dysrhythmias.

3. Uncontrolled hypertension at screening.

4. Stroke or transient ischemic attack in the 24 weeks before screening.

12. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder,
coagulation disorders, or screening blood tests that, in the opinion of the
Investigator, indicate altered coagulability (e.g., PT, INR, aPTT) at screening.

13. An uncontrolled thyroid disorder

1. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has
either not been treated with either radioactive iodine and/or surgery or that has
been treated with radioactive iodine and/or surgery, but has required ongoing
continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e.,
methimazole or propylthiouracil) in the 24 weeks before screening.

2. Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement
therapy or dose adjustment of replacement therapy in the 12 weeks before
screening.

14. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 x
ULN at screening.

15. Subjects whose ALT, AST, or ALP exceeds by more than 50% on Visit 2 reading compared
to Visit 1. Note: If the ALT, AST, or ALP values on Visit 2 exceed by more than 50%
from Visit 1, then a third value will be measured (within 1- 2 weeks) to assess for
the trend. If the third value shows continued increase ≥ 10%, then subject is
considered ineligible for randomization.

16. Any of the following laboratory values at screening:

1. Platelets < 100 × 109/L

2. Albumin < 3.2 g/dL

3. eGFR < 60 mL/min/1.73 m2

4. ALP > 10 x ULN

5. ALT or AST > 250 U/L

17. Participation in another interventional clinical study and receipt of any other
investigational medication (within 12 weeks prior to randomization up to end of
study).

18. History of malignancy in the past 5 years and/or active neoplasm with the exception of
resolved superficial non-melanoma skin cancer.

19. Contraindications to Saroglitazar Magnesium or has any conditions affecting the
ability to evaluate the effects of Saroglitazar Magnesium.

20. Known allergy, sensitivity, or intolerance to the study drug, comparator, or
formulation ingredients.

21. Pregnancy-related exclusions, including:

1. Pregnant/lactating female (including positive pregnancy test at screening).

2. Fertile women and men, UNLESS using effective contraceptive methods (such as an
intra-uterine device or other mechanical contraception method with condom or
diaphragm and spermicide) throughout the study. For male subjects, contraception
measures (condom and spermicide) must be taken during the study, either by the
male participant or his female partner. (Note: Enrolled females otherwise must be
surgically sterilized for at least 24 weeks before screening or postmenopausal,
defined as 52 weeks with no menses without an alternative medical cause or
following sexual abstinence.)

22. History or other evidence of severe illness or any other conditions that would make
the subject, in the opinion of the Investigator, unsuitable for the study (such as
poorly controlled psychiatric disease, HIV, coronary artery disease, or active
gastrointestinal conditions that might interfere with drug absorption).

Drug, Other
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CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)

CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung (DELFI-L201)

David Midthun
All
50 years to 80 years old
This study is NOT accepting healthy volunteers
2022-307659-P01-RST
22-003100
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Inclusion Criteria:

  • Ability to understand and provide written informed consent.
  • Age ≥ 50 years and ≤ 80 years.
  • Current or former smoker.
  • ≥ 20 pack-years (pack years = number of packs per day × number of years smoked).
  • An initial or annual lung cancer screening chest CT..


Exclusion Criteria:

  • Evidence of any cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ (transitional cell carcinoma in situ and bladder carcinoma in situ are exclusionary) within 2 years prior to enrollment
  • Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies).
  • Any history of hematologic malignancies or myelodysplasia.
  • Any history of organ tissue transplantation.
  • Any history of blood product transfusion within 120 days prior to enrollment.
  • Current pregnancy.
  • Any condition that in the opinion of the Investigator should preclude the participant’s participation in the study.

Eligibility last updated 8/2922. Questions regarding updates should be directed to the study team contact.

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Precision Promise Platform Trial for Metastatic Pancreatic Cancer

A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

Robert McWilliams
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307671-P01-RST
22-003163
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Inclusion Criteria:

- Age ≥ 18 years.

- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) and eligible for treatment in the first line or second line settings.

- Acceptable histologies include adenosquamous carcinoma, mucinous adenocarcinoma, hepatoid carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated
carcinoma, and undifferentiated carcinoma with osteoclast-like-cells, and adenocarcinoma. Pancreatic neuroendocrine tumors (PNET) are excluded.

o Note: prior adjuvant or neoadjuvant chemotherapy is permitted if the last dose was > 12 months prior to the diagnosis of metastatic disease.

- Radiographically measurable disease of at least one site by computed tomography (CT) scan (or magnetic resonance imaging, if allergic to CT contrast media) as defined by
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 21-day window, prior to randomization.

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

- Adequate organ function (lab results must be obtained within the 21-day window prior to randomization)

- Absolute neutrophil count ≥ 1500/mm^3.

- Hemoglobin ≥ the lower limit of normal (LLN) or 9g/dL.

- Platelets ≥ 100,000/mm^3.

- Serum creatinine ≤ 1.0 x upper limit normal (ULN), or calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault).

- Albumin ≥ 3.0 g/dL.

- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN (up to ≤ 5 x ULN in presence of liver metastasis).

- Total bilirubin ≤ 1.5 x ULN.

- INR ≤ 1.5 x ULN (up to ≤ 2 x ULN for subjects on anticoagulation therapy).

- Subjects must be willing to provide protocol-mandated tissue and blood samples for diagnostic and research purposes as a condition of enrollment into the trial.

- Able to swallow pills, capsules or tablets.

- Able to adhere to study visit schedule and other protocol requirements.

- Females of childbearing potential [defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy
(the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the
preceding 24 consecutive months)] must:

- Have a negative serum or urine pregnancy test (?-human chorionic gonadotropin [?-hCG]) as verified by the study doctor within 14 days prior to randomization;

- Commit to complete abstinence from heterosexual contact or agree to use medical doctor-approved contraception throughout the study without interruption while receiving study treatment and for at least 6 months following last dose of study treatment.

- Males must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with a pregnant female or a
female of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.

- HIV-infected subjects on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HIV viral load test should be performed at screening and be negative (i.e., undetectable).

- HBV-infected subjects are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HBV viral load test should be performed at screening and be negative (i.e., undetectable).

- Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured. Subjects with HCV infection who are currently on treatment are eligible if
the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HCV viral load test should be performed at screening and be negative (i.e., undetectable).

- Subjects with a history of brain metastases are eligible provided they show evidence of stable lesions (and no new lesions) with no evidence of tumor progression for at
least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. In addition, any neurological
symptoms that developed either as a result of the brain metastases or their treatment, must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed > 7 days prior to the first dose of trial therapy.

- No known leptomeningeal disease.

- Subjects with a prior or concurrent malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational
regimen are eligible. Subjects receiving any active therapy for a concurrent secondary malignancy are excluded.

- Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using New York Heart Association Functional Classification. To be eligible for this trial, subjects should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.

- Understands the nature of the study and has agreed to participate by voluntarily signing the IRB approved informed consent.


Exclusion Criteria:


- Received any therapy within 21 days (or 5 half-lives, whichever is shorter,) prior to randomization.

- Has had major surgery within 14 days prior to enrollment.

- History of known allergy or hypersensitivity to any of the study treatments or any of their excipients or contraindication to any of the study treatments as outlined in the
local prescribing information (e.g., United States Prescribing Information [USPI]).

- Pre-existing peripheral neuropathy > Grade 1, as defined by CTCAE V 4.03.

- Known active tuberculosis infection.

- Serious, non-healing wound, ulcer, bone fracture, or abscess.

- The inability to swallow pills, capsules or tablets.

- Subjects who received a combination of two investigational agents as part of first-line therapy (novel + novel) are excluded. Subjects who received one investigational agent or one investigational agent combined with an FDA approved
chemotherapy regimen in first line will be allowed to be enrolled in Precision PromiseSM for second line therapy.

- Receiving any active therapy for a concurrent secondary malignancy. Subjects with a prior or concurrent malignancy whose natural history does not have the potential to
interfere with the safety or efficacy assessment of the investigational regimen are eligible.

- History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
hypersensitivity pneumonitis or multiple allergies.

- QTc > 450 msec if male and QTc > 470 msec if female.

- Uncontrolled or severe cardiac disease (history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the prior 6 months), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia
[including atrial flutter/fibrillation].

- Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using New York Heart Association Functional Classification. Subjects worse than Class 2 are excluded. Class 2 is defined as slight limitation of physical
activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.

- Active, uncontrolled infections (bacterial, viral, or fungal infection(s)) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment (i.e., subjects must be afebrile for > 48 hours off antibiotics).

- Active, known or suspected autoimmune disease, including systemic lupus erythematosus, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or autoimmune hepatitis.

o Subjects with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible to participate.

- Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications. Subjects receiving replacement therapy of 10 mg of prednisone (or the equivalent hydrocortisone dose) per day are eligible.

- Receipt of live vaccines within 30 days prior to the first dose of study treatment or while on active treatment within the trial. (examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza
vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted).

- Any significant medical condition, laboratory abnormality or psychiatric illness that would limit the subject's ability to comply with study requirements.

- Subjects that discontinued previous treatment for pancreatic adenocarcinoma due to a treatment-related Grade 3 toxicity.

- For toxicity discontinuations < Grade 3, AE(s) must resolve to Grade 1 or baseline in order to be considered eligible for this trial.

- Subjects that have received allogenic bone marrow or solid organ transplants are excluded.

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A Pilot Study to Investigate Non-Invasive Positive Pressure Ventilation on Oxygen Saturations without Supplemental Oxygen at Altitude

Non-Invasive Positive Pressure Ventilation on Oxygen Saturations without Supplemental Oxygen at Altitude

Bruce Johnson
All
18 years to 89 years old
This study is NOT accepting healthy volunteers
2022-307677-H01-RST
22-003189
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Inclusion Criteria:

  • Healthy male or female participants.
  • Between the ages of 18 and 89.
  • Must have had experience as a pilot or passenger in an unpressurized general aviation aircraft at altitudes above 8,000 feet and have not experienced any serious adverse effects from this experience (such as serious vertigo, loss of consciousness, any cardiac or respiratory dysfunction, or any other illness requiring medical treatment). 
  • Participants need to be able to complete cognitive tests.
  • Must be fluent in English.


Exclusion Criteria:

  • Patients < 18 years of age or > 89 years of age.
  • Pregnant women.
  • Unable to read and speak English.
  • History of Cardiac disease, Pulmonary disease, Cerebrovascular disease, Neurological disease, Vertigo, or Syncope.
  • Any documented incidences of Serious Adverse effects from General Aviation.
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Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Patient Outcomes after Hepatic Artery Infusion Pump Placement

Cornelius Thiels
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307678-P01-RST
22-003190
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Inclusion Criteria:

  • Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for localized unresectable liver metastases from colorectal cancer.
  • Age ≥ 18 years old.
  • Written consent.


Exclusion Criteria:

  • Age < 18 years old.
  • Absence of written consent.
  • Systemic disease.
  • Pregnancy.
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A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects with Glioblastoma Brain Tumors

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

Terence Burns
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-307691-P01-RST
22-003261
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Inclusion Criteria:

  • Male or female.
  • Between > 18-80 years of age.
  • Able and willing to give informed consent 
  • Subjects with a suspected glioblastoma tumor on pre-operative brain imaging scans.
  • Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care.
  • Karnofsky Performance Score > 70.
  • Able to communicate sensations during the Exablate BBBD procedure.


Exclusion Criteria:

  • Tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem.
  • Multifocal tumors.
  • MRI or clinical findings of:
    • Active or chronic infection(s) or inflammatory processes;
    • Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages;
    • Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis.
  • MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices.
  • Significant cardiac disease or unstable hemodynamic status:
    • Documented myocardial infarction within six months of enrollment;
    • Unstable angina on medication;
    • Unstable or worsening congestive heart failure;
    • Left ventricular ejection fraction below the lower limit of normal;
    • History of a hemodynamically unstable cardiac arrhythmia;
    • Cardiac pacemaker;
    • History of hypersensitivity to Perflutren lipid microsphere or its components; e.g., polyethylene glycol.
  • Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication).
  • Unable to discontinue use of anti-coagulant/antiplatelet therapy as per local standard.
  • History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding.
  • Abnormal coagulation profile (Platelets < 80,000), PT (> 14) or PTT (> 36), and INR > 1.3.
  • Known cerebral or systemic vasculopathy.
  • Significant depression and at potential risk of suicide.
  • Known sensitivity/allergy to gadolinium or DEFINITY®.
  •  Active seizures despite medication treatment (defined as > 1 seizure per week) which could be worsened by disruption of the blood brain barrier.
  • Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning.
  • Positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis.
  • Potential blood-borne infections which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess.
  • Any contraindications to MRI scanning, including:
    • Large subjects not fitting comfortably into the scanner;
    • Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia.
  • Impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73m^2.
  • Severe Respiratory Illness: chronic pulmonary disorders; e.g.,severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, subjects with a history of severe drug allergies, asthma or hay fever, and multiple allergies where the benefit/risk of administering Definity® is considered unfavorable by the study physicians in relation to the product labeling for Definity®.
  • Currently in a clinical trial involving an investigational product or non-approved use of a drug or device.
  • Pregnancy or lactation.
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Bipolar Disorder Measures in Clinical Care - Patient Preferences on Measures

Bipolar Disorder Measures in Clinical Care

William Leasure
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307697-P01-RST
22-003286
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Inclusion Criteria:

  • 18 years or older with a clinician diagnosis of bipolar disorder (any bipolar disorder type including bipolar I disorder, bipolar II disorder, cyclothymic disorder, and unspecified bipolar and related disorder).
  • Ability to consent to participation in research. 
  • Patients (n=10) will be recruited from those currently receiving treatment in the included clinics in the Mayo Clinic (Collaborating Institution). 
  • Additionally, stakeholder partners at the Depression and Bipolar Support Alliance will publicize our research study and identify 10-15 individuals with bipolar disorder currently receiving treatment to participate.


Exclusion Criteria:

  • Among participants recruited from the Mayo Clinic, individuals who are not intending to return to care in that system.
  • No exclusion criteria apply to participants recruited from the Depression and Bipolar Support Alliance.
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A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma (FAPI-46 PDAC)

Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma

Ajit Goenka
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307706-P01-RST
22-003295
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Inclusion Criteria:


1. Pathologically confirmed pancreatic ductal adenocarcinoma

2. Treatment-naïve

3. Staged as resectable or borderline-resectable

4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e.,
chemotherapy, radiation therapy, or combination) and subsequent possible surgical
resection

5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

6. Age ≥ 18 years

7. Completed informed consent as determined per the IRB of record


Exclusion Criteria:


1. Pregnant as determined by a pregnancy test as per institutional guidelines for
individuals of child-bearing potential

2. Declining to use effective contraceptive methods during the study (for individuals of
child-producing potential)

3. Need for emergent surgery that would be delayed by participation

4. Bacterial, viral, or fungal infections requiring systemic therapy

5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney
failure, liver failure, systemic or local inflammatory or autoimmune diseases or other
conditions) that in the opinion of the investigator, physician of record and/or Sofie
could compromise patient safety and/or protocol objectives.

6. Known diagnosis of autoimmune disorders

7. Patients receiving any other investigational agent within the past 28 days

8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits
to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of
the [68Ga]FAPI-46 injection.

9. Known hypersensitivity to any excipients used in [68Ga]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

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

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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Endocrine Therapy-Induced Alopecia Natural History Evaluation among Female Breast Cancer Survivors

Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia

Elizabeth Cathcart-Rake
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-307712-P01-RST
22-004341
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Registration
•Inclusion Criteria

  • Age ≥ 18 years
  • Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease).
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Filling into one of the 5 groups discussed in section 5.0 (understanding that groups will close once they complete their accrual goals of 30 patients.
  • Willingness to complete questionnaires every 3 months.
  • Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy).

Registration
•Exclusion Criteria

  • Verbal baseline alopecia ≥ 2 on an 11 point scale (from none=0 to severe=10).   The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss.
  • Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3).
  • Prior use of endocrine therapy for breast cancer.
  • Receipt of chemotherapy over the previous 6 months.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

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Detection of Diastolic Dysfunction Using Artificial Intelligence Applied to a Single Handheld Ultrasound Image

Diastolic Dysfunction Using Artificial Intelligence Applied to a Single Handheld Ultrasound Image

Patricia Pellikka
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307715-H01-RST
22-003324
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Inclusion Criteria:

  • Adult male and female, age from 18 years old.
  • Having signs and symptoms of HFpEF. HFpEF (EF ≥ 40%, PCWP at rest ≥15 mm Hg).
  • With 1, 2, 3 grades or indeterminate degree of DD (ACC/AHA stages C and D HF).


Exclusion Criteria:

  • Reduced Ejection Fraction (EF ≤ 39%), mitral valve prosthesis, mitral stenosis.

Eligibility last updated 9/16/22. Questions regarding updates should be directed to the study team contact.

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