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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.

3802 Study Matches

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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
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Inclusion Criteria:


1. Is greater than 50 years of age

2. Has at least a 10-year life expectancy

3. Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c

4. Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL

5. Has Gleason score 3+4 or 4+3

6. Has no evidence of extraprostatic extension by mpMRI

7. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by
biopsy

8. Physician is able to visualize prostate gland adequately on transrectal ultrasound
imaging during enrollment evaluation

9. 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

10. 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)

11. Has signed a written informed consent and in the judgment of the physician, the study
is in the best interest of the subject

12. Understands and accepts the obligation and is logistically able to present for all
scheduled follow-up visits


Exclusion Criteria:


1. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

2. Is unfit for anesthesia or has a contraindication for agents listed for paralysis

3. Has an active urinary tract infection (UTI)

4. Has a history of bladder neck contracture

5. Is interested in future fertility

6. Has a history (within 3 years) of inflammatory bowel disease

7. Has a concurrent major debilitating illness

8. Had active treatment for a malignancy within 3 years, including malignant melanoma,
except for prostate cancer or other types of skin cancer

9. Has any active implanted electronic device (e.g., pacemaker)

10. Is unable to catheterize due to a urethral stricture disease

11. Has had prior or current prostate cancer therapies:

1. Biologic therapy for prostate cancer

2. Chemotherapy for prostate cancer

3. Hormonal therapy for prostate cancer within three months of procedure

4. Radiotherapy for prostate cancer

5. Surgery for prostate cancer

12. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or
prostatic implants

13. Has had prior major rectal surgery (except hemorrhoids)

14. 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))

15. Is actively bleeding, is anticoagulated or on blood thinning medications, or has a
bleeding disorder

16. Is a member of a vulnerable population such as prisoners, handicapped or mentally
disabled persons, or economically or educationally disadvantaged persons

17. In the opinion of the treating physician, has a contraindication listed in the current
NanoKnife System User Manual (section 2.3)

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

Eligibility last updated 3/16/23. Questions regarding updates should be directed to the study team contact.

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The Effect of Etavopivat on Oxygen-binding Affinity, Skeletal Muscle Blood Flow, Maximal Oxygen Uptake During Exercise in Hypoxia: A Single-arm Crossover Trial

FORMA Study

Michael Joyner
All
18 years to 50 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-304762-H01-RST
21-005324
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  1.  

Inclusion Criteria:

  • Subjects must have the ability to understand, and sign written informed consent, which must be obtained prior to any study-related procedures being completed;
  • Adult female subjects of non-childbearing potential may participate in the study if they are either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or are post-menopausal, defined as spontaneous amenorrhea for at least 2 years as of screening visit;
  • Sexually active female subjects of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) or sexually active male subjects may participate in the study if they agree to use a medically accepted contraceptive regimen during their participation in the study and for 90 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy and include;
    • For male subjects enrolled in the study include the following:
      • Condoms with spermicide, or
      • Surgical sterilization of subject at least 26 weeks before the Screening Visit (vasectomy)
    • For female subjects enrolled in the study include the following:
      • Intrauterine device for at least 12 weeks before the Screening Visit;
      • Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit;
      • Diaphragm used in combination with spermicide; or
      • Male partner: condom with spermicide;
  • Male subjects must agree to abstain from sperm donation and not plan to father a child (including sperm donation) through 90 days after administration of the last dose of study drug;
  • Female subjects may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 90 days of last study drug administration;
  • Female subjects must have a negative result for the urine pregnancy test at the Study Visit #1 (screen and enrollment) and within 24-48 hours of each visit where exercise and hypoxia are involved;
  • Subjects must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and human immunodeficiency virus (HIV) antibody at the Screening Visit or documented in the medical chart within the last 1 year;
  • Subjects must be willing and able to abide by all study requirements (including the ability to swallow study tablets) and restrictions;
  • Subjects must be adult males or females between 18 and 50 years of age (inclusive) at the time of the screening visit;
  • Subjects must be in general good health, based upon the results of medical history and a physical examination performed by a physician, with vital signs, laboratory profile, and a 12-lead ECG, as judged by the Investigator at Screening and first period Check-in. Screening assessments may be repeated once (blood pressure may be repeated twice) at the Investigator’s discretion;
  • Subjects must have a body mass index (BMI) within the range of 18 kg/m2 to 33 kg/m2 (inclusive) and a minimum body weight of 50 kg at the Screening Visit; All participants will be evaluated on a case-by-case basis and inclusion in the study will be up to the discretion of the principal investigator;
  • Subjects must be physically active, including ≥3 days per week of structured aerobic (endurance) exercise or cross-training (resistance training + aerobic) type exercise for a combined 90+ minutes per week
  • Subjects must refrain from vigorous exercise and alcohol for 24 hours and caffeine 12 hours before study visits.
  • Subjects must have a negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines,  cocaine, barbiturates, and phencyclidine), cotinine, and alcohol at the Screening Visit.
  • For Phase 2 only, participants must have a negative COVID-19 test prior to Study Visits #2 and #4 per Institutional Guidelines for Aerosol Generating Procedures. The study team will follow institutional requirements throughout the study, and COVID test will be removed if institutional guidelines change.
  1.  


Exclusion Criteria:

  • History of gastrointestinal (GI) surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, with the exception of appendectomy;
  • History of malignancy within previous 5 years (other than successfully treated basal cell or squamous cell skin cancer, or carcinoma-in-situ of the cervix);includes prostatic intraepithelial neoplasia (PIN)
  • History of clinically significant arrhythmia, left or right bundle branch block, 2nd or 3rd degree atrioventricular (AV) block, pacemaker or implantable cardioverter-defibrillator;
  • Abnormal and clinically significant 12-lead ECG, including QT interval corrected for heart rate according to Fridericia’s formula (QTcF) > 450 ms, QRS interval ≥ 120 ms, PR interval > 220 ms, based on average of triplicated ECG, assessed at Screening and first study (pre-treatment) visit. If any of these test results are out of range the test can be repeated once;
  • Systolic blood pressure < 90 or > 150 mmHg (or >95th percentile for age) or diastolic blood pressure < 50 or > 95 mmHg (or > 95th percentile for age), at Screening and first period Check-in. If blood pressure is out of range, up to two repeated assessments are permitted;
  • A family history of QT prolongation or sudden cardiac death;
  • History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus;
  • Has had an acute illness considered clinically significant by the Investigator within 14 days prior to the study drug administration;
  • History of alcohol abuse or dependence within one year prior to Screening (self report more than 14 units of alcohol per week; one unit = 150 mL wine, 360 mL beer or 45 mL of 40% alcohol)or positive for ethanol in urine screening test (cutoff >10mg/dL)
  • Concerns for nicotine dependence or recent use prior to screening or intention to use nicotine products during the course of the study; or positive for nicotine and metabolites (cotinine, nornicotine, anabasine) in the urine screening test. 
  • Use of a prohibited prescription or non-prescription drugs and dietary supplements (including herbal and alternative medications), as specified in Section 6.2;
  • Has received an investigational drug, including vaccines (COVID-19 vaccines and booster shots), within five times the elimination half-life (if known) or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study;
  • History of allergy or hypersensitivity to etavopivat or excipients;
  • Subject has a history of chronic skin conditions including psoriasis, eczema or any recurring rash/dermatitis requiring oral or topical corticosteroids or chronic skin softeners within 12 months prior to screening;
  •  
  • Difficulty with venous or arterial access or unsuitable or unwilling to undergo intravenous or intra-arterial catheter insertion.
  • Has lost or donated > 550 mL (or > 10 mL/kg if < 18 yrs) of whole blood or blood products within 12 weeks prior to study drug administration;
  • Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements;
  • Has any finding that, in the view of the Investigator, would compromise the subject’s safety requirements;
  • Evidence of clinically significant (or undergoing active medical treatment) hematologic, renal, endocrine, pulmonary, cardiac, GI, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study;
  • Laboratory results (serum chemistry, hematology) outside the normal range at the Screening Visit that are considered clinically significant in the opinion of the Investigator. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
  • Iron deficiency anemia (as evidenced by abnormal iron level, and/or serum ferritin with reduced hemoglobin)
  •  Any elevation of aspartate aminotransferase and alanine aminotransferase 
  • > 1.5× the upper limit of normal (ULN), and bilirubin greater than ULN at the Screening Visit is exclusionary; or
  • Currently prescribed or taking any medications or supplements (see Section 6.2.1). Any over-the-counter medications or supplements will be evaluated by the primary investigator/sponsor medical monitor on a case-by-case basis.

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

Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Mayo Clinic — Rochester, MN

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Pilot Trial (MC211003)

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy

Stacy D'Andre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305219-P01-RST
21-011969
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • English speaking.
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
  • At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
  • Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Able to provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • No evidence of residual cancer.
  • Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
      • Platelet count > 100,000/mm^3;
      • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
      • Hemoglobin > 11 g/dL;
      • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
      • Alkaline phosphatase ≤ 1.2 x ULN;
      • Serum creatinine ≤ 1.2 x ULN.

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
  • Use of other cannabis products within 30 days prior to registration.
  • History of allergy to cannabis products.

Crossover Re-Registration –

Inclusion Criteria:

  • Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

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

 

Drug, Other, Behavioral
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Mayo Clinic — Rochester, MN

Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users

All
18 Years to 65 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04003805
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Inclusion Criteria:

• Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
• Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
• Biochemically confirmed regular smoking status by a NicAlert test level of 6;
• Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
• No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
• Subjects are in good physical health (no unstable medical condition);
• Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
• Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
• Women who are not pregnant or nursing or planning to become pregnant;
• Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:

• Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
• Currently using nicotine replacement or other tobacco cessation products;
• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
• Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
• Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
• Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
• Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
• Pregnant or breastfeeding;
• Failure to agree to take adequate protection to avoid becoming pregnant during the study;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic BP greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Expired air carbon monoxide (CO) level greater than 80 ppm;
• Self-reported allergies to propylene glycol or vegetable glycerin;
• Adverse reactions when previously using electronic cigarettes;
• Household member enrolled in the study concurrently;
• Unable to read for comprehension or completion of study documents;
• Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Drug: Standardized Research E-cigarette (SREC), Drug: Nicotine Mini-Lozenge
Smoking, Cigarette
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University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota Hanna Vanderloo, RN, MSN

Worldwide Retrospective Pregnancy Data Collection: ExAblate Treatment of Symptomatic Uterine Fibroids

A Study to Collect Worldwide Pregnancy Data Following ExAblate Treatment of Symptomatic Uterine Fibroids

Gina Hesley
All
up to 55 years old
This study is NOT accepting healthy volunteers
0000-116588-P01-RST
14-003910
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Eligibility Criteria

  • All patients covered under privacy laws (consent or waiver) known to have become pregnant following the ExAblate treatment for their Uterine Fibroids .
Uterine fibroid
Reproductive system, Uterine leiomyoma
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Mayo Clinic — Rochester, MN

Depression, Anxiety, and Traumatic Stress in People with Myocarditis and Their Identified Supports: A Comprehensive Survey-Based Study

A Study to Evaluate Depression, Anxiety, and Traumatic Stress in People with Myocarditis and Their Identified Supports

Paul Croarkin
All
18 years and over
This study is NOT accepting healthy volunteers
2020-300867-H01-RST
20-005550
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Inclusion Criteria:

  • Subjects will be adults (aged 18+ years)..
  • Must have self-identified myocarditis.
  • Adults (men and women) who self-identify as a caregiver of someone with myocarditis and control adult patients.
  • All participants, regardless of group membership (myocarditis patients, caregivers, controls) will be required to understand written English.


Exclusion Criteria:

  • Subjects under 18 years of age.
  • Unable to understand written English.

 

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Mayo Clinic — Rochester, MN

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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Mayo Clinic — Rochester, MN

Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss (DEKS)

Impact of Donor Diabetes on DMEK Success and Endothelial Cell Loss (DEKS)

Sanjay Patel
All
30 years to 90 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305614-P01-RST
21-008560
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Inclusion Criteria
•Participant:

  • Age range 30- < 91 years with minimum life expectancy of at least 1 year.
  • Willingness to return to study site for follow up at 1 month and 1 year.
  • Fluent in English or Spanish.
  • Willingness to have fingerstick blood sample collected to determine HbA1c level at entry and at 1 year. If determined to be diabetic at baseline, participant will be advised to seek medical care.

Inclusion Criteria
•Study Eye:

  • Clinically recommended for DMEK, and able to schedule DMEK between 5 to 90 days after enrollment.
  • Presence of a condition related to endothelial dysfunction which will be treated by DMEK.  Eligible indications for DMEK include:
    • Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
    • Phakic FECD with or without cataract;
    • Triple procedure including DMEK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed;
    • Pseudophakic FECD with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL b. Pseudophakic corneal edema with posterior capsule supported, sulcus supported, or scleral-fixated posterior chamber IOL without FECD;
    • Failed Descemet stripping automated endothelial keratoplasty (DSAEK) or DMEK without exclusionary criteria, as described below.


Exclusion Criteria:

  • Pregnant or planning to become pregnant prior to the DMEK study surgery, based on verbal report.
  • Lack cognitive capacity such that consent could not be provided.
  • Presence of a condition that has a high probability for failure (e.g., failed penetrating keratoplasty, uncontrolled uveitis).
  • Stromal vascularization that will impede assessment of recipient stroma clarity.
  • Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy.
  • Indication for surgery that is not suitable for DMEK (e.g, keratoconus, stromal dystrophies and scars).
  • Aphakic corneal edema with or without FECD.
  • Anterior chamber IOL in study eye prior to DMEK or planned placement of anterior chamber IOL during DMEK.
  • Planned IOL exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study DMEK.
  • Pre-operative central sub-epithelial or stromal scarring that could impact post-operative recipient stromal clarity assessment.
  • Presence of anterior synechiae.
  • Peripheral anterior synechiae in the angle greater than a total of three clock hours.
  • Uncontrolled glaucoma with or without prior filtering surgery, tube shunt placement, or MIGS. Uncontrolled glaucoma is defined as intraocular pressure > 25mm Hg.
  • Controlled glaucoma with prior tube shunt placement for glaucoma (controlled glaucoma with MIGS is allowed).
  • Fellow eye visual acuity < 20/200 due to an ocular condition other than a cornea disease that would be a candidate for DMEK.
  • IOP < 8 mmHg.
  • Topical Rho kinase inhibitor, including Rhopressa, used within 1 month prior to study entry and anticipated during the course of the study.

Eligibility last updated 5/18/22. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery
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Mayo Clinic — Rochester, MN

Traveling-wave Transcranial Electric Stimulation (TravelingTES)

All
18 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT05399381
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Inclusion Criteria:
1. Age between 18 and 45 years old. 2. Confident level of English language.
Exclusion Criteria:
1. History or evidence of chronic neurological or mental disorder. 2. Metal or electric implant in the head, neck, or chest area. 3. History of head injuries with loss of consciousness. 4. Any acute or chronic medical condition that requires ongoing pharmacological treatment. 5. Pregnancy or breast-feeding. 6. Alcohol or drug addiction.
Device: Transcranial alternating current stimulation (tACS)
Working Memory
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University of Minnesota — Minneapolis, Minnesota Ivan Alekseichuk, PhD - (ialeksei@umn.edu)

Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT) (REACT)

A Study to Detect Hyperkalemia Using Smartphone-enabled EKG

John Dillon
All
50 years to 89 years old
This study is NOT accepting healthy volunteers
2021-305023-H01-RST
21-006298
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Inclusion Criteria:

  • Age greater than/equal to 50 years and able to provide consent.
  • Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.


Exclusion Criteria:

  • Patients underage < 50.
  • Do not meet inclusion criteria.
  • Unstable patients requiring emergent resuscitation.
  • Patients unable to provide consent.
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Mayo Clinic — Rochester, MN

Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL

All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05296525
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Inclusion Criteria:
1. Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows: 1. Received at least 2 prior lines of therapy 2. Transplant ineligible patients allowed assuming they meet criterion a. 3. Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion 4. FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL 2. Patients must be at least 18 years of age 3. Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion Criteria:
1. CNS lymphoma 2. Time between previous treatment and first dose of study treatment (rituximab): 1. Allogeneic HSCT < 6 months prior to study treatment 2. Autologous HSCT < 3 months prior to study treatment 3. CAR-T < 2 months prior to study treatment
Drug: GDA-201
Non-Hodgkin Lymphoma
lymphoma, GDA-201, NK cells, rituximab, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
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Regents of the University of Minnesota — Minneapolis, Minnesota Veronika Bachanova, MD

Healthy Immigrant Community: Mobilizing the Power of Social Networks (HIC)

Healthy Immigrant Community: Mobilizing the Power of Social Networks

Mark Wieland
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305750-H01-RST
21-009339
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Inclusion Criteria:

  • Self-identification as Hispanic or Somali.
  • Member of a social network identified in the social network analysis.
  • Age ≥ 18 years.
  • Willingness to participate in all aspects of the study.
  • Provision of informed consent.


Exclusion Criteria:

  • < 18 years old.
  • Pregnancy at the time of enrollment.
  • Sserious medical conditions or disabilities that would make physical activity difficult.
  • To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating in the intervention, but they will be excluded from the measurements and analyses.

Eligibility last updated 8/30/21. Questions regarding updates should be directed to the study team contact.

Behavioral
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Mayo Clinic — Rochester, MN

A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients with Advanced Solid Tumors

A Dose Escalation Study of HFB301001 in Adult Patients with Advanced Solid Tumors

Konstantinos Leventakos
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305765-P01-RST
21-009057
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Inclusion Criteria:


- Previously received the following lines of systemic therapy for the
advanced/metastatic disease:

- Soft tissue sarcoma: at least 1 line of therapy

- Renal cell carcinoma: at least 2 lines of therapy;

- Uterine carcinosarcoma: at least 1 line of therapy;

- Hepatocellular carcinoma: at least 1 line of therapy

- Head and neck squamous cell carcinoma: at least 2 lines of therapy

- Suitable site to biopsy at pre-treatment and on-treatment

- Measurable disease as determined by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 and immune-RECIST (iRECIST)

- Eastern Cooperative Oncology Group performance status of 0 or 1.


Exclusion Criteria:


- Systemic anti-cancer therapy within 2 weeks prior to start of study drug.

- For soft tissue sarcoma and uterine carcinosarcoma patients only: prior immune therapy

- Therapeutic radiation therapy within the past 2 weeks

- Prior exposure to agents targeting the OX40 receptor;

- Active autoimmune disease requiring systemic treatment in the previous 2 years;

- Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune
suppressive therapy.

- Persisting toxicity of >Grade 1 relating to prior anti cancer therapy with the
following exceptions:

- All grades of alopecia are acceptable;

- Endocrine dysfunction on replacement therapy is acceptable.

- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy,
or unstable psychiatric condition;

- Major surgery within 2 weeks of the first dose of study drug;

- History or presence of drug or non-drug induced interstitial lung disease or
pneumonitis ≥Grade 2;

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to monoclonal antibodies or any excipient of HFB301001;

- Known active malignancy, with the exception of the specific cancer under investigation
in this trial, that required treatment within the previous 2 years.

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

Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.

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A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients with Neovascular Age-Related Macular Degeneration

UBX1325 for Treatment of Neovascular ARMD

Matthew Starr
All
50 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305828-P01-RST
21-009324
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Inclusion Criteria:

  • Patients aged ≥ 50 years.
  • Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening with either the CNV or fluid involving the center of the fovea.
  • Neovascular AMD patients who have had at least 3 anti-VEGF treatments in the study eye in the preceding 6 months prior to Screening, no less often, than approximately every 2 months
  • BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1. On Day 1, BCVA cannot be 10 or more letters from Screening:
    • Note: if both eyes are eligible, the one with the poorer BCVA should be chosen. If BCVA is equal, the eye with the greatest potential for vision gains, in the opinion of the Investigator, should be selected.
  • BCVA in the non-study eye of 35 ETDRS letters (equivalent to 20/200 on the Snellen chart) or better.
  • IOP ≤ 23 mmHg in the study eye.
  • Clear ocular media and adequate pupillary dilation to permit CFP, SD-OCT, and adequate BCVA evaluation.
  • Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.


Exclusion Criteria:

  • Concurrent disease in the study eye or structural damage, other than nAMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye. This includes, but is not limited to, the following:
    • Macular edema of etiologies other than nAMD;
    • Clinically significant subretinal fibrosis;
    • Subfoveal lipid with atrophy involving center of fovea;
    • Cataract requiring surgery during the study period;
    • RPE atrophy or tear or rips involving the macula;
    • Presence of macular hole;
    • History of uveitis;
    • Vitreomacular traction;
    • Clinically significant epiretinal membrane (ERM);
    • Aphakia or Anterior Chamber Intraocular Lens (A/C IOL);
    • Other retinovascular disease.
  • Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to Screening (mild blepharitis is acceptable)
  • Subretinal hemorrhage with bleeding area ≥ 4 disc area in the study eye
  • History of vitrectomy in the study eye
  • History of intraocular, periocular, or corneal surgery in the study eye within 3 months prior to screening, or anticipated need for such surgery during the study
  • History of panretinal photocoagulation (within 6 months) or macular laser photocoagulation (within 3 months) in the study eye prior to Day 1
  • History of corneal transplant in the study eye
  • Concomitant use of > 2 medications for the treatment of glaucoma and unstable glaucoma in the study eye (i.e., inadequate IOP control). Combination drugs, if given in a single drop, are considered 2 medications
  • Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
  • Presence of severe myopia (-8 diopters or greater) in the study eye
  • The use of intraocular steroids in the study eye within the last 2 years prior to screening
  • History of Visudyne® photodynamic therapy in the study eye
  • Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus imaging 
  • Intraocular surgery, including cataract surgery, in the study eye ≤ 3 months of screening
  • Known allergy to any component (phosphate buffered saline and polysorbate 80) of the Study Drug or to any component of Aflibercept, or a clinically relevant sensitivity to fluorescein dye
  • Female patients who are pregnant, lactating, or of childbearing potential who do not agree to use highly effective methods of birth control (e.g., progesterone-only hormonal contraception, double barrier, or intrauterine device) during the study and for 3 months following the last dose of Study Drug. Postmenopausal females (> 45 years old and without menses for more than 1 year) and surgically sterilized females are exempt from these requirements.
  • Male patients who do not agree to use a highly effective method of contraception during the study and for 3 months following the last dose of Study Drug, if sexually active with a female partner of childbearing potential.
  • Patients who within 3 months of screening received or are concurrently on another investigational drug or vaccine study, including patients who previously received treatment in a UBX1325 study. Coronavirus Disease 2019 (COVID-19) vaccinations are permitted prior to or during the course of the study.
  • Any uncontrolled medical condition, in the opinion of the Investigator, would preclude participation in this study, including, but not limited to, history of malignancy within the last 3 years (however, non-facial, basal cell carcinoma is allowed), history of myocardial infarction within the last 6 months, or concomitant therapy.

Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.

 

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

Using Transcranial Magnetic Stimulation Evoked Potentials to Diagnose

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

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


Exclusion Criteria:

  • Demographic characteristics: < 18 or  ≥ 65 years of age.
  • This exclusion criterion is implemented primarily to keep research team and patient safe. It is common for patients with psychosis to be agitated and sometimes violent in acute settings. It is also common for hostility/violence to be completely resolved with adequate treatment. Hence, a patient with recent violence while unmedicated, can have very low risk of violence once adequately treated. Risk of violence will be assessed on case-by-case basis for this study, taking into account legal history, documented history of hostility/violence in medical records, response to medications, medication non-compliance. Clinical judgment will be used to identify and exclude patients who pose significant risk of violence.
  • 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.
  • 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.

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

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

Schizoaffective disorder, Schizophrenia
Brief reactive psychosis, Catatonia, Delusional disorder, EEG, Schizoaffective disorder, Schizophrenia, Schizophreniform disorder, Transcranial magnetic stimulation
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Oberto-301, Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.

Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.

Joleen Hubbard
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-306928-P01-RST
22-000514
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Inclusion Criteria:


1. Provide written informed consent for the trial.

2. Adults 18 years or older on the day of signing informed consent.

3. Histologically or cytologically confirmed CRC that is metastatic.

4. Primary and/or metastatic tumor(s) that is known to be MSS as determined locally

5. Must have had 2-3 prior lines of therapy for CRC in the advanced or metastatic
setting, including all of the following in the absence of contraindications: a)
fluoropyrimidine, b) oxaliplatin, c) irinotecan, d) one or more biologics depending on
the clinical scenario. Prior regorafenib and/or TAS-102 are allowed but not required.
Note: a line of therapy is generally considered >2 weeks of exposure to the same
regimen followed by radiographically documented progression. Agents that are
mechanistically similar (e.g. 5-fluorouracil and capecitabine) and are used
interchangeably due to tolerability but not progression may be considered as
components of the same regimen upon discussion with the medical monitor.

6. Willingness to undergo biopsy prior to study therapy and after approximately 6 weeks
of study therapy. If biopsy on study is not feasible, then archival tissue must be
available from within 90 days of signing consent.

7. Willingness to undergo buccal swab prior to study therapy for the determination of HLA
profile.

8. Documented radiographic progression after the last regimen prior to entry on this
study.

9. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only
be considered as measurable disease if disease progression has been unequivocally
documented at that site since radiation.

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

11. Adequate organ functions as defined by the following laboratory parameters at baseline
(laboratory parameters outside of these ranges that are deemed clinically
insignificant should be discussed with the medical monitor):

1. Absolute neutrophil count ≥1.5 x 109/L;

2. Hemoglobin ≥9 g/dL: transfusion to achieve this cutoff is not allowed within 14
days of first dose of study therapy;

3. Platelet count ≥100,000/mm3;

4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper
limit of normal (ULN)
•ASL and/or ALT may be ≤5 x ULN in the setting of liver
metastases;

5. Total bilirubin ≤ 1.5 x institutional ULN;

6. Serum creatinine within normal limits or calculated creatinine clearance >60
mL/min/1.73 m2 using the Cockroft-Gault method (Appendix 2) for participants with
serum creatinine levels above or below the institutional normal range;

7. Albumin ≥3.0 g/dL;

8. Acceptable coagulation parameters including international normalized ratio (INR)
<1.5 and partial thromboplastin time (PTT) ≤ institutional ULN in the absence of
anticoagulation (participant on anticoagulants must be discussed with the medical
monitor).

12. Has no major existing comorbidities or medical conditions that will preclude therapy
in the view of the investigator.

13. Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria
for Adverse Events, Version 5.0 (NCI-CTCAE v 5.0) of all clinically significant toxic
effects of prior therapies (with exception of peripheral neuropathy).

14. Female participants are eligible to participate if at the time of screening are not
pregnant, not breastfeeding, and at least one of the following conditions applies: (a)
Not a woman of childbearing potential (WOCBP); or (b) WOCBP who (i) agrees to use
highly effective contraception starting with the screening visit through 90 days after
the last dose of study treatment; and (ii) must have a negative urine or serum
pregnancy test within 72 hours prior to receiving any dose of study medication. If the
urine test is positive or cannot be confirmed as negative, a serum pregnancy test will
be required.

- Childbearing potential is defined by at least one of the following: (a) ≥50 years
of age and has not had menses for greater than 1 year; (b) amenorrheic for ≥2
years without a hysterectomy and bilateral oophorectomy and a
follicle-stimulating hormone value in the postmenopausal range upon pre-study
(screening) evaluation; (c) has had hysterectomy, bilateral oophorectomy or tubal
ligation.

- Highly effective contraception is defined in Appendix 3 or per national or local
guidelines.

- Abstinence is acceptable if this is the established and preferred method of
contraception/lifestyle of the participant.

15. Male participants with a female partner(s) of childbearing potential must agree to use
highly effective contraception throughout the study starting with the screening visit
through 90 days after the last dose of study treatment is received by the male
participant. Male participants with pregnant partners must agree to use a condom; no
additional method of contraception is required for the pregnant partner.

- Abstinence is acceptable if this is the established and preferred method of
contraception of the participant.


Exclusion Criteria:


1. Prior treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other
checkpoint inhibitors.

2. Has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy,
or immunotherapy) within 28 days of the first dose of study therapy or 5 half-lives
(whichever is shorter) if at least 10 days have elapsed between the last dose of such
agents and the first dose of study therapy. NOTE: Patients who have been given
palliative radiotherapy to peripheral sites (e.g., bone metastases) may enroll before
28 days have elapsed if they have recovered from any acute toxicities.

3. Has received a live vaccine within 28 days of the first dose of study therapy.

4. Has had major surgical procedure, open biopsy or significant traumatic injury within
28 days of the first dose of study therapy.

5. Participating in another research study involving receipt of an investigational
product 21 days prior to study therapy.

6. History of autoimmune disease, including but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associated with antiphospholipid
syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,
multiple sclerosis, vasculitis, or glomerulonephritis. Note: Patients with a history
of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
are eligible for this study. Patients with controlled Type I diabetes mellitus on a
stable dose of insulin regimen are also eligible for this study.

7. Receiving systemic corticosteroids within one week prior to the first dose of study
therapy. Exceptions: corticosteroid use as a premedication for intravenous (IV)
contrast, intermittent corticosteroid use (e.g., daily prednisone at doses of ≤10 mg
or equivalent), bronchodilators, inhaled steroids, or local steroid injections (except
at the proposed injection site of PolyPEPI1018) are acceptable.

8. History of anaphylaxis in relation to vaccination or the administration of a protein
product.

9. Has known allergy to any component of the study treatment formulation(s).

10. Has symptomatic interstitial lung disease (ILD) or ILD which may interfere with
detection and management of new immune-related pulmonary toxicity.

11. Prior allogeneic bone marrow transplantation or solid organ transplant.

12. Has known, active central nervous system (CNS) metastases and/or leptomeningeal
metastases. Patients with previously treated, stable CNS metastases may participate if
(a) there is no evidence of progression by imaging [magnetic resonance imaging (MRI)
or computed tomography (CT) as used during the prior imaging] at least 28 days prior
to the first dose of study therapy; (b) resolution or return to baseline of neurologic
symptoms; and (c) no requirement for steroids to manage symptoms of brain metastases
for at least 28 days prior to first dose of study therapy.

13. Active infection requiring systemic therapy.

14. Significant liver cirrhosis defined as Child-Pugh Class B or C (Appendix 4).

15. Active infection with human immunodeficiency virus (HIV) except participants who are
currently stable on antiretroviral therapy (ART) for at least 4 weeks and agree to
adhere to ART during study therapy, have HIV viral load of <400 copies per milliliter
(/mL) at screening (or undetectable per local criteria), and have CD4 T cell counts
≥200/microliter.

16. Active hepatitis B (HBV) or C (HCV) infection. For participants with evidence of HBV
infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated. For participants with HCV, infection must have been treated and cured or
participants are currently on treatment and have an undetectable HCV viral load.

17. History or evidence of cardiovascular disease, chronic respiratory disease,
gastrointestinal disease, liver disease, renal disease, endocrine disorder or any
other medical or psychiatric condition that in the opinion of the investigator will
significantly increase the safety risk for the subject or confound the interpretation
of the study data.

18. Pregnant or breast-feeding or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 90 days
after the last dose of study treatment.

19. History of another active malignancy that has required therapy within 2 years prior to
first dose of study therapy, except basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, prostate cancer or in situ cervical cancer that has undergone
potentially curative therapy or is felt by the investigator to be at low risk for
recurrence is allowed.

20. Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results.

21. In the opinion of the investigator, participant has rapidly progressing disease, OR
has life expectancy <3 months, OR would be unable to receive at least one study
treatment.

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

Eligibility last updated 12/20/22. Questions regarding updates should be directed to the study team contact.

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Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty

Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient TJA

Matthew Abdel
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306974-H01-RST
22-000012
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Inclusion Criteria:

  • Adult patients age ≥ 18.
  • Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.


Exclusion Criteria:

  • Individuals < 18 years of age.

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

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68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy

Diagnostic 68Ga-PSMA-11 PET/CT

Geoffrey Johnson
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-307849-P01-RST
22-003732
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Inclusion Criteria:

  • An adult male patient who:
    • Is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a Nuclear Medicine Physician or Radiologist in the Nuclear Medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB).
    • Is acceptable to be potentially eligible for therapy but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future.
    • Is acceptable to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer.
    • Is eligible to be documented in the medical record by the clinical practice.
    • Has not received a 68Ga-PSMA-11 PET/CT or PET/MR, or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility.
    • Does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan.
    • An adult above the age of 18.


Exclusion Criteria:

  • A patient who is:
    • Under the age of 18.
    • Unable to consent per Mayo guidelines.
    • Unable to lay still, or otherwise successfully complete the imaging exam.

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

Diagnostic Test
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Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated To Chemotherapy or Radiation, In Advanced Cancer Patients – A Confirmatory Phase III MNCCTN Trial

Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Advanced Cancer Patients

Charles Loprinzi
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304197-P01-RST
21-011317
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically-confirmed cancer in an advanced incurable stage.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale).
  • Serum creatinine < 2.0 mg/dl and SGOT (AST) or SGPT (ALT) values < 3 times upper limits of normal, ≤ 120 days prior to registration.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Able to provide written informed consent.
  • Able to complete questionnaire(s) by themselves or with assistance.

Registration


Exclusion Criteria:

Any of the following because this study involves:

  • An agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant persons;
    • Nursing persons.
  • Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible).
  • Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for ≤ 30 days prior to registration or planned during protocol therapy (patients may have received prochloperazine and other phenothiazines as prior anti-emetic therapy).           
  • Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection (including HIV);
    • cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient;
    • psychiatric illness/social situations that would limit compliance with study requirements.
  • Inability to swallow oral formulations of the agent(s).
  • Tube feeding or nasogastric tube.

Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.

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

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

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

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

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

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


Exclusion Criteria:

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

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

Drug, Other
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Evaluation of Cochlear Implantation at Mayo Clinic (ECI)

Evaluation of Cochlear Implantation

Matthew Carlson
All
Not specified
This study is NOT accepting healthy volunteers
2022-306830-H01-RST
22-000183
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Inclusion Criteria:

  • All patients that underwent cochlear implantation at the Mayo Clinic starting 1/1/1982.
  • If patients declined MN research authorization, they may be contacted for consent for approval.


Exclusion Criteria:

  • Patients that did not undergo cochlear implantation at the Mayo Clinic.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

 

 

 

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An Observational Cohort Study of Long-Term Outcomes of Orthotopic Liver Transplantation in People With Hemophilia (HOT)

ATHN 11: A Study of Liver Transplantation Outcomes

Rajiv Pruthi
All
18 years and over
This study is NOT accepting healthy volunteers
2020-300748-P01-RST
20-005235
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Inclusion Criteria:

  • Congenital hemophilia A or B of any severity, who have and have not undergone a live transplant.
  • Age ≥ 18 years of age.
  • Sex assigned at birth was male.


Exclusion Criteria:

  • Individuals < 18 years of age.

Eligibility last updated 6/2/22. Questions regarding updates should be directed to the study team contact.

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ACCL2031, A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND #149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors (ACCL2031)

A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor

Nadia Laack
All
4 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2020-302527-P01-RST
20-010883
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Inclusion Criteria:


- >= 4 and < 18 years at time of study entry

- Patients must weigh 15 kg or greater at time of study entry

- Newly diagnosed or recurrent primary brain tumors that have not received prior cranial
radiotherapy

- Planned focal, cranial or craniospinal radiation treatment for a primary brain tumor

- The patient must have receptive and expressive language skills in English, French or
Spanish since the neurocognitive function and quality of life (QOL) assessment
instruments are available in these languages only

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- Age: 4 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 male; 0.8 female

- Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 male; 1 female

- Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 male; 1.2 female

- Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 male; 1.4 female

- Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 male; 1.4 female

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L

- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L

- The patient must be able to undergo magnetic resonance imaging

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met


Exclusion Criteria:


- Life expectancy of less than 18 months

- Pre-existing conditions:

- Any contraindication or allergy to memantine

- Intractable seizures while on adequate anticonvulsant therapy, defined as more
than one seizure per month for the past 2 months or since initiating
anticonvulsant therapy

- Co-morbid systemic illnesses, psychiatric conditions, social situations, or other
severe concurrent disease which, in the judgment of the investigator, would make
the patient inappropriate for entry into this study or interfere significantly
with the proper assessment of safety and toxicity of the prescribed regimens or
would limit compliance with the study requirements

- Patients with a motor, visual, or auditory condition that precludes computerized
neurocognitive assessments are not eligible to participate

- Patients with any medical condition or taking medications that lead to
alterations of urine pH towards the alkaline condition (e.g., renal tubular
acidosis, carbonic anhydrase inhibitors, sodium bicarbonate)

- Personal history of prior cranial or craniospinal radiotherapy is not allowed

- Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents
are allowed as per standard of care clinical treatment guidelines

- Female patients who are pregnant are excluded since fetal toxicities and teratogenic
effects have been noted for the study drug. A pregnancy test is required for female
patients of childbearing potential

- Lactating females who plan to breastfeed their infants

- Sexually active patients of reproductive potential who do not agree to use an
effective contraceptive method for the duration of their study participation

Drug, Procedure/Surgery, Other
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A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI) (iTBS rTMS in MCI)

iTBS rTMS in Mild Cognitive Impairment

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


- Must speak English fluently

- Diagnosis of MCI as defined by:

- Clinical diagnosis by a neurologist

- Neuropsychological testing support of MCI

- Meet criteria for MCI

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

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

- Essentially preserved general cognitive function

- Largely intact functional activities

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

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

- Clinical Dementia Rating=0.5

- Geriatric Depression Scale score less than 6

- Medically stable and in good general health

- Not pregnant, lactating, or of childbearing potential

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

- Adequate visual and auditory abilities to complete neuropsychological testing

- Ability to provide informed consent

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


Exclusion Criteria:


- Inability to communicate in the English language

- Meet criteria for dementia

- Contraindications to TMS or MRI, including patients who have

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

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

- Any true positive findings on the TMS safety screening form

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

- History of epilepsy or seizures

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

- History of traumatic brain injury

- History of intracranial mass or lesion

- History of stroke, including hemorrhagic stroke and ischemic stroke

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

- Psychiatric disorders

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

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

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

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

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

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

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

- Pregnancy or suspected pregnancy

- Participation in another concurrent interventional clinical trial

- Any unstable medical condition

- Inability to provide informed consent

- Inability to adhere to the protocol

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

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

Device
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Contrast Enhanced Breast PCD-CT Compared to MR or mammograms for Staging of Breast Cancer in the Breast and Regional Nodes

Breast MR

Tiffany Sae-Kho
Female
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305687-H01-RST
21-008825
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Inclusion Criteria:

  • Adult female patients 18 to 99 years of age.
  • Patients with proven breast cancer and nodal metastases referred for staging breast MR within the Department of Radiology.
  • Patients who are able and willing to sign the informed consent.
  • Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).


Exclusion Criteria:

  • Minors under 18 years of age.
  • Patients unable to provide written informed consent.
  • Pregnancy.
  • eGFR ≤ 30 (4,5).
  • History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
  • Any history of premedication prior to iodinated contrast.
  • Patients that consent to participation but do not undergo their clinically indicated MR scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).

Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.

 

 

Behavioral, Device
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EA2174, A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Shanda Blackmon
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
2022-306824-P01-RST
22-000135
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Inclusion Criteria:

STEP 1:

  • Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II).
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy.
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Hemoglobin (Hgb) ≥ 9 g/dL (within less than or equal to 14 days prior to randomization).
  • Leukocytes ≥ 3,000/mm^3 (within less than or equal to 14 days prior to randomization).
  • Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy.
  • Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy.
  • Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy.
  • Patients must have no contraindication to receiving radiation therapy.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
    • Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years; OR
    • Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years.
  • Date of last evidence of disease.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs.
  • For patients with evidence of CHF, myocardial infarction (MI), cardiomyopathy, or myositis, cardiac evaluation including lab tests and cardiology consultations including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram.
  • Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility.
  • Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from carboplatin, paclitaxel, or nivolumab. All females of childbearing potential must have a blood test or urine study done within 2 weeks prior to registration to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
  • If patient says 'Yes' to "I choose to take part in the imaging study and will have the diffusion weighted magnetic resonance imaging (MRI) scans": patients must be able to tolerate MRI scans:
    • No history of untreatable claustrophobia;
    • No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies;
    • Weight compatible with limits imposed by the MRI scanner table.

STEP 2:

  • Patient registration must not exceed 12 weeks from time of esophagectomy.
  • Patients must have a post-operative ECOG performance status of 0-2
  • Absolute neutrophil count ≥ 1,500/mcL (within less than or equal to 14 days prior to randomization).
  • Platelets ≥ 100,000/mcL (within less than or equal to 14 days prior to randomization).
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization).
  • AST (SGOT)/ ALT (SGPT) ≤ 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Serum creatinine ≤ 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization).
  • Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical computed tomography (CT) scan. Patients must also have a negative surgical margin (R0 resection).
  • Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients must not be receiving any other investigational agents.
  • Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from nivolumab or ipilimumab. All females of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to registration to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy.
  • Women of childbearing potential (WOCBP) and sexually active males must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one month (female patients) or one week (male patients) prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for female patients) and for 7 months after the last dose of study drug (for male patients who are sexually active with WOCBP). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine, Radiation, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Esophageal cancer, Stomach cancer
Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Esophagectomy, Medical Oncology, Primary adenocarcinoma of esophagogastric junction, Radiation therapy
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Natural History of Myhre Syndrome (MS)

Examining the Natural History of Myhre Syndrome

Lisa Schimmenti
All
18 years and over
This study is NOT accepting healthy volunteers
2022-306944-H01-RST
21-013116
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Inclusion Criteria:

  • 18 years or older.
  • Diagnosis of Myhre Syndrome.


Exclusion Criteria:

  • Individuals < 18 years of age.

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

 

Laryngotracheal stenosis
Myhre syndrome, Neuropsychological assessment, Respiratory system
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Heart Failure (HF) Clinic Biobank

Heart Failure (HF) Clinic Biobank

Horng Chen
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307126-H01-RST
22-000991
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Inclusion Criteria:

  • Patients referred to the Mayo Clinic HF Clinic with a diagnosis of heart failure who have a clinical blood draw scheduled.
  • Adults ≥ 18 years old.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Any history of Hemoglobin less than 9 mg/dL during the past 3 months.
  • Active cancer.

Eligibility last updated 1/28/22. Questions regarding updates should be directed to the study team contact.

 

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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
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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.

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Imaging of Prostatic Anatomy in Patients with Known Prostate Cancer and Those at High-Risk using Magnetic Resonance Elastography: A Feasibility Study

Imaging of Prostatic Anatomy in Patients with Known Prostate Cancer and Those at High-Risk using Magnetic Resonance Elastography

Lance Mynderse
Male
40 years to 85 years old
This study is NOT accepting healthy volunteers
0000-112691-H01-RST
12-002070
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Inclusion Criteria:

  • Male volunteers with prostate cancer 
  • Healthy individuals (ages 40-85)


Exclusion Criteria:

  • An absolute contraindication to MR examination  
  • Urethral stricture 
  • Current urinary tract infection or positive Gram stain of the urine
Cancer, Prostate cancer
Magnetic resonance elastography, Malignant tumor of prostate, Medical Oncology, Reproductive system
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