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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.

612 Study Matches

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A Phase 1b, Single-blind, Placebo-controlled, Adaptive Design, Outpatient Trial to Assess the Effects of Single Oral Tablet Doses of OPC-214870 on Photic-induced Paroxysmal Electroencephalogram Responses in Subjects Who Have Demonstrated Photoepileptiform Discharges on Electroencephalogram With or Without Seizures

A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870

David Burkholder
All
18 years to 64 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122947-P01-RST
19-011533
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Inclusion Criteria:

  • Male and female subjects between 18 and 64 years of age, inclusive.
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive.
  • Subjects with a diagnosis and history of photoparoxysmal response on EEG.
  • Subjects must be stable for 1 month prior to screening. Stable is defined as having no change in concomitant therapy and no worsening in the opinion of the investigator.
  • Subjects may be treatment-naïve to AEDs or currently treated with up to 3 AEDs.
  • Subjects must have a reproducible standardized photosensitivity range on EEG of at least 3 points in at least 1 eye condition.
  • Subjects who agree to remain abstinent, or practice double-barrier forms of birth control, from trial to screening through 90 days after the last dose of IMP, OR males and females of non-childbearing potential who are documented as sterile (i.e., male subjects who have undergone bilateral orchidectomy and female subjects who have undergone bilateral oophorectomy, bilateral salpingectomy, or hysterectomy, or who have been postmenopausal for at least 12 months.


Exclusion Criteria:

  • History of non-epileptic seizures.
  • History of status epilepticus in the past 5 years.
  • An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results.
  • Positive urine drug screen for substance of abuse or upon check in to the trial site. Benzodiazepines are excluded as a drug of abuse, but are allowed as rescue medication or when part of subject's stable concomitant medication at enrollment.
  • History of drug and/or alcohol abuse within 24 months prior to screening.
  • Consumption of grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 7 days prior to dosing.
  • Consumption of more than 1 alcoholic drink within 24 hours prior to dosing. Food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate) must remain stable throughout the trial.
  • Extreme physical activity within 24 hours before screening and visit.
  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
  • Subject having taken an investigational drug within 30 days preceding screening.
  • Use of over-the-counter drugs, herbal medicines, or vitamin supplements within 14 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics within 30 days prior to dosing.
  • Subjects who had neurosurgery in last 6 months. -Subjects on a ketogenic diet.
  • History of significant sleep disorders, or any disorder or activity that causes sleep deprivation.
  • Subjects who work "night shifts."
  • Subjects with uncontrolled sleep disorders; subjects should be on a stable dose of sleep medications.
  • History of, or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV), and/or HIV antibodies.
Drug therapy, Drug, Other
Epilepsy
Epilepsy, Nervous system
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The Impact of Automated Zonal Control of Indoor Air Pollutants on Cardiopulmonary Health, Sleep Quality, the Human-indoor Microbiome, and Comfort in a Simulated Apartment

A Study to Evaluate the Impact of Automated Zonal Control of Indoor Air Pollutants in a Simulated Apartment

Bruce Johnson
All
25 years and over
This study is NOT accepting healthy volunteers
0000-122958-P01-RST
19-011638
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Inclusion Criteria:

  • Individuals 25 years of age or over.
  • Individuals with a regular schedule of at least 5 working days a week that are not shift work.
  • Ability to relocate to the Well Living Lab for four weeks (25 nights).
  • Willing to remain in the lab after waking up until all specimens and measures are completed.
  • Ability to fulfill scripted tasks, including cooking and cleaning.
  • Ability to have blood drawn and urine samples collected one time prior to move-in and two times per week for a four-week period.
  • Ability to provide informed consent.


Exclusion Criteria:
 

  • Individuals with abnormal blood tests of lipids or biomarkers of liver and kidney dysfunction.
  • Individuals who are smokers or having quit smoking <1 year prior.
  • Individuals who have a respiratory infection.
  • Individuals who have signs and symptoms of obstructive pulmonary disease, asthma, heart failure or cardiac arrhythmia.
  • Individuals who use corticosteroids, anti-arrhythmic medication, beta-blockers, anti-inflammatory drugs or aspirin.
  • Individuals who have occupations with increased air pollution exposure.
  • Women who are pregnant or intend to become pregnant during the duration of the study.
  • Women who are experiencing menopausal transition.
  • Individuals with a history of mood or psychiatric disorders.

Individuals who perform shift work.

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Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

A Study to Evaluate Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker

Andres Acosta
All
18 years to 75 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122966-H01-RST
19-011697
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Inclusion Criteria:

  • Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
  • Age: 18-75 years old.
  • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
  • Women of childbearing potential must agree to use a method of effective contraception during study participation.
  • Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
  • Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.


Exclusion Criteria:

  • History of Abdominal bariatric surgery.
  • Weight is greater than 450 lbs. (204 kg).
  • Recent use (within the last three months) of any antiobesity medication.
  • Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
  • Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
  • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
  • Hypersensitivity or contraindication to the study medication.
  • Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
  • Principal Investigator discretion.
Drug, Other
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CELLTOP Part II: A Phase II Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury

A Study to Evaluate Autologous Adipose Derived Mesenchymal Stem Cells to Treat Spinal Cord Injury Patients

Mohamad Bydon
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122969-H01-RST
19-011706
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Inclusion Criteria:

  • Male or female aged 18 years and older.
  • Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle.  Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
  • Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer.  Monitoring will include perinatal and neonatal outcome.  Any SAEs associated with pregnancy will be recorded. 
  • AIS grade A or B of SCI at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional improvement
  • SCI must be traumatic, blunt/non-penetrating in nature and not degenerative.
  • Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments.
  • Full understanding of the requirements of home exercise program prescribed by physical and occupational therapists.
  • Once the nature of the study is fully explained and prior to any study-related procedure is initiated the subject is willing to provide written, informed consent and complete HIPAA documentation.


Exclusion Criteria:

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • AIS grade of SCI other than A or B at the time of injury.
  • Non-traumatic SCI.
  • History of receiving mesenchymal stem cell, gene or exosome therapy for any indications.
  • History of intra-spinal infection
  • History of superficial infection in the index spinal level within 6 months of study.
  • Evidence of current superficial infection affecting the index spinal level at the time of enrollment.
  • On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
  • Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
  • Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline.
  • Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater.
  • Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes, osteoporosis).
  • History of malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
  • History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
  • Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
  • Known allergy to local anesthetics of other components of the study drug.
  • Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
  • History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry.
  • Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment.
Drug, Regenerative injection therapy, Spinal cord injury rehabilitation
Spinal cord injury
Cellular therapy, Nervous system, Physical therapy, Regenerative medicine therapy, Spinal cord injury, Spinal injury, Stem cell injection, Stem cell therapy
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An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients with Endometriosis (OPINE) (OPINE)

A Study to Evaluate a Wearable Biosensor and Mobile Platform in Endometriosis Patients

Tatnai Burnett
Female
21 years to 49 years old
This study is NOT accepting healthy volunteers
0000-122972-P01-RST
19-011719
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Inclusion Criteria:

  • Able to give a written Informed Consent Form.
  • Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting).
  • Female patients aged ≥ 21 and < 50 years.
  • Patient who meets either A or B or both in the following criteria:
    • Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation;
    • Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
  • Patient who meets either A or B in the following criteria:
    • Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have reqular menses (i.e., 21-38 days) within 38 days prior to the study participation;
    • Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period 6. Patient has a moderate to severe endometriosis associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation.


Exclusion Criteria:

  • Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
  • Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
  • Patient has more than five surgical histories in pelvic area.
  • Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
  • Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
  • Patient has a planned surgery during the study.
  • Patient had a surgery within 4 weeks prior to the study participation.
  • Patient has a planned trip overseas during the study participation.
  • Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.
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Validation of Dried Blood Spot Testing for HIV Screening and Syphilis Serology

A Study to Screen HIV and Syphilis Screening Using Dried Blood Spot Testing

Mary Kasten
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122978-H01-RST
19-011796
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Inclusion Criteria:

  • Patients who are > 18 years of age.
  • Patients who are either known to be HIV seropositive or have a positive syphilis serology or who require HIV or syphilis serologic testing as part of their routine care.


Exclusion Criteria:

  • Unable due to cognitive or physical limitations to understand dried blood spot collection instructions or to safely perform finger-stick for DBS self-collection.
  • Patients who are unable to give informed consent.
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MC1973: A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk

Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk

Ivy Petersen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122983-H01-RST
19-011871
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Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either:
    • Deemed a candidate for complete macroscopic resection of the primary sarcoma; OR
    • Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy.
  • No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging.
  • Eastern Cooperative oncology Group (ECOG) Performance Status (PS) ≤ 3.
  • Life expectancy greater than 6 months.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Ability to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).


Exclusion Criteria:

  • Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma.  In other words, treatment on this trial would require re-irradiation of tissues.
  • Patients with nodal or distant metastases.
  • Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies.
  • Any of the following:
      •  
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
Behavioral, Radiation, Other
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Pilot Studies on Non-invasive Measures of Cardiac Hemodynamics during Submaximal Exercise

A Study to Measure Cardiovascular Blood Flow During Submaximal Exercise

Bruce Johnson
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122984-H01-RST
19-011882
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Inclusion Criteria:

  • Healthy participants above the age 18 years old.
  • Participants capable of performing submaximal exercise.


Exclusion Criteria:
 

  • Participants less than the age of 18 years and older than 65.
  • Participants with compromised cardiovascular or pulmonary function.
  • Unable to pedal an exercise ergometer.

 

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ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA) (ARREST)

ARrest RESpiraTory Failure From PNEUMONIA

Ognjen Gajic
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122986-P01-RST
19-011892
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Inclusion Criteria:
 

  • Severe Pneumonia defined as hospitalization for acute (< 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L), OR known current immunosuppression preventing inflammatory response.
  • Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.


Exclusion Criteria:
 

  • A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments).
  • Contraindication or known allergy to inhaled corticosteroids or beta-agonists.
  • Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation).
  • Intubation (or impending intubation) prior to enrollment.
  • This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment.
  • Do Not Intubate order but does not include a "Do Not Resuscitate" order.
  • Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome.
  • Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization.
  • Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours, or K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved.
  • Younger than 18 years of age.
  • Pregnancy.
Drug, Corticosteroid and corticosteroid derivative therapy, Drug therapy, Corticosteroid and/or corticosteroid derivative therapy
Acute respiratory failure, Hypoxemia, Pneumonia, Respiratory failure
Acute respiratory failure, Hypoxemia, Patient requires hospitalization, Pneumonia, Respiratory system
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ROR1905: Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

Allison Garda
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-122989-H01-RST
19-011924
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Able to provide written consent.
  • Patient has given permission to give tumor/blood sample for research testing.
  • Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma.
  • Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV.
  • Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits.
  • Consent to allow blood specimens to be shared with potential external collaborators.
  • Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC):
    • FIGO 2019 Stage IB2-IIIC or not a surgical candidate;
    • Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy.


Exclusion Criteria:
 

  • Other active malignancy ≤ 2 years prior to registration. 
    • EXCEPTIONS:  Non-melanotic skin cancer.
    • NOTE:  If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer.
  • Pregnancy or lactation.
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol.

Eligibility last updated 3/24/22. Questions regarding updates should be directed to the study team contact.

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Transform the Practice – Pilot Study: Radio Signal Characterization of Seizures

A Study to Evaluate Radio Signal Characterization of Seizures

Melissa Lipford
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123001-H01-RST
19-012065
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Inclusion Criteria:

  • Consented adult (18+) male and female subjects who are admitted to the Mayo Clinic Hospital (Saint Marys Campus) Inpatient Epilepsy Monitoring Unit.
  • Have a confirmed diagnosis of epilepsy (by a Mayo Clinic Neurologist).


Exclusion Criteria:

  • Subjects who are pregnant or may be pregnant.
  • Pediatric patients (< 18 years of age).
  • Subjects who are unable to provide consent.
  • Those admitted primarily for classification of indeterminate (possibly non-seizure) events.
  • Subjects who plan to have more than one additional person in the room with them during nocturnal hours (10 pm – 6 am) (excluding clinical providers).
  • Subjects who have an implanted vagal nerve stimulator or other neurostimulation device.
  • Patients with implantable drug delivery systems or implanted cardiac devices (including pacemakers and defibrillators).
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Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery with the Obstetric Quality of Recovery Tool

A Study to Evaluate Postpartum Recovery After Cesarean Delivery Using the Obstetric Quality of Recovery Tool

Emily Sharpe
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123005-H01-RST
19-012077
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Inclusion Criteria:

  • Women 18 years of age or older.
  • Patients who receive neuraxial anesthesia for elective cesarean delivery.
  • Singleton or multiple gestations.


Exclusion Criteria:

  • Age < 18 years old.
  • Gestational age < 32 weeks.
  • Women whose infants have died or are in the neonatal intensive care unit after delivery.
  • Inability to read or understand written English.
  • Failed neuraxial anesthesia requiring general anesthesia.
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In Vivo Development of Sodium Magnetic Resonance Imaging Technology

Sodium MRI Pilot

Timothy Kline
All
18 years to 65 years old
This study is NOT accepting healthy volunteers
0000-123006-H01-RST
19-012099
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Inclusion Criteria:

  • Men and women.
  • Ages ≥ 18 to ≤ 65 years old.
  • Able to tolerate lying motionless, flat on one's back in an MRI scanner for no more than 60 minutes.
  • Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD).


Exclusion Criteria:

  • No contraindication to MRI.
  • No implanted devices within the body (shunts, clips, plates, etc.).
  • No dental braces or retainer wires.
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The Role of WNT/b-catenin Signaling in Human Alveolar Macrophages (AMs) in Modulating Host Defense and Pulmonary Inflammation

A Study to Evaluate the Role of WNT/b-catenin Signaling in Human Alveolar Macrophages (AMs) in Adjusting Inflammation

Jie Sun
All
Not specified
This study is NOT accepting healthy volunteers
0000-123010-H01-RST
19-012187
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Inclusion Criteria:

  • Children 0-18-years-old.
  • Children who undergo flexible bronchoscopy with BAL as above part of their clinical management.


Exclusion Criteria:

  • Exclusion criteria for the control and PBB groups included the presence of hereditary.
  • Respiratory diseases (such as cystic fibrosis), clinical history of primary aspiration, neuromuscular problems.
  • Primary or secondary immune deficiencies, invasive infections such as Mycobacterium tuberculosis.

 

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Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (EPAS)

A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (EPAS)

Brian Lundstrom
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123016-P01-RST
19-012307
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Inclusion Criteria:


- Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE)
2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure
(secondary generalization). The final determination shall be made by the Investigator
based on a clinical description of the seizures and previous diagnostic testing that
includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one
ictal event

- Anticipated average of 6 or more focal (partial) onset seizures per month during CMM
phase, with no more than 30 consecutive seizure-free days during the CMM phase

- Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness

- Age 18 or older at the time of enrollment

- Willing and able to complete the diary, with or without the assistance of a caregiver,
in a reliable way as assessed by the clinical staff

- Able to use the Patient Programmer with or without the assistance of a caregiver

- Ability of the subject or legal representative to understand and provide signed
consent for participating in the study

- Willing and available to attend visits as scheduled and to comply with the study
protocol


Exclusion Criteria:


- Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE)
2017 classification)

- Seizure frequency is too frequent that subject is unable to provide daily count in
order to maintain a reliable seizure diary

- Any episode of convulsive status epilepticus within the 12 months prior to the
Enrollment Visit

- Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to
the Enrollment Visit

- Surgical candidate for and willing to undergo resective surgery

- Evidence of a neurological condition that is likely to progress (e.g., brain tumor,
arteriovenous malformations or cavernous angiomas)

- Diagnosed with a progressive or degenerative neurological disorder affecting the brain

- Significant medical condition that may impact study participation in the opinion of
the investigator

- Presence of any of the following within 1 year prior to the Enrollment Visit:
psychiatric illness hospitalization, suicide attempt or symptoms of psychosis
(hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a
medication

- Malignancy or history of malignancy within 1 year prior to the Enrollment Visit
(excluding resected basal cell carcinomas)

- Presence of implanted electrical stimulation medical device anywhere in the body
(e.g., cardiac pacemakers, spinal cord stimulator, RNS) or any metallic implants in
the head (e.g., aneurysm clip, cochlear implant). In the case of an implanted vagus
nerve stimulator (VNS), CMM study assessment collection may occur with the device
implanted but may not begin until the VNS has been off for at least 30 days. The VNS
generator must be explanted prior to or at the time of the DBS neurostimulator implant
and the leads removed or trimmed and capped. In the case of a subject who had been
previously implanted with a responsive neurostimulator (RNS) but had a full system
explant, a subject cannot begin CMM study assessment collection until the RNS has been
off for at least 30 days.

- Risk factors that would put the participant at risk for intraoperative or
postoperative bleeding. This includes administration of any antiplatelet or
anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use,
chronic aspirin use of greater than 325 mg/day, and any participant with a history of
hemorrhagic stroke

- History of drug or alcohol abuse within the past year

- Condition or disease that is known to require repeat magnetic resonance imaging (MRIs)

- Currently participating, or plans to participate, in another investigational study
unless written approval is provided by the Medtronic study team

Implant Criteria

- Experienced an average of 6 or more focal (partial) onset seizures per month during
CMM phase, with no more than 30 consecutive seizure-free days (all seizure types)

- Completed a qualifying baseline diary. A qualifying baseline diary meets at least one
the following criteria: 1) a study diary with at least 28 completed days; 2) a
pre-existing diary with at least 70 completed days.

- Completed 3-month CMM visit

- No suicide attempt or other self-harm behaviors within past year (assessed by Columbia
Suicide Severity Rating Scale (C-SSRS) at 3-month CMM Visit)

- For female subjects of child-bearing potential, has negative pregnancy test and if
sexually active continues using reliable form of birth control.

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

Eligibility last updated10/11/22. Questions regarding updates should be directed to the study team contact.

Device, Deep brain stimulation
Epilepsy, Seizure
Deep brain stimulation, Localization-related epilepsy, Nervous system, Tonic-clonic epilepsy
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Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE) (BEAGLE)

Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

Xiaoxi Yao
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123025-H01-RST
19-012411
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Inclusion Criteria:

  • Adult patients (18 years or older) who have had a 10-second 12-lead ECG at Mayo Clinic and have a CHA2DS2-VASc ≥ 2 for men or CHA2DS2-VASc ≥3 for women.
  • Adult patients who have AI-detected AF and are eligible for anticoagulation will be eligible for the first group of patients.
  • Adult patients who do not have AI-detected AF but are similar to the first group in other aspects will be eligible as part of the second group of patients.


Exclusion Criteria:

  • Patients with diagnosed atrial fibrillation or atrial flutter, on anticoagulation or have another indication for anticoagulation (e.g., mechanical valve), missing DOB or sex in EHR, history of intracranial bleeding, history of end-stage kidney disease, or have an implantable cardiac monitoring device (pacemaker, debfibrillator, implanted loop recorded).
  • Patients who are deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.
Device
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Prospective Assessment of Changes in Plasma Biomarkers in Patients with Gliomas Receiving Standard Therapy

A Study to Assess Metabolic Changes in the Blood with Standard Treatment in Patients with Gliomas

Sani Kizilbash
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123035-H01-RST
19-012496
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Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Patients with histopathologic or molecular confirmation of either IDH-mutant diffuse astrocytoma or IDH-mutant anaplastic astrocytoma.
  • Patients who will be proceeding to receive routine standard of care treatment (radiation with concurrent oral temozolomide) at Mayo Clinic, Rochester.


Exclusion Criteria:
 

  • Patients who have previously received any adjuvant therapy (radiation, chemotherapy, investigational) directed towards the glioma.
  • Patients who have been previously treated with Gliadel wafers.
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A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban

PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Alberto Pochettino
All
18 years and over
Phase 3, Feasibility
This study is NOT accepting healthy volunteers
0000-123036-P01-RST
19-012512
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Inclusion Criteria:

  • Male or female at least 18 years of age at the time of giving informed consent.
  • Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
  • Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
  • Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
  • Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (e.g., barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
  • Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.


Exclusion Criteria:

  • Mechanical valve in any position other than aortic valve.
  • Any cardiac surgery in the three months (90 days) prior to enrollment.
  • Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
  • Known hypersensitivity or other contraindication to apixaban.
  • On dialysis or a creatinine clearance < 25 mL/min.
  • Ischemic stroke or intracranial hemorrhage within 3 months.
  • Active pathological bleeding at the time of screening for enrollment.
  • Active endocarditis at the time of screening for enrollment.
  • Pregnant, plan to become pregnant, or are breast feeding.
  • On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
  • History of non-compliance with recommended monthly INR testing.
Device, Drug, Radiation, Coagulation factor Xa inhibitor prophylaxis, Drug therapy, Administration of prophylactic coagulation factor Xa inhibitor
Aortic valve disease, Aortic valve stenosis, Heart valve disease
Aortic valve prosthesis, Aortic valve repair and replacement, Apixaban, Cardiovascular system, Heart valve surgery, Prosthetic heart valve in situ, apixaban
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Transplant Caregiver (CG) Research Registry

Caregiver Registry

Cassie Kennedy
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123038-H01-RST
19-012536
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Inclusion Criteria:

  • Solid organ transplant candidates (18 years or older) on deferred, active, or inactive transplant waiting lists.
  • Nominated adult caregivers (18 years or older) of solid organ transplant patients listed for deceased donor solid organ transplantation.
  • CG identified in the electronic medical record.


Exclusion Criteria:

  • Individuals unwilling to provide consent.
  • Patients or CG unable to complete questionnaires or consents due to limited English proficiency.
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Development and Validation of Innovative Hybrid Molecular Imaging, 68Ga-PSMA-dual Contrast PET/MRI and 68Ga-PSMA PET/CT, to Transform the Care of Patients with Hepatocellular Carcinoma

A Study to Develop and Validate Hybrid Molecular Imaging to Transform the Care of Hepatocellular Carcinoma Patients

Ajit Goenka
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-123040-P01-RST
19-012563
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Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC.
  • Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy.
  • No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm).
  • For the systemic therapy arm, patients who have had unequivocal progression after prior LRT and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.


Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC.
  • Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to PET/MRI).
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan.
  • Subjects with higher than the weight/size limitations of PET/MRI or PET/CT scanner.
  • Subjects with contraindication to MRI (relevant to PET/MRI):
    • Subjects who have a heart pacemaker;
    • Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain;
    • Subjects who have implanted devices with magnets;
    • Subjects who have other implanted electronic devices;
    • Subjects who have deep brain stimulator;
    • Subjects who have vagal nerve stimulator;
    • Subjects with cochlear (ear) or auditory implants.
Administration of antineoplastic agent, Biopsy of liver lesion, Liver excision, Nuclear medicine procedure, PET CT of whole body, Radiation, Excision of liver, Diagnostic Test, Procedure/Surgery
Cancer, Hepatocellular carcinoma, Liver cancer
Cancer treatment, Chemoembolization for liver cancer, Digestive system, Gadobutrol, Gadoxetic acid [INN], Gallium Ga-68, Gallium Ga-68 gozetotide, Liver cell carcinoma, Liver transplant, Liver tumor ablation, Medical Oncology, Radioembolization for liver cancer, gadobutrol, gadoxetate, gallium, Liver resection, Gallium Ga 68 gozetotide [USAN]
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A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients with Celiac Disease

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients

Joseph Murray
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-123041-P01-RST
19-012571
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Inclusion Criteria:

  • Adults aged 18 to 80 years, inclusive.
  • Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy.
  • Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes).
  • Has followed a GFD for > 12 months immediately prior to study entry.
  • Negative for tTG and negative or weak positive for DGP-IgA/IgG during screening.
  • Male or female, and using at least 2 acceptable birth control methods or who are sterile or postmenopausal.
  • Capable of understanding and complying with protocol requirements.
  • Patient understands and has signed the informed consent form.


Exclusion Criteria:

  • Refractory celiac disease.
  • Selective IgA deficiency.
  • Positive for HLA-DQ8 (DQA1*03, DQB1*0302).
  • Previous treatment with tolerance-inducing therapies for celiac disease.
  • Known wheat allergy.
  • Part B only: History of hyperacute or prolonged symptoms following gluten exposure.
  • Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation.
  • History of dermatitis herpetiformis.
  • Pregnant or breastfeeding.
Drug, Drug therapy
Celiac disease
Celiac disease, Digestive system
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Effect of Olorinab on Gastrointestinal Transit in Patients with Irritable Bowel Syndrome

A Study to Evaluate the Effect of Olorinab on Gastrointestinal Transit in Patients with Irritable Bowel Syndrome

Michael Camilleri
All
18 years to 70 years old
Phase 1/2
This study is NOT accepting healthy volunteers
0000-123045-P01-RST
19-012613
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Inclusion Criteria:

  • Individuals aged 18 to 70 years, inclusive, at Screening.
  • Clinical diagnosis of IBS-C or IBS-D according to Rome IV criteria at Screening.
  • Body mass index (BMI) 18.0 to 40.0 kg/m2, inclusive at Screening.
  • Understands the study procedures, is willing and able to comply with the study procedures, and is able to give informed consent.
  • Negative test results for alcohol and selected drugs at Screening and Day 1.
  • Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening.
  • Subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for subjects with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS.
  • If treated with any of the following medications, dosing must be stable for 90 days prior to Screening and the subject must agree to maintain the same dose of  medication throughout the study:
    • Tricyclic antidepressants, tetracyclic antidepressants (e.g., mirtazapine), selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or anticonvulsants (e.g., pregabalin or gabapentin) for conditions other than IBS pain;
    • Benzodiazepines or non-benzodiazepine hypnotics, administered at bedtime for conditions other than IBS pain.


Exclusion Criteria:

  • Pregnant or lactating.
  • Structural or metabolic diseases/conditions that affect the gastrointestinal system.
  • Diagnosis of IBS-M or unsubtyped IBS (IBS-U).
  • Unable to withdraw the following medications that alter GI transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide):
    • Stimulant laxatives, osmotic laxatives, magnesium or aluminum-containing antacids, over the counter fiber, stool softeners, probiotics, bismuth subsalicylate, prokinetics;
    • Antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, sodium-proton exchanger NHE3 inhibitors.
      • Note: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.
  • Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee).
  • Any colonic or major abdominal surgery (e.g., bariatric surgery [including gastric banding], cholecystectomy, stomach surgery, small-/large-bowel surgery, or abdominal large vessel surgery), except that in IBS-C subjects a history of cholecystectomy more than 6 months prior to Screening is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Screening.
  • History of colorectal cancer, inflammatory bowel disease, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.
  • History of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, or impaired intestinal circulation (e.g., aortoiliac disease).
  • Other GI diseases such as peptic ulceration, GI bleeding, or GI inflammatory disease (e.g., esophagitis, gastritis, or duodenitis) within 6 months prior to Screening. The following conditions will not exclude a subject: acute gastritis that resolved without complication,
  • and gastroesophageal reflux disease (GERD).
  • Use of any of the following medications within 30 days prior to Screening and for the duration of the study:
    • Opioids;
    • The following are excluded if they are prescribed for IBS pain: tricyclic antidepressants, tetracyclic antidepressants (eg, mirtazapine), SSRIs, SNRIs, anticonvulsants (e.g., pregabalin or gabapentin);
    • Medical or recreational marijuana, tetrahydrocannabinol (THC), cannabidiol (CBD), synthetic cannabinoids, or other cannabis derivatives for any indication;
    • Benzodiazepines, or non-benzodiazepine hypnotics, unless administered at bedtime for conditions other than IBS pain.
  • Use of cigarettes or any other nicotine-containing products within 30 days of Screening.
  • Prior (within 15 days of Screening) or anticipated concomitant use of GI antibiotics.
  • Ongoing treatment with GLP-1 or amylin analogues or agonists.
  • Any elective major surgery planned or anticipated at any time during the study.
  • History of pancreatitis of any etiology, cholecystitis, or symptomatic gallbladder stone disease within 6 months prior to Screening.
  • Have received tube feeding, defined formula diets, or parenteral alimentation within 30 days prior to Screening.
  • History of cerebrovascular disease (e.g., stroke, transient ischemic attacks), acute coronary syndrome, myocardial infarction, or unstable angina within 6 months prior to Screening.
  • History or presence of:
    • Risk factors for Torsade de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
    • Sick sinus syndrome, second or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QT interval corrected by Fridericia's formula (QTcF) interval, or clinically significant conduction abnormalities.
  • Clinically significant cardiac history or presence of ECG findings as judged by the Investigator or qualified designee at Screening or Day 1, including each criterion as listed below:
    • Abnormal sinus rhythm (heart rate < 40 or > 100 beats per minute [bpm]);
    • QTcF interval > 470 ms (If there is an abnormal result, ECGs are to be repeated 3 times to obtain a mean QTcF before excluding patient);
    • QRS interval ≥ 110 ms;
    • PR interval ≥ 220 ms.
  • Uncontrolled hypertension with an abnormal supine blood pressure defined as a systolic blood pressure (SBP) ≥ 160 mm Hg or a diastolic blood pressure (DBP) ≥ 100 mm Hg, confirmed by at least 1 repeated measurement at Screening.
  • Tachycardia defined as a resting heart rate ≥ 120 bpm or bradycardia defined as a resting heart rate of ≤ 40 bpm, confirmed by at least 1 repeated measurement at Screening.
  • Hypotension with an abnormal supine blood pressure defined as SBP < 90 mm Hg or DBP < 60 mm Hg, confirmed by at least 1 repeated measurement at Screening.
  • Orthostatic hypotension consisting of SBP decrease of ≥ 20 mm Hg or a DBP decrease of ≥ 10 mm Hg approximately 3 minutes after standing from a 5-minute supine position, confirmed by at least 1 repeated measurement at Screening.
  • Hepatic dysfunction (history of cirrhosis or abnormal serum alanine aminotransferase [ALT] or aspartate transaminase [AST] > 3 × upper limit of normal [ULN]); total direct bilirubin > 2 × ULN, or alkaline phosphatase > 2 × ULN at Screening.
  • Clinically significant renal insufficiency (i.e., serum creatinine > 2.5 mg/dL or estimated glomerular filtration rate [eGFR] ≤ 60 mL/min/1.73 m2) based on CKD-EPI equation at Screening.
  • History of insulin-dependent diabetes mellitus.
  • Significant history or clinical manifestation of any endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, GI, neurological or psychiatric disorder, malignancy (with the exception of treated basal cell carcinomas), or any other condition as determined by the Investigator (or designee), that would prevent the individual from participating in the study due to risk to the scientific validity of study assessments or to personal well-being of the subject.
  • History of severe head injury or history of seizures.
  • Current suicidal ideation or history of suicide attempt or a hospitalization for a major psychiatric condition within 1 year prior to Screening.
  • History of alcohol use disorder or substance use disorder within 2 years of Screening.
  • Subjects who do not agree to use a highly effective method of contraception if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of study treatment for female subjects and for 90 days after the last dose of study treatment for male subjects. Highly effective methods of contraception include the following:
    • Oral, implantable, transdermal or injectable contraceptives (starting ≥ 60 days before administration of study treatment) in combination with diaphragm with vaginal spermicide, cervical cap with vaginal spermicide, or male condom;
    • Standard intrauterine device (IUD; e.g., Copper T 380A IUD), intrauterine system (IUS; e.g., LNg 20 IUS
      •progesterone IUD), progesterone implant, or tubal sterilization (≥ 6 months after surgery) in combination with a female condom with spermicide, a diaphragm with vaginal spermicide, cervical cap with vaginal spermicide, or male condom;
    • Post vasectomy and male condom, partner using diaphragm with spermicide, cervical cap with spermicide, estrogen and progesterone oral contraceptives (“the pill”), estrogen and progesterone transdermal patch, vaginal ring, or progesterone
    • injection;
    • Complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. If a subject who is abstinent at the time of signing the informed consent form (ICF) becomes sexually active they must agree to use contraception as described previously;
    • Females who are surgically sterile (defined as women with documentation of prior hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as: 12 consecutive months with no menses without an alternative medical cause) are not considered to be of childbearing potential; otherwise women are considered to be of childbearing potential;
    • Male study participant must agree to utilize medically acceptable methods of contraception as described above with female partners of childbearing potential.
  • Use of any prescription medications/products or available over the counter (e.g., St John’s wort) which are known to chronically alter drug absorption or elimination processes and/or are known to induce or inhibit cytochrome P450 (CYP) 3A4/5 within 30 days or 5 half-lives (whichever is longer) prior to Screening.
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator or history of severe allergies (e.g., any history of anaphylaxis to medication[s] or allergens and/or asthma requiring hospitalization).
  • Identified active infection and/or fever (defined as axillary or forehead temperature ≥ 37.4°C, oral temperature ≥ 37.7°C, or rectal or ear temperature ≥ 38.3°C) at Screening or Day 1.
  • Blood donation or significant blood loss within 8 weeks prior to Screening.
  • Plasma donation within 7 days prior to Screening.
  • Participated in another clinical study (e.g., investigational drug or device study) within 30 days or 5 half-lives (whichever time period is longer) or 6 weeks for biologic therapies prior to Screening.
  • Consumption of foods and beverages containing grapefruit or Seville oranges within 14 days prior to Day 1.
Drug
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Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Molly Jeffery
All
15 years and over
This study is NOT accepting healthy volunteers
0000-123046-P01-RST
19-012615
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Inclusion Criteria:

  • Age 15 and over (15+ will only occur in dental setting).
  • English- or Spanish-speaking.
  • Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed.
  • Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone.
    • We do not anticipate many opioid-naïve people receiving an opioid analgesic for acute pain will receive the following drugs, however, we will not exclude otherwise eligible patients who receive one of the following drugs: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol.
    • All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
  • Opioid naive (no use of prescribed opioids or illicit opioids, including medical or non-medical use, in the past 6 months) by self-report.
  • Willing and able to give consent and participate in study.
  • Able to access a mobile device (smartphone or tablet) with web access every day to complete study surveys.
  • Willing to connect Fitbit to a device that can regularly link to Hugo for data transfer.
  • Willing to use the health data sharing platform.
  • Released/discharged to home after their visit.


Exclusion Criteria:
 

  • Pain thought to be caused by a systemic disease very likely to progress to chronic pain (e.g., sickle cell disease, fibromyalgia, lupus, multiple sclerosis, etc.).
  • Cancer or end-of-life pain.
  • Unable to give consent and be enrolled within 3 days of their visit.

 

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Assessment of Traumatic Brain Injury with Multiparametric Magnetic Resonance Elastography

Medical and Resource Facilitation Intervention After Traumatic Brain Injury (MRFI)

Ziying Yin
All
10 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-123048-H01-RST
19-012651
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We propose recruiting a total of 150 subjects with ages ranging from 18 to 99 including 3 groups: (1) mTBI+/RHI+: 50 patients with diagnosed mild traumatic brain injury (mTBI) and with the history of organized contact-sports; (2) mTBI-/RHI+: 50 age (by decades) /sex-matched participants that has a history of organized contact-sports but without diagnosed mTBI; (3) mTBI-/RHI-: 50 age (by decades)/sex-matched control participants with no history of organized contact-sports and no diagnosis of mTBI. It is not anticipated that these subjects will have mild cognitive impairment (MCI) from the TBI. MCI is a syndrome defined as a cognitive decline greater than expected for an individual’s age and education level but that does not interfere with activities of daily living.

Group 1 recruitment mTBI+/RHI+:

Residents of Olmsted County, Minnesota who were diagnosed with mTBI will be identified by using the medical-records linkage system of the Rochester Epidemiology Project (REP) between 2017 and 2020. The REP indexes all medical information of individuals residing and receiving care in Olmsted County, Minnesota. Individuals will be identified if they had a diagnostic code in the medical records suggestive of a potential head injury (Table 1),then the medical records will be reviewed for the dates of the specific codes and determined whether a mTBI occurred based on the Mayo Classification System for TBI severity (Definite, Probable, and Possible). By this definition, a “Definite” TBI had to have at least one of the following: loss of conscious of ≥30 minutes, post-traumatic anterograde amnesia of ≥24 hours, intracerebral hematoma, subdural hematoma, epidural hematoma, cerebral contusion, hemorrhagic contusion, penetrating TBI (dura penetrated) or subarachnoid hemorrhage; a “Probable” TBI had to have at least one of the following: loss of consciousness of momentary to <30 minutes, post-traumatic anterograde amnesia of momentary to <24 hours, or depressed, basilar, or linear skull fracture; a “Possible” TBI had to have at least two of the following: blurred vision, confusion (mental state changes), dazed, dizziness, focal neurologic symptoms, headache, or nausea.

If the “Probably” or “Possible” TBI criteria apply to the trauma event, the event will be considered as a mTBI.

The participation of organized contact-sport will be self-reported. Potential participants will be approached with the phone script and/or the letter. If the patient expresses willingness to participate, we will send him/her the follow-up letter or email with a tentative study visit date according to his/her preference. The consent form will be enclosed with the letter/email for his/her review. The questionnaire about the history of contact-sports play will also be enclosed.

Table 1- Codes for traumatic brain injury-related emergency department visits and hospitalizations as recommended by Center for Disease Control and Prevention

Description

ICD-9-CM Codes

Concussion

850

Cerebral laceration and contusion

851

Intracranial injury of other and unspecified nature

854

Injury to optic nerve and pathways

950.1-950.3

Head injury, unspecified

959.01

Inclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Possible” or “Probably” TBI as defined above.
  2. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

 

Exclusion Criteria for Group 1 (mTBI+/RHI+):

  1. A history of “Definite” TBI as defined above.
  2. A history of chronic neurological disease;
  3. Pregnancy or breastfeeding;
  4. Inability to provide consent.

 

Group 2 and Group 3 recruitment:

Recruitment of these paid, groups 2 and 3 participants will be conducted (1) through established Mayo Clinic Rochester research study advertisements, and (2) through Mayo Clinic Study of Aging (MCSA) that provides a list of Olmsted County, MN residents who enrolled in MCSA, from whom matched control will be drawn. The participation of organized contact-sport will be self-reported.

Inclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of participating in at least one organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 2 (mTBI-/RHI+):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

Inclusion Criteria for Group 3 (mTBI-/RHI-):

  1. No history of participating in any organized contact-sport (e.g., football, hockey, soccer, rugby, lacrosse, martial art, etc.) featuring officiated competition.
  2. No history of “Definite”, “Possible” or “Probably” TBI as defined above.
  3. Able to understand the goal of the project and give informed consent/assent;
  4. Age ≥18 years;

Exclusion Criteria for Group 3 (mTBI-/RHI-):

  1. A history of chronic neurological disease;
  2. Pregnancy or breastfeeding;
  3. Inability to provide consent.

 

The 3 groups will be age- (by decades) and sex-matched. We will start by recruiting the 3 groups together for the efficiency of data collection. During the recruitment process, if we notice a certain age range or sex is lacking, we will focus on targeting this particular age group or sex group to ensure the maximum matching. For example, if we particularly looking for 18-25-year-old male volunteers with no history of contact-sports participation in group 3, we will have a 2nd advertisement focusing on this particular age group and/or sex group.

 

Remuneration of $75 will be provided for each participant. If the participant were asked to return for additional imaging, remuneration of $75 will be provided for each visit.

 

All subjects will be carefully screened by MRI personnel to be certain that they do not have any contraindication to an MRI exam such as foreign bodies in the brain or eye or an incompatible device such as a cardiac pacemaker. This safety screening is part of the routine clinical practice and is performed before any subject is permitted to enter the scanning room. The patients and parents will be given the option of withdrawing from the study at any point in the project without jeopardizing their medical care at Mayo Clinic. Patients requiring sedation to complete the MRI will be excluded from the study.

 

Pregnant or nursing women are not eligible to participate in this study.  If the participant wishes to participate with the study she will be asked about her pregnancy status.  If she thinks she may be pregnant or if she is unsure of her pregnancy status, she will be offered a no-charge urine pregnancy test before proceeding with any study visit imaging.

 

We will attempt to recruit an equal number of men and women, but the final proportions will be dependent upon the available subjects in the disease group. Although we will make every effort to include minority subjects, most of the subjects enrolled in Rochester will be of Caucasian background which is a reflection of the regional demographics.

 

If there is a question on whether or not the subject has the capacity to provide informed consent, the investigator or a member of the study team will assess the patient by reviewing questions regarding the study such as:

  1. Can you tell me the purpose of this study?
  2. Do you have to be in this study?
  3. Can you tell me what will happen if you agree to take part in this study?
  4. What will happen to you if you choose not to be in the study?

 

If it is determined that the subject does not have the capacity to provide informed consent, the subject will then be excluded from the study.

 

The investigator or coordinator will meet with the potential participants in a private consult room to review and discuss the details of the study using the informed consent document as a guide. The discussion will include all of the elements of informed consent. Potential participants will be given an opportunity to ask questions and we be provided a copy of the informed consent document.

Behavioral, Other, Multiparametric magnetic resonance elastography
Concussion, Head injury, Sports injury, Traumatic brain injury, Traumatic injury, Head and brain injury
Concussion injury of brain, Injury while engaged in sports activity, MRI, Magnetic resonance elastography, Musculoskeletal system, Nervous system
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Mayo Clinic — Rochester, MN

PIANO: Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes: Long-term Outcomes of In-Utero Biologic and Thiopurine Exposure (PIANO)

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Sunanda Kane
Female
0 years to 45 years old
This study is NOT accepting healthy volunteers
0000-123049-P01-RST
19-012655
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy.


Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age.
  • Confirmed multiple gestation.

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

 

Inflammatory bowel disease
Complication occurring during pregnancy, Digestive system, Inflammatory bowel disease, Reproductive system
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Mayo Clinic — Rochester, MN

Evaluation of 7T Magnetic Resonance Imaging in Multiple Sclerosis

A Study to Evaluate 7T Magnetic Resonance Imaging in Multiple Sclerosis

Padraig Morris
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123051-H01-RST
19-012681
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • Capable of giving consent.
  • Established diagnosis of Multiple Sclerosis according to McDonald Criteria (2018). Patients may be diagnosed with any of the conventional phases of MS, primary progressive, relapsing remitting, secondary progressive etc.
  • Willing to participate in a 7T MRI examination within a few days of their clinical 3T or 1.5T examination.


Exclusion Criteria:

  • Age < 18 years old.
  • Any metallic implant, device implant, ventriculoperitoneal shunt, cardiac valve, pacemaker which would constitute a contraindication to 7T imaging.
  • Previous craniotomy.
  • Permanent facial makeup (for brain scanning).
  • Suffer from claustrophobia.
  • Pregnancy.
  • Fever / elevated temperature.

 

 

 

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GUARD-AF: ReducinG Stroke By Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals (GUARD-AF)

A Study to Evaluate Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals

David Rushlow
All
70 years and over
Post Market
This study is NOT accepting healthy volunteers
0000-123055-P01-RST
19-012705
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Inclusion Criteria

  • Men and women, ≥ 70 years of age.
  • New or established patients in the primary care practice.
  • Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the CMS Medicare Claims Database and to access data from health records.
  • Health insurance by Medicare Parts A & B (Medicare Fee-for-service).


Exclusion Criteria:

  • Oral anticoagulation (OAC) for any indication at the time of enrollment.
  • History of atrial fibrillation (AF) or atrial flutter (AFL) as documented in the patient’s current medical problem list.
  • Any condition the investigator considers a contraindication to OAC; e.g., bleeding that required medical attention or severe renal impairment.
  • Any condition the investigator considers will prevent compliance with study instructions.
  • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders).
  • History of allergy to adhesive.
  • Patient is not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
Device
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ROR1903: Spatially Fractionated Radiation (GRID) Therapy for Tumors of the Head and Neck, Thorax, Abdomen, and Extremities (GRID)

A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors

Dawn Owen
All
18 years and over
This study is NOT accepting healthy volunteers
0000-123063-H01-RST
19-012801
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Inclusion Criteria:

  • Males and females, age ≥ 18 years.
  • Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
  • Histological confirmation of oncologic diagnosis.
  • Completed oncologic imaging (per discretion of treating physician).
  • ECOG Performance Status 0-3.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Provide informed written consent.


Exclusion Criteria:
 

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Women of childbearing potential who are unwilling to employ adequate contraception.
  • 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.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.  NOTE:  Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled inter-current illness including, but not limited to, 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.
Radiation, Radiotherapy to abdomen, Radiotherapy to head, Radiotherapy to neck, Radiotherapy to pelvis, Radiotherapy to thorax
Cancer, Head and neck cancer, Lung cancer, Stomach cancer
Cancer treatment, Digestive system, Fractionated radiation therapy, Medical Oncology, Neoplasm of abdomen, Neoplasm of extremity, Neoplasm of head and neck, Neoplasm of pelvis, Neoplasm of thorax, Radiation therapy, Reproductive system, Respiratory system
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Mayo Clinic — Rochester, MN

Gathering Evidence to Determine Whether Modifications are Necessary to the Kansas City Cardiomyopathy Questionnaire (KCCQ) to Address Possible Interpretation Differences by Men and Women

A Study to Evaluate if Modifications to the Kansas City Cardiomyopathy Questionnaire Are Needed to Address Interpretation Differences by Gender

Shannon Dunlay
All
22 years and over
This study is NOT accepting healthy volunteers
0000-123064-H01-RST
19-012802
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Inclusion Criteria:

  • Age ≥ 22 years old.
  • A clinician-diagnosed NYHA I-IV heart failure.
  • LVEF ≤ 40% on most recent cardiac imaging.
  • Ability to read, speak and understand English.
  • Access to a telephone for interviews or ability to meet study staff in person for an interview.
  • Ability and willingness to participate in all study related activities.
  • Provide informed written or verbal consent based on site IRB requirements.


Exclusion Criteria:
 

  • Clinically significant cognitive or memory impairment in the opinion of research staff (e.g., patient has trouble holding a conversation, patient exhibits signs of disorientation).
  • Currently hospitalized.
  • Individuals who have left ventricular assist device (LVAD) or are planning to have surgery to implant an LVAD within 2 weeks of screening.
  • Individuals who have received a cardiac transplant at any time prior to screening.
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Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Effect of Senolytics in Patients with Chronic Diseases Associated with Cellular Senescence

Jad Sfeir
All
55 years and over
This study is NOT accepting healthy volunteers
2020-101784-P01-RST
19-007740
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Inclusion Criteria:

  • Adults self-referred or referred by their physicians starting a senotherapeutic intervention.
  • Any individual with senescence-associated medical conditions as defined above, refractory to current standards or care, or without known treatments.
  • Any individual taking senotherapeutic agents or performing dietary restriction for any reason.


Exclusion Criteria:

  • Absolute contraindications to indicated senotherapeutic agents due to drug-drug or other interactions.
  • Pregnancy or breast-feeding.
  • Clinically significant dehydration, infection, renal or hepatic insufficiency.
  • Excessive acute or chronic alcohol use.
  • Acutely ill individuals requiring hospitalization, emergency, or urgent care.
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Mayo Clinic — Rochester, MN